Advances in Training for Laparoscopic and Robotic Surgery

Henk Schreuder Advances in Training for Laparoscopic and Robotic Surgery

Vooruitgang in training van laparoscopische en robot geassisteerde chirurgie (met een samenvatting in het Nederlands)

Proefschrift

ter verkrijging van de graad van doctor aan de Universiteit van Utrecht op gezag van de rector magnificus, prof. dr. G.J. van der Zwaan ingevolge het besluit van het college voor promoties in het openbaar te verdedigen op

woensdag 2 november 2011 des middags om 12.45 uur Advances in Training for Laparoscopic and Robotic Surgery

Author: Henk W.R. Schreuder Cover design: Gordon Nealy, Mimic Technologies, Seattle and Gerrit Cats Lay-out: Barbara Hagoort, Multimedia, UMC Utrecht, Netherlands Printed by: Ipskamp Drukkers, Enschede, The Netherlands

ISBN/EAN: 978-94-6191-010-3

No part of this thesis may be reproduced, stored in a retrieval system of any nature, or transmitted in any form or by any means, without written permission of the author door

Publication of this thesis was supported by 3-Dmed®, Bayer Schering Nederland, BMA BV (Mosos), Covidien Nederland BV, Division of Woman & Baby (UMC Utrecht), Dutch Society for Simulation in Healthcare (DSSH), Ferring B.V., Hendrik Willem Rudolf Schreuder GlaxoSmithKline, Ipsen Farmaceutica B.V., Johnson & Johnson Medical BV, Krijnen Medical geboren 19 oktober 1966 te Haarlem Innovations B.V., Medical Dynamics, Memidis Pharma b.v., Merck Sharp & Dohme BV, Mimic Technologies Inc., Nederlandse Vereniging voor Endoscopische Chirurgie (NVEC), Nycomed bv, Olympus Nederland B.V., Raadgevers Kuijkhoven, Sigma Medical, Simendo BV, Skills Meducation, Stöpler Instrumenten en Apparaten, Surgical Science Sweden AB, Toshiba Medical Systems Nederland, Van Beek Medical bv., Welmed B.V., ZekVinos Promotor: Prof. dr. R.H.M. Verheijen

Co-promotoren: Dr. M.P. Schijven Dr. R.P. Zweemer

Voor Anna Content

Chapter 1 Introduction 8 Part II Robotic Surgery 126 History of laparoscopic surgery and simulation in laparoscopy Learning surgical skills Chapter 8 Robotic Surgery 128 Aim and outline of this thesis BJOG 2009;116:198-213.

Part I Laparoscopy 26 Chapter 9 From open radical hysterectomy to robot assisted laparoscopic 160 radical hysterectomy for early stage cervical cancer: aspects of a Chapter 2 Implementation of simulation in surgical practice: 28 single institution learning curve Minimally invasive surgery has taken the lead: Gynecol Surg 2010;7:253-258. The Dutch experience Med Teach 2011;33:105-115. Chapter 10 Validation of a novel virtual reality simulator for robotic surgery 172 Submitted for publication Chapter 3 Laparoscopic skills training using inexpensive box trainers: Which 48 exercises to use when constructing a validated training course Chapter 11 Training and learning robotic surgery: time for a more structured 192 BJOG, in press approach: a systematic review BJOG, in press Chapter 4 An ‘Intermediate Curriculum’ for Advanced Laparoscopic Skills 68 Training using Virtual Reality Simulation Chapter 12 Discussion, conclusions and future perspectives 220 J Minim Invasive Gynecol 2011 Jul 23. [Epub ahead of print]. Chapter 13 Summary in English 234 Chapter 5 Face and construct validity of virtual reality simulation of 86 Samenvatting in het Nederlands 244 laparoscopic gynecologic surgery Am J Obstet Gynecol 2009;200:e1-e8. Chapter 14 Appendices 252 Manual skills training 254 Chapter 6 Grading surgical skills curricula and training facilities for minimally 100 Notes on co-authors 264 invasive surgery Thesis review committee 269 Submitted for publication Acknowledgements - Dankwoord 272 Chapter 7 Increasing experience in laparoscopic staging of early ovarian 112 List of publications 280 cancer Curriculum Vitae 284 Gynecol Surg 2011 Jul 14. [Epub ahead of print]. Grants 288

Introduction and outline of this thesis

The word laparoscopy is derived from the Greek words lapara, meaning “the soft part of the body between ribs and hip, flank, loin,” and skopein, which means “to look at or survey” 1 Introduction Chapter 1

History In the following years laparoscopy became an accepted diagnostic procedure and gynecologists became the users and advocates of this new technique. After the introduc- History of laparoscopy tion of the dual puncture technique by Kalk, it became possible to perform therapeutic By the end of the 19th century, endoscopes had been well established for evaluating the interventions in the abdominal cavity.14 In the early 1930s the first reports of laparoscopic urinary tract, anorectum1,2, larynx, esophagus and stomach.3 At that time the chest and interventions, mainly adhesiolysis and biopsies, were published by Fervers and Ruddock.15 abdomen were not yet accessible for endoscopy. The first laparoscopy is attributed to Fervers still used oxygen as distention medium and noticed small explosions in the George Kelling, a German surgeon from Dresden, who started to follow Mikulicz with abdominal cavity while using instruments with high frequency electrical current for stomach insufflations and in 1901 examined the abdominal cavity from a dog by inserting coagulation. He concluded it was safer to use carbon oxide as distention medium.16 a cystoscope through a small incision in the abdominal wall and using pneumoperitone- Boesch, a Swiss gynecologist performed the first tubal ligation by electro coagulation in um for better visualization.4 Subsequently, he wanted to apply this method, called ‘celios- 193617 and the first ectopic pregnancy diagnosed by laparoscopy was published in 1937.18 copy’, in humans, but his first putative subjects either refused or died prematurely, so In 1938, Janos Veress, a Hungarian physician, developed a needle to create a pneumo hence he was not the first to publish the use of celioscopy in humans. A Swedish inter- thorax in patients with tuberculosis. This spring-loaded needle consisted of an inner nist, Hans Christian Jacobaeus, who developed his method in the same period, was the stylet that automaticly converted the sharp edge to a rounded and incorporated a side first to publish about this new endoscopic technique used in humans and called it ‘lapa- hole.19 The needle was quickly adopted by laparoscopists for creating the pneumoperito- roscopy’.5,6 (Figure 1) In the same year, Bernheim, a surgeon at John Hopkins School of neum with minimal risk of injuring intra abdominal organs and for most gynecologists Medicine described his early experiences with the technique and called it ‘organoscopy’.7 the ‘Veress Needle’ is still the instrument of choice. In the decades thereafter, several refinements for the laparoscopic technique were invent- The next revolution in laparoscopy was the development of the rod-lens system by Har- ed. The trocar endoscope in 19128, the sharp pyramidal point of the trocar for puncture in old Hopkins20 and the cold light by Karl Stortz. This development allowed laparoscopists 19209, the needle for induction of the pneumoperitoneum in 192110, the insufflator in to see more clearly and reduced the risk of thermal injuries due to incandescent light. 192111, and widening of the viewing angle of the laparoscope in 1923.12 For insufflation of After the publication of Raoul Palmer, a French gynecologist, in the mid 1950s there was a the abdominal cavity, filtered air or oxygen was used until in 1924 Zollikofer, a Swiss rapid growth of laparoscopy. He changed the approach form culdoscopy in lithotomy gynecologist, introduced carbon dioxide, which is used until today.13 position to the upper abdomen and later to the lower abdomen while placing the patient in Trendelenburg position. For patient safety he stressed to monitor the abdominal Figure 1. Pioneers of laparoscopy 105 pressure and to maintain it at 25 mmHg.21 In 1961, Palmer was the first gynecologist to recover an oocyte for in vitro fertilization using laparoscopy.22 Interestingly, Patrick Step- toe was inspired by Palmer whom he met for the first time at a conference in Amsterdam in 1959. His laparoscopic experience was noted by Richard Edwards and their co-operation eventually led to the first laparoscopic oocyte retrieval (on November 10th, 1977) to result in a successful pregnancy.23 Unfortunately, the wider use of laparoscopy lead to a higher incidence of complications and the enthusiasm for laparoscopic surgery was tempered in the 60s and 70s. The Ger- man gynecologist Kurt Semm, who was a strong advocate for laparoscopic surgery, played a vital role in keeping laparoscopy alive in those years. (Figure 2) He contributed greatly to the development of operative laparoscopy and his team provided several important new developments in instrumentation. Examples are an automatic insufflation device, a bipolar coagulation instrument, a tissue morcellator, a suction and irrigation system and many others.24,25 Forty year after the development of the Verris needle, Harrith Hasson, an American gynecologist, improved the safety of laparoscopy with the development of the ‘Hasson trocar’, an instrument applied for an open entry technique.26 Semm’s commitment to laparoscopy and teaching also lead to the invention of the Pelvi- trainer (box trainer), which allows trainee’s until today to learn the specific psychomotor skills needed for laparoscopic surgery.27 In 1982, Semm performed the first laparoscopic appendectomy. However, he did not report this breakthrough not until 1983 as the public

10 11 Introduction Chapter 1 and professional perception of laparoscopic surgery was still hostile at the time.28 In the Robot assisted laparoscopic surgery is considered by many to be the next major evolution 70s, he was even forced to change the name laparoscopy into pelviscopy.29 in minimal invasive surgery. The first concept of surgical robotics was developed in the In the late 70’s and early 80’s there was a turning point due to the development of video late 80’s at the National Aeronautics and Space Centre (NASA).35 In 1994 the FDA laparoscopy by Camran Nezhat, an American gynecologist. Initially this new technique approved the first robotic system for laparoscopy, a voice driven camera holder, the Auto- was heavily criticized and labeled as “dangerous”. However, his efforts eventually were mated Endoscopic System for Optimal Positioning (AESOP®).36 Several robotic systems accepted, after proving that endometriosis could be treated with video laparoscopy, with were developed in the following years, like the master-slave laparoscopic manipulator results as good as those of open surgery.30,31 Shortly thereafter the first laparoscopic system (ARTREMIS®)37 and the EndoAssist®.38 In the late 90s two complete robotic hysterectomy was performed by Harry Reich in 1988.32 From that time, laparoscopic systems for laparoscopic surgery became available. The Zeus® robotic system (Computer surgery started also in other specialties to grow as a surgical technique. General surgeons Motion, Goleta, CA) and the da Vinci® Surgical System (dVSS) (Intuitive Surgical, were relatively slow to adopt the laparoscopic technique and it would not be till 1987 until Mountain View, CA). Both systems have remote manipulators which are controlled by a the first laparoscopic cholecystectomy was performed by the French surgeon Phillip surgical work station. In 2003 Computer Motion was taken over by Intuitive Surgical and Mouret. Unfortunately the procedure was still received with major skepticism by his today the Zeus® robotic system is no longer available. The dVSS is currently the only colleagues and it was not until 1993 before his contributions to general surgery were fully commercially available telerobotic system for laparoscopic surgery in humans. The dVSS acknowledged.33 One of the great contributors to laparoscopy in general surgery was was approved for general surgery by the Food and Drug Administration (FDA) in 2000 Berci, a surgeon in Los Angeles, who developed new instruments and explored new and since then clearance for use of this instrument in many other specialties has been applications of laparoscopic surgery.34 In the 90s and early 21st century, the rapid intro- granted. duction of new instruments, technical modifications and multiple port laparoscopies The first robotic operations in humans were performed in the late 90’s. Thomas Falcone, increased the applications of laparoscopic surgery considerably. In the field of an American gynecologist performed in 1997 a tubal anastomosis using the Zeus® robot- laparoscopic gynecologic surgery more and more complex procedures were performed ic system39 and the first operations with the dVSS were performed in 1999 in the field of by pioneers, like Childers, Nezhat, Dargent and others. Nowadays almost every ab cardiothoracic surgery.40 In 2000, urologists started to use the dVSS, performing the dominal procedure can be performed by laparoscopy and the technique is widely used for radical prostatectomy for cancer of the prostate.41 This was the start for an exponential benign and malignant diseases in the abdomen. growth of robot assisted procedures in the last decade. It is a mater of time before other surgical robots will become commercially available as Figure 2. Pioneers in the development of instrumental laparoscopy, Kurt Semm (1927-2003) and Raoul Palmer several other prototypes are under development. In conjunction with the European (1904-1985) 105 Commission Joint Research Centre the ALF-X® (Advanced Laparoscopy through Force refleCTion) telesurgical robotic system has been developed.42,43 A prototype of the Sofie Surgical Robot®, was developed in 2010 by the Eindhoven Technology University, Nether- lands.44,45 Other robot projects are the Vesalius Robot® by the K.U. of Leuven, Belgium46 and the DLR-MiroSurge® robotic system of the Institute of Robotics and Mechatronics (German Aerospace Center, Oberpfaffenhofen, Germany).47,48 These systems are providing tactile feedback to the surgeon. The latest innovations in laparoscopy are laparoendoscopic single-site surgery (LESS) and natural orifice translumenal endoscopic surgery (NOTES). LESS and NOTES are both driven by the efforts to improve upon morbidity and the cosmetic results of laparoscopic surgery. In LESS, also referred to as single incision laparoscopic surgery (SILS), the laparoscopic surgery is performed through a single incision within the umbilicus.49 In NOTES the instruments are placed through natural orifices (mouth, anus and vagina) and then crossed into the abdomen. In this way laparoscopic surgery is possible without any skin incision.50 For both techniques, new instruments and trocars are necessary and a new learning curve must be mastered.

12 13 Introduction Chapter 1

History of simulation in laparoscopy system itself. To combine the advantages of computerized assessment in virtual reality Surgery has been using simulation for centuries, mainly in the form of animal models, simulators with traditional box trainers the TrEndo™ tracking system was developed by cadavers, and, recently materials that represent tissue or an organ. Only the last decades the Delft University of Technology. This system is attached to the box trainer and is special simulation tools for minimally invasive laparoscopic surgery have been invented. measuring the movements of the laparoscopic instruments, and the data are transferred In 1985 Kurt Semm constructed the pelvi-trainer, a practical surgical model whereby to a computer.67 The gaming industry is interested in simulation for surgery and the trainees could practice laparoscopic techniques firstly by viewing through the plexiglas Nintendo Wii™ gaming console allows hand movements similar to those performed in transparent trainer, then by covering the trainer and lastly by working via the video laparoscopy. Currently the development of a serious game for training basic skills for screen.51 (Figure 3) This traditional box trainer for laparoscopy is still used today and laparoscopy on the Nintendo Wii™ platform is under development.68 The development plays an important role in training students, residents and surgeons to acquire skills would make training skills for minimally invasive surgery at home possible.69,70 needed for laparoscopy.

Figure 3. Classic box trainer 106 Learning Surgical Skills

Learning models The traditional model of learning surgical skills has been that of apprenticeship learning where trainees start by observing clinical practitioners and gradually are given more tasks to perform as their competence grows. This also is referred to as the traditional Halstead model, who described the concept of clinical training, so called “see one, do one, teach one”.71 This model worked well until in the late 20th century, but the last decades surgery has changed, and more and more procedures are performed with minimally invasive surgery. This type of surgery requires different skills compared to open surgery and lends itself for simulation based training. Our societal norms are changing and it is considered unethical to operate on patients without having the appropriate surgical skills. Moreover, there is a reduction of working hours for residents and pressure on operating room efficacy, which are both reducing teaching time. Together with the increasing knowledge about training, learning and how to asses surgical skills it is time to question the traditional Halstedian Model. Various theories of cognitive motor learning to facilitate skills acquisition have been described. The ‘theory of Kopta’, also referred to as the three-stage theory of Fitts and Posner, is widely accepted. This theory emphasizes the importance of both observation and practice and describes three phases in the acquisition of motor skills. These phases In the early 1990’s, the first steps in the development of virtual reality based simulators are: 1) cognitive phase - observing new procedures, performance is erratic and the for surgery were made. The first prototypes of virtual reality trainers for surgery were a surgical skill is carried out in steps, 2) integrative phase - involving feedback during limb simulator and a cholecystectomy simulator.52,53 None of these early prototypes practice and knowledge is translated in appropriate motor behavior, and, 3) autonomous reached commercialization. The first commercially successful virtual reality simulator for phase - continuing practice results in efficient performance without cognitive input minimally invasive laparoscopic surgery was the MIST-VR™. This simulator combined a resulting in automatic movement.72,73 mechanical box trainer with an abstract graphic image and provided easy training tasks.54 The theory of Schmidt focuses on the relationship between movement parameters. When Since then several virtual reality simulators for laparoscopy have been released and trainees practice a maneuver, they learn the relationship between their movement and issues like depth perception and tactile feedback have been addressed.55-61 Nowadays the outcome, which improves their understanding of the outcome and their control of complete surgical procedures are available on certain virtual reality simulators and their the movement parameters. In this theory trainees will learn the relationship between validity and importance for training laparoscopic skills is well established.62-64 In 2010 the manipulation more quickly and outcome if they practice exercises in a wide variety and first realistic virtual reality simulators for robotic assisted laparoscopic surgery were experience making errors. According to Schmidt, practice that lacks variety will not launched.65,66 Recently, these simulation programs have been incorporated in the robotic provide enough information for adequate learning.74 This knowledge is important when

14 15 Introduction Chapter 1 incorporating exercises for box training or virtual reality training in a training curriculum. Simulation The theory described by Collins in the ‘cognitive apprenticeship model’ emphasizes the Depending on the type of education there are different levels of retention in conventional early stages of learning. Within the cognitive apprenticeship model there is a crucial role education. Lectures generally have a low retention rate while teaching others has the high- for the cognitive processes of experts during complex task performance. This model con- est retention rate. Just like in conventional education there are different levels of retention tains six teaching methods: modeling, coaching, scaffolding, articulation, reflection, and in multimedia education. (Table 2) There is a high retention rate for simulator learned exploration.75 practical skills and students using simulation outperform traditionally educated students Learning psychologist, K. Anders Ericsson emphasizes the importance of focused significantly.79 The high retention rate is one of the main reasons why simulation models attention and practice in acquiring expert skills. He stresses that time of the day is are very suitable for learning practical skills. To achieve proficiency in minimally invasive important and the morning is the best time to practice, since the ability to perform practical skills a variety of different simulators can be used, depending on the surgical skill complex cognitive activities is high.76 Ericsson was also the first to describe the concept to be learned. Box trainers are relatively simple and cost effective. They are best used for of deliberate practice.77,78 Deliberate practice refers to the idea that educational inter basic skills training and practice suturing. Animal models have the advantage of tissue ventions must be consistent and sustained in order to promote lasting knowledge and reality, and can be used for procedural training and dissection skills. However their use is skills. This theory provides several concepts that can contribute to the development of limited by high costs and for ethical reasons. Human cadaver training simulates the real simulation-based training for minimally invasive surgery. (Table 1) The goal of deliberate anatomy. Although tissue structure has changed the anatomy stays the same, which makes practice with respect to simulation based training for minimally invasive surgery is this type training suitable for advanced procedural training. Finally, virtual reality simulation constant improvement of knowledge, skill and professionalism. has shown to be an effective way of teaching minimally invasive surgical skills and is The concepts of these models of learning must all be considered when designing and suitable for learning basic skills and/or complete surgical procedures. (Table 3) implementing an effective simulator training curriculum. Trainees require focused attention, which translates into protected uninterrupted time to observe, practice, obtain Table 2. Retention rates of learning trainer feedback, experience procedure variety, and reflect on the acquisition of a new Conventional education Retention rate Multimedia education skill. For minimally invasive surgery the earlier stages of skills training should take place Teach others 90 % Integrated simulation in a skills laboratory using simulation until automaticity in basic skills is achieved. Practicing yourself 75 % Simulation Mastering the basic skills allows the trainee to focus on more complex issues in the Discussion groups 50 % Web seminars Demonstration 30 % Animate operating room, which will be an advantage for the trainee, trainer and patient. Audio visual 20 % Powerpoint Reading 10% Streaming media Table 1. Deliberate practice in training minimally invasive surgery Lecture 5 % Pod cast 1. Motivated learners (e.g. surgical residents) Adapted from the NTL Institute for Applied Behavioral Science104 2. Engagement with a well-defined learning objective (e.g. laparoscopic surgery) 3. Appropriate level of difficulty Table 3. Types of simulation 4. Focused, repetitive practice Simulation Advantages Disadvantages Best use 5. Precise educational measurements 6. Informative feedback for educational sources (e.g. simulators, teachers) Cheap Low fidelity Basic skills Trainees monitoring their learning experiences and correct strategies, errors, and levels of Box trainer Reusable/portable Low face validity Certain discrete skills 7. understanding (e.g. automated feedback form simulators, portfolio) Minimal Risk Only basic tasks (suturing, anastomosis) 8. Evaluation to reach mastery standard (e.g. competence level) Costs 9. Advance to another task or procedure (e.g. practice variety) High Fidelity Ethical issues Advanced procedural Animal model Procedure simulation Special facilities knowledge Adapted from William C. McGaghie103 Single use Dissection skills Anatomical differences

High Fidelity Costs Advanced procedural Fresh human cadaver Procedure simulation Availability knowledge “True” anatomy Compliance of tissue Dissection skills

Reusable Costs Basic skills Virtual reality trainer Data capture Maintenance Procedural skills Objective assessment Acceptability Minimal setup time 16 Adapted from Reznick & MacRae94 17 Introduction Chapter 1

Validation skills, but also for advanced procedural skills. The setup can vary from a box A simulator and the provided exercises need to be validated before the simulator trainer or virtual reality simulator in the residents room to a large skills centre with can be used or implemented in surgical skills curriculum. Validation measures animal training facilities. A well designed skills laboratory should contain simula- whether a simulator is actually teaching or evaluating what it is intended to teach tion tools which are appropriate for the mission of the laboratory.89 A more stan- or measure. To assess the validity of a simulator a number of validation levels dardized approach to the setup and use of skills laboratories is desirable.90 The have been developed. The first steps of validation are Face validity, which is majority of program directors consider a skills laboratory important, but unfortu- assessed by having experts review the content of the simulator to see if it is nately a substantial number of hospitals still lack such facilities. Although the cost appropriate, and Content validity, which is defined as an assessment of the validity of a skills laboratory, depending on the size and the equipment, vary considerably of a simulator based on a detailed examination of the content of the test items. they can be a major burden to start a skills training facility.91 However when ad- Face and content validity are both subjective types of validation. The next step is justed and equipped to the needs of the people working near to it, the demands of Construct validity which is the ability of the simulator to differentiate between the institute in which it is hosted, and the skills curricula set by the different medi- experts and novices performing a given task. Discriminative validity is a more cal specialties, skills training for minimally invasive surgery can be cost-effective.92 sophisticated, quantitative form of validation in which factors that should correlate highly do correlate highly, and factors that should not correlate show a poor Skills curricula correlation. The ultimate form of validity for a surgical simulator is Predictive In formal education, a curriculum is the set of courses, and their content, offered validity, which is defined as the extent to which the scores on the simulator are at a school or university. A curriculum is prescriptive, and is based on a more predictive for actual performance in the operating room.80,81 general program which merely specifies what topics must be understood or skills must be mastered and to what level to achieve a particular grade or standard.93 Learning curve Surgical skill acquisition can be described as a three stage progression model: a The phrase “learning curve” was first applied in the field of airline manufacturing cognitive stage (knowledge), an associative stage (technical skill) and an auto by T.C. Wright in 1936.82 Since the last decades it has become an integral part of nomous stage (adequate judgment). All three stages need to be addressed in a surgical training. A learning curve is the graphical presentation of the changing good surgical skills curriculum.94 A more general development of a surgical skills rate of learning for a given surgical procedure before a surgeon reaches a accepted curriculum in which an integrated approach of all three stages is well documented plateau. Typically, the increase in retention of skills is the sharpest after the initial is described by Gallagher et al.95 An eight step approach to set up a surgical skills attempts, and then gradually evens out, meaning that less and less new informa- curriculum regardless of specialty program, should include: 1) didactic teaching, tion or skills are retained after each repetition.83 For surgical procedures the 2) instruction, 3) common errors, 4) test of didactic information, 5) technical skills learning curve is usually reflected in operating time, blood loss and complication training, 6) provide immediate feedback, 7) provide summative feedback, 8) in- rate. For oncologic procedures radicality of surgery and recurrence rate are also clude repeated trials, learning curve and a proficiency performance goals.95 A skills taken into account. The length of the learning curve for a given surgical procedure curriculum could also be designed in modular way. A sequential, progressive, depends on the complexity of the procedure, skills of the surgeon and the case modular surgical skills curriculum is described by McClusky et al.96 The modular volume. The learning curve for relatively common procedures84 is substantially system distinguishes five different modules: 1) knowledge acquisition, 2) psycho- shorter then the learning curve for complex laparoscopic procedures.85-87 Perform- motor assessment & initial acquisition, 3) integration of knowledge & psycho ing complex laparoscopic procedures in high volume centers can significantly motor skills, 4) supervised ‘real-world’ application, 5) mastery. With such a reduce the learning curve.86 Extensive surgical experience in classical open surgery stepwise or modular system in mind, it is possible to develop proper competence does not reduce the length of the learning curve for the same procedure performed based surgical skills curricula for all type of procedures. Depending on the goal of laparoscopicly. the curriculum, different simulators or specific tasks, as long they themselves are validated, may be incorporated in the curriculum. To be effective, skills training Skills laboratory should be incorporated in a proper skills curriculum.97 Surgical skills laboratories provide a space where trainee’s can develop the necessary skills for minimally invasive surgery in a safe environment before oper- Assessment of surgical skills ating on patients. The availability of a facility for residents to train basic Assessment can be defined as the process of documenting knowledge, skills, laparoscopic skills was rated as the most important item in a skills laboratory.88 A attitude, and beliefs.98 In 1990, psychologist George Miller proposed a pyramidal skills laboratory for minimally invasive surgery can be equipped for training basic framework for the assessment of clinical competence. At the bottom of the

18 19 Introduction Chapter 1

pyramid is knowledge (“knows”), followed by competence (“knows how”), performance Outline of this thesis (“shows how”), and action (“does”) which is the top of the pyramid.99 The top level of This thesis consists of two parts. Part I is covering methods for training and learning this pyramid is the target of assessment and gives information about doctor’s conventional minimal invasive laparoscopic surgery and the learning curve in advanced performance (eg performance of a practical skill). There are several different assessment laparoscopic procedures. Besides, issues with respect to skills laboratory, skills curricula tools, which can be classified as observational and non observational tools. Observation- and the implementation of training are addressed. Part II is covering the new develop- al tools can be used during skills training but also during actual operations. Currently the ment of robot assisted minimal invasive laparoscopic surgery. Learning curves in robot Objective Structured Assessment of Technical Skills (OSATS) program is seen as the assisted surgery and aspects of training and learning robot assisted surgery are standard for technical surgical skills assessment. This instrument, designed in 1997, adressed. consists of a global rating scale and a procedure-specific checklist.100 Although the OSATS was originally designed for a skills laboratory setting it is often used (or modified) for the Part I Laparoscopy assessment of surgical procedures.63 The OSATS program has been extensively studied Chapter 2 describes the current state of laparoscopic skills training in the Netherlands and shows good construct validity, internal consistency and inter-rater reliability. and the challenges of implementing a nationwide skills curriculum. However, there are still some shortcomings which make OSATS suitable for assessment Chapter 3 describes new exercises for laparoscopic skills training and provides a literature for learning (formative assessment), but not for assessment of learning (summative overview of available exercises to be used in box trainers. assessment) in the operating room.101 A global rating scale especially designed for lapa- Chapter 4 describes the development and validation of a new intermediate skills curricu- roscopy is the Global Operative Assessment of Laparoscopic Skills (GOALS).102 This lum for more experienced laparoscopists for the SIMENDO™ virtual reality simulator. rating scale is tested in multiple studies but should only be used for formative assess- Chapter 5 describes the establishment of face and construct validity of the gynecology ment.101 Non-observational tools for assessment of surgical skills are virtual reality modules for the LapSim™ Virtual Reality trainer. simulators and motion analysis devices. They both use an automated and computerized Chapter 6 describes the development of a validated rating system for skills laboratory assessment process of specific procedural events. In this way a virtual reality simulator and skills curricula. provides objective assessment of performance at the end of each exercise. In motion Chapter 7 describes the learning curve for the laparoscopic staging procedure in early analysis, performance is determined by graphical representation of movement and time. ovarian cancer. In general, acceptable and effective assessment tools should be feasible, reliable and valid. Part II Robotic Surgery Chapter 8 presents a narrative review of the technique, applications, aspects of training and future perspectives of robot assisted laparoscopic surgery. Aim of this thesis Chapter 9 describes the learning curve of a single surgeon for the robot assisted radical In this thesis we aim to describe and examine new developments in training for minimally hysterectomy and a comparison with the open radical hysterectomy. invasive laparoscopic surgery. Training methods, learning curves, training curricula and Chapter 10 describes the validation of the dV-Trainer™ virtual reality simulator for robot the implementation of training for conventional laparoscopy and robot assisted assisted laparoscopic surgery. laparoscopic surgery are addressed. Chapter 11 presents a systematic review of the current state of training and learning robot assisted laparoscopic surgery and provides guidelines for the development of a training Issues addressed in this thesis are program. 1) Validation of new training tools for minimally invasive laparoscopic and robotic surgery. Chapter 12 presents the discussion and conclusions, the most important aspects of 2) Demonstrate learning curves for certain minimally invasive laparoscopic and robot training conventional laparoscopy and robot assisted laparoscopic surgery are outlined. assisted gynecologic procedures. 3) Identify items which are important for developing a structured training curriculum for minimally invasive laparoscopic and robotic surgery. 4) Highlight issues which are encountered with the implementation of a structured training curriculum for minimally invasive laparoscopic and robotic surgery.

20 21 Introduction Chapter 1

References 35. Fisher SS, McGreevy MM, Humphries J. Proceedings of the 1986 Workshop on Interactive 3-Dimensional Graphics. ISBN 0897912284 1987;1-12. 1. Nitze M. Beobachtung-Und Untersuchungsmethode Fur Harnohre, Harnblase Und Rectum. Wien Med 36. Unger SW, Unger HM, Bass RT. AESOP Robotic Arm. Surg Endosc 1994;8:1131. Wochenschr 1879;29:649. 37. Schurr MO, Buess G, Neisius B, Voges U. Robotics and Telemanipulation Technologies for Endoscopic 2. Nitze M. Zur Photographie Der Menschlichen Harnblase. Med Wochenschr 1893;2:744. Surgery. A Review of the ARTEMIS Project. Advanced Robotic Telemanipulator for Minimally Invasive 3. Mikulicz J. Uber Gastroskopie Und Osophagoskopie. Wien Med Presse 1881;45:1405. Surgery. Surg Endosc 2000;14:375-81. 4. Kelling G. Uber Osophagoskopie, Gastroskopie Und Zolioscopie. Munch Med Wochenschr 1902;49:21-4. 38. Aiono S, Gilbert JM, Soin B, Finlay PA, Gordan A. Controlled Trial of the Introduction of a Robotic 5. Jacobeaus H. Uber Die Moglichkeit, Die Zystoskopie Bei Untersuchung Seroser Hohlungen Camera Assistant (EndoAssist) for Laparoscopic Cholecystectomy. Surg Endosc 2002;16:1267-70. Anzuwneden. Munch Med Wochenschr 1910;57:2090-2. 39. Falcone T, Goldberg JM, Margossian H, Stevens L. Robotic-Assisted Laparoscopic Microsurgical Tubal 6. Jacobeaus H. Kurze Ubersicht Uber Meine Erfahrungen Mit Der Laparothorakoskopie. Munch Med Anastomosis: a Human Pilot Study. Fertil Steril 2000;73:1040-2. Wochenschr 1911;58:2017. 40. Boehm DH, Reichenspurner H, Detter C, Arnold M, Gulbins H, Meiser B, Reichart B. Clinical Use of a 7. Bernheim BM. Organoscopy. Ann Surg 1911;53:764-7. Computer-Enhanced Surgical Robotic System for Endoscopic Coronary Artery Bypass Grafting on the 8. Nordentoft S. Uber Endoskopie Geschlossener Kavitaten Mittels Meines Trokar-Endoskopes. Verh Dtsch Beating Heart. Thorac Cardiovasc Surg 2000;48:198-202. Ges Gynakol 1912;41:78. 41. Abbou CC, Hoznek A, Salomon L, Lobontiu A, Saint F, Cicco A, Antiphon P, Chopin D. [Remote 9. Orndoff BH. The Peritoneoscope in Diagnosis of Diseases of the Abdomen. J Radiol 1920;1:307. Laparoscopic Radical Prostatectomy Carried Out With a Robot. Report of a Case]. Prog Urol 2000;10:520-3. 10. Korbsch R. Die Laparoskopie Nach Jakobaeus. Berl Klin Wochenschr 1921;38:696. 42. European Commission Joint Research Centre. http://ec.europa.eu/dgs/jrc. Accessed 27-3-2011. 11. Goetze O. Die Neues Verfabren Der Gasfullung Fur Das Pneumoperitoneum. Munch Med Wochenschr 43. Sofar S.p.A. http://www.sofarfarm.com/html_ita/home/home.asp. Accessed 27-3-2011. 1921;51:233. 44. Eindhoven University of Technology. http://w3.tue.nl. Accessed 27-03-2011. 12. Unverricht W. Die Thorakoskopie Und Laparoskopie. Berl Klin Wochenschr 1923;2:-502. 45. Sofie (surgical robot). http://en.wikipedia.org/wiki/Sofie_(surgical_robot). Accessed 27-3-2011. 13. Zollikofer R. Zur Laparoskopie. Schweiz. Schweiz Med Wochenschr 1924;54:264. 46. Vesalius robot. http://www.vesaliusrobot.com. Accessed 10-4-2011. 14. Kalk H. Erfahrungen Mit Der Laparoskopie (Zugleich Mit Beschreibung Eines Neuen Instrumentes). Z 47. Institute of Robotics and Mechatronics, DLR, German Aerospace Center. http://www.dlr.de. Accessed Klin Med 1929;111:303. 10-4-2011. 15. Ruddock JC. Peritoneoscopy. West J Surg 1934;392. 48. Hagn U, Konietschke R, Tobergte A, Nickl M, Jorg S, Kubler B, Passig G, Groger M, Frohlich F, Seibold U, 16. Fervers C. Die Laparoskopie Mit Dem Cystoskope: Ein Beitrag Zur Vereinfachung Der Technik Und Zur Le-Tien L, bu-Schaffer A, Nothhelfer A, Hacker F, Grebenstein M, Hirzinger G. DLR MiroSurge: a Endoskopischen Strangdurchtrennung in Der Bauchole. Med Klin 1933;1042. Versatile System for Research in Endoscopic Telesurgery 17. Boesch PF. Laproskopie. Schweiz Z Krankenh Anstaltw 1936;6:62. 149. Int J Comput Assist Radiol Surg 2010;5:183-93. 18. Hope R. The Differential Diagnosis of Ectopic Pregnancy by Peritoneoscopy. Surg Gynecol Obstet 49. Fader AN, Cohen S, Escobar PF, Gunderson C. Laparoendoscopic Single-Site Surgery in Gynecology. Curr 1937;64:229. Opin Obstet Gynecol 2010;22:331-8. 19. Veress J. Neues Instrument Zur Ausfuhrung Von Brust-Oder Bauchpumktionen Und Pneumothorax 50. Sodergren MH, Clark J, Athanasiou T, Teare J, Yang GZ, Darzi A. Natural Orifice Translumenal Behandlung. Dtsch Med Woschenschr 1938;64:1480. Endoscopic Surgery: Critical Appraisal of Applications in Clinical Practice. Surg Endosc 2009;23:680-7. 20. Hopkins HH. On the Diffraction Theory of Optical Images. Proc Soc Lond 1953;A217:408. 51. Semm K. Pelvi-Trainer, a Training Device in Operative Pelviscopy for Teaching Endoscopic Ligation and 21. Palmer R. La Coeloscopie Gynecologique, Ses Possibilities Et Ses Indications Actualles. Semin Hop Paris Suture Technics. Geburtshilfe Frauenheilkd 1986;46:60-2. 1954;30:441. 52. Delp SL, Loan JP, Hoy MG, Zajac FE, Topp EL, Rosen JM. An Interactive Graphics-Based Model of the 22. Klein R, Plamer R. Technique De Prelevement Des Ovules Humains Par Ponction Folliculaire Sous Lower Extremity to Study Orthopaedic Surgical Procedures. IEEE Trans Biomed Eng 1990;37:757-67. Coelioscopie. C R Seances Soc Biol Fil 1961;155:1919-21. 53. Satava RM. Virtual Reality Surgical Simulator. The First Steps. Surg Endosc 1993;7:203-5. 23. Steptoe PC, Edwards RG. Birth After the Reimplantation of a Human Embryo 54. Seymour NE, Gallagher AG, Roman SA, O’Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual Reality 148. Lancet 1978;2:366. Training Improves Operating Room Performance: Results of a Randomized, Double-Blinded Study. Ann 24. Semm K. Das Pneumoperitoneum mit CO2. Demling L, Ottenjann R (eds) In Endoscopie Methoden. Surg 2002;236:458-63. Munich: 1967, 167. 55. Broe D, Ridgway PF, Johnson S, Tierney S, Conlon KC. Construct Validation of a Novel Hybrid Surgical 25. Semm K. Tissue-Puncher and Loop-Ligation: New Aids for Surgical Therapeutic Pelviscopy Simulator. Surg Endosc 2006;20:900-4. (Laparoscopy): Endoscopic Intra-Abdominal Surgery. Endoscopy 1978;10:119. 56. Duffy AJ, Hogle NJ, McCarthy H, Lew JI, Egan A, Christos P, Fowler DL. Construct Validity for the LAPSIM 26. Hasson HM. Open Laparoscopy Vs Closed Laparoscopy: a Comparison of Complication Rates. Adv Laparoscopic Surgical Simulator. Surg Endosc 2005;19:401-5. Planned Parenthood 1978;13:41. 57. Gallagher AG, Richie K, McClure N, McGuigan J. Objective Psychomotor Skills Assessment of 27. Semm K. Endoscopic Intraabdominal Surgery. Kiel: Christian-Albrect Universitat, 1984. Experienced, Junior, and Novice Laparoscopists With Virtual Reality. World J Surg 2001;25:1478-83. 28. Semm K. Endoscopic Appendectomy. Endoscopy 1983;15:59-64. 58. Maithel S, Sierra R, Korndorffer J, Neumann P, Dawson S, Callery M, Jones D, Scott D. Construct and 29. Semm K. Atlas of Gynecologic Laparoscopy and Hysteroscopy. Philadelphia, PA: Saunders, 1975. Face Validity of MIST-VR, Endotower, and CELTS: Are We Ready for Skills Assessment Using Simulators? 30. Nezhat C, Crowgey S, Nezhat F. Surgical Treatment of Endometriosis Via Laser Laparoscopy. Fertil Steril Surg Endosc 2006;20:104-12. 1986;45:778-82. 59. McDougall EM, Corica FA, Boker JR, Sala LG, Stoliar G, Borin JF, Chu FT, Clayman RV. Construct Validity 31. Nezhat C, Siegler A, Nezhat C, Seidman D, Luciana A. Operative Gynecologic Laparoscopy: Principles and Testing of a Laparoscopic Surgical Simulator. J Am Coll Surg 2006;202:779-87. Techniques. New York, NY: McGraw-Hill, 2000. 60. Schijven M, Jakimowicz J. Construct Validity: Experts and Novices Performing on the Xitact LS500 32. Reich H, DeCaprio J, McGlynn F. Laparoscopic Hysterectomy. J Gynaecol Surg 1989;2:213-5. Laparoscopy Simulator. Surg Endosc 2003;17:803-10. 33. Litynski GS. Erich Muhe and the Rejection of Laparoscopic Cholecystectomy (1985): a Surgeon Ahead of 61. Verdaasdonk EG, Stassen LP, Monteny LJ, Dankelman J. Validation of a New Basic Virtual Reality His Time. JSLS 1998;2:341-6. Simulator for Training of Basic Endoscopic Skills: the SIMENDO. Surg Endosc 2006;20:511-8. 34. Berci G, Brooks PG, Paz-Partlow M. TV Laparoscopy. A New Dimension in Visualization and 62. Gurusamy K, Aggarwal R, Palanivelu L, Davidson BR. Systematic Review of Randomized Controlled Trials Documentation of Pelvic Pathology. J Reprod Med 1986;31:585-8. on the Effectiveness of Virtual Reality Training for Laparoscopic Surgery. Br J Surg 2008;95:1088-97.

22 23 Introduction Chapter 1

63. Larsen CR, Grantcharov T, Schouenborg L, Ottosen C, Soerensen JL, Ottesen B. Objective Assessment of 90. Gould JC. Building a Laparoscopic Surgical Skills Training Laboratory: Resources and Support. JSLS Surgical Competence in Gynaecological Laparoscopy: Development and Validation of a Procedure- 2006;10:293-6. Specific Rating Scale. BJOG 2008;115:908-16. 91. Korndorffer JR, Jr., Stefanidis D, Scott DJ. Laparoscopic Skills Laboratories: Current Assessment and a 64. Thijssen AS, Schijven MP. Contemporary Virtual Reality Laparoscopy Simulators: Quicksand or Solid Call for Resident Training Standards. Am J Surg 2006;191:17-22. Grounds for Assessing Surgical Trainees? Am J Surg 2010;199:529-41. 92. Stefanidis D, Hope WW, Korndorffer JR, Jr., Markley S, Scott DJ. Initial Laparoscopic Basic Skills 65. Kenney PA, Wszolek MF, Gould JJ, Libertino JA, Moinzadeh A. Face, Content, and Construct Validity of Training Shortens the Learning Curve of Laparoscopic Suturing and Is Cost-Effective. J Am Coll Surg DV-Trainer, a Novel Virtual Reality Simulator for Robotic Surgery. Urology 2009;73:1288-92. 2010;210:436-40. 66. Seixas-Mikelus SA, Stegemann AP, Kesavadas T, Srimathveeravalli G, Sathyaseelan G, Chandrasekhar R, 93. Curriculum. http://en.wikipedia.org/wiki/Curriculum. Accessed 10-4-2011. Wilding GE, Peabody JO, Guru KA. Content Validation of a Novel Robotic Surgical Simulator. BJU Int 94. Reznick RK, MacRae H. Teaching Surgical Skills--Changes in the Wind. N Engl J Med 2006;355:2664-9. 2010;107:1130-5. 95. Gallagher AG, Ritter EM, Champion H, Higgins G, Fried MP, Moses G, Smith CD, Satava RM. Virtual 67. Chmarra MK, Klein S, de Winter JC, Jansen FW, Dankelman J. Objective Classification of Residents Based Reality Simulation for the Operating Room: Proficiency-Based Training As a Paradigm Shift in Surgical on Their Psychomotor Laparoscopic Skills. Surg Endosc 2010;24:1031-9. Skills Training. Ann Surg 2005;241:364-72. 68. Grendal Games. www.grendel-games.com. Accessed 27-3-2011. 96. McClusky DA, III, Smith CD. Design and Development of a Surgical Skills Simulation Curriculum. World 69. Badurdeen S, bdul-Samad O, Story G, Wilson C, Down S, Harris A. Nintendo Wii Video-Gaming Ability J Surg 2008;32:171-81. Predicts Laparoscopic Skill. Surg Endosc 2010;24:1824-8. 97. Stefanidis D, Heniford BT. The Formula for a Successful Laparoscopic Skills Curriculum. Arch Surg 70. Bokhari R, Bollman-McGregor J, Kahoi K, Smith M, Feinstein A, Ferrara J. Design, Development, and 2009;144:77-82. Validation of a Take-Home Simulator for Fundamental Laparoscopic Skills: Using Nintendo Wii for 98. Epstein RM, Hundert EM. Defining and Assessing Professional Competence. JAMA 2002;287:226-35. Surgical Training. Am Surg 2010;76:583-6. 99. Miller GE. The Assessment of Clinical Skills/Competence/Performance. Acad Med 1990;65:S63-S67. 71. Halsted WS. The Training of the Surgeon. Bull Johns Hopkins Hosp 1904;15:267-75. 100. Martin JA, Regehr G, Reznick R, MacRae H, Murnaghan J, Hutchison C, Brown M. Objective Structured 72. Fitts PM, Posner MI. Human performance. Belmont, CA: Brooks/Cole, 1967. Assessment of Technical Skill (OSATS) for Surgical Residents. Br J Surg 1997;84:273-8. 73. Kopta JA. The Development of Motor Skills in Orthopaedic Education. Clin Orthop Relat Res 1971;75:80-5. 101. van Hove PD, Tuijthof GJ, Verdaasdonk EG, Stassen LP, Dankelman J. Objective Assessment of Technical 74. Schmidt RA. A Schema Theory of Discrete Motor Skill Learning. Psychol Rev 1975;82:225-60. Surgical Skills. Br J Surg 2010;97:972-87. 75. Collins A, Brown JS. Cognitive apprenticeship: teaching the crafts of reading, writing, and mathematics. 102. Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM. A Global Resnick LB (ed) Knowing, learning, and instruction: essays in honor of Robert Glaser. Hilldale, NJ: Assessment Tool for Evaluation of Intraoperative Laparoscopic Skills. Am J Surg 2005;190:107-13. Lawrence Erlbaum Associates, 2011, 453-94. 103. McGaghie WC. Research Opportunities in Simulation-Based Medical Education Using Deliberate 76. Ericsson KA. The acquisition of expert performance: an introduction to some of the issues. Ericsson KA Practice. Acad Emerg Med 2008;15:995-1001. (ed) The road to excellence: the acquisition of expert performance in the arts and sciences, sports, and 104. NTL Institute for Applied Behavioral Science. http://www.ntl.org. Accessed 28-3-2011. games. Mahwah, NY: Lawrence Erlbaum, 1996, 1-50. 105. Modlin IM, Kidd M, Lye KD. From the Lumen to the Laparoscope. Arch Surg 2004;139:1110-26. 77. Ericsson KA. Deliberate Practice and the Acquisition and Maintenance of Expert Performance in 106. Goedecke Montage service. http://www.goedecke-montageservice.de. Accessed 10-4-2011. Medicine and Related Domains. Acad Med 2004;79:S70-S81. 78. Ericsson KA. Deliberate Practice and Acquisition of Expert Performance: a General Overview. Acad Emerg Med 2008;15:988-94. 79. Kincaid JP, Bala S, Hamel C, Sequeira WJ, Bellette A. Effectiveness of Traditional vs. Web-based Instruc- tion for Teaching an Instructional Module for Medics. IST-TR-01-06. 2001. Orlando: Institute for Simulation and Training, University of Central Florida. 80. Gallagher AG, Ritter EM, Satava RM. Fundamental Principles of Validation, and Reliability: Rigorous Science for the Assessment of Surgical Education and Training. Surg Endosc 2003;17:1525-9. 81. McDougall EM. Validation of Surgical Simulators 150. J Endourol 2007;21:244-7. 82. Wright TP. Factors Affecting the Costs of Airplanes. J Aeronaut Sci 1936;3:122-8. 83. Learning curve. http://en.wikipedia.org/wiki/Learning_curve. Accessed 28-3-2011. 84. Ghomi A, Littman P, Prasad A, Einarsson JI. Assessing the Learning Curve for Laparoscopic Supracervical Hysterectomy. JSLS 2007;11:190-4. 85. Chong GO, Park NY, Hong DG, Cho YL, Park IS, Lee YS. Learning Curve of Laparoscopic Radical Hysterectomy With Pelvic and/or Para-Aortic Lymphadenectomy in the Early and Locally Advanced Cervical Cancer: Comparison of the First 50 and Second 50 Cases. Int J Gynecol Cancer 2009;19:1459-64. 86. Eden CG, Neill MG, Louie-Johnsun MW. The First 1000 Cases of Laparoscopic Radical Prostatectomy in the UK: Evidence of Multiple ‘Learning Curves’. BJU Int 2009;103:1224-30. 87. Secin FP, Savage C, Abbou C, de La TA, Salomon L, Rassweiler J, Hruza M, Rozet F, Cathelineau X, Janetschek G, Nassar F, Turk I, Vanni AJ, Gill IS, Koenig P, Kaouk JH, Martinez PL, Pansadoro V, Emiliozzi P, Bjartell A, Jiborn T, Eden C, Richards AJ, Van VR, Stolzenburg JU, Rabenalt R, Su LM, Pavlovich CP, Levinson AW, Touijer KA, Vickers A, Guillonneau B. The Learning Curve for Laparoscopic Radical Prostatectomy: an International Multicenter Study. J Urol 2010;184:2291-6. 88. Hagen SS, Ferguson KJ, Sharp WJ, Adam LA. Residents’ Attitudes About the Introduction of a Surgical Skills Simulation Laboratory. Simul Healthc 2010;5:28-32. 89. MacRae HM, Satterthwaite L, Reznick RK. Setting Up a Surgical Skills Center. World J Surg 2008;32:189-95.

24 25 Part I Laparoscopy Implementation of simulation in surgical practice: Minimally invasive surgery has taken the lead: The Dutch experience 2

Henk W.R. Schreuder Guid Oei Mario Maas Jan C.C. Borleffs Marlies P. Schijven

Medical Teacher 2011;33:105-115 Implementation of simulation in surgical practice Chapter 2

Introduction Abstract In healthcare, as in society at large, computer aided implementation of innovations has Minimal invasive techniques are rapidly becoming standard of surgical technique become daily practice. Computer-aided scanning by MRI, (PET)CT and other technical for many surgical procedures. To train the skills necessary to apply these techniques, modalities in radiology; device-driven steering mechanisms in endoscopy, self-employable box-trainers and/or inanimate models may be used, but these trainers lack the stenting devices in cardiology and vascular surgery, full robotic surgical systems in possibility of inherent objective classification of results. In the last decade virtual laparoscopic surgery are examples of such advances. Laparoscopic surgery may the area reality (VR) trainers were introduced for training minimal invasive techniques. in which computer-aided implementations are most prominently visible, as this young Minimally Invasive Surgery (MIS) is, by nature, very suitable for this type of training. specialty has always been driven by technological innovation and has been an early The specific psychomotor skills and eye-hand coordination needed for MIS can be adopter of novel techniques, from its start. mastered largely using VR simulation techniques. It is also possible to transfer skills In the twenty-first century, minimally invasive surgical (MIS) techniques have become the learned on a simulator to real operations, resulting in error reduction and shorten- standard of surgical care for many patients. Unlike open surgery, MIS is, by its nature, a ing of procedural operating time. Authors aim to enlighten the process of gaining technique that is very suitable for simulation-based training. The specific psychomotor acceptance in the Netherlands for novel training techniques. The Dutch Societies of skills and eye-hand coordination needed for this type of surgery can be trained easily Surgery, Obstetrics and Gynecology and Urology each developed individual training through simulation.1,2 For skills training, box-trainers or computer-enhanced trainers may curricula for MIS using simulation techniques, to be implemented in daily practice. be used, but the last decade new virtual reality trainers have been introduced for training The ultimate goal is to improve patient safety. The authors outline the opinions of minimally invasive techniques. Nowadays, simulation training, often enhanced using actors involved such as: different simulators, surgical trainees, surgeons, surgical virtual reality techniques is used for a wide range of training purposes: laparoscopy3, societies, hospital boards, government and the public. The actual implementation robot-assisted surgery4, endoscopy5, cystoscopy6, hysteroscopy7and intervention radiolo- of nationwide training curricula for MIS is, however, a challenging step. gy. 8 It is possible to transfer skills learned on a simulator to real operations, leading to less errors and shorter operating time.9,10 Recently, e-learning programs and ‘Serious Games’ for MIS, embedding a training curriculum, step-by-step approaches, encouraging the making and solving of mistakes and a diversity of storylines have been introduced.11 The traditional ‘apprentice-mentor’ education model is commonly used to learn surgical skills. In this model, surgery is largely mastered through observation, followed by imita- tion of the actions of the mentor. For MIS, this model is challenged due to several factors. Reduced working hours and increased numbers of residents on the work floor results in less exposure to surgery. Constant innovation in treatment modalities to be learnt by the mentors reduces the number of surgical procedures available for teaching and learning of apprentices. Furthermore, the continuous pressure on reducing operation time in order to be more cost effective and the ethical aspects to limit patient morbidity, to reduce complications and to maximize patient safety drive the public awareness and demand professional responsibility. In 2008, after publishing their report entitled “Risks minimally invasive surgery underestimated”,12 the Dutch government demanded strict rules for MIS. As a result, requirements for skills training were defined by the surgical societies, and hospitals were obliged to implement these requirements in their training programs. Nowadays every resident in surgical training and every surgeon needs to demonstrate that he or she possesses minimum standards of skill before operating on patients. Performing MIS without demonstrated competence is considered unethical and unprofessional. In this view, it has become mandatory to establish objective validated measurable levels of practical skills prior to start MIS on patients. Since these skills can be mastered using simulation techniques, it is not surprising that MIS has taken the lead in using simulation applications for training.9 The Dutch Societies of Surgery, Obstetrics

30 31 Implementation of simulation in surgical practice Chapter 2 and Gynecology and Urology each developed a training curriculum for MIS, to be Table 1. Validated box/video trainers for minimally invasive laparoscopic surgery implemented in daily practice.13 The implementation of a nationwide trainings curriculum Name Trainer type Face Construct Predictive for MIS will be a next step. The Dutch Society for Simulation in Healthcare (DSSH)14 Validity Validity Validity provides a platform to share experiences, which will accelerate a nationwide implemen McGill Inanimate System for Training and Box trainer yes yes yes tation of proficiency-based training curricula. This paper describes current developments Evaluations of Laparoscopic Skills (MISTELS)19 regarding MIS training and illustrates the Dutch experiences with development and Fundamentals of laparoscopic Surgery (FLS)18 Box trainer yes yes yes implementation of training curricula for MIS. Yale Laparoscopic Skills and Suturing Programme Laparoscopic Surgical no yes no (YLSSP)49 trainer

Simulation in minimally invasive surgery Southwestern videotrainerstations15 Videotrainer yes yes yes

150 Specific psychomotor skills are needed to perform MIS. Hand-eye coordination, adap SIMULAB LapTrainer with no yes no SimuVision LTS-10 tation from 3-dimensions to a 2-dimensional screen, dealing with the fulcrum effect--the need for the surgeons to move their hand in the opposite direction in which the tip of the SIMULAB 251 LapTrainer with no yes no instrument intends to go--acquiring fine motor skills to handle the long instruments SimuVision LTS-10 without proper tactile feedback--the sense of touch when applying force--these are all SIMULAB 352 LapTrainer with yes yes no SimuVision LTS-10 skills which the future laparoscopist needs to master.1 Simulation has proven to be a Laparoscopic Skills Testing and Training (LASTT)53 Szabo trainer box yes yes no proper tool to learn and train these skills.9,15 Several simulation modalities can be used for learning and training MIS. There are different animal models, box/video trainers and Legacy Inanimate System for Laparoscopic Team Ethicon Laptrainer no yes no virtual reality simulators to choose from. In addition, ‘serious gaming’ has entered the Training (LISETT)54 field of minimally invasive surgical training as well. Pelv-Sim 55 Pelv-Sim box trainer no yes no

56 Figure 1. Box trainers for training MIS Lentz (6 tasks developed by author) Mirrored trainer and box no yes no trainer

Black (5 tasks, developed by author) 57 Video trainer no yes no

Kolkman (5 tasks developed by author)58 Box trainer no yes no

Clevin (5 tasks developed by author)59 Box trainer no yes no

Risucci 200160 Box trainer no yes no

Box training Box and video trainers provide a relatively easy and cheap simulation model for MIS. These platforms usually consist of a normal laparoscopic tower with a training box, but are also available as stand alone units with an inbuilt camera (Figure 1). For the acquisition of basic laparoscopic skills box trainers are equally effective as VR trainers.16 Box trainers provide realistic haptic feedback, yet objective assessment is difficult and an expert observer must be available to asses performance. The last decade different box/ video trainer models and exercises have been developed. When using box trainers it is important to use validated exercises with a proper training goal. An overview of validated exercises is given in Table 1. The Fundamentals of Laparoscopic Surgery (FLS) program17 implemented existing box trainer exercises in its program.18 For the FLS program a

32 33 Implementation of simulation in surgical practice Chapter 2 special portable box trainer with an inbuilt camera was developed. Performance on this Table 2. Validated virtual reality simulators for minimally invasive laparoscopic surgery box trainer correlated well with objective assessment of intraoperative performance.19 For VR Simulator Construct Predictive Haptic Basic Procedural Curriculum Team training MIS at home, portable and inexpensive box trainers can be used. 20 validity validity feedback skills task training Simendo61 Laparoscopy yes no no yes no yes yes

Figure 2. Virtual reality simulation (images provide by Surgical Science™) ProMiss62 Laparoscopy yes no yes yes yes yes yes

MIST-VR2 Laparoscopy yes yes no yes no yes no

Procedicus Laparoscopy yes no yes yes no yes no KSA63

Lap Mentor64 Laparoscopy yes yes yes yes yes no no

Lap Sim65 Laparoscopy yes yes no yes yes yes yes

EndoTower66 Laparoscopy yes no no yes no no no

Xitact LS 50067 Laparoscopy yes yes yes yes yes no no

SepSurgery68 Laparoscopy yes no no yes yes no no

Lap-VR69 Laparoscopy yes no yes yes yes yes yes

dV-Trainer4 Robotic surgery yes no no yes no no no

RoSS33 Robotic surgery yes no no yes no no no

Virtual reality training Virtual reality (VR) simulators (Figure 2) provide a safe and standardized environment to Figure 3. Laparoscopic Cholecystectomy e-training program (image provided by Redllamatech®) practice specific skills for MIS and have the surplus value of being able to measure performance outcome of the trainee simultaneously and objectively.21 Compared to box/ video trainers, VR simulators are at least as effective and can supplement standard laparoscopic box/video training.3 Unlike box trainers, most VR simulators lack realistic tactile feedback. To overcome this problem, augmented reality laparoscopic simulators have been developed. These training devices provide both objective assessment after performance and realistic tactile feedback.22 In the last decade, several VR simulators have been developed and validated (Table 2). In contrast to box trainers, VR trainers have the capacity to train both basic skills as well as simulate full procedural surgical tasks (e.g. the laparoscopic salpingectomy or laparoscopic cholecystectomy). These innovations could be used in addition to box trainers to train skills needed in more advanced surgical procedures. VR training improves overall laparoscopic surgical skills and the acquired skills on a VR simulator are, in itself, not procedure specific.23 There is a significant correlation between operative performance and psychomotor performance on VR reality simulators.24 Above all the newly learned skills on the VR simulator are transferable to actual laparoscopic operations in human patients.9,25

34 35 Implementation of simulation in surgical practice Chapter 2

E-learning & Serious gaming robot-assisted laparoscopic surgery.32 This type of surgery is becoming more and more In the last decade, the use of e-learning has rapidly grown. Many students browse the accepted and there is a growing need for training residents and fellow’s in this type of internet routinely, for search, play and information purposes. In fact, these elements are surgery. Two new VR simulators for robotic surgery are recently validated and face and needed for successful learningw. In most modern medical curricula, e-learning is construct validity were established.4,33 In the field of gynecology, hysteroscopy is an introduced to satisfy this need for modern information gathering. Traditional classroom important minimally invasive tool to treat abnormalities inside the uterine cavity. Training problem based learning can also be transferred to a virtual environment, like in Second hysteroscopy is traditionally done using a porcine bladder to simulate the cavity and per- Life, thus enabling a modern yet familiar environment for problem based learning.26 form resections, which has been shown to improve resident performance.34 In 2009, a VR Applications for MIS have, likewise, been initiated. Web based applications like the World simulator especially for hysteroscopy was introduced and validated.7 The use of Electronic Book of Surgery (WebSurg)27 are widely used in the surgical community. This simulation is nowadays well established in training MIS in most areas. For open surgery online learning portal contains a large collection of streaming and downloadable HD simulators are still difficult to develop. quality videos of surgical procedures; combined with how-to step-by-step surgical teaching guidelines to aid the implementation of MIS procedures for various surgical Team training disciplines. Training how to act in the operation theatre or emergency room generally happens on Recently, the first interactive e-learning program for MIS was introduced. The ‘Simpraxis™ individual basis. In practice, however, a hospital patient is treated by a multidisciplinary Laparoscopic Cholecystectomy Trainer’ is a customizable interactive simulation software team. It has been shown that giving multidisciplinary team training to clinical teams training platform for cognitive learning of surgical procedures.28 It integrates multimedia leads to improvements in dealing with fatigue, teambuilding, communication, recognizing (such as video, 3D models, radiology, illustrations, text, and still images, all captured dangerous situations, decision-making and providing feedback.35 For the purpose of such from live procedures) and combines them with expert cognitive training pedagogy to team training specific full body simulators are developed. These high fidelity patient create a powerful simulation of the procedure (Figure 3). All these elements combined simulators can be fully programmed to simulate an acute disorder. Scenarios can be simulate the feeling of performing the actual physical procedure while only using a tailored to specific target groups. Participants can be tested on their individual clinical computer. There is a detailed assessment of performance and one should complete the skills and competence to work together under pressure as a team. Training in a medical whole module within a set score to pass. The e-learning module is certified by the simulation centre with high fidelity simulators offers the opportunity to train rare Accreditation Council for Continuing Medical Education of the USA and in this way it is emergency scenarios under standardized conditions and give targeted feedback on possible to earn CME credits. functioning as individual and team. Training of health care teams in emergency situations Besides e-learning, there is also a place for ‘Serious Gaming’ in learning MIS. Since there promotes cooperation and reduces the number of communication errors.36 Therefore is a positive correlation between video game skills and laparoscopic surgical skills, video residents should not only be trained in medical knowledge and skills, but also in games may be a practical training tool to help surgeons.29 Badurdeen et al demonstrated collaboration and communication, two other competencies of the CanMED model.37 a skill overlap between certain games for the Nintendo Wii™ gaming console and basic Eighty percent of the time spent in a recently established multidisciplinary Gyn & OB laparoscopic skill tasks.30 This gaming console is relatively inexpensive, allows natural simulation training focuses on communication and collaboration. The concept can easily hand movements similar to those performed in laparoscopy and can be effectively used be transferred to other specialties and multidisciplinary team training for surgical as a ‘take-home’ simulator.31 Another application of serious gaming is creating an online residents will be introduced in 2010. competition for VR simulation training, which may enhance voluntary skills training.11

Animal Models Current state of implementation of skills training for minimally invasive Animal models, mainly pig models, have the advantage of simulating tissue handling surgery in the Netherlands and clinical scenario’s better then any other simulation model and are still frequently used for procedure and device training in-company supported programs. Due to In the Netherlands MIS is professionally organized. The Dutch Society of Surgery, Dutch financial, legal and ethical reasons, animal model training is slowly being replaced by Society of Obstetrics and Gynecology and the Dutch Society of Urology each have their other simulation models. With the new generation of VR simulators this shift is possible own working group on MIS, together combined and represented by the Dutch Society of without compromising on the quality of the skills training. Endoscopic Surgery. In November 2007, the Dutch Inspectorate for Healthcare published a firm report entitled “Risks minimally invasive surgery underestimated”, expressing its Other simulators in MIS concern regarding endoscopic surgery and patient safety in the Netherlands.12 Training in Recently, new VR simulators for other fields of MIS were developed. A new area of MIS is MIS was found to be inadequately structured and implemented. A need for national

36 37 Implementation of simulation in surgical practice Chapter 2

standardized training programs for MIS, with strict criteria, was stressed and firm Table 3. Separate training programs for MIS training in the Netherlands recommendations were stated. Furthermore, a number of nationally endorsed hospital General Surgery interventions were demanded; many of which surpassing specialist-specific boundaries. Three step curriculum to be completed in the first two years of training In reaction, various working groups of the respective clinical medical specialties started Step 1 developing structured, competency-based MIS curricula including appropriate outcome - Staff endorsed knowledge module evaluation. Step 2 - Validated laparoscopic psychomotor skills curriculum. This can be box/video trainer, VR trainer or porcine General Surgery ex-vivo gallbladder or a combination. A standardized surgical training protocol for MIS was developed by the Dutch Society of - Only after completion of step 1 and 2 progress to step 3 Endoscopic Surgery and the Working Group for Endoscopic Surgery, residing under the Step 3 Dutch Society for Surgery. A pre-set level of knowledge is required and further develop- - Living anaesthetized pig model for teaching laparoscopic surgical steps and procedures ment of laparoscopic know-how and skills embedded in a 3-step curriculum (Table 3). This level-of-skill must be tested and periodically re-evaluated. As a consequence, if a res- Gynecology ident is no longer able to pass a certain level of knowledge or skill, he or she is no longer General format to be filled in regional allowed in the clinical surgical laparoscopic setting as a first operator on patients. More Year 1 precisely, every resident in training for surgery must follow this curriculum and pass the - Combined two day course with exam (theory, practical skills) test before embarking on patient surgery and must have the opportunity to train - Regular competence based practical skills training in own hospital, validated local exam to be past before repeatedly on a permanently available and functional laparoscopic training setting. starting with laparoscopy Ideally, a supervising, certified surgeon is present to correct posture and problems of the - Starting with level I (easy) procedures training environment. The nationwide implementation of this three step curriculum is Year 2-4 not an easy process, as many regions have their own programs. Nevertheless, it is to be - Regular assessment of skills in operating room and skills lab using OSATS expected that these programs will adhere to the standardized training protocol in the - With gaining experience starting with level II (moderate) procedures near future as it is the framework against which these programs will be tested by the - Retention of skills measured by repeating simulator exam with increasing difficulty every 6-12 months government. Year 5-6 - Combined two day advanced course with exam (theory and practical skills) in year 5 Gynecology - Regular assessment of skills in operating room and skills lab using OSATS The Dutch Society of Gynecological Endoscopy developed recommendations for training - Retention of skills measured by repeating simulator exam with increasing difficulty every 6-12 months and learning MIS early 2008, which were accepted by the national society. In this report, a format for a structured competence based curriculum for learning MIS is described Urology (Table 3). The hospitals were obliged to have a box trainer or a VR trainer. In gynecology Competence based Program “Basic Laparoscopic Urological Skills”: including the complexity of laparoscopic procedures is defined by the European Society of Knowledge exam 38 Gynecologic Endoscopy. In the six years of training, skills up to level II need to be Practical exam laparoscopic skills exam acquired. The courses are organized regionally, on a small scale, to secure enough - Abstracted from the FLS training model with two new exercises developed more specific for urology practical exposure and personal feedback for the participants. Practical training on - Yearly nationwide examination simulators is mainly done in the separate teaching hospitals. Unfortunately, the availability Notes: OSATS = Objective Structured Assessment of Technical Skills70 of skills labs and simulation facilities still varies among the different hospitals. This hampers the implementation process and can make passing a simulation exam before starting surgery difficult. In some regions, a portfolio for laparoscopic surgery is used. This enables a good insight in the progression of the resident.

38 39 Implementation of simulation in surgical practice Chapter 2

Urology and identification of the stakeholders (e.g. one specialty or more specialties) and The Dutch Foundation of Endourology forms the platform for urological endoscopic resources are important early on in its development. The personnel, space resources and skills training. A large national project “Training in Urology” with a focus on the develop- equipment purchased should be tailored by the curricular needs and not the other way ment of extended educational programs, using validated training models was started in around.44 If not, one could end up with an expensive empty shell, being a beautifully 2007. A special module “Basic Laparoscopic Urological Skills” for training MIS in urology equipped, empty space with a disappointed staff to run it. was developed (Table 3). Residents receive the program when they start training and can start the basic skills training in their own hospital. Figure 4. Virtual reality skills centre for training MIS (UMC Utrecht, the Netherlands)

Skills curricula and skills laboratory: common denominators and differences

Providing sophisticated simulators to hospitals is not enough to assure that trainees will start training. Simulator training should be incorporated in an obligatory training program. If this does not happen, most trainees will simply not be sufficiently motivated to train.39 To be optimally effective, the simulator training should be incorporated not only in an obligatory, but also in a competency-based training program. These programs are based on the progression of the trainee rather than on parameters measuring merely efficiency (such as ‘path length’ or time spent on training). This is important as we know now that the rate of progression, as reflected in the individual learning curve, may vary considerably among trainees.40 Surgical skill acquisition can be subdivided in a three stage progression model: a cognitive stage (knowledge), an associative stage (technical skill) and an autonomous stage (adequate judgment). All three stages need to be addressed in a good surgical skills curriculum.41 The practical surgical skill curricula developed in the last decade mainly focus on the associative stage. Some authors describe a more general development of a surgical skills curriculum in which an integrated approach of all three stages is well documented. Gallagher et al describe an eight step approach to set up a surgical skills curriculum regardless of specialty program, including 1) didactic teaching, 2) instruction, 3) common errors, 4) test of didactic information, 5) technical skills training, 6) provide immediate feedback, 7) provide summative feedback, 8) include repeated trials, learning curve and a proficiency performance goal.42 McClusky et al give a good description of a sequential, progressive, modular surgical skills curriculum. The modular system distinguishes five different modules; Module 1, knowledge acquisition, Module 2, psychomotor assessment & initial acquisition, Module 3, integration of knowledge & psychomotor skills, Module 4, supervised ‘real-world’ application, Module 5, mastery.43 With such a stepwise or modular system in mind, it is possible to develop proficiency or competence based surgical skills curricula for all type of procedures. Depending on the goal of the curriculum, different simulators or specific tasks, as long they themselves are validated, may be incorporated in the curriculum. When bringing a well-designed surgical skills curriculum into practice, an appropriate environment such as a skills centre is essential (Figure 4). Before setting up a skills centre it is important to define the mission of the centre. Definition of the purpose(s)

40 41 Implementation of simulation in surgical practice Chapter 2

Discussion portfolios of general surgery and gynecology. When building a skills laboratory, it is important to adjust or equip the skills laboratory based on the needs of the people work- Developing and implementing a nation wide training program for MIS is a very complex ing near to it, the demands of the institute in which it is hosted, and the skills curricula and demanding process. The guidelines, derived from the report of the Dutch set by the different professional embodiments. In this way skills training for MIS can be Inspectorate of Healthcare in 2007, enforced the development of structured competency- cost-effective.48 based training programs in surgery, obstetrics and gynecology and urology.12 These three front running subspecialties using MIS now have their own program on paper, but they all experience problems with nationwide implementation of the programs. Facilities are Conclusions not always properly equipped, teaching staff is not always willing or able to teach such a curriculum, and residents are often too occupied with daily practice core activities to Simulation based training is effective for training MIS and the learned skills have shown train.45 Eventually, most often human barriers are the hardest to overcome. The NVMO to be transferable into the operating room, leading to improvement of patient safety. special interest group in Skills & Simulation and the DSSH are building bridges between Simulators should not be used on their own, but should be incorporated in a competency- the different subspecialties for optimal use of resources and to enhance standardization or proficiency- based laparoscopic training curriculum, using criteria set by the of training programs. professional community, to be enforced by the hospital board. To implement such a In all programs, simulation based training to a certain level of competence is stated to be curriculum, good cooperation between institutional board, program director, department mandatory before the trainee can start MIS on patients as a first operator. To implement chair, medical staff and trainees is thus essential. In the Netherlands the subspecialties and enforce this, a change in culture of residents and staff is required. Without additional of Surgery, Obstetrics and Gynecology and Urology each developed a training curriculum support from the department chair and institution board of the hospital, this is almost a for MIS. These subspecialties are now challenged with the implementation of the training mission impossible. A key factor is the motivation of staff and trainees, who all should curricula and notice that funding, motivation and commitment are crucial factors. commit themselves to the agreed training program. Trainee motivation may be influenced Perhaps most crucial is, however, the human factor. Different viewpoints on proposed to a certain extent. Internal motivation of trainees varies from person to person and is national curricula are of course important but on the other side, cause serious delay in difficult to change, but external motivation of trainees can be influenced by staff and pro- implementation. A better approach would be to start the implementation once agreed gram directors, by organizing time to train during working hours, setting-up a upon by the respective societies, and sharpen the curricula using careful and timely competition, giving feedback, providing a small and easy accessible skills lab in the evaluation. The Dutch Society for Simulation in Healthcare, a fast growing national residents room and so on. Department chairs and program directors should simulation platform, provides a excellent platform for communication and sharing communicate the skills program to all involved and should create the allocated training knowledge between the different subspecialties, medical educators and hospital managers time during working hours; instead of trusting trainees to train by themselves in their as far as it concerns simulation based training. off-duty hours.41,45 It should be clear what is expected from trainees and staff. Furthermore, staff must agree on the issue not to allow residents to operate on patients Acknowledgements unless they have reached the set level of competence. The dedication and quality of staff The authors thank Dr. ir. Frank Delbressine for reading the outline and Barbara Schout, regarding MIS training could be of decisive importance for the success of a nationwide MD, PhD for providing the urology information. training program. The institutional board must facilitate the initiative in terms of offering space and resource for the initiative. The government, at last, through defining rules and Practice points checking the current status of implementation, is the key in enforcing timely action on - Simulator training cannot stand on its own, but needs to be a part of a training the proper implementation of proposed nationwide curricula and those institutes lacking curriculum. to do so. We know that many factors can affect the effectiveness of a surgical skills - A simulator on itself is not ‘valid’. It is the way it is used in a particular teaching curriculum for MIS. When creating a skills curriculum, one should take these factors into curriculum that determines its validity for the cause. account, in order to optimize skills acquisition and improve trainee readiness for the - Proficiency based skills training leads to less errors in the operating room and reduces operating room. Important factors are: deliberate practice, trainee motivation, operating time. performance feedback, task demonstration, practice distribution, task difficulty, practice - Well-developed training programs must be demanded by the government, developed variability, proficiency-based training, and performance assessment.46 To enhance self and defined by the medical societies and facilitated by the hospitals. directed learning and to evaluate results a portfolio for the trainee is a useful tool.47 In the - Allocated time for training and consequences when not fulfilling the training Netherlands, a separate section for MIS training was introduced in the subspecialty requirements stimulate skills training.

42 43 Implementation of simulation in surgical practice Chapter 2

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Schijven MP, Reznick RK, ten Cate OT, Grantcharov TP, Regehr G, Satterthwaite L, Thijssen AS, MacRae 16. Munz Y, Kumar BD, Moorthy K, Bann S, Darzi A. Laparoscopic Virtual Reality and Box Trainers: Is One HM. Transatlantic Comparison of the Competence of Surgeons at the Start of Their Professional Career. Superior to the Other? Surg Endosc 2004;18:485-94. Br J Surg 2010;97:443-9. 17. Fundamentals of Laparoscopic Surgery Program (FLS). www.flsprogram.org Accessed 30-8-2010. 46. Stefanidis D. Optimal Acquisition and Assessment of Proficiency on Simulators in Surgery. Surg Clin 18. Ritter EM, Scott DJ. Design of a Proficiency-Based Skills Training Curriculum for the Fundamentals of North Am 2010;90:475-89. Laparoscopic Surgery. Surg Innov 2007;14:107-12. 47. Lewis CE, Tillou A, Yeh MW, Quach C, Hiatt JR, Hines OJ. Web-Based Portfolios: a Valuable Tool for 19. Fried GM, Feldman LS, Vassiliou MC, Fraser SA, Stanbridge D, Ghitulescu G, Andrew CG. Proving the Surgical Education. J Surg Res 2010;161:40-6. Value of Simulation in Laparoscopic Surgery. Ann Surg 2004;240:518-25. 48. Stefanidis D, Hope WW, Korndorffer JR, Jr., Markley S, Scott DJ. Initial Laparoscopic Basic Skills 20. Al-Abed Y, Cooper DG. A Novel Home Laparoscopic Simulator. J Surg Educ 2009;66:1-2. Training Shortens the Learning Curve of Laparoscopic Suturing and Is Cost-Effective. J Am Coll Surg 21. Aggarwal R, Moorthy K, Darzi A. Laparoscopic Skills Training and Assessment. Br J Surg 2004;91:1549-58. 2010;210:436-40. 22. Botden SM, Jakimowicz JJ. What Is Going on in Augmented Reality Simulation in Laparoscopic Surgery? 49. Rosser JC, Rosser LE, Savalgi RS. Skill Acquisition and Assessment for Laparoscopic Surgery. Arch Surg Surg Endosc 2009;23:1693-700. 1997;132:200-4. 23. Lucas SM, Zeltser IS, Bensalah K, Tuncel A, Jenkins A, Pearle MS, Cadeddu JA. Training on a Virtual 50. Mettler L, Zuberi N, Rastogi P, Schollmeyer T. Role and Value of Laparoscopic Training Devices in Reality Laparoscopic Simulator Improves Performance of an Unfamiliar Live Laparoscopic Procedure. J Assessing Nondominant and Two-Handed Dexterity. Gynecol Surg 2006;3:110-4. Urol 2008;180:2588-91. 51. Kirby TO, Numnum TM, Kilgore LC, Straughn JM. A Prospective Evaluation of a Simulator-Based 24. Kundhal PS, Grantcharov TP. Psychomotor Performance Measured in a Virtual Environment Correlates Laparoscopic Training Program for Gynecology Residents. J Am Coll Surg 2008;206:343-8. With Technical Skills in the Operating Room. Surg Endosc 2009;23:645-9. 52. Dayan AB, Ziv A, Berkenstadt H, Munz Y. A Simple, Low-Cost Platform for Basic Laparoscopic Skills 25. Aggarwal R, Ward J, Balasundaram I, Sains P, Athanasiou T, Darzi A. Proving the Effectiveness of Virtual Training. Surg Innov 2008;15:136-42. Reality Simulation for Training in Laparoscopic Surgery. Ann Surg 2007;246:771-9. 53. 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54. Zheng B, Denk PM, Martinec DV, Gatta P, Whiteford MH, Swanstrom LL. Building an Efficient Surgical Team Using a Bench Model Simulation: Construct Validity of the Legacy Inanimate System for Endoscopic Team Training (LISETT). Surg Endosc 2008;22:930-7. 55. Arden D, Hacker MR, Jones DB, Awtrey CS. Description and Validation of the Pelv-Sim: a Training Model Designed to Improve Gynecologic Minimally Invasive Suturing Skills. J Minim Invasive Gynecol 2008;15:707-11. 56. Lentz GM, Mandel LS, Lee D, Gardella C, Melville J, Goff BA. Testing Surgical Skills of Obstetric and Gynecologic Residents in a Bench Laboratory Setting: Validity and Reliability. Am J Obstet Gynecol 2001;184:1462-8. 57. Black M, Gould JC. Measuring Laparoscopic Operative Skill in a Video Trainer. Surg Endosc 2006;20:1069-71. 58. Kolkman W, van der Put M, Wolterbeek R, Trimbos J, Jansen F. Laparoscopic Skills Simulator: Construct Validity and Establishment of Performance Standards for Residency Training. Gynecol Surg 2008;5:109-14. 59. Clevin L, Grantcharov TP. Does Box Model Training Improve Surgical Dexterity and Economy of Movement During Virtual Reality Laparoscopy? A Randomised Trial. Acta Obstet Gynecol Scand 2008;87:99-103. 60. Risucci D, Cohen JA, Garbus JE, Goldstein M, Cohen MG. The Effects of Practice and Instruction on Speed and Accuracy During Resident Acquisition of Simulated Laparoscopic Skills. Curr Surg 2001;58:230-5. 61. Verdaasdonk EG, Stassen LP, Schijven MP, Dankelman J. Construct Validity and Assessment of the Learning Curve for the SIMENDO Endoscopic Simulator. Surg Endosc 2007;21:1406-12. 62. Pellen MG, Horgan LF, Barton JR, Attwood SE. Construct Validity of the ProMIS Laparoscopic Simulator. Surg Endosc 2009;23:130-9. 63. Strom P, Kjellin A, Hedman L, Johnson E, Wredmark T, Fellander-Tsai L. Validation and Learning in the Procedicus KSA Virtual Reality Surgical Simulator. Surg Endosc 2003;17:227-31. 64. Zhang A, Hunerbein M, Dai Y, Schlag PM, Beller S. Construct Validity Testing of a Laparoscopic Surgery Simulator (Lap Mentor): Evaluation of Surgical Skill With a Virtual Laparoscopic Training Simulator. Surg Endosc 2008;22:1440-4. 65. Larsen CR, Grantcharov T, Aggarwal R, Tully A, Sorensen JL, Dalsgaard T, Ottesen B. Objective Assessment of Gynecologic Laparoscopic Skills Using the LapSimGyn Virtual Reality Simulator. Surg Endosc 2006;20:1460-6. 66. Stefanidis D, Haluck R, Pham T, Dunne JB, Reinke T, Markley S, Korndorffer JR, Jr., Arellano P, Jones DB, Scott DJ. Construct and Face Validity and Task Workload for Laparoscopic Camera Navigation: Virtual Reality Versus Videotrainer Systems at the SAGES Learning Center. Surg Endosc 2007;21:1158-64. 67. Schijven MP, Jakimowicz JJ, Carter FJ. How to Select Aspirant Laparoscopic Surgical Trainees: Establishing Concurrent Validity Comparing Xitact LS500 Index Performance Scores With Standardized Psychomotor Aptitude Test Battery Scores. J Surg Res 2004;121:112-9. 68. Buzink SN, Goossens RH, De RH, Jakimowicz JJ. Training of Basic Laparoscopy Skills on SimSurgery SEP. Minim Invasive Ther Allied Technol 2010;19:35-41. 69. Iwata N, Fujiwara M, Kodera Y, Tanaka C, Ohashi N, Nakayama G, Koike M, Nakao A. Construct Validity of the LapVR Virtual-Reality Surgical Simulator. Surg Endosc 2011;25:423-8. 70. Martin JA, Regehr G, Reznick R, MacRae H, Murnaghan J, Hutchison C, Brown M. Objective Structured Assessment of Technical Skill (OSATS) for Surgical Residents. Br J Surg 1997;84:273-8.

46 47 Laparoscopic skills training using inexpensive box trainers: Which exercises to choose when constructing a validated training course 3

Henk W.R. Schreuder Caroline B. van den Berg Eric J. Hazebroek René H.M. Verheijen Marlies P. Schijven

BJOG: An International Journal of Obstetrics and Gynaecology In press Laparoscopic skills training using box trainers Chapter 3

Introduction Abstract To perform laparoscopic surgery safely, several unique psychomotor skills are required Objective from the surgeon. These include adaptation to the conversion from 3 dimensional to 2 To obtain face and construct validity for a new training course to be used in any type dimensional vision, bi-manual dexterity, handling long instruments with an amplified of box/video trainer and to give a comprehensive overview of validated exercises for tremor, dealing with the fulcrum effect and reduced tactile feedback. Simulation can be box/video training. used to master these skills. Training on simulation models leads to a faster pace of the learning curve of the individual surgeon in a safe environment, thereby decreasing the Design burden on operating time and costs and increasing patient safety.1,2 Nowadays, different Cross-sectional study simulation models and -scenarios have been introduced and incorporated in various laparoscopic training curricula.3 In general, these models can be categorized as in vivo Setting anaesthetized or ex vivo animal trainers, high fidelity and low fidelity virtual reality University Medical Centre simulators and inanimate box or video trainers.1,4-8 The training capacities of box trainers and virtual reality trainers are comparable and no difference was found in laparoscopic Population skills acquisition when incorporating virtual reality trainers in a training curriculum based Students, residents and consultants on box trainers.9 There is a good correlation between both trainers for the assessment of laparoscopic skills, although box trainers do require a supervisor for assessment whereas Methods outcome assessment is embedded in most virtual reality trainers.10 Participants (n=42) were divided in three groups according to their laparoscopic experience: ‘Novices’(n=18), ‘Intermediates’(n=14) and ‘Experts’(n=10). A laparo- Compared with virtual reality trainers, box trainers have the advantage of being inexpen- scopic training course consisting of six exercises was constructed. To emphasize sive, easy realizable and thus better availability throughout hospitals. Next, standard precision, a penalty score was added. Every participant performed two repetitions of endoscopic instruments may be used and haptic feedback is preserved as in the operative the exercises; total score per exercise was calculated. To determine face validity, par- environment. This contributes to the reality of training and a proper transfer of skills to ticipants filled in a questionnaire after completion of the exercises. An evidence- the operating room. Because of their low cost, box trainers are a feasible choice in provid- based literature search for validated box/video trainer exercises was performed. ing training opportunities at home.11 In a cost-effective laparoscopic skills curriculum, box trainers may be used alone or in combination with virtual reality trainers and/or Main outcome measures animate models. A major advantage of box trainers is the preservation of haptic feedback Face and construct validity and literature overview and the opportunity to use standard endoscopic instruments. This kind of feedback is important to simulate laparoscopic surgery in a realistic way. Chmarra et al found a Results positive influence of box training on laparoscopic exercises when tactile forces do play an The mean score of the ‘experts’ was set as training target. Total scores appeared to important role (e.g. stretching, grasping).12 Even though box training lacks integrated be positively correlated with individual’s laparoscopic experience. The overall score objective assessment compared with virtual reality simulation, this feature is considered and the score for each exercise was significantly higher in the intermediate and to be an important one. Box training may thus be considered indispensable in a truly expert group when compared with the novice group (P-value≤0.001). All partici- comprehensive laparoscopic training curriculum. pants completed the questionnaire. The overall assessment of the exercises was considered to be good. The course was found to be most appropriate for training Before implementing and using any simulation model in a laparoscopy curriculum, it is residents year 1-3. important to determine the validity of the simulation model. Important steps in this process are the aspects of face- and construct validity of the box trainer for training Conclusion purposes. Face validity specifically addresses the question to what extent the instrument Face and construct validity for an inexpensive course for box/video training was does simulate what it is supposed to represent, and thus refers to the degree of established. A comprehensive and practical overview of all validated and published resemblance between the box trainer and the actual construct (development of psycho- exercises for box/video trainers is provided in order to facilitate an inexpensive, but motor laparoscopic surgical skill), as judged by a specific target population. Construct optimal and tailored selection for training purposes. validity refers to the degree of empirical foundation of the box trainer. Thus, a logical

50 51 Laparoscopic skills training using box trainers Chapter 3

difference in outcome between two research populations (e.g. experienced surgeons out- precision, was calculated by adding the exercise completion time to the penalty score. A perform inexperienced surgeons on the box trainer curriculum) is to be expected.13 lower score correlated with a better performance. The goal of the different exercises is to Unfortunately, scientific validation of these relatively inexpensive and commercially train and test various skills, such as hand-eye coordination, manual dexterity, depth per- available exercises for box trainers is relatively scarce. ception and interaction of the dominant and non-dominant hand. The different exercises The aim of this study was to establish face and construct validity of six newly developed are described in detail below. exercises for a box/video trainer to be used in a laparoscopic skills program. In addition to the validation study, we provide a clear and practical overview of the currently available Figure 1. validated exercises for box trainers. 1. “Post and sleeve” 2. “Loops and wire” 3. “Pea on a peg”

Methods

A newly developed set of laparoscopic exercise boards to be used in a box/video trainer was used for this study (3-Dmed®, Franklin, Ohio, USA). From April to June 2010, a validation study was performed at the department of gynaecology of the University Medical Centre in Utrecht, The Netherlands. All exercises were performed in a 42 x 32 x 24 cm box trainer with a fixed position camera (Covidien® Surgical Box, Mansfield, MA, USA). Two reusable laparoscopic graspers (Karl Storz®, Tuttlingen, Germany) were used to perform the exercises. A simple digital timer was used to measure the time. 4. “Wire chaser - one hand” 5. “Wire chaser - two hands” 6. “Zig-Zag loops”

Participants Medical students (5th and 6th year medical school), residents and consultants from the department of gynaecology, surgery and urology participated in the study (n=42). According to their respective laparoscopic experience, three study groups were formed. Group 1 ‘novice’ (n=18) consisted of medical students with no laparoscopic experience. Group 2 ‘intermediate’ (n=14) consisted of residents with moderate laparoscopic experience. ‘Moderate laparoscopic experience’ was defined as having performed none or less than 10 advanced laparoscopic procedures. In this group, residents in their 1st to 6th year of training in gynaecology, surgery or urology participated. Group 3 ‘experts’ (n=10) consisted of experienced laparoscopic surgeons, who all had performed >50 advanced procedures. Advanced procedures for gynaecologists were: laparoscopic Exercise 1: hysterectomy, laparoscopic sacrocolpopexy and laparoscopic lymphadenectomy. For gen- ‘Post and Sleeve’ (Video 1). The six sleeves are positioned on the left side of the board. eral surgeons: laparoscopic Nissen fundoplication, laparoscopic colectomy and laparo- The sleeves have to be picked up with the left hand, passed over to the right hand and scopic bariatric procedures. For urologists the laparoscopic prostatectomy was selected then be transferred to their mirrored posts on the opposite side. After the six sleeves as an advanced procedure. None of the participants had previous experience with this have been moved successfully to the other side, the exercise is to be repeated in opposite specific laparoscopic training set. direction, now starting with the right hand. Per dropped sleeve 10 penalty points are counted. Exercises Four different boards, each with a different configuration, were available to perform box Exercise 2: trainer exercises. We defined six exercises: ‘Post and Sleeve’, ‘Loops and Wire’, ‘Pea on a ‘Loops and Wire’ (Video 2).The board is positioned with four loops in front, two pipe Peg’, ‘Wire Chaser (one hand)’, ‘Wire Chaser (two hands)’ and ‘Zig-Zag Loops’ (Figure 1). cleaners are lying in front. The first pipe cleaner has to be introduced from the right side A proper description of the exercises was constructed and exercise-specific penalty scores trough the loops; the next pipe cleaner from the left side. Next, the two pipe cleaners were defined. Outcome parameters were set, and the ‘overall score’, based on time and must be passed through the first two rows of four loops, alternating dominant hand

52 53 Laparoscopic skills training using box trainers Chapter 3

maneuvers whenever appropriate. The task is finished when both pipe cleaners are Construct validity successfully placed through the two rows of loops. If a pipe cleaner is passed alongside a To establish construct validity, all participants performed the six different exercises twice. loop during the procedure, 10 penalty points are counted. Before each exercise the participants read the short instruction. Next, each exercise was briefly explained verbally and subsequently demonstrated by the test supervisor. The first Exercise 3: run was used as familiarization run, whereas the second run was in fact used to ‘Pea on a Peg’ (Video 3). The board is positioned with the cup, containing at least 25 determine construct validity. The individual times and scores of the three groups were wooden beads, in front. Fourteen wooden beads must be taken out one-by-one from the compared in order to evaluate the discriminative capacity of the task set for trainees with cup and be placed on various pegs of different height. The left side of the pegboard has different laparoscopic experience. Based on the extracted data the target levels for each to be completed with the left hand, the right side with the right hand. When a bead is exercise and the six exercises together were defined by calculating the mean scores of the dropped next to the pegboard, it can not be used anymore. When a bead falls on the expert group. pegboard it has to be picked up again in order to be successfully placed on a peg. Ten penalty points are counted when a bead is dropped on the pegboard; twenty penalty Statistics points are counted when a bead falls off the pegboard. SPSS 15.0 statistical software (SPSS Inc, Chicago, IL) was used to analyze the data. One- way ANOVA (analysis of variance) with multiple comparisons (post hoc Bonferroni test) Exercise 4: was used to obtain differences between the 3 groups. P values ≤ 0.05 were considered to ‘Wire Chaser’-one hand (Video 4). The board is positioned with the text “one hand” in be statistically significant; alpha was chosen at the 0.05 level. front. Three rings, with decreasing diameter, must be transferred one-by-one to the other side of the wire, using the dominant hand. If the ring is lost by the instrument, 10 penalty Literature search points are counted. To create an overview of the currently available and validated box trainer exercises a search using the Pubmed, Embase and Cochrane database engines was performed Exercise 5: between 1970 and May 2010. To avoid missing recent and not yet indexed articles we did ‘Wire Chaser’-two hands (Video 5). The board is positioned with the text “two hands” in not use MeSH-terms in our search. The following syntax was entered: (“validity” OR front. Three rings, with decreasing diameter, must be transferred one-by-one to the other “validation” OR “value” OR “valid” OR “validating”) AND (“laparoscopy” OR “laparo- side of the wire, starting with the dominant hand. Both hands are used and hands need scopic” OR “laparoscopies” OR “minimally invasive” OR “minimal invasive” OR “MIS” to change after each curve in the ring. If the ring is lost by the instrument, 10 penalty OR “box” OR “bench” OR “inanimate” OR “video”) AND (“education” OR “skills” OR points are counted. “skills” OR “training” OR “trainer” OR “exercise” OR “exercises” OR “simulator” OR “simulation” OR “instruction” OR “instructions” OR “teaching” OR “drill” OR “drills”). Exercise 6: The articles were screened on title and abstract. Articles handling about virtual reality ‘Zig-Zag Loops’ (Video 6). The board is positioned with four loops in front, the rope is training and about simulation of specific surgical procedures and articles in another lan- lying in front. The rope must b e passed through the four loops of the first and second guage than English, Dutch or German were excluded. The remaining articles were row of the loop-board, resulting in a zigzag pattern. This has to be done by using both screened for possibly relevant references. hands, starting from the right side. If the rope is passed besides a loop during the procedure, 10 penalty points are counted.

Face validity All participants were asked to fill out a questionnaire, immediately after performing the six exercises in order to obtain information about their general characteristics, educational background and their general impression of the exercises. Question 1-8 related to demographics and laparoscopic experience. Question 9-24 included questions about the exercises’ appearance, materials, feasibility, difficulty, training capacity and opportunities for implementation. The questions were presented on a 5-point Likert scale.

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Results Face validity The participants (n=42) were categorized into three groups based on their laparoscopic All participants completed the questionnaire (n=42). The overall assessment of the experience: novices (n=18), intermediates (n=14), experts (n=10). Demographic data and exercises for developing laparoscopic psychomotor skill was considered to be uniformly previous training experience are shown in Table 1. Intermediates had more training ‘good’, all being rated above 4.0 on the 5-point Likert scale (Table 2). The novices, inter- experience on box trainers and virtual reality trainers than experts. mediates and experts rated the complete program of six exercises 4.1, 4.3 and 4.1 points, respectively. Difficulty of exercises was rated to be between ‘intermediate’ and ‘difficult’. Table 1. Characteristics participants The participants were also asked for their opinion about the suitability of these exercises Novices Intermediates Experts to different levels of laparoscopic experience. They expected the exercises to be the most (n=18 ) (n=14) (n=10) appropriate for post graduate residents year 1-3 and the least appropriate for laparoscopic Mean age (range) 24 (23-26) 29 (25-34) 43 (36-54) experts. After the general assessment, participants had to evaluate each exercise sepa- Gender rately. The assessment of different aspects of the exercises separately is shown in Table 3. Male 6 8 9 Female 12 6 1 Table 2. Face validity (general assessment) Hand dominance Novices Intermediates Experts Mean Left hand dominant 2 2 0 (n=18 ) (n=14) (n=10)

Medical Specialty Suitability to train psychomotor skills 4.2 ± 0.6 4.1 ± 1.3 4.4 ± 0.5 4.2 ± 0.9 Gynecology N/A 8 6 Surgery N/A 3 3 Possibility to assess the exercises on the Urology N/A 3 1 3.9 ± 0.5 3.7 ± 1.0 3.6 ± 0.7 3.7 ± 0.7 basis of objective parameters Experience laparoscopic box training (times) none 14 3 2 Difficulty exercises 3.2 ± 0.6 3.3 ± 0.8 3.4 ± 0.5 3.3 ± 0.7 1-5 4 3 2 6-10 0 3 1 These exercises are appropriate for box 11-20 0 3 0 4.3 ± 0.7 4.2 ± 0.9 4.6 ± 0.7 4.3 ± 0.7 training >20 0 2 5 Training capacity Experience laparoscopic box training (hours) eye/hand coordination 4.1 ± 0.7 4.3 ± 0.9 4.3 ± 0.7 4.2 ± 0.7 N/A 14 3 2 depth perception 3.3 ± 0.8 3.7 ± 1.4 3.4 ± 1.2 3.5 ± 1.1 1-5 4 0 3 training both hands separately 4.0 ± 0.6 4.2 ± 0.4 4.3 ± 0.5 4.1 ± 0.5 6-10 0 3 1 training both hands together 3.8 ± 0.8 4.2 ± 0.4 4.0 ± 0.0 4.0 ± 0.6 11-20 0 7 2 21-50 0 1 2 Fitness for different levels of experience: >50 0 0 0 residents PGY 1-3 4.3 ± 0.5 4.9 ± 0.3 4.4 ± 0.7 4.5 ± 0.5 residents PGY 4-6 3.1 ± 1.1 3.8 ± 1.0 4.4 ± 0.7 3.6 ± 1.1 Experience laparoscopic virtual reality training (times) medical specialist 2.6 ± 1.1 3.1 ± 0.7 3.7 ± 1.1 3.0 ± 1.0 none 14 3 3 laparoscopic expert 2.0 ± 1.0 2.1 ± 0.8 2.6 ± 1.1 2.2 ± 0.8 1-5 4 8 3 6-10 0 2 1 Box training should be part of a 4.1 ± 0.6 4.6 ± 0.6 4.5 ± 0.7 4.4 ± 0.7 11-20 0 0 1 laparoscopic curriculum >20 0 1 2 VR training should be part of a 3.9 ± 0.8 4.6 ± 0.5 4.6 ± 0.7 4.3 ± 0.8 Experience laparoscopic virtual reality training (hours) laparoscopic curriculum none 15 3 3 1-5 2 6 3 Box training and VR training should both 4.2 ± 0.7 4.9 ±0.3 4.8 ± 0.4 4.6 ± 0.6 6-10 0 2 2 be part of a laparoscopic curriculum 11-20 1 3 0 21-50 0 0 2 Overall assessment 4.1 ± 0.4 4.3 ± 0.6 4.1 ± 0.6 4.1 ± 0.5 >50 0 0 0 Data are presented as mean ± SD. *Ratings on a 1 to 5 Likert scale (1=very bad/strongly disagree, 2 = bad/ Laparoscopic experience Non or <10 > 50 disagree, 3 = neutral, 4 = good/agree, 5 = very good/strongly agree). VR= virtual reality. N/A advanced Advanced procedures procedures Data are presented as mean (range) or number. N/A = not applicable. 56 57 Laparoscopic skills training using box trainers Chapter 3

Table 3. Face validity (assessment by exercise) Construct validity Novices Intermediates Experts Mean All participants (n=42) completed the two repetitions of the six exercises. The score for (n=18 ) (n=14) (n=10) each exercise and the overall score are shown in Table 4. The overall mean score and the Exercise 1: ‘Post and sleeve’ 4.0 ± 0.5 4.4 ± 0.4 4.2 ± 0.6 4.2 ± 0.5 score for each exercise was significantly higher in both the intermediate- (P<0.001) and Appearance 4.1 ± 0.6 4.4 ± 0.5 4.3 ± 0.9 4.2 ± 0.7 expert group (P<0.001), compared to the novice group. The overall mean scores of the Practicability 4.1 ± 0.5 4.6 ± 0.5 4.7 ± 0.5 4.4 ± 0.5 novices, intermediate and expert group were 1891, 1022 and 763 respectively. There was a Material 4.1 ± 0.9 4.6 ± 0.5 4.4 ± 0.7 4.3 ± 0.8 significant difference comparing the novice group with the intermediate (P<0.001) or Projection in the box 4.1 ± 0.8 4.4 ± 0.7 3.8 ± 0.4 4.1 ± 0.7 Training capacity 3.9 ± 0.7 4.2 ± 0.7 4.0 ± 0.9 4.0 ± 0.7 expert group (P<0.001). No statistical significance was reached between the intermediate and the expert group (P=0.369) (Figure 2). However, the set-up is likely to be construct Exercise 2: ‘Loops and wire’ 3.9 ± 0.5 3.8 ± 0.8 4.1 ± 0.6 3.9 ± 0.6 valid in the sense that more laparoscopic experience appeared to be associated with a Appearance 3.9 ± 0.6 3.9 ± 1.0 3.9 ± 0.6 3.9 ± 0.7 better performance. Practicability 4.1 ± 0.6 4.1 ± 0.8 4.7 ± 0.7 4.3 ± 0.6 Material 3.9 ± 1.0 3.8 ± 1.1 4.4 ± 0.8 4.0 ± 0.9 Construct validity (total score = time + penaties) Projection in the box 4.0 ± 0.8 4.0 ± 0.9 3.9 ± 1.0 4.0 ± 0.8 Table 4. Training capacity 3.8 ± 0.6 3.9 ± 0.7 3.7 ± 0.8 3.8 ± 0.7 Exercises Group 1 Group 2 Group 3 ANOVA Multiple Post Hoc Novices Intermediates Experts comparisons Bonferroni Exercise 3: ‘Pea on a peg’ 4.0 ± 0.6 4.3 ± 0.6 4.3 ± 0.6 4.2 ± 0.6 (n=18 ) (n=14) (n=10) Appearance 4.1 ± 0.8 4.5 ± 0.7 4.5 ± 0.7 4.3 ± 0.7 Mean score Mean score Mean score P value P value Practicability 3.7 ± 0.8 4.0 ± 1.0 4.3 ± 0.7 4.0 ± 0.9 (range) (range) (range) Material 4.1 ± 0.9 4.1 ± 1.2 4.2 ± 0.8 4.1 ± 0.9 Projection in the box 3.9 ± 0.8 4.0 ± 0.7 3.5 ± 0.7 3.8 ± 0.8 Post and 299 (159-602) 161 (91-307) 120 (78-232) <0.001 1 > 2 <0.001 Training capacity 4.3 ± 0.8 4.6 ± 0.5 4.3 ± 0.8 4.4 ± 0.7 sleeve 1 > 3 <0.001 2 > 3 0.759 Exercise 4: ‘Wire chaser’ (one hand) 3.5 ± 0.7 3.4 ± 1.2 3.6 ± 0.7 3.5 ± 0.9 Appearance 3.8 ± 0.6 3.9 ± 1.3 3.8 ± 0.6 3.8 ± 0.9 Loops and 176 (111-298) 108 (59-176) 86 (61-121) <0.001 1 > 2 <0.001 1 > 3 <0.001 Practicability 3.3 ± 0.8 3.2 ± 1.4 4.0 ± 1.1 3.5 ± 1.1 wire 2 > 3 0.690 Material 3.6 ± 1.1 3.2 ± 1.4 3.6 ± 1.2 3.5 ± 1.1 Projection in the box 3.4 ± 1.2 3.6 ± 1.2 3.4 ± 1.1 3.5 ± 1.2 Pea on a peg 771 (345-1450) 404 (186-768) 313 (203-552) <0.001 1 > 2 <0.001 Training capacity 3.5 ± 0.9 3.3 ± 1.3 3.4 ± 1.0 3.4 ± 1.0 1 > 3 <0.001 2 > 3 1.000 Exercise 5: ‘Wire chaser’ (two hands) 3.7 ± 0.6 3.6 ± 1.1 3.4 ± 0.6 3.6 ± 0.8 Appearance 3.8 ± 0.6 3.7 ± 1.3 3.9 ± 0.6 3.8 ± 0.9 Wire chaser 195 (60-417) 113 (31-306) 69 (23-182) <0.001 1 > 2 0.019 Practicability 3.5 ± 0.8 3.4 ± 1.2 3.6 ± 1.0 3.5 ± 0.9 (one hand) 1 > 3 <0.001 Material 3.8 ± 0.7 3.4 ± 1.2 3.7 ± 1.1 3.6 ± 1.0 2 > 3 0.573 Projection in the box 3.5 ± 0.9 3.8 ± 1.1 3.0 ± 1.2 3.5 ± 1.1 Wire chaser 317 (191-503) 166 (78-371) 127 (74-248) <0.001 1 > 2 <0.001 Training capacity 3.9 ± 0.8 3.6 ± 1.1 3.3 ± 0.8 3.7 ± 0.9 (two hands) 1 > 3 <0.001 2 > 3 0.685 Exercise 6: ‘Zig-Zag loops’ 4.1 ± 0.7 4.0 ± 0.7 4.1 ± 0.9 4.1 ± 0.7 Zig-Zag loops 134 (69-219) 70 (29-136) 48 (28-82) <0.001 1 > 2 <0.001 Appearance 4.1 ± 0.8 3.9 ± 0.9 4.3 ± 0.8 4.0 ± 0.8 1 > 3 <0.001 Practicability 4.3 ± 0.9 4.1 ± 0.7 4.4 ± 0.8 4.3 ± 0.8 2 > 3 0.397 Material 4.0 ± 0.9 4.1 ± 0.8 4.4 ± 1.1 4.1 ± 0.9 Projection in the box 4.3 ± 0.7 3.9 ± 0.8 3.8 ± 0.9 4.0 ± 0.8 Overall Score 1891 (1102- 1022 (621-2030) 763 (523-1199) <0.001 1 > 2 <0.001 Training capacity 3.9 ± 0.9 3.9 ± 0.8 3.8 ± 0.9 3.9 ± 0.8 2683) 1 > 3 <0.001 2 > 3 0.369 Data are presented as mean ± SD. *Ratings on a 1 to 5 Likert scale (1 = very bad, 2 = bad, 3 = neither good nor bad, 4 = good, 5 = very good). One-way ANOVA (analysis of variance) was used to define the difference between the three groups. Multiple comparisons with the Post Hoc Bonferroni test was used to define the difference between the three groups separately. Exact P-values were calculated and are shown to three decimals places.

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Figure 2. The total score of the six exercises of group 1 (novice), group 2 (intermediate) and group 3 (expert). Table 5. Overview validated box trainer exercises The difference between group 1 and 2 and 1 and 3 was significant (P<0.001). * and º are outliers. Skill set Trainer Exercise Validity Price Commercially exercises available

Schreuder 2010 Box trainer 1) Post & Sleeve Face validity (present study) $ 165,- Yes 2500 (3-Dmed skill (peg board) Construct validity (present game kit) 2) Loops & Wire study) (pipe cleaner) - Better performance with 2000 * 3) Pea on a Peg more laparoscopic (bead transfer) experience 4) Wire Chaser 1500 (one hand) 5) Wire chaser otalscore T (two hands) 6) Zig-Zag loops 1000 (rope passing)

MISTELS Box trainer 1) Pegboard patterns Face validity1 Unknown Partly in FLS 500 (McGill 2) Pattern cutting Construct validity1,14-16,21 1 2 3 Inanimate System 3) Clip application - Better performance with Group for Training and 4) Placement ligating loop more laparoscopic Evaluations of 5) Mesh placement experience Laparoscopic 6) Intracorporeal knot - Improvement after training Skills) 7) Extracorporeal knot External validity1 Overview validated box training exercises Predictive/concurrent The literature search resulted in one thousand one hundred sixty-five articles of which after validity1,4,22 screening twenty articles remained (Figure 3). These articles describe validated box trainer exercises, which are either commercially available or give a description how to build them. FLS Box trainer Exercise 1, 2, 4, 6 and 7 Exercise 3 and 5 of the original $377,50 Yes (Fundamentals from MISTELS MISTELS program were From these articles an overview was extracted of the main features of the exercises (Table 5). of Laparoscopic removed because of high costs Surgery and no substantially added value23 Predictive Validity32,33 Figure 3. Flowchart literature search YLSSP Laparoscopic 1) Cup drop drill Construct validity: Unknown Unknown Search in Pubmed, (Yale Surgi-trainer 2) Rope pass drill - Significantly different Embase and Cochrane Laparoscopic 1) Triangle transfer drill performance between databases Screening on title and abstract: Skills and 1) Laparoscopic suturing trained surgeons and Suturing residents for exercise 1 and Inclusion criteria: Program) 3, no significant difference 1165 titles - domain: simulation of for exercise 2 and 434 laparoscopic surgery Excluding duplicates - Improvement after training7 - determinant: box/video (-147) - Significant different trainer exercises 1018 titles performance (+ peg transfer - outcome: validity MISTELS)18

Exclusion criteria 55 titles Southwestern Video trainer Exercise 1-4 Yale LSSP Face validity36 Unknown Unknown + Construct validity - virtual simulation No full text available Video trainer - Better performance with - simulation of a specic (-4) stations Checkerboard task surgical procedure 51 titles (Jones)35 more laparoscopic - language other than English, experience36,37 Screening full text Dutch or German - Improvement after (-37) training7,38,39 14 titles Concurrent validity38,39 Screening related articles/references 20 titles (+6)

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Skill set Trainer Exercise Validity Price Commercially Skill set Trainer Exercise Validity Price Commercially exercises available exercises available

SIMULAB LapTrainer with Mettler 2006 Construct validity29 ±$ 225.- Yes Black 2006 Video trainer 1) Rope pass Construct validity41 Unknown Yes SimuVision 1) Touching 16 plastic pegs - Better performance with (resemble 2) Peg drop - Better performance with (MISTELS) LTS-10 2) Pull 14 flags from nail more laparoscopic MISTELS) 3) Peg exchange more laparoscopic poles experience for task 2-5 4) Needle pass experience 3) Put rubber rings over - Improvement after training 5) Knot tie nail poles 4) Key trainer task Kolkman 2008 Box trainer 1) Pipe cleaner Construct validity19 < € 25,- No 5) IC suturing and knot (developed by 2) Placing rubber band - Better performance with (can be Kirby 2008 Construct validity17 author, based on 3) Placing beads more laparoscopic constructed 1) Peg board task - Better performance with MISTELS tasks) 4) Cutting circle experience by trainer) 2) Key trainer task more laparoscopic 5) Intra-corporeal knot - Improvement after training 3) Curved-line cutting task experience tying 4) Circle-cutting task - Improvement after training 5) EC suturing and knot Clevin 2008 Box trainer 1) Moving pegs on a board Construct validity:26 Not No 6) IC suturing and knot (developed by (upside-down 2) Cutting out a circle of a - Improvement after training applicable (can be Dayan 2008 author) plastic wash sponge (assessed by VR trainer constructed 1) Rope passing tub) 3) Introducing an epidural LapSim) by trainer) 28 2) Transferring pegs Face validity catheter into a tube 28 3) IC suturing and knot Construct validity 4) Applying clips on a cord - Better performance with 5) Cutting out the inner more laparoscopic balloon of two balloons experience (enucleation cyst)

LASTT Szabo trainer 1) Measuring 14 targets Face validity2730 € 800,- Yes (Laparoscopic box 2) Placing cylinders on six Construct validity27,30 Skills Testing and coloured targets - Better performance with Training) 3) Push pins on circular more laparoscopic Discussion holes experience - Improvement after training In this study, face- and construct validity was obtained for six newly available exercises for LISETT (Legacy Ethicon 1) Peg transportation Construct validity40 Unknown Unknown laparoscopic skills training. Combined, they constitute a short training curriculum ready Inanimate System Laptrainer 2) Intracorporeal suture - Better performance with to use in any box or video trainer. A significant difference between non-experienced and for Laparoscopic tasks performed by 2 more laparoscopic experienced laparoscopic participants was found. However, the difference between the Team Training) participants experience intermediate group and expert group was not statistically significant. An explanation

Lentz 2001 Mirrored 1) Running the bowel Construct validity6 <$50 No could be the fact that the participants in the intermediate group were already used to trainer and box 2) Moving TicTacs - Better performance with (can be train on both box and/or virtual reality trainers. This bias is unavoidable since box trainer 3) Doubling an elastic hair more laparoscopic constructed training is nowadays an essential part of their laparoscopic training and most residents band over 2 posts experience by trainer) 4) Peg-board task have spent therefore more training on simulators then experts. Two out of the six 5) Running a pipe cleaner exercises in the current study show some similarity to exercises described in other 6) Racing balls through laparoscopic programs; exercise 1 (‘Post and Sleeve’)14-18 and exercise 2 (‘Loops and wickets Wire’).19 Quite innovative exercises are exercise 3 (‘Pea on a Peg’), exercise 4 (‘Wire Pelv-Sim Pelv-Sim box 1) Closing vaginal cuff Construct validity25 <$50 No chaser’-one hand) and exercise 5 (‘Wire chaser’-two hands). A majority of the participants (developed by trainer 2) Transposing an ovary - Better performance with (can be found exercise 3 (‘Pea on a Peg’) to be the most difficult exercise, but assessed this author) 3) Ligate IP ligament more laparoscopic constructed exercise very positive. Probably this is due to the fact that this exercise trains important 3) Closing fascial incision experience by trainer) - Improvement after training skills, like subtle movement and coordination. In laparoscopic surgery the trainee/surgeon needs to acquire new and different skills compared to open surgery. In this training course, the conversion from 3 dimensional to

62 63 Laparoscopic skills training using box trainers Chapter 3

2 dimensional vision and dealing with the fulcrum effect is being trained in all exercises. compared to box trainers, which can be a burden for many hospitals. In these situations, Bi-manual dexterity is specifically trained in exercise 2, 3, 4, 5 and 6. Handling long a well-designed, competence based validated laparoscopic skills curriculum using box instruments with amplified tremor is specifically trained in exercise 3, which needs trainers only, can be very sufficient. Palter et al. investigated resident perceptions regard- precision and stability of the instruments. The reduced tactile feedback plays a role in ing different forms of laparoscopic simulation. Their study showed residents even pre- exercise 3. Task time is an important parameter in simulation training, but task time ferred box training above VR training for training advanced laparoscopic skills. This alone has its limitations. One may cause serious adverse events when performing too should be taken in to account when designing a surgical skills curriculum for advanced fast in laparoscopy. To overcome this problem and to force the trainee to work carefully a laparoscopy.31 penalty score for certain mistakes was introduced. The penalty score will keep the trainee Today, laparoscopic simulators play an important role in learning and training minimal more focused compared with using task time alone, and prevents trainees ‘chasing’ for invasive surgery. To maximize training capacities the simulators should be implemented efficiency whereas compromising precision. This kind of scoring system was previously in an obligatory competence or proficiency based laparoscopic skills curriculum. In such used in other box training validation studies.17,19 a curriculum, box/video trainers and/or virtual reality trainers may be used alone or in Laparoscopic simulators have become an indispensable part of every laparoscopic skills combination. Only validated exercises with a proper training goal should be used in a program. To be optimal effective, simulator training should be incorporated in an skills curriculum. In terms of cost-effectiveness, the box trainer remains unsurpassed. obligatory and competence based laparoscopic skills curriculum. This implies that training is based on the progress of the trainee instead of being based on the mere time Acknowledgements spent on training. For program directors it is now possible, by choosing different We would like to thank all participants. exercises, to develop and tailor their own laparoscopic skills curriculum to their resources, goals and needs. In these way affordable skills curricula can be created. Special attention has to be paid in choosing exercises to be used in a self constructed unmonitored laparoscopic skills curriculum. These exercises should be clearly described and validated. Before embarking on independent training, a demonstration must be provided in order to avoid misinterpretations and a test round must be observed to check the system and inappropriate handling of instruments. There must also be a clear and pre-defined goal or level that is to be reached by the trainee.20 Through the years, several exercises to be used in box trainers were developed. The McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) has been widely studied.1,14-16,21,22 Based on certain MISTELS tasks the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) developed the Fundamentals of Laparoscopic Surgery (FLS) program.23 The FLS program includes a box trainer based technical skill component, a didactic component and an assessment component.24 Next to this complete program, which is used world wide, we think there is a need for easy usable exercises for box training. Such exercises could be used in box trainers in the OR department or in the resident room and could be incorporated in training curricula. However, many of the available exercises are not validated for their intended purpose. We provide, next to the exercises validated in this study, an overview of the currently available and valideated exercises for box or video trainers (Table 5). This may be helpful for trainers and program directors in the selection of the appropriate training exercises in constructing a training curriculum. Most of the exercises can be constructed by the instructor6,25,26 or are readily commercially available.17,22,23,27-30 Besides box trainers, VR trainers may used in a laparoscopic skills curriculum. VR trainers have the advantage of objective assessment and high fidelity simulators are able to offer training of full procedural tasks. As for haptic feedback, authors believe that they are potentially inferior to a box trainer. A disadvantage of VR are the high costs when

64 65 Laparoscopic skills training using box trainers Chapter 3

References 26. Clevin L, Grantcharov TP. Does Box Model Training Improve Surgical Dexterity and Economy of Movement During Virtual Reality Laparoscopy? A Randomised Trial. Acta Obstet Gynecol Scand 1. Fried GM, Feldman LS, Vassiliou MC, Fraser SA, Stanbridge D, Ghitulescu G, Andrew CG. Proving the 2008;87:99-103. Value of Simulation in Laparoscopic Surgery. Ann Surg 2004;240:518-25. 27. Campo R, Reising C, van Belle Y, Nassif J, O’Donovan P, Molinas CR. A Valid Model for Testing and 2. Munz Y, Kumar BD, Moorthy K, Bann S, Darzi A. Laparoscopic Virtual Reality and Box Trainers: Is One Training Laparoscopic Psychomotor Skills. Gynecol Surg 2010;7:133-41. Superior to the Other? Surg Endosc 2004;18:485-94. 28. Dayan AB, Ziv A, Berkenstadt H, Munz Y. A Simple, Low-Cost Platform for Basic Laparoscopic Skills 3. Medina M. Formidable Challenges to Teaching Advanced Laparoscopic Skills. JSLS 2001;5:153-8. Training. Surg Innov 2008;15:136-42. 4. Feldman LS, Sherman V, Fried GM. Using Simulators to Assess Laparoscopic Competence: Ready for 29. Mettler L, Zuberi NF, Rastogi P, Schollmeyer T. Role and Value of Laparoscopic Training Devices in Widespread Use? Surgery 2004;135:28-42. Assessing Nondominant and Two-Handed Dexterity. Gynecol Surg 2006;3:110-4. 5. Jakimowicz JJ, Cuschieri A. Time for Evidence-Based Minimal Access Surgery Training--Simulate or Sink. 30. Molinas CR, de Win G, Ritter O, Keckstein J, Miserez M, Campo R. Feasibility and Construct Validity of a Surg Endosc 2005;19:1521-2. Novel Laparoscopic Skills Testing and Training Model. Gynecol Surg 2008;5:281-90. 6. Lentz GM, Mandel LS, Lee D, Gardella C, Melville J, Goff BA. Testing Surgical Skills of Obstetric and 31. Palter VN, Orzech N, Aggarwal R, Okrainec A, Grantcharov TP. Resident Perceptions of Advanced Gynecologic Residents in a Bench Laboratory Setting: Validity and Reliability. Am J Obstet Gynecol Laparoscopic Skills Training. Surg Endosc 2010;24:2830-4. 2001;184:1462-8. 32. McCluney AL, Vassiliou MC, Kaneva PA, Cao J, Stanbridge DD, Feldman LS, Fried GM. FLS Simulator 7. Rosser JC, Rosser LE, Savalgi RS. Skill Acquisition and Assessment for Laparoscopic Surgery. Arch Surg Performance Predicts Intraoperative Laparoscopic Skill. Surg Endosc 2007;21:1991-5. 1997;132:200-4. 33. Sroka G, Feldman LS, Vassiliou MC, Kaneva PA, Fayez R, Fried GM. Fundamentals of Laparoscopic 8. Scott DJ, Young WN, Tesfay ST, Frawley WH, Rege RV, Jones DB. Laparoscopic Skills Training. Am J Surg Surgery Simulator Training to Proficiency Improves Laparoscopic Performance in the Operating Room-a 2001;182:137-42. Randomized Controlled Trial. Am J Surg 2010;199:115-20. 9. Katz R. Methods of Training Using Pelvic Trainers. Curr Urol Rep 2006;7:100-6. 34. Rosser JC, Jr., Rosser LE, Savalgi RS. Objective Evaluation of a Laparoscopic Surgical Skill Program for 10. Madan AK, Frantzides CT. Substituting Virtual Reality Trainers for Inanimate Box Trainers Does Not Residents and Senior Surgeons. Arch Surg 1998;133:657-61. Decrease Laparoscopic Skills Acquisition. JSLS 2007;11:87-9. 35. Jones DB, Brewer JD, Soper NJ. The Influence of Three-Dimensional Video Systems on Laparoscopic 11. Newmark J, Dandolu V, Milner R, Grewal H, Harbison S, Hernandez E. Correlating Virtual Reality and Task Performance. Surg Laparosc Endosc 1996;6:191-7. Box Trainer Tasks in the Assessment of Laparoscopic Surgical Skills. Am J Obstet Gynecol 2007;197:546-4. 36. Hamilton EC, Scott DJ, Fleming JB, Rege RV, Laycock R, Bergen PC, Tesfay ST, Jones DB. Comparison of 12. Chmarra MK, Dankelman J, van den Dobbelsteen JJ, Jansen FW. Force Feedback and Basic Laparoscopic Video Trainer and Virtual Reality Training Systems on Acquisition of Laparoscopic Skills. Surg Endosc Skills. Surg Endosc 2008;22:2140-8. 2002;16:406-11. 13. Schijven MP. Virtual reality simulation for laparoscopic cholecystectomy: the process of validation and 37. Korndorffer JR, Jr., Clayton JL, Tesfay ST, Brunner WC, Sierra R, Dunne JB, Jones DB, Rege RV, Touchard implementation in the surgical curriculum outlined. 2005. CL, Scott DJ. Multicenter Construct Validity for Southwestern Laparoscopic Videotrainer Stations. J Surg Ref Type: Thesis/Dissertation Res 2005;128:114-9. 14. Dauster B, Steinberg AP, Vassiliou MC, Bergman S, Stanbridge DD, Feldman LS, Fried GM. Validity of the 38. Coleman RL, Muller CY. Effects of a Laboratory-Based Skills Curriculum on Laparoscopic Proficiency: a MISTELS Simulator for Laparoscopy Training in Urology. J Endourol 2005;19:541-5. Randomized Trial. Am J Obstet Gynecol 2002;186:836-42. 15. Derossis AM, Fried GM, Abrahamowicz M, Sigman HH, Barkun JS, Meakins JL. Development of a Model 39. Scott DJ, Bergen PC, Rege RV, Laycock R, Tesfay ST, Valentine RJ, Euhus DM, Jeyarajah DR, Thompson for Training and Evaluation of Laparoscopic Skills. Am J Surg 1998;175:482-7. WM, Jones DB. Laparoscopic Training on Bench Models: Better and More Cost Effective Than Operating 16. Fraser SA, Klassen DR, Feldman LS, Ghitulescu GA, Stanbridge D, Fried GM. Evaluating Laparoscopic Room Experience? J Am Coll Surg 2000;191:272-83. Skills: Setting the Pass/Fail Score for the MISTELS System. Surg Endosc 2003;17:964-7. 40. Zheng B, Denk PM, Martinec DV, Gatta P, Whiteford MH, Swanstrom LL. Building an Efficient Surgical 17. Kirby TO, Numnum TM, Kilgore LC, Straughn JM. A Prospective Evaluation of a Simulator-Based Team Using a Bench Model Simulation: Construct Validity of the Legacy Inanimate System for Laparoscopic Training Program for Gynecology Residents. J Am Coll Surg 2008;206:343-8. Endoscopic Team Training (LISETT). Surg Endosc 2008;22:930-7. 18. Urwitz-Lane RS, Lee RH, Peyre S, Rahman S, Kwok L, Muderspach L. Impact of Laparoscopic Experience 41. Black M, Gould JC. Measuring Laparoscopic Operative Skill in a Video Trainer. Surg Endosc on Performance on Laparoscopic Training Drills Among Obstetrics and Gynecology Residents: a Pilot 2006;20:1069-71. Study. J Minim Invasive Gynecol 2009;16:72-5. 19. Kolkman W, van de Put MAJ, Wolterbeek R, Trimbos JBMZ, Jansen FW. Laparoscopic Skills Simulator: Construct Validity and Establishment of Performance Standards for Residency Training. Gynecol Surg 2008;5:109-14. 20. Stefanidis D, Heniford BT. The Formula for a Successful Laparoscopic Skills Curriculum. Arch Surg 2009;144:77-82. 21. Derossis AM, Antoniuk M, Fried GM. Evaluation of Laparoscopic Skills: a 2-Year Follow-Up During Residency Training. Can J Surg 1999;42:293-6. 22. Fried GM, Derossis AM, Bothwell J, Sigman HH. Comparison of Laparoscopic Performance in Vivo With Performance Measured in a Laparoscopic Simulator. Surg Endosc 1999;13:1077-81. 23. Peters JH, Fried GM, Swanstrom LL, Soper NJ, Sillin LF, Schirmer B, Hoffman K. Development and Validation of a Comprehensive Program of Education and Assessment of the Basic Fundamentals of Laparoscopic Surgery. Surgery 2004;135:21-7. 24. FLS Program. [www.flsprogram.org] Accessed 6 January 2011. 25. Arden D, Hacker MR, Jones DB, Awtrey CS. Description and Validation of the Pelv-Sim: a Training Model Designed to Improve Gynecologic Minimally Invasive Suturing Skills. J Minim Invasive Gynecol 2008;15:707-11.

66 67 An ‘Intermediate Curriculum’ for Advanced Laparoscopic Skills Training using Virtual Reality Simulation 4

Henk W.R. Schreuder Diederick van Hove Juliënne A. Janse René H.M. Verheijen Laurents P.S. Stassen Jenny Dankelman

Journal of Minimally Invasive Gynecology 2011 Jul 21. Epub ahead of print Virtual reality curriculum for advanced laparoscopic skills training Chapter 4

Introduction Abstract Since its introduction, laparoscopic surgery has become of great importance to the Study Objective practice of surgical care. However, laparoscopic surgery requires different skills compared To estimate face- and construct validity for a novel curriculum designed for inter to open procedures, leading to a recognized learning curve.1 Laparoscopic surgery mediately skilled laparoscopic surgeons on the Simendo® virtual reality simulator. It requires distinct psychomotor abilities, ambidextrous and hand-eye coordination, depth consists of five exercises, focusing on training precision and coordination between perception, and manipulation of delicate structures with limited haptic sensation. both hands. It is now widely accepted that skills training outside the operating room is essential for Design residents. The use of animal models is prohibited in several countries. Box trainers and Prospective study (Canadian Task Force II-2) video trainers have the disadvantage of the lack of automated performance assessment. In comparison, virtual reality (VR) trainers provide a safe and standardized environment Setting to practice specific skills and simultaneously measure objectively the performance of the Three University hospitals and 4 teaching hospitals in the Netherlands trainee.2 VR training can supplement standard laparoscopic box (video) training and is at least as effective.3,4 In recent years, several VR trainers have been validated for training in Subjects general surgery,5,6 urology7 and gynecology8,9 and a significant correlation between Residents, consultants and laparoscopic experts (N=69) in the fields of general operative performance and psychomotor performance on VR simulators has been surgery, gynecology and urology participated. Participants were divided into four demonstrated.10 The acquired skills on a VR simulator are not procedure specific. Rather, groups based on their level of laparoscopic experience: ‘residents year 1-3’ (N=15), VR training improves overall laparoscopic surgical skills.11 Skills acquired on a VR ‘residents year 4-6’ (N=17), ‘consultants’ (N=19) and ‘laparoscopic experts’ (N=18). simulator are transferable to actual laparoscopic operations in animals and in human patients.12-17 Implementation of standardized VR training curricula in residency training Interventions programs is preferred in order to acquire a predetermined level of proficiency before Participants completed three runs of five exercises. The first run was an introduction progression to the operating theatre.15,18,19 However, most VR curricula focus on basic and the second and third run were used for analysis. The parameters ‘time’, ‘path laparoscopic skills and are suited for junior residents, whereas senior residents prefer length’, ‘collisions’ and ‘displacement’ were compared between groups. Afterwards live animal training and training on box/video trainers for more advanced skills the participants completed a questionnaire to evaluate their laparoscopic experience training.20-21 With attention being raised for continuous training and assessment,20 and identify issues concerning the simulator and exercises. a more complex training program is needed. These more complex training programs should focus on ambidextrous skill development and precision of instrument handling, Measurements and Main Results aiming at the more experienced residents and surgeons. The expert group was significantly faster (p<.05) than other groups in 4 of 5 exercises. For this study, a set of VR exercises was developed to train more advanced laparoscopic The parameter displacement demonstrated a significant difference between the skills. The exercises provide a new challenge when the trainee has succeeded the basic expert group and other groups in two of the four exercises in which this parameter exercises. This provides increasing levels of training difficulty and practice variety, which was relevant (p<0.05). In the questionnaire (N=68), training capacity of the will improve the retention and transfer of simulator-acquired skills.21 The aim of the pres- curriculum was scored with a median of 4 points on a 5-point Likert scale. Of all ent study was to evaluate face- and construct validity for the developed set of exercises participants, 92.6% indicated that this curriculum is suitable as an addition to a for training and assessment of advanced laparoscopic skills on this VR simulator. basic skills module within their residency program.

Conclusion Face- and construct validity were estimated for an advanced virtual reality curriculum for intermediately skilled laparoscopic surgeons. The results indicate that the curriculum is suitable for training of residents and consultants and to assess and maintain their laparoscopic skills.

70 71 Virtual reality curriculum for advanced laparoscopic skills training Chapter 4

Materials and methods Figure 1. 1) Handles of the Virtual Reality Trainer, 2) Slide & Drop, 3) Clip a vessel, 4) Ring & Needle, 5) The Carrousel, 6) Single Knot (images provided by Simendo®) Curriculum development The new exercises for the SIMENDO® Virtual Reality simulator (Simendo, Rotterdam, The Netherlands) were developed during the six months prior to the study. In the development phase a gynecologist and a general surgeon worked closely together with the computer programmer to design exercises appropriate for surgeons and residents who have passed the initial learning curve of laparoscopic surgery and already perform laparoscopic procedures without assistance. This resulted in an “intermediate 1 2 curriculum” consisting of five exercises (Figure 1, number 2 to 6). Every exercise was designed to train precision, stability, ambidextrous coordination and co-operation between the left and the right instrument. The exercises, their training goals and the measured parameters are described in Table 1.

Table 1. Overview of the five exercises in the ‘intermediate curriculum’ Exercise name Exercise description Training goals Parameter

Slide & Drop Dropping of 4 balls into holes Ambidextrous Task time, path length, 3 4 under slides, which need to be coordination displacement (change in moved by the opposite hand location of the floor and slides)

Clip a vessel Applying 4 clips at designated Ambidextrous Task time, path length, places while completely coordination and precision precision of clip application, grasping the vessel training displacement (change in location of the vessel)

Ring & Needle Putting a needle through a ring Ambidextrous Task time, path length, 5 6 thrice, while keeping the ring coordination, stability and displacement (change in stable precision training location of the ring)

The Carrousel Grasping 3 dices of a carousel Ambidextrous Task time, path length, Participants and stacking them as a tower coordination, stability and stacked dices Surgeons and residents in gynecology, urology and general surgery from three regions in on a small plateau precision training the Netherlands were recruited for voluntary participation (n=69). Four groups were

Single Knot Tying a single knot around a Ambidextrous Task time, path length and formed based on laparoscopic experience and status. Group 1 (n=15) consisted of post- bar, while keeping the bar coordination and stability displacement (change in graduate residents year 1-3 (PGY 1-3), group 2 (n=17) of post-graduate residents year 4-6 stable location of the bar), (PGY 4-6), group 3 (n=19) consisted of consultants and group 4 (n=18) of expert collisions ( too much laparoscopic surgeons. Consultants and laparoscopic experts were differentiated based on pressure on the floor’ the number of selected “advanced laparoscopic” procedures performed. For gynecologists the selected procedures were: laparoscopic hysterectomy, laparoscopic sacrocolpopexie and laparoscopic lymphadenectomy. For general surgeons the selected procedures were: laparoscopic Nissen fundoplication, laparoscopic colectomy and laparoscopic bariatric procedures. For urologists laparoscopic prostatectomy was selected as an advanced procedure. To be considered an expert the number of performed advanced procedures should be more than 10 for at least two of the selected procedures, or more than 50 for one of the selected procedures to be considered an expert. Characteristics of the different groups are

72 73 Virtual reality curriculum for advanced laparoscopic skills training Chapter 4 shown in Table 2. All participants where asked for their prior experience with laparoscopic Face validity skills training. Experience with box-trainers (video-trainers), virtual reality trainers and live- Face validity is defined as the extent to which the simulation (or test) resembles the animal training was estimated in hours. experience in the real world.22 To investigate this, participants filled out a questionnaire immediately after performing the five exercises on the simulator. The participant’s demo- Equipment graphics, laparoscopic training experience and laparoscopic theatre experience were The SIMENDO® Virtual Reality simulator (Simendo, Rotterdam, The Netherlands) was evaluated. Additionally, the opinion of each participant about the simulator was asked. used. This system consists of a software interface and two hardware laparoscopic The first section of the questionnaire contained five questions on the realism of the instruments (Figure 1, number 1) connected with a USB plug to a laptop computer simulator; the second section consisted of ten questions regarding the training capacities (Acer® Aspire 5924G). The laptop contains an Intel® Core™ 2 Duo processor T5550 (1.83 in general and the suitability for training residents or surgeons. In the third section, six GHz, 667 MHz FSB, 2 MB L2 cache), TurboCache™ 3 GB DDR2, with graphical card questions were asked to evaluate each exercise separately. The questions were presented NVIDIA® GeForce™ 8600 GT, 15.4” WXGA Acer Crystalbyte™ LCD monitor and software on a 5-point Likert scale.23 Finally, two statements were given concerning the addition of Microsoft Windows XP™. the “intermediate curriculum” to the existing “novice curriculum” of this simulator and the implementation of this simulator in the current residency training programs. These Table 2. Characteristics of the different study groups could be answered with “agree”, “disagree” or “no opinion”. Total n = 69 Group 1 Group 2 Group 3 Group 4 residents PGY 1-3 residents PGY 4-6 consultants laparoscopic experts Construct validity (n=15) (n=17) (n=19) (n=18) Construct validity is defined as the extent to which a simulation (test) is able to identify Gender Male/ M: n=6 M: n=12 M: n=12 M: n=15 the quality, ability or trait it is designed to measure. This simulation addresses technical Female F: n=9 F: n=5 F: n=7 F: n=3 skills and it is therefore expected that it differentiates between a good (expert) and a bad Mean age (range) 30 (26-35) 33 (29-37) 46 (35-63) 45 (33-58) performer (novice).22 To investigate construct validity the participants performed three consecutive repetitions of each of the five exercises of the curriculum. The exercises were Criteria Resident PGY 1-3 Resident PGY 4-6 non or < 50 > 50 advanced ‘Slide and Drop’ (Video 1), ‘Clip a Vessel’ (Video 2), ‘Ring and Needle’ (Video 3), ‘The advanced procedures* procedures* Carrousel’ (Video 4) and ‘Single Knot’ (Video 5). Before starting on the simulator, the exercises were briefly explained by the test supervisor, and introduced with an instruction Distribution within 1st year: n=1 4th year: n=6 years consultant years consultant video for each exercise. The first run of each exercise was used to familiarize the group 2nd year: n=6 5th year: n=6 ≤5 year: n=7 ≤5 year: n=3 participant with the simulator, and verbal instructions were given whenever necessary. 3rd year: n=8 6th year: n=5 >5 year: n=12 >5year: n=12 >10 year: n=7 >10year: n=5 The second and third repetitions were used for analysis and participants received >20 year: n=4 >20 year: n=2 minimal or no guidance during these runs. To evaluate construct validity the following parameters were compared between the different groups for each exercise separately: 1) Specialism Sur: n=7 Sur: n=6 Sur: n=6 Sur: n=11 task time, 2) path length, 3) displacement and 4) collisions. Gyn: n=8 Gyn: n=5 Gyn: n=11 Gyn: n=6 Uro: n=0 Uro: n=6 Uro: n=2 Uro: n=1 Use of statistics Dominant hand R: n=13 R: n=15 R: n=18 R: n=18 Data were analyzed using the statistical software package SPSS 16.0 (SPSS Inc, Chicago, L: n=2 L: n=2 L: n=1 L: n=0 IL). Differences in performance between groups were analyzed using the Kruskal-Wallis test. If the Kruskal-Wallis Test resulted in a significant difference, then a separate analysis Can tie a knot n=6 n=12 n=13 n=18 laparoscopically was performed, comparing the expert group with the other groups, using the Mann- Whitney test with post-hoc Dunn’s (Bonferroni) correction. To verify the minimum sam- *advanced procedures are in laparoscopic gynecology: hysterectomy, sacrocolpopexie, pelvic lymfadenectomy - in surgery: Nissen fundoplication, bariatric procedures, colectomy - in urology: prostatectomy. ple size a power analysis was performed. A total sample of 68 subjects achieves a power of 0.81 using the Kruskal-Wallis Test with a target significance level of 0.05. The average within group standard deviation assuming the alternative distribution is 1.0. (PASS 2008 NCSS, LCC. Kayville, UT). A level of p<.05 was considered to be statistically significant. Values are presented as medians unless stated otherwise.

74 75 Virtual reality curriculum for advanced laparoscopic skills training Chapter 4

Figure 2. Training experience of the participants (n=69) on box-trainers, the SIMENDO virtual reality trainer, Results other virtual reality trainers and live animals Prior Training Experience on box trainers Experience on Simendo Nearly all residents and experts, but only 50% of the consultants, had experience on 20 20 box-trainers. Most experts had completed significantly more training hours on box-trainers than the other groups. Approximately half of the participants had experience on VR

15 15 trainers. Several participants had prior experience with the virtual reality simulator used in this study. These participants were equally divided among the four groups, and therefore had no significant influence on the statistical group comparison as a whole. 10 10 The majority of the residents did not have experience with live animal training in contrast to the experts, who nearly all had a history of life animal training (Figure 2).

5 5 Face validity Number of participants (n) Number of participants (n) Of the 69 participants 68 participants (97%) filled out the questionnaire. Table 3 0 0 summarizes the median values of the scores considering the realism and training capac- PGY 1-3 PGY 4-6 Regular surgeonsExperts PGY 1- PGY 4-6 Regular surgeonsExperts ity of the curriculum. The training capacity of the curriculum in general was appreciated 3 with a median score of 4.0. Hand-eye coordination and the training capacity of coopera-

Groups Groups tion of the right and left hand were both rated with a 4.0. The suitability of the inter mediate curriculum to train PGY 1-3, PGY 4-6, consultants and expert laparoscopic surgeons was rated 5.0, 4.0, 4.0 and 3.0, respectively. The results for face validity by exercise Experience on VR simulators Experience on live animals are shown in Table 4. The realism of depth perception received the lowest score (3.0). 20 20 The lack of haptic feedback was scored as ‘disturbing’ in two exercises, receiving relatively low scores. Despite these drawbacks, 92.6% of the participants agreed that the new curriculum for this virtual reality trainer was suitable for implementation in the current 15 15 resident training programs. The remaining 7.4% of the participants answered this question with ‘no opinion’. 10 10 Construct validity All of the 69 participants completed the three repetitions of the five exercises. Median 5 5 values of the measured parameters in the second and third run for all exercises are Number of participants (n) Number of participants (n) shown in Table 5. The parameter ‘task time’ was significantly different between the groups in four exercises. Experts (group 4) performed significantly faster compared to one or 0 0 PGY PGY 4 Regular surgeonExpert PGY PGY 4 Regular Expe more of the other groups in four of the five exercises (Figure 3): ‘Slide & Drop’: group 4 1-3 1-3 rt -6 s - s 6 surgeons versus group 1, 2 and 3 (p=.009; .045; .009), ‘Ring & Needle: group 4 versus group 1 (p=0.027), ‘The Carrousel’: group 4 versus group 1, 2 and 3 (p=.003; .033; <.001) and Groups s Groups ‘Single Knot’: group 4 versus group 2 (p=.033). In the exercise ´Clip a Vessel’ there was 0 hours no significant difference in task time between the expert group and other groups. Addi- < 10 hours tionally for the ‘Single Knot’ exercise, task time was compared between participants who 10-20 hours were already able to tie an intracorporeal knot and those who were not. The latter ones >20 hours took almost twice as long (66.67 versus 102.13 seconds, p=<.001).

76 77 Virtual reality curriculum for advanced laparoscopic skills training Chapter 4

Table 3. Face validity of the intermediate curriculum as a whole (n=68, median (interquartile range) on a 1 to 5 Table 4. Face validity of the individual exercises of the curriculum (n=68, median (interquartile range) on a 1 to Likert scale ) 5 Likert scale) Question Group 1 Group 2 Group 3 Group 4 Overall Question Slide & Drop Clip a Vessel Ring & Needle The Carrousel Single Knot residents residents PGY consultants laparoscopic (n=68) PGY 1-3 (n=15) 4-6 (n=17) (n=19) experts (n=17)

What do you think of the Do you think the training 4.0 (4.0 – 5.0) 4.0 (3.0 – 4.0) 4.0 (3.3 – 4.0) 4.0 (4.0 – 4.0) 4.0 (4.0 – 5.0) realism of the curriculum goal is reached? (not at concerning………? (not all…….yes for sure) realistic……very realistic) the appearance of the 4.0 (4.0 – 5.0) 4.0 (4.0 – 5.0) 4.0 (3.0 – 5.0) 4.0 (4.0 – 5.0) 4.0 (4.0 – 5.0) What do you think of……….? instruments (very bad……..very good) the set-up of the exercise 4.0 (4.0 – 5.0) 4.0 (4.0 – 4.8) 4.0 (3.0 – 5.0) 4.0 (4.0 – 5.0) 4.0 (4.0 – 5.0) the movements of the 4.0 (4.0 – 4.0) 4.0 (3.5 – 4.0) 3.5 (3.0 – 4.0) 3.0 (3.0 – 4.0) 4.0 (3.0 – 4.0) instruments freedom of movements of 4.0 (3.0 – 4.0) 4.0 (3.5 – 4.0) 4.0 (3.0 – 4.0) 4.0 (3.0 – 4.0) 4.0 (3.0 – 4.0) the movements of the 4.0 (4.0 – 4.0) 4.0 (3.0 – 5.0) 4.0 (3.0 – 4.0) 4.0 (4.0 – 4.0) 4.0 (4.0 – 5.0) the instruments instruments depth perception 3.0 (2.0 – 3.0) 2.0 (2.0 – 3.0) 2.0 (2.0 – 3.0) 3.0 (1.5 – 3.0) 3.0 (2.0 – 3.0) the depth perception 3.0 (2.0 – 4.0) 3.0 (3.0 – 4.0) 3.0 (2.0 – 3.8) 3.0 (2.0 – 4.0) 3.0 (2.0 – 4.0)

interaction of the 3.0 (2.0 – 4.0) 3.0 (2.0 – 4.0) 3.0 (2.0 – 3.0) 3.0 (2.0 – 3.0) 3.0 (2.0 – 3.0) the training capacity of the 4.0 (4.0 – 4.0) 4.0 (4.0 – 5.0) 4.0 (3.0 – 4.0) 4.0 (4.0 – 4.8) 4.0 (3.3 – 5.0) instruments with other exercise objects The lack of haptic feedback 2.0 (2.0 – 3.0) 2.0 (2.0 – 3.0) 3.0 (2.0 – 4.0) 3.0 (2.0 – 4.0) 3.0 (2.3 – 4.0) is (very disturbing…….not What do you think of the disturbing at all) training capacity of the curriculum………? (very bad…….very good) in general 4.0 (4.0 – 5.0) 4.0 (4.0 – 4.0) 4.0 (4.0 – 5.0) 4.0 (3.0 – 4.0) 4.0 (4.0 – 4.0) The displacement parameter was significantly different between the expert group and eye-hand coordination 4.0 (4.0 – 5.0) 4.0 (4.0 – 5.0) 5.0 (4.0 – 5.0) 5.0 (4.0 – 5.0) 4.0 (4.0 – 5.0) other groups in two of four exercises in which this parameter was relevant (it was not rel- depth perception 3.0 (2.0 – 4.0) 2.0 (2.0 – 3.0) 3.0 (2.0 – 4.0) 2.0 (1.5 – 3.0) 3.0 (2.0 – 3.0) evant in ‘The Carrousel’). The experts (group 4) showed less displacement of the slides instrument navigation in 4.0 (4.0 – 4.0) 4.0 (3.0 – 4.0) 4.0 (3.0 – 5.0) 4.0 (3.0 – 5.0) 4.0 (3.0 – 4.0) in ‘Slide & Drop’ compared to the consultants (group 3) (p=0.027). In the exercise ‘Single general Knot’ the experts (group 4) showed less displacement of the bar while tying a knot than training left and right hand 4.0 (4.0 – 5.0) 4.0 (4.0 – 4.5) 4.0 (4.0 – 5.0) 4.0 (3.0 – 5.0) 4.0 (4.0 – 5.0) both resident groups: group 4 versus group 1 and 2 (p=.012; .024). separately In the exercise ‘The Carrousel’ significant differences in path length were observed. The training co-operation 4.0 (4.0 – 5.0) 4.0 (4.0 – 5.0) 4.0 (3.0 – 5.0) 4.0 (4.0 – 5.0) 4.0 (4.0 – 5.0) path length of the expert group was significantly shorter compared to the consultants: between left and right hand (multiple tasking) group 4 versus group 3 (p=0.03). In the other four exercises there were no significant differences in path length. The parameter precision, used in the exercise ´Clip a Vessel´ The intermediate curriculum showed no significant difference between the expert group and the other groups. For the is suitable to train………. parameter collision in the exercise ‘Single Knot’, the experts (group 4) had significantly (not suitable………very suitable) less collisions with the floor: group 4 versus group 1 and 2 (p=.009; <.001). Residents PGY 1 to 3 5.0 (4.0 – 5.0) 4.0 (4.0 – 5.0) 5.0 (4.0 – 5.0) 4.0 (3.0 – 5.0) 5.0 (4.0 – 5.0) Residents PGY 4 to 6 4.0 (4.0 – 4.0) 4.0 (4.0 – 5.0) 5.0 (4.0 – 5.0) 4.0 (3.5 – 5.0) 4.0 (4.0 – 5.0) Consultants 4.0 (4.0 – 4.0) 4.0 (4.0 – 5.0) 4.0 (3.0 – 5.0) 4.0 (2.5 – 4.0) 4.0 (3.3 – 5.0) Laparoscopic experts 3.0 (2.0 – 3.0) 2.0 (2.0 – 3.0) 3.0 (2.0 – 5.0) 3.0 (2.0 – 4.0) 3.0 (2.0 – 4.0)

78 79 Virtual reality curriculum for advanced laparoscopic skills training Chapter 4

Table 5. Construct validity Figure 3. Total task time for the four different groups performing the five exercises (bars are medians, boxes Group 1 Group 2 Group 3 Group 4 p show inter quartile range, whiskers show range, dots are outliers and large horizontal bars indicate statistically residents residents consultants laproscopic Value* significant differences, specified with p-values) PGY 1-3 PGY 4-6 experts n=15 n=17 n=19 n=18 Slide & Drop Clip a Vessel Slide & Drop 300 p=0.009 300 p=0.045 Task time 124.85 (103.59 – 144.02) 121.74 (105.77 – 154.93) 135.82 (109.06 – 151.72) 93.99 (78.32 – 119.61) .007 p=0.009 Path length (R) 61.50 (45.00 – 74.50) 54.50 (45.75 – 64.25) 71.00 (48.00 – 92.00) 57.25 (41.13 – 71.00) .463 200 200 Path length (L) 61.00 (55.00 – 72.00) 54.00 (48.75 – 68.50) 74.00 (55.00 – 96.00) 53.75 (47.13 – 71.88) .091

Displacement 5.68 (4.42 – 11.81) 9.97 (6.13 - 12.18) 16.18 (10.23 – 20.23) 8.38 (7.37 – 9.70) .003 Time (sec) 100 Time (sec) 100

Clip a Vessel Task time 49.40 (32.41 – 67.79) 39.83 (33.92 – 63.84) 49.34 (34.59 – 59.68) 37.37 (28.03 – 53.04) .406 0 0 1:PGY 1-3 2:PGY 4-6 3: 4:Experts 1:PGY 1-3 2:PGY 4- 3: 4:Experts Path length (R) 21.00 (11.50 – 24.00) 15.75 (14.50 – 22.00) 22.00 (16.25 – 25.25) 19.75 (15.25 – 25.63) .313 Consultants Consultants

Path length (L) 11.50 (10.50 – 14.00) 14.75 (11.38 – 19.00) 17.00 (13.50 – 22.50) 13.75 (10.63 – 19.13) .110 6 Displacement 0.84 (0.78 – 0.88) 0.84 (0.78 – 0.89) 0.90 (0.85 – 0.94) 0.88 (0.82 – 0.92) .043 Groups Groups Precision** 0.50 (0.00 – 1.50) 0.50 (0.13 – 0.50) 0.50 (0.50 – 1.00) 0.50 (0.00 – 1.00) .715

Ring & Needle Ring & Needle Carrousel Task time 173.43 (113.70 – 196.61) 116.51 (102.77 – 144.41) 109.69 (95.00 – 173.59) 108.40 (89.06 – 142.94) .043 p=0.027 300 300 p=0.003 Path length (R) 91.00 (58.00 – 117.50) 72.50 (65.25 – 83.75) 83.50 (69.25 – 96.75) 88.25 (57.38 – 109.25) .619 p=0.033 p<0.001 Path length (L) 83.50 (49.00 – 105.00) 67.00 (52.00 – 75.50) 77.50 (59.25 – 87.50) 72.25 (53.25 – 82.88) .400 200 200 Displacement 39.74 (25.62 – 58.45) 35.42 (27.32 – 38.32) 38.43 (26.76 – 51.17) 28.70 (25.32 – 31.78) .160

Carrousel Time (sec) 100 Time (sec) 100 Task time 138.60 (107.93 – 161.22) 122.11 (100.45 – 149.78) 155.69 (104.96 – 204.08) 99.17 (72.84 – 111.89) .001

Path length (R) 53.50 (42.50 – 60.13) 48.50 (44.25 – 60.25) 73.50 (59.00 – 95.88) 50.00 (46.75 – 63.00) <.001 0 0 Path length (L) 37.25 (24.88 – 44.88) 33.50 (26.50 – 50.25) 53.00 (27.75 – 58.63) 31.00 (27.75 – 33.75) .072 1:PGY 1-3 2:PGY 4-6 3:C 4:Experts 1:PGY 1-3 2:PGY 4-6 3:C 4:Experts onsultants onsultants Displacement - - - - -

Single Knot Groups Groups Task time 84.45 (65.93 – 111.78) 77.01 (69.06 – 97.56) 60.49 (51.34 – 88.46) 66.07 (47.43 – 84.47) .021

Path length (R) 58.50 (42.00 – 83.50) 58.50 (52.25 – 84.25) 47.25 (34.75 – 70.63) 68.00 (54.25 – 77.75) .271 300 Single Knot Path length (L) 59.00 (55.50 – 74.00) 63.00 (46.50 – 87.25) 61.50 (51.50 – 89.50) 55.00 (49.50 - 77) .873

Displacement 9.03 (7.46 – 11.45) 9.42 (6.09 – 10.33) 7.61 (5.96 – 10.71) 5.33 (4.88 – 7.69) .015 * p=0.033 Collision*** 0.00 (0.00 – 0.00) 0.50 (0.00 – 1.00) 0.50 (0.13 – 0.88) 0.00 (0.00 – 1.00) .007 200

Median values (interquartile range) for all relevant parameters. For every parameter a p-value is stated per exercise. When a parameter is not stated for an exercise, it was not defined for that exercise. Time (sec) 100 Task time in seconds, Path length and displacement in arbitrary units, R=right instrument, L=left instrument, *=p-value for Kruskal-Wallis, non-parametric test, **= Number of incorrect applied clips, ***=Number of collisions with the floor 0 1:PGY 1-3 2:PGY 4-6 3: 4:Experts Co nsultants

Groups 80 81 Virtual reality curriculum for advanced laparoscopic skills training Chapter 4

Discussion A subgroup analysis was done to see if there was any correlation between the answer of a participant to this specific question and his or her results on the simulator. Nocorrelation In this study, face and construct validity were estimated for a new set of exercises for was found. training and assessment of intermediate laparoscopic skills on a commercially available Madan et al found no difference in laparoscopic skills acquisition when incorporating VR virtual reality simulator. The vast majority of participants indicated that the virtual reality trainers in a curriculum based on box-trainers.24 There was also no difference in skills simulator is a useful tool for training laparoscopic skills to residents, urologists, improvement when comparing VR trainers and computer-enhanced box-trainers.25 gynecologists and surgeons. Construct validity was demonstrated by the fact that the Therefore one could argue whether haptic feedback is really necessary for training basic intermediate curriculum was able to differentiate between subjects with varying laparo- laparoscopic skills in VR trainers. Haptic feedback in VR simulators might play a more scopic experience. More precisely, the expert laparoscopic surgeons performed important role in more complex procedural exercises where there is a need to apply force significantly faster in exercises which required most intensive cooperation of the right on tissue structures (laparoscopic hysterectomy, laparoscopic myomectomy, laparo and left hand in comparison to the other groups. This suggests training capacity of the scopic cholecystectomy). Chmarra et al showed that VR trainers without haptic feedback curriculum for these groups of trainees, i.e. not only for laparoscopic novices. should only train tasks where force application is not required.26 Additionally, for two exercises the experts showed less displacement of structures than In this study, participants emphasized the importance of introduction of VR in a residency other groups. In the ‘Slide & Drop’ exercise they outperformed the consultant group and laparoscopic training program, confirming findings by other authors.27 However, previous in the ‘Single Knot’ exercise they outperformed both resident groups. This strokes with studies have shown that without any form of obligation or assessment, trainees are the thought that expert surgeons are highly efficient in their movements and that this is a typically not sufficiently motivated to use VR simulators.28-30 To make sure a VR simulator skill which distinguishes them from other groups and which could be trained. will be used, the exercises need to be implemented in a complete laparoscopic training Although differences were found, the discriminative properties of the exercises vary. The curriculum and failing of these exercises must have certain consequences. For instance, most discriminative exercises are ‘Slide and Drop’ and ‘The Carrousel’. This can be trainees should not be allowed to perform laparoscopic surgery on patients, at the explained by the fact that in these exercises the left and right instruments need to work position of primary surgeon, as long as they fail to reach the pre-set performance levels closely together for a longer period of time. This coordination skill is more prominent in during training. This will have a positive effect on operating times and patient safety.15 more advanced laparoscopic procedures and therefore correlates with more experience. When incorporating a VR trainer in a laparoscopic training curriculum one should The least discriminative exercise is ‘Clip a Vessel’. This exercise may not be discriminative carefully choose the exercises and only use validated exercises, construct validity being because it is a relatively short and easy to perform. Task time was the most discriminative the minimum requirement. A complete VR curriculum should have exercises targeting parameter. However, task time has often been subject of discussion when addressing different levels of experience and ideally should contain basic skills, advanced skills and distinction in the level of laparoscopic skills. Task time alone does not provide enough procedural tasks (like salpingectomy, cholecystectomy or appendectomy). Such a information about accuracy and precision. Therefore, on its own, this parameter should curriculum is motivating for participants with different levels of experience. The present not be considered to distinguish different levels of experience. This means that the study adds an intermediate module to laparoscopic virtual reality training and construct validity of this curriculum cannot be considered very solid at this stage. Further demonstrates the appreciation by the possible trainees. Adherence to a training modification of the exercises could improve their differentiating capability. curriculum is also influenced by the ease of participation and receiving feedback. Furthermore, it can be argued that some participants would perform better than others Face- and construct validity have been estimated for the ‘intermediate curriculum’ on this due to previous experience on this specific simulator. In one exercise (‘Clip a Vessel’), simulator. Although results for face validity were unequivocally positive, construct validity indeed participants with experience on this specific simulator performed better than cannot be considered very solid at this stage. This curriculum might eventually not only participants who had no experience on this simulator. However, the distribution of be suitable for residents throughout their surgical training, but also for consultants. It participants with experience with this particular simulator is equal among all groups, so would therefore offer a training continuum for residents in addition to basic VR skills it is not expected that the differences between groups are affected by this previous training and might also open this training environment for the registered surgeon. To experience. Depth perception and the lack of haptic feedback were indicated as improve construct validity, modification of exercises might be needed and further limitations of the VR simulator used in this study. In order to enhance depth perception, research should focus on the predictive validity of this simulator to show whether it can features such as shadows were added during development of the software. To clarify the predict eventual better performance in the operating room. position of structures the shadow is mimicked on the floor of the simulation environment. The lack of haptic feedback or unrealistic haptic feedback in VR simulators Acknowledgments is often stated as a major disadvantage of VR simulators in comparison with box-trainers. We would like to thank all the residents and consultants who voluntarily participated in this In this study, most participants confirmed the lack of haptic feedback to be disturbing. study. We would like to thank Ass. Prof. M.J.C. (René) Eijkemans from the Julius Centre for Health Sciences and Primary care, University of Utrecht, the Netherlands for his help with 82 the statistical analysis. 83 Virtual reality curriculum for advanced laparoscopic skills training Chapter 4

References 24. Madan AK, Frantzides CT. Substituting virtual reality trainers for inanimate box trainers does not decrease laparoscopic skills acquisition. JSLS. 2007;11:87-89. 1. Figert PL, Park AE, Witzke DB, Schwartz RW. Transfer of training in acquiring laparoscopic skills. J Am 25. Kanumuri P, Ganai S, Wohaibi EM, Bush RW, Grow DR, Seymour NE. Virtual reality and computer- Coll Surg. 2001;193:533-537. enhanced training devices equally improve laparoscopic surgical skill in novices. JSLS. 2008;12:219-226. 2. Aggarwal R, Moorthy K, Darzi A. Laparoscopic skills training and assessment. Br J Surg. 2004;91:1549- 26. Chmarra MK, Dankelman J, van den Dobbelsteen JJ, Jansen FW. Force feedback and basic laparoscopic 1558. skills. Surg Endosc. 2008;22:2140-2148. 3. Gurusamy K, Aggarwal R, Palanivelu L, Davidson BR. Systematic review of randomized controlled trials 27. Rosenthal R, Gantert WA, Hamel C, Metzger J, Kocher T, Vogelbach P, Demartines N, Hahnloser D. The on the effectiveness of virtual reality training for laparoscopic surgery. Br J Surg. 2008;95:1088-1097. future of patient safety: Surgical trainees accept virtual reality as a new training tool. Patient Saf Surg. 4. Gurusamy KS, Aggarwal R, Palanivelu L, Davidson BR. Virtual reality training for surgical trainees in 2008;2:16. laparoscopic surgery. Cochrane Database Syst Rev. 2009;CD006575. 28. Kossi J, Luostarinen M. Virtual reality laparoscopic simulator as an aid in surgical resident education: 5. Schijven M, Jakimowicz J. Construct validity: experts and novices performing on the Xitact LS500 two years’ experience. Scand J Surg. 2009;98:48-54. laparoscopy simulator. Surg Endosc. 2003;17:803-810. 29. van Dongen KW, van der Wal WA, Rinkes IH, Schijven MP, Broeders IA. Virtual reality training for 6. Verdaasdonk EG, Stassen LP, Monteny LJ, Dankelman J. Validation of a new basic virtual reality simulator endoscopic surgery: voluntary or obligatory? Surg Endosc. 2008;22:664-667. for training of basic endoscopic skills: the SIMENDO. Surg Endosc. 2006;20:511-518. 30. Verdaasdonk EG, Dankelman J, Schijven MP, Lange JF, Wentink M, Stassen LP. Serious gaming and 7. Watterson JD, Beiko DT, Kuan JK, Denstedt JD. Randomized prospective blinded study validating voluntary laparoscopic skills training: a multicenter study. Minim Invasive Ther Allied Technol. acquistion of ureteroscopy skills using computer based virtual reality endourological simulator. J Urol. 2009;18:232-238. 2002;168:1928-1932. 8. Larsen CR, Grantcharov T, Aggarwal R, Tully A, Sorensen JL, Dalsgaard T, Ottesen B. Objective assessment of gynecologic laparoscopic skills using the LapSimGyn virtual reality simulator. Surg Endosc. 2006;20:1460-1466. 9. Schreuder HW, van Dongen KW, Roeleveld SJ, Schijven MP, Broeders IA. Face and construct validity of virtual reality simulation of laparoscopic gynecologic surgery. Am J Obstet Gynecol. 2009;200:540-548. 10. Kundhal PS, Grantcharov TP. Psychomotor performance measured in a virtual environment correlates with technical skills in the operating room. Surg Endosc. 2009;23:645-649. 11. Lucas SM, Zeltser IS, Bensalah K, Tuncel A, Jenkins A, Pearle MS, Cadeddu JA. Training on a virtual reality laparoscopic simulator improves performance of an unfamiliar live laparoscopic procedure. J Urol. 2008;180:2588-2591. 12. Aggarwal R, Ward J, Balasundaram I, Sains P, Athanasiou T, Darzi A. Proving the effectiveness of virtual reality simulation for training in laparoscopic surgery. Ann Surg. 2007;246:771-779. 13. Ahlberg G, Enochsson L, Gallagher AG, Hedman L, Hogman C, McClusky DA, III, Ramel S, Smith CD, Arvidsson D. Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies. Am J Surg. 2007;193:797-804. 14. Hyltander A, Liljegren E, Rhodin PH, Lonroth H. The transfer of basic skills learned in a laparoscopic simulator to the operating room. Surg Endosc. 2002;16:1324-1328. 15. Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, Schroeder TV, Ottesen BS. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial.BMJ. 2009;338:b1802. 16. Schijven MP, Jakimowicz JJ, Broeders IA, Tseng LN. The Eindhoven laparoscopic cholecystectomy training course--improving operating room performance using virtual reality training: results from the first E.A.E.S. accredited virtual reality trainings curriculum. Surg Endosc. 2005;19:1220-1226. 17. Seymour NE, Gallagher AG, Roman SA, O’Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002;236:458-463. 18. Aggarwal R, Crochet P, Dias A, Misra A, Ziprin P, Darzi A. Development of a virtual reality training curriculum for laparoscopic cholecystectomy. Br J Surg. 2009;96:1086-1093. 19. Panait L, Bell RL, Roberts KE, Duffy AJ. Designing and validating a customized virtual reality-based laparoscopic skills curriculum. J Surg Educ. 2008;65:413-417. 20. Stassen LP, Bemelman WA, Meijerink J. Risks of minimally invasive surgery underestimated: a report of the Dutch Health Care Inspectorate. Surg Endosc. 2010;24:495-498. 21. Issenberg SB, McGaghie WC, Petrusa ER, Lee GD, Scalese RJ. Features and uses of high-fidelity medical simulations that lead to effective learning: a BEME systematic review. Med Teach. 2005;27:10-28. 22. Gallagher AG, Ritter EM, Satava RM. Fundamental principles of validation, and reliability: rigorous science for the assessment of surgical education and training. Surg Endosc. 2003;17:1525-1529. 23. Matell MS, Jacoby J. Is There an Optimal Number of Alternatives for Likert Scale Items? Educational and Psychological Measurement. 1971;31:657-674.

84 85 Face and construct validity of virtual reality simulation of laparoscopic gynecologic surgery 5

Henk W.R. Schreuder Koen W. van Dongen Susan J. Roeleveld Marlies P. Schijven Ivo A.M.J. Broeders

American Journal of Obstetrics & Gynecology 2009; 200: e1-e8 Virtual reality simulation of laparoscopic gynecologic surgery Chapter 5

Introduction Abstract Laparoscopy is a widely used operation technique in gynecology. In the Netherlands all Objective gynecologists should be able to perform basic laparoscopic procedures (diagnostic To validate virtual reality simulation in assessing laparoscopic skills in gynecology; laparoscopy, ectopic pregnancy, salphingo-oophorectomy) at the end of their training. by establishing the extent of realism of the simulation to the actual task (face The advantages of minimal access surgery have been proven repetitively and comprise validity) and the degree to which the results of the test one uses reflects the subject less pain, shorter hospital stay and faster recovery1. With the growing use of laparoscopy tested (construct validity). it is important to realize that the laparoscopic technique requires different skills compared to open surgical procedures. It requires distinct psychomotor abilities, hand- Study design eye coordination and depth perception. At present residents-in-training for gynecologist subjects (N=56) were divided in three groups: novices (n=15), intermediates (n=20) are learning most of the specific laparoscopic skills in the operating room. There is no and experts (n=21). Participants completed three repetitions of a training program consensus or agreement on the method with which to learn and measure laparoscopic consisting of four basic skills and three gynecologic procedural simulations. The performance. Virtual reality simulation could provide a safe and objective method to performance was compared between groups using a post hoc t test with the support residents in training, the basic skills of laparoscopy before performing surgery in Bonferroni technique. Face validity was determined by using a questionnaire of 27 the operating room. statements. Virtual reality trainers are widely used in the airline industry and the military2. Simulation provides the opportunity to expose trainees to infrequent experienced or risky procedures. Results A simulator can create a safe, controlled, and standardized environment to practice Resulting from the questionnaire, the opinion about the realism and training specific skills and could be able to objectively measure the performance of a subject. capacities of the tasks was favorable among all groups. The degree of prior Besides training, simulators are capable to asses the skills of a subject in training laparoscopic experience was reflected in the outcome performance parameters of simultaneously. There is growing interest in the potential role for medical simulation in the tasks. Experts achieved significant better scores on specific parameters. gynecology2 and particularly the potential role of the virtual reality3 because the traditional box trainers and animal models require human monitored evaluation which makes them Conclusion subjective, expensive and time consuming. In the last few years several basic and more The results of this study indicates acceptance, and thus face validity of the system advanced virtual reality laparoscopic simulators were developed and validated4;5. The among both reference (novice, intermediate) and expert group. There is a significant LapSim (Laparoscopic Simulator) surgical simulator is a system designed to simulate difference between subjects with different laparoscopic experience and thereby basic and advanced laparoscopic tasks in a virtual environment that closely resembles an construct validity for the laparoscopic simulator could be established. operative field4;5. With increasing interest in simulation programs it is important to investigate the validation of a surgical simulator. Validity is defined as “the property of being true, correct and in conformity with reality”. For the surgical simulator this means; does it measure what it is designed to measure? Validation is comprised of a number of principles. To accomplish the different parts of validation, several benchmarks have been developed to asses the validity of a testing instrument. These include face validity, content validity, construct validity, concurrent validity, discriminate validity, and predictive validity4;6;7.The validation of the virtual reality simulators for training endoscopic surgical skills in surgery has been evaluated repetitively8-15. Although some of the training modules on the virtual reality laparoscopic simulators are especially designed to train gynecologists, validation for this surgical specialty has only started recently16;17;18. This study focuses on two important types of validity. First, there is the most basic level of validity, face validity e.g. the degree of resemblance between a concept instrument (simulator) and the actual construct (laparoscopic procedure), as judged by a specific target population (both references (=novice) and experts). to see if it seems appropriate. Secondly construct

88 89 Virtual reality simulation of laparoscopic gynecologic surgery Chapter 5

validity, e.g. the degree of empirical foundation of a concept instrument, based on Figure 1. The LapSim virtual reality simulator, the sterilisation, the salpingectomy and the myoma suturing theoretical constructs. In practice: often based on the presence of a logical difference in simulation skill. (pictures provided by, Surgical Science Sweden AB) outcome between two research populations, such as experienced surgeons performing better than inexperienced ones on a certain procedure as set up by the instrument. The aim of this study was to investigate face and construct validity of the (LapSim) virtual reality surgical simulator in gynecology.

Materials and Methods

Participants Gynecologists, residents in training for gynecology and medical students from the University Medical Centre Utrecht were recruited for voluntary participation. The 56 participants had varying experience in laparoscopic surgery. Three groups were formed based on the laparoscopic experience of the subjects. Group one consisted of 15 medical students with no laparoscopic surgical experience (novices), group two of 20 residents in training for gynecologist with some laparoscopic experience (performed 10 to 75 laparoscopic procedures; intermediate) and group three consisted of 21 gynecologists and some senior residents who all performed more than 100 laparoscopic procedures (experts). None of the participants had prior experience with the virtual reality simulator.

Equipment The LapSim (Laparoscopic Simulator) consist of a 18-inch TFT monitor and a laparoscopic interface module (Immersion Inc., San Jose, CA, USA) with two instruments and a footswitch (Figure 1). The software runs on a dual-processor Pentium IV computer with Construct Validity 256 MB RAM and Geforce graphics card, using Windows XP. The software consists of The training module evaluated in this study consists of four basic skills and three two modules, the LapSim Basic Skills 2.5 and the LapSim Gyn (Laparoscopic Simulator gynecologic procedures. The first tasks camera navigation (video 1), Instrument navigation Gynecology) software (Surgical Science Ltd, Gothenburg, Sweden). The Basic Skills 2.5 (video 2) and the coordination (video 3) task provides basic navigational skills for camera package consists of nine different tasks with increasing complexity. The LapSim gyn sim- and instrument handling as described by Van Dongen et al and Duffy et all8;14. The final ulates parts of three procedures: tubal occlusion, salpingectomy in ectopic pregnancy basic task clip applying (video 4), is a complex task in which multiple instruments must be and the final suturing stage of the myomectomy procedure (Figure 1). The system does used to cut a vessel between two applied clips as described by Larsen et al17. After not possess haptic feedback. finishing the four basic tasks participants performed three simulations of gynecologic procedures. First the tubal occlusion (sterilization) procedure (video 5). In a virtual reality Face validation environment both tuba need to be occluded by clips or in a second session, by All participants filled in a questionnaire after performing the different skills on the coagulating and cutting the tuba. One hand navigates the camera and the other simulator. Next to the participant’s demographics and laparoscopic experience, the manipulates an instrument. Available instruments are a grasper, bipolar grasper, questionnaire consisted of 27 statements about the LapSim. The first 11 were about the diathermic scissors, a suction/rinsing device and clip applier. Again performance realism of the simulator, the second 10 about the training capacities of the simulator. parameters are measured by the system. The specific task parameters are applied clips, These were presented on a 5-point ordinal answering scale (from not realistic/useless to left and right side clip distance, bleeding and blood loss. The second gynecologic very realistic/very useful). There was one statement concerning the lack of haptic procedure is a salpingectomy (video 6). In this procedure an ectopic pregnancy has to be feedback. Finally, five statements concerning the need for training and assessment by dissected from the fallopian tube and surrounding membrane using bipolar graspers virtual reality were proposed which could be answered with ‘agree’, ‘disagree’ or ‘do not and/or a diathermic scissor as described by Larsen et al and Aggarwal et al16;17. The last know’. training task is the closure of the uterine wall cavity after a myomectomy (video 7). With

90 91 Virtual reality simulation of laparoscopic gynecologic surgery Chapter 5 two needle holders, a needle and thread three sutures have to be correctly placed, three versus group two and group two versus group one. Only the basic clip applying skill tightened and tied. The system measured minimal tissue bite, knot error and ripped and the gynecologic sterilization module didn’t show this trend. The sterilization stitched. Maximum time in this study was set for five minutes. simulation showed some significant performance parameters. Most difference was found in the ectopic pregnancy procedure. None of the subjects could complete the myoma After verbal instructions the participants performed three repetitions of this training suturing procedure within the set time limit of five minutes. Five of the 56 subjects (9%) module composed of the seven different tasks. The first repetition was considered as a were able to tie one knot, the other subjects none. From these five participants four were familiarization to the virtual reality simulator. The average performance of the second from the expert group and one from the intermediate group. and third repetition was used in the analysis. Table 1. Results statements; face validity (n=56) Use of statistics What do you think about the realism of…. Novice Intermediate Expert Total p-value < 0.05 Data were analyzed using the statistical software package SPSS 12.0 (SPSS Inc., Chicago, ( 1; not realistic to 5; very realistic) Group 1 group 2 group 3 mean (n=15) (n=20) (n=21) IL). Analysis of variance (ANOVA) was used with Post hoc analysis using the Bonferroni test to determine the difference in face and construct validity between the three groups. the appearance of the instruments 3.86 4.10 3.83 3.94 the movement of the instruments 3.86 3.70 3.33 3.62 P-value < 0.05 was considered statistically significant. Values are presented as means the freedom of movement of the instruments 3.57 3.45 3.72 3.58 unless stated otherwise. the function of the instruments 3.71 3.45 3.44 3.52 the tissue reaction on manipulation 3.14 3.00 2.28 2.79 3<2; p=0.042 3<1; p=0.023 Results the appearance of organs 3.29 3.15 3.28 3.23 the appearance of needle and thread (n=47) 2.86 3.35 2.38 2.87 3<2; p=0.021 the sterilisation skill (tuba occlusion) 3.71 3.60 3.11 3.46 Face validation the ectopic pregnancy skill 3.57 3.50 3.22 3.42 Table 1 shows the mean values of the scores for the first 21 statements. The first 11 the myoma suturing skill (n=46) 2.43 2.53 2.33 2.43 statements about the realism of the LapSim had a mean score of 3.29. The lowest scores the overall ergonomics 3.36 3.15 3.50 3.33 were given for the realism of the myoma suturing skill (2.43), the tissue reaction on manipulation (2.79) and the appearance of needle and thread (2.87). The training What do you think about the training capacities of… capacities of the LapSim were rated higher (mean 3.86) especially for the simulator in (1; useless to 5; very useful) general (4.38) and to train hand-eye coordination (4.46). Some answers showed significant differences between the expert and the two other groups (Table 1). The overall the simulator in general 4.43 4.60 4.11 4.38 3<2; p=0.034 scores of the experts were lower compared to the scores of the intermediates and the simulator to train hand-eye coordination 4.29 4.55 4.50 4.46 the simulator to train depth perception 3.71 3.75 2.94 3.46 3<2; p=0.020 novices. The lack of haptic feedback, was scored as most disturbing with scores of 2.61 the skill; camera navigation 3.64 3.85 3.72 3.75 from the experts versus 2.50 from the intermediate and novice subjects. the skill; instrument navigation 3.93 3.90 4.06 3.96 The majority of the subjects agreed that the LapSim virtual reality trainer is an useful the skill; coordination 4.07 4.00 4.00 4.02 instrument to train endoscopic techniques to residents. Especially hand-eye coordination the skill; sterilisation 1 (with clips) 3.93 4.05 3.33 3.77 3<2; p=0.039 (table 2). Gynecologists were not all convinced that the simulator could measure the skill; sterilisation 2 (with cutting ) 4.00 4.15 3.33 3.83 3<2; p=0.008 endoscopic skills for an endoscopic procedure. the skill; ectopic pregnancy 4.21 3.90 3.50 3.85 3<1; p=0.020 the skill; myoma suturing (n=48) 3.36 3.22 2.81 3.13

Construct validity How disturbing is the lack of haptic feedback The 56 subjects were equally distributed based on level of experience (group 1 n = 15, (1; very disturbing to 5; totally not disturbing) 2.50 2.50 2.61 2.54 group 2 n = 20, group 3 n = 21). The mean age in the groups was: group 1; 25 year, group Ratings on a 5-point ordinal answering scale (from 1 = not realistic/useless to 5 = very realistic/very usuful). 2; 32 year and group 3; 42 year. From the 56 participants everyone completed the three repetitions of the seven tasks. The parameters which showed a significant difference between groups are shown in table 3. Comparisons between the expert (group 3) and novice (group 1) subjects demonstrated the most significant difference. For most of the basic skills there was a trend towards better performance on all parameters for group

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Table 2. The statistical significant parameters of each task; construct validity The total path length and angular path were significant longer in group one versus group Task with parameter Group 1 Group 2 Group 3 Significant three (P = .003 and P = .010). The blood loss was significant more in group one than Novice Intermediate Expert difference group two (P = .010) and group three (P = 0.00). The boxplot figure 3 also shows that (n=15) (n=20) (n=21) (p < 0.05) there was less variability in performance in the experts group than the intermediate and Camera navigation Path length (meter) 4.34 4.04 3.32 3<1 and 3<2 novice subjects group. Angular path (degrees) 1720 1556 1223 3<1 and 3<2 Figure 2. Boxplots of results of four basic skills together. Parameters time (seconds), path length (meter), Instrument navigation angular path (degrees) and tissue damage (number of times). Right instrument time (seconds) 37.8 33.7 30.3 3<1 Left instrument time 37.1 33.0 29.1 3<1 700 20,00 Tissue damage (number times) 3.37 2.78 1.91 3<1 24 Coordination 600 9 Total time 106 104 90 3<1 and 3<2 9 Instrument misses (%) 47.0 35.8 22.1 3<1 15,00 500 Camera path length 1.68 1.30 1.10 3<1 Camera angular path 859 671 563 3<1 ath_length Time P Clip applying 400 No significant parameter 10,00

Sterilisation clip 300 36 Total time 79.0 88.8 67.4 3<2 Applied clips (number) 2.07 2.70 2.16 3<2 and 2>1 Right side clip distance (mm) 19.7 15.5 18.6 2<1 and 2<3 200 5,00 Left instrument angular path 191 241 131 3<2 1 2 3 1 2 3 Group Group Sterilisation cut Bleeding (mililiter/second) 0.11 0.11 0.04 3<2 6000 20,00 32 Ectopic pregnancy 18 Total time 384 251 212 3<1 and 2<1 Blood loss (mililiter) 198 113 86 3<1 and 2<1 5000 19 15,00 Unremoved diss tissue (number) 0.60 0.31 0 3<1 Left instrument path length 3.68 2.80 2.13 3<1 Right instrument path length 5.84 4.21 2.73 3<1 10,00 Angular-path

Right instrument angular path 1082 778 469 3<1 4000 Tissue_damage

Figure 2 shows the performance parameters time, path length, angular path and tissue 5,00 damage for the four basic skills together. The more experienced the group the better was 3000 the performance. There was a significant difference for path length and angular path between group three and two (P = .028 and P = .022) and between three and one 0 (P = 0.00, and P = 0.00). The ectopic pregnancy module showed the most distinctive dif- 1 2 3 1 2 3 ference in performance between the three groups (figure 3). The experts performed best, Group Group followed by the intermediates and novices. In this ectopic pregnancy module group one was significant slower than group two (P = .005) and group three (P = 0.00).

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Figure 3. Boxplots of results of the ectopic pregnancy skill. Parameters time (seconds), path length (meter), the three groups. Although we could confirm the construct validity of the LapSim, there angular path (degrees) and blood loss (ml). was a difference in the discriminative properties of the skills. In the basic skills most difference between the groups was found in camera navigation, instrument navigation 800 20,00 and coordination. Not all measured parameters are able to show a difference between 700 the groups, this was also found by Woodrum et al19. This group used three of the four basic skills we used in this study (coordination, instrument navigation and clip applying). 15,00 600 Interestingly, our research confirms their results indicating that time, path length and angular path are the most discriminative parameters. In our study, the coordination skill 500 showed besides time, three other significant parameters (instrument misses, camera 10,00 41 ath_length

Time 400 P path length and camera angular path) and the instrument navigation skill showed another significant parameter (tissue damage instead of path length). In this study the 300 5,00 clip applying skill did not show a significant performance parameter, whereas Woodrun et al19 found three parameters (time, incomplete target areas and blood loss) and Larssen 200 et al17 found also three parameters (time, path length and angular path) to differentiate 100 0 significant between the groups. A possible explanation for the smaller difference between 1 2 3 1 2 3 the groups in this skill could be the fact that the task is complex. There are some pitfalls Group Group that can contribute to a longer performance of the task. Therefore one short familiarization run might not be enough for a reliable measure of the performance of this task. It 5000 500 can not be excluded that the study is underpowered, because no power calculation was

11 done on for hand. 4000 10 400 Within the gynecologic procedural simulations the removal of the ectopic pregnancy discriminates the best, as reflected in outcome performance parameters of the different 37 groups. The ectopic pregnancy simulation also scored best by the experts in the 3000 300 33 questionnaire about the realism and training capacities of the LapSim. The gynecologic

Angular-path suturing skill was not showing a difference among the groups simply because none of Blood_loss 2000 200 the participants could finish this exercise in the available time. Probably it was too 45 * complicated, especially within the restricted time set of five minutes. Further more the graphics of this complicated skill could be improved. Especially the view and fluency of 1000 100 the needle and suture itself. It is important to realize that in this study not all performance parameters measured by 0 0 the LapSim system were able to differentiate between subjects with different levels of 1 2 3 1 2 3 experience. This could possibly be explained by the size of the study, or because these Group Group parameters might not be valid measures of laparoscopic performance. For procedural tasks one could develop a scoring system which is build on certain clinical relevant Comment performance parameters. In general surgery this was done for the clip and cutting-phase The questionnaire demonstrated reasonable face validity. The majority of participants of a laparoscopic cholecystectomy12. believed the LapSim could become a useful tool in training laparoscopic skills to In the present study the construct validity of the gynecology module is demonstrated. residents and gynecologists. No other studies are known that describe face validity of the The myoma suturing skill needs to be improved and investigated but the removal of the LapSim VR simulator for the use in gynecology. ectopic pregnancy is a valid and realistic simulation of the VR trainer. This is consistent The LapSim was able to differentiate between subjects with varying laparoscopic with the findings of other studies16;17. experience; the performance of the subjects on the virtual reality simulator was The sterilization simulation showed some significant performance parameters but less proportional to their laparoscopic experience. Twenty out of 82 parameters in different than the salpingectomy simulation. In this task on some parameters the novices skills were sensitive enough to show a significant difference between the performances of preformed better than the intermediates. This could be explained by different factors. The

96 97 Virtual reality simulation of laparoscopic gynecologic surgery Chapter 5 sterilization simulation is not very structured. There is no real parameter to determine if References the sterilization is established (clip on the right place? or tuba cut completely through?) and the exercise does not stop automatically. Perhaps it was necessary to give the 1. Garry R. The benefits and problems associated with minimal access surgery. Aust.N.Z.J.Obstet.Gynaecol. 2002;42:239-44. subjects more instructions about this task. 2. Macedonia CR, Gherman RB, Satin AJ. Simulation laboratories for training in obstetrics and gynecology. In the last few years several studies concerning the validation of the basic skills of LapSim Obstet.Gynecol. 2003;102:388-92. for training endoscopic skills have been published by different studies on surgical 3. Letterie GS. How virtual reality may enhance training in obstetrics and gynecology. Am.J.Obstet.Gynecol. residents8;9;11;13;14;19;20 These studies have shown construct validity for the LapSim virtual 2002;187:S37-S40. 4. Carter FJ, Schijven MP, Aggarwal R, Grantcharov T, Francis NK, Hanna GB et al. Consensus guidelines reality simulator in general surgery. In the field of gynecology Larssen et al showed for validation of virtual reality surgical simulators. Surg.Endosc. 2005;19:1523-32. construct validity for the LapSim simulator17. Aggarwal et al16 showed that virtual reality 5. Schijven M, Jakimowicz J. Virtual reality surgical laparoscopic simulators. Surg.Endosc. 2003;17:1943-50. simulation is usefull in the early part of the learning curve for residents who wish to learn 6. Aggarwal R, Moorthy K, Darzi A. Laparoscopic skills training and assessment. Br.J.Surg. 2004;91:1549-58. 7. Gallagher AG, Ritter EM, Satava RM. Fundamental principles of validation, and reliability: rigorous to perform the salpingectomy for ectopic pregnancy. An overview of the use of virtual science for the assessment of surgical education and training. Surg.Endosc. 2003;17:1525-29. reality trainers in gynecology is recently given by Hart R et al. In concordance with our 8. Duffy AJ, Hogle NJ, McCarthy H, Lew JI, Egan A, Christos P et al. Construct validity for the LAPSIM opinion, they conclude that virtual reality training will become an essential part of clinical laparoscopic surgical simulator. Surg.Endosc. 2005;19:401-05. 21 9. Eriksen JR, Grantcharov T. Objective assessment of laparoscopic skills using a virtual reality stimulator. training in the near future . Surg.Endosc. 2005;19:1216-19. In conclusion the findings of this study are one of the first steps of confirming that virtual 10. Hyltander A, Liljegren E, Rhodin PH, Lonroth H. The transfer of basic skills learned in a laparoscopic reality laparoscopic simulators have great promise in gynecological training. It is an simulator to the operating room. Surg.Endosc. 2002;16:1324-28. objective and constant system which can measure a trainee’s skill level. Virtual Reality 11. Langelotz C, Kilian M, Paul C, Schwenk W. LapSim virtual reality laparoscopic simulator reflects clinical experience in German surgeons. Langenbecks Arch.Surg. 2005;390:534-37. simulators are still expensive and should be used by all surgical specialties to justify the 12. Schijven M, Jakimowicz J. Construct validity: experts and novices performing on the Xitact LS500 costs. Implementing them in the different training programs (general surgery, urology laparoscopy simulator. Surg.Endosc. 2003;17:803-10. and gynecology) will have additional value, next to the box trainers and hands on training. 13. Sherman V, Feldman LS, Stanbridge D, Kazmi R, Fried GM. Assessing the learning curve for the acquisition of laparoscopic skills on a virtual reality simulator. Surg.Endosc. 2005;19:678-82. Specialized fellowships for laparoscopic surgery still are needed to train advanced 14. van Dongen KW, Tournoij E, van dZ, Schijven MP, Broeders IA. Construct validity of the LapSim: Can the competent laparoscopic surgeons. All the participants in our study thought it was an LapSim virtual reality simulator distinguish between novices and experts? Surg.Endosc. 2007. useful instrument to train eye-hand coordination and almost all thought it was an useful 15. Verdaasdonk EG, Stassen LP, Monteny LJ, Dankelman J. Validation of a new basic virtual reality simulator for training of basic endoscopic skills: the SIMENDO. Surg.Endosc. 2006;20:511-18. instrument to train endoscopic skills. Face and construct validity in gynecology are 16. Aggarwal R, Tully A, Grantcharov T, Larsen CR, Miskry T, Farthing A et al. Virtual reality simulation established for this simulator. Further research should be done on the predictive validity training can improve technical skills during laparoscopic salpingectomy for ectopic pregnancy. BJOG. of the simulator, to show if training on the simulator predicts better performance in the 2006;113:1382-87. operating theater. 17. Larsen CR, Grantcharov T, Aggarwal R, Tully A, Sorensen JL, Dalsgaard T et al. Objective assessment of gynecologic laparoscopic skills using the LapSimGyn virtual reality simulator. Surg.Endosc. 2006;20:1460-66. 18. Hart R, Doherty DA, Karthigasu K, Garry R. The value of virtual reality-simulator training in the development of laparoscopic surgical skills. J.Minim.Invasive.Gynecol. 2006;13:126-33. 19. Woodrum DT, Andreatta PB, Yellamanchilli RK, Feryus L, Gauger PG, Minter RM. Construct validity of the LapSim laparoscopic surgical simulator. Am.J.Surg. 2006;191:28-32. 20. Ro CY, Toumpoulis IK, Ashton RC, Jr., Jebara T, Schulman C, Todd GJ et al. The LapSim: a learning environment for both experts and novices. Stud.Health Technol.Inform. 2005;111:414-17. 21. Hart R, Karthigasu K. The benefits of virtual reality simulator training for laparoscopic surgery. Curr.Opin. Obstet.Gynecol. 2007;19:297-302.

98 99 Grading surgical skills curricula and training facilities for minimally invasive surgery 6

Ellen Hiemstra Henk W.R. Schreuder Anne M. Stiggelbout Frank Willem Jansen

Submitted for publication Grading surgical skills curricula and training facilities Chapter 6

Introduction Abstract In teaching hospitals all over the world, skills laboratories have been set up in order to Objective train and assess minimally invasive (e.g. laparoscopic) surgical skills outside the To develop an international consensus based list of criteria to qualify skills laborato- operating room in a safe, reproducible environment.1 This development is driven by ries and skills curricula for minimally invasive surgery (MIS). quality and patient safety concerns, a restriction in resident working hours and increasing costs of operating room time.2 Simulator acquired skills are proven to be transferable to Design the actual operations on patients, leading to a faster operating time and, more important, Prospective inventory. to fewer errors.3, 4 However, no guideline exists on how to design and use a MIS skills laboratory, nor has a Sample well-recognized standard been defined. The lack of consensus on the appropriate 23 experts in MIS. equipment is one of the most common impediments.5 Furthermore, a well equipped skills laboratory does not automatically generate skilled surgeons. Simulation centers are Methods underutilized, with minimal voluntary use of the models outside the realm of research Three quality domains for skills laboratory were defined; Personnel and Resources, studies or a structured mandatory training curriculum.6, 7 Nevertheless, there is agree- Trainee motivation and training Curriculum. A list of consensus-based criteria, ment on at least the need for properly implemented, monitored, and evaluated training 9 items per domain, was made and the experts in MIS were asked to rate each item curricula for MIS skills.8-10 on a 0 to 3 scale in level of importance. This study is an attempt to develop an international and consensus based set of quality criteria for a skills laboratory for training MIS. These criteria include aspects of the design Main Outcome Measures of the skills laboratory and the training curriculum. Quality criteria may help current and Consensus-based list for rating the quality of skills laboratories and skills curricula. future designers and clinicians to implement skills laboratories in their hospitals.

Results All experts rated the items on the consensus list. No item was added to this list. In Materials and Methods the domain Personnel and Resources; the presence of a box trainer, a laparoscopic expert and the availability of financial resources were considered the most In order to develop a criteria framework for rating skills laboratories for laparoscopic important. In the domain Trainee motivation; mandatory training supervised by surgery, a recognised consensus based approach was used.11 This approach enables laparoscopic experts were considered the most important. In the domain integrating empirical evidence where it exists with the views of experts. Curriculum; the presence of a structured skills curriculum, dedicated time for skills First, three quality domains were defined: Personnel and Resources, Trainee motivation training, and a yearly evaluation of the progress and maintenance of laparoscopic and Curriculum. These domains were inspired on the study of Stefanidis et al. who skills of the resident were considered the most important factors. explored the evidence in the surgical literature regarding laparoscopic curriculum development, and who tried to identify the factors that influence the successful Conclusions incorporation of simulator training into resident’s curriculum.12 Regarding trainee The consensus list can be used when setting up a skills laboratory, but also for motivation, external motivation of the trainee is addressed, which refers to interventions verifying the quality of an existing laboratory. From there, the focus for new aimed at modifying behaviour, because the individual internal motivation seems difficult developments can be chosen. to influence.12 Additionally, three authors (EH, HS and FWJ) independently searched the current literature for criteria that a skills laboratory should meet and categorized these items per domain. For this search, the electronic databases MEDLINE, EMBASE, Current Contents, Science Citation Index and the Cochrane database, were used. In a consensus meeting between the three authors, the lists of criteria were discussed, and an integrated consensus list was formed. Next, the consensus list was sent electronically to known worldwide experts in training of

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MIS skills, or a paper version of the consensus list was given to them if he/she visited a Table 1. Consensus list congress meeting in 2009 and 2010. An expert in MIS was defined as a gynecologist, Item Rating who is well recognized as an expert in advanced laparoscopic surgery, who has three or Personnel & resources 0 1 2 3 more publications on MIS related topics, and is actively involved in the organisation of 1. availability 24 hours a day MIS training program in his/her teaching hospital. They were asked to rate each item on 2. space for at least 4 trainees to train simultaneously 3. presence of a lab technician a 0 to 3 scale in level of importance for a skills laboratory. In this scale the following 4. presence of a curriculum director (a laparoscopic expert) definitions were chosen: 0) not important for rating a skills laboratory; 1) optional item 5. presence of a box (/video) trainer for a skills laboratory; 2) item that expresses good quality of a skills laboratory; and 3) 6. presence of a virtual reality trainer indispensible for a good laboratory. The experts were also instructed to add missing 7. effective instruction material for the use of the trainer(s) (e.g.video CDrom) items to the list. 8. presence of an animal lab 9. availability financial resources for the skills lab 10. …. Results Trainee motivation 0 1 2 3 1. training sessions are supervised by a laparoscopic expert The consensus list contained 9 items per domain (Table 1). In total, 23 experts were 2. training sessions are supervised by a lab technician selected from 14 countries in Europe, North - and South America and Australia. They 3. a proficiency (i.e. expert) based training goal has been set were either electronically, or in person, asked to fill out the consensus list. All 23 agreed 4. the training goal is based on time and precision to participate and have rated the nine items per domain (Personnel and Resources, 5. training is mandatory Trainee motivation and Curriculum). None of the respondents added a new item to the 6. residents are not allowed to perform surgery if predefined skills level is not reached list. The median scores are shown in Table 2 and the separate results per item are 7. awards are given for good attendance 8. presence of tasks of increasing level of difficulty displayed as bar charts. 9. variability is present in the laparoscopic tasks In the domain Personnel and Resources the presence of a lab technician was considered 10. …. the least essential for a skills laboratory since it was rated with a median score of 1. The three items considered most important were the presence of a curriculum director Curriculum 0 1 2 3 (laparoscopic expert), the presence of a box trainer and the availability of financial 1. presence of a structured skills curriculum resources. All these item received a median score of 3: indispensable for a good laboratory 2. time is dedicated for skills training in the residency curriculum (Figure 1). 3. monthly training sessions are organized In the domain Trainee motivation, the fact that the training should be mandatory is 4. presence of “over training” (i.e. better than training goal) facilities 5. Repetitive training over various training sessions considered the most important. Thereafter, supervision of training by a laparoscopic 6. Maintenance of training expert and residents not allowing to perform surgery if the predefined skills level is not 7. Retention of skills is established every 12 months reached was considered of importance (Figure 2). 8. training goal increases with progression in residency In the domain Curriculum, the presence of over-training facilities (i.e. training after the 9. progress in laparoscopic skills is incorporated in yearly evaluation of resident initially required level of proficiency is achieved) was considered least important (median 10. …. score: 1). Four items were rated with a median score of 3 by the responding experts: the presence of a structured skills curriculum, time dedicated for skills training, maintenance of skills, and a yearly evaluation of the progress in laparoscopic skills of the resident (Figure 3). As a result, an expert rating list with the median score is presented (Table 2).

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Table 2. Median score expert opinion consensus list Figure 1. Expert opinion domain ‘Personal and Resources’. Item Median score 20 20 20 Personnel & resources 15 15 15 1. availability 24 hours a day 2 10 10 10 2. space for at least 4 trainees to train simultaneously 2 requency requency requency F F 3. presence of a lab technician 1 F 5 5 5 4. presence of a curriculum director (a laparoscopic expert) 3 0 0 0 5. presence of a box (/video) trainer 3 0 123 0 1 2 3 0 123 6. presence of a virtual reality trainer 2 Availability 24 hrs a day Space for a least 4 trainees to Presence of a lab technician train simultaneously 7. effective instruction material for the use of the trainer(s) 2 20 20 20 8. presence of an animal lab 2 9. availability financial resources for the skills lab 3 15 15 15

10 10 10 Trainee motivation requency requency requency F F 1. training sessions are supervised by a laparoscopic expert 3 F 5 5 5 2. training sessions are supervised by a lab technician 2 0 0 0 3. a proficiency (i.e. expert) based training goal has been set 2 0 123 0 1 2 3 0 123 4. the training goal is based on time and precision 2 Presence of a curriculum Presence of a box trainer Presence of a virtual reality director (laparoscopic expert) 5. training is mandatory 3 20 20 20 6. residents are not allowed to perform surgery if predefined skills level is not reached 3 7. awards are given for good attendance 2 15 15 15 8. presence of tasks of increasing level of difficulty 2 10 10 10 9. variability is present in the laparoscopic tasks 2 requency requency requency F F F 5 5 5

Curriculum 0 0 0 1. presence of a structured skills curriculum 3 0 123 0 1 2 3 0 123 E ective instruction material Presence of an animal lab Availability nancial resources 2. time is dedicated for skills training in the residency curriculum 3 for the use of the trainer(s) for the skillslab 3. monthly training sessions are organized 2 4. presence of “over training” (i.e. better than training goal) facilities 1 5. Repetitive training over various training sessions 2 6. Maintenance of training 3 7. Retention of skills is established every 12 months 2 Discussion 8. training goal increases with progression in residency 2 9. progress in laparoscopic skills is incorporated in yearly evaluation of resident 3 For the setting of a laparoscopic skills laboratory in a (teaching) hospital the bottom line is that a box trainer model and financial resources are required. The training has to be mandatory, to be supervised by a laparoscopic expert and residents should not perform (supervised) in vivo laparoscopic surgery if the predefined skills level is not reached. Skills training should be imbedded in a structured curriculum with time scheduled for training. Finally, maintenance of skills, and a yearly evaluation of the skills level are recommended. Our detailed consensus list can be used when a MIS skills laboratory has to be set. Furthermore, it gives cues for verifying the quality of an already existing laboratory, just by using the list of items as a checklist. From there, the focus for improvement or new developments can be chosen. In the domain Personnel and Resources, the presence of a box trainer is considered relatively more important than the presence of a virtual reality (VR) trainer. This finding is consistent with recent results of Palter et al, who found in their inventory that residents prefer box trainers above VR simulators for training the more advanced laparoscopic

106 107 Grading surgical skills curricula and training facilities Chapter 6

Figure 2. Expert opinion domain ‘Trainee motivation’. Figure 3. Expert opinion domain ‘training Curriculum’.

20 20 20 20 20 20 15 15 15 15 15 15 10 10 10 10 10 10 requency requency requency requency requency requency F F F F F F 5 5 5 5 5 5 0 0 0 0 0 0 0 123 0 1 2 3 0 123 0 123 0 1 2 3 0 123 Training sessions are supervised Training sessions are supervised Pro ciency based training Presence of a structured skills Time is dedicated for skills training Monthly training sessions are by a laparoscopic expert by a lab technician goals have been set curriculum in the residency curriculum organised 20 20 20 20 20 20 15 15 15 15 15 15 10 10 10 10 10 10 requency requency requency requency requency requency F F F F F F 5 5 5 5 5 5 0 0 0 0 0 0 0 123 0 1 2 3 0 123 0 123 0 1 2 3 0 123 Training goal is based on time Training is mandatory Residents are not allowed to Presence of over-training (i.e. better Repetitive training over various Maintainance of training and precision perform surgery if predi ned than the training goal facilities) training sessions skills level is not reached 20 20 20 20 20 20 15 15 15 15 15 15 10 10 10 10 10 10 requency requency requency requency requency requency F F F F F F 5 5 5 5 5 5 0 0 0 0 0 0 0 123 0 1 2 3 0 123 0 123 0 1 2 3 0 123 Awards are given for good Prsesence of tasks of increasing Variability is present in the Retention of skills is Training goal increases with Progress in laparoscopic skills is attendence level of diculty laparoscopic tasks established every 12 months progression in residency incorporated in yearly evaluation of resident skills.13 On the contrary, both trainer types have a good correlation for the assessment of motivated throughout their entire specialty training, on the other hand, basic laparo laparoscopic skills.14 VR trainers allow solitary training while the supervisor can monitor scopic skills should be acquired as early as possible in residency after which residents the resident’s skills level electronically. The required presence of a supervisor during box can expand their proficiency in the operating room in learning anatomy, pathology, and training has the advantage that surgical knowledge can be transmitted. Furthermore, the operating techniques, while maintenance of the basic skills is all there is left to do.16 presence of a laboratory technician is rated low. This could be explained by the fact that In the third domain Curriculum there is a clear consensus about incorporating the skills an enthusiastic laparoscopic expert can fulfil this role. However, in our opinion the training for MIS in a proficiency based training curriculum. It is important to dedicate presence of a permanent availability of a technician gives a professionalizing of skills time for skills training during working hours and organize repetitive training sessions. laboratory, with all its advantages. Overall, the presence of a mandatory, structured and competency based skills training In parallel with the importance of setting the training mandatory, it was found that most curriculum is the key to success.12, 18, 19 residents do not reach the performance standards of basic laparoscopic skills if the skills With the increasing pressure on guaranteed skilfulness of surgeons, many MIS specialty training is voluntary.15 Furthermore, training until a predefined level of skills is superior teaching hospitals feel the need to implement training facilities outside the OR. Although over time based training, because the time required varies and training till a certain level it is essential to define the purpose and to indentify resources early in the development induces an external motivation. Ideally the training should be proficiency based16 and of a skills laboratory, the reality is often the other way around.1 As a result, many hospitals supervised by a laparoscopic expert. Training exercises should not be based on time only, have designed laboratories based on an individual trainer’s ideas and preferences. and a score for precision should be added.17 It can be argued whether the exercises Besides, curriculum development is lagging.4 The strength of this study is that a should have an increasing level of difficulty. On the one hand this may keep the trainees consensus based rating system has been developed with agreement of laparoscopic

108 109 Grading surgical skills curricula and training facilities Chapter 6

experts worldwide. However, the selection of the 23 experts might be a limiting factor, References because it depended on the definition we chose which was in part based on their 1. MacRae HM, Satterthwaite L, Reznick RK. Setting up a surgical skills center. World J Surg 2008;32:189-195. reputation in their peers field. 2. Gould JC. Building a laparoscopic surgical skills training laboratory: resources and support. JSLS A generally accepted set of criteria potentiates a system of accreditation for laparoscopic 2006;10:293-296. skills laboratories. Similarly, the American College of Surgeons has developed a system 3. Larsen CR, Soerensen JL, Grantcharov TP et al. Effect of virtual reality training on laparoscopic surgery: for accreditation of laboratories regarding general surgical skills in institutes.20 These randomised controlled trial. BMJ 2009;338:b1802. 4. Stefanidis D, Hope WW, Korndorffer JR, Jr., Markley S, Scott DJ. Initial laparoscopic basic skills training criteria are used to determine whether an institute meets the minimum requirements for shortens the learning curve of laparoscopic suturing and is cost-effective. J Am Coll Surg 2010;210:436-440. accreditation as a Level II (Basic Education) or a Level I (Comprehensive Education) 5. Korndorffer JR, Jr., Dunne JB, Sierra R, Stefanidis D, Touchard CL, Scott DJ. Simulator training for institute. In the light of the mounting number of studies on MIS skills training without laparoscopic suturing using performance goals translates to the operating room. J Am Coll Surg 2005;201:23-29. practical implications, our set of criteria can be used as a framework useful in daily 6. Chang L, Petros J, Hess DT, Rotondi C, Babineau TJ. Integrating simulation into a surgical residency practice, and possibly for accreditation purposes in the future. More in detail, a skills program: is voluntary participation effective? Surg Endosc 2007;21:418-421. laboratory can be assessed rating the presence of an item with the corresponding median 7. van Dongen KW, van der Wal WA, Rinkes IH, Schijven MP, Broeders IA. Virtual reality training for endoscopic surgery: voluntary or obligatory? Surg Endosc 2008;22:664-667. score of our expert rating list (Table 2). That way, items that are considered more relevant 8. Korndorffer JR, Jr., Stefanidis D, Scott DJ. Laparoscopic skills laboratories: current assessment and a call according to our expert panel receive higher ratings. As a result, a MIS skills laboratory for resident training standards. Am J Surg 2006;191:17-22. with a MIS skills curriculum can obtain at maximum 62 points (20 points for Personnel 9. Park A, Witzke DB. Training and educational approaches to minimally invasive surgery: state of the art. and Resources, 21 points for Trainee motivation and 21 points for Curriculum). This total Semin Laparosc Surg 2002;9:198-205. 10. Schijven MP, Schout BM, Dolmans VE, Hendrikx AJ, Broeders IA, Borel Rinkes IH. Perceptions of score can be used to choose the focus for future developments. Additionally, a practical surgical specialists in general surgery, orthopaedic surgery, urology and gynaecology on teaching application might be that a basic MIS laboratory should have at least the items with a endoscopic surgery in The Netherlands. Surg Endosc 2008;22:472-482. median score 3, while a comprehensive MIS laboratory should also have all items with a 11. Elwyn G, O’Connor A, Stacey D et al. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ 2006;333(7565):417. median score of 2 for the certification. 12. Stefanidis D, Heniford BT. The formula for a successful laparoscopic skills curriculum. Arch Surg 2009;144:77-82. 13. Palter VN, Orzech N, Aggarwal R, Okrainec A, Grantcharov TP. Resident perceptions of advanced laparoscopic skills training. Surg Endosc 2010;24:2830-4. Conclusion 14. Newmark J, Dandolu V, Milner R, Grewal H, Harbison S, Hernandez E. Correlating virtual reality and box trainer tasks in the assessment of laparoscopic surgical skills. Am J Obstet Gynecol 2007;197:546-4. In conclusion, this rating list can be used to set up and maintain a minimally invasive 15. Kolkman W, Wolterbeek R, Jansen FW. Gynecological laparoscopy in residency training program: Dutch skills laboratory. In a skills laboratory, at least a box trainer has to be present with a perspectives. Surg Endosc 2005;19:1498-1502. 16. Korndorffer JR, Jr., Scott DJ, Sierra R et al. Developing and testing competency levels for laparoscopic proficiency based training program. The training should be incorporated in a formal skills training. Arch Surg 2005;140:80-84. curriculum which is obliged prior to attendance of real in vivo surgery in order to enhance 17. Smith CD, Farrell TM, McNatt SS, Metreveli RE. Assessing laparoscopic manipulative skills. Am J Surg patient safety. 2001;181:547-550. 18. Gallagher AG, Ritter EM, Champion H et al. Virtual reality simulation for the operating room: proficiency- based training as a paradigm shift in surgical skills training. Ann Surg 2005;241:364-372. 19. McClusky DA, III, Smith CD. Design and development of a surgical skills simulation curriculum. World J Surg 2008;32:171-181. 20. American College of Surgeons. http://www.facs.org/education/accreditationprogram. Accessed 31-03-2011

110 111 Increasing experience in laparoscopic staging of early ovarian cancer 7

Henk W.R. Schreuder Tyrza O.S. Pattij Ronald P. Zweemer W. Marchien van Baal René H.M. Verheijen

Gynecological Surgery 2011 Jul 14. Epub ahead of print Increasing experience in laparoscopic staging of early ovarian cancer Chapter 7

Introduction Abstract The risk of an unexpected ovarian malignancy is estimated to be 1% or less in We assessed the effect of increasing experience of a single surgeon (learning curve) premenopausal women and 3.0% in postmenopausal woman.1 The majority of these in the laparoscopic staging procedure for women with early ovarian cancer and adnexal cysts and masses are managed by general gynaecologists, which may lead to compared the results with the literature. We retrospectively analyzed a total of 25 inadequate staging of ovarian cancer during the primary operation.2,3 As a consequence women with apparent early stage ovarian cancer who underwent a laparoscopic these patients have two options: 1) second surgery to be optimally staged since optimal staging procedure by the same surgeon. Three time periods, based on date of staging is an independent prognostic parameter for survival or 2) chemotherapy, since surgery, were compared with respect to operating time, amount of lymph nodes non optimal staged patients benefit from adjuvant chemotherapy.4 In patients there are harvested and surgical outcome using. There was no significant difference in subgroups who have little or nothing to gain from adjuvant chemotherapy and it appears operation time, estimated blood loss and hospital stay between the three periods. to be safe to withhold adjuvant chemotherapy from patients with early stage disease who There was however, a significant increase in the median number of pelvic and para- are optimally staged.5 aortal lymph nodes harvested (group1= 6.5, group 2= 8.0 and group 3 = 21.0, The traditional procedure for staging ovarian cancer is through laparotomy with a midline P<0.005). For the total period median operation time was 235 minutes and median incision, exposing the whole peritoneal cavity.6 Since 1994 several mainly small studies estimated blood loss was 100 ml. The median length of hospital stay was 4.0 days. have been published by a limited group of centres on the results of a laparoscopic Two intra-operative and two postoperative complications occurred. The upstaging approach to the staging of early ovarian cancer.7-22 Laparoscopic staging proves to be rate was 32%. The mean interval between initial surgery and laparoscopic staging accurate and feasible in ovarian cancer patients and has the advantages of minimal was 51.2 days. Mean duration of follow up was 43 months, range (1-116). Five (20%) invasive surgery. These advantages include less blood loss,8,17,18,21 optical magnification of patients had recurrences and 2 (8%) patients died of the disease. In conclusion, laparoscopic inspection,12,14,17 shorter hospital stay,8,10-12,16-18,21 shorter time interval to there is a significant learning curve for the laparoscopic full staging procedure in adjuvant chemotherapy10,17 and faster return of bowel movements.17,18 Laparoscopic ovarian cancer. In our study this is mainly reflected in the amount of lymph nodes staging provides similar complication rates as open surgery.8,16 Despite studies proving harvested and not in the total operating time. the feasibility, accuracy and safety of laparoscopic staging in early ovarian cancer, laparotomy is still advocated by the majority of centres. One of the reasons for a slow implementation of minimal invasive techniques in complex oncological surgery may be a long learning curve. The learning curve of the laparoscopic staging procedure in ovarian cancer has never been addressed. However Eltabbakh et al. demonstrated clearly a learning curve in the laparoscopic staging procedure for endometrial cancer.23 Our study primarily focuses on the learning curve of a single surgeon in the laparoscopic staging procedure in women with early ovarian cancer and the surgical outcome of these patients.

Patients and methods

A retrospective chart review was undertaken and identified 25 cases of laparoscopic staging of apparent early stage ovarian cancer, all operated by the same surgeon (RV) in the period from June 2001 to October 2009. To obtain clinical and pathologic information we reviewed the patient’s medical records. The following information was obtained, age, BMI, surgical procedure, pre- and postoperative FIGO stage, histopathology, days between first operation and staging laparoscopy, operation time, estimated blood loss, number of pelvic and para-aortic nodes, complications, hospital stay, nature of subsequent treatment, delay in chemotherapy, length of follow-up, recurrence and mortality. Postoperative complications were defined as occurring within 30 days after the

114 115 Increasing experience in laparoscopic staging of early ovarian cancer Chapter 7 procedure. Most ovarian carcinomas were diagnosed at final histopathology, after a first biopsies from diaphragm, left and right paracolic gutter, peritoneal reflection of the operation where a malignancy was not anticipated. After the final pathologic diagnosis, bladder and pouch of Douglas. Residual adnexal tissue and/or the residual infundibulo- patients were scheduled for a laparoscopic staging procedure. Pre-operative investigations pelvic ligament on the side of the originally involved ovary was removed. Comprehensive after the diagnosis of malignancies included: CA 125 measurement, ultrasound and CT- surgical staging further involved transperitoneal lymph node sampling from the pelvic scan. All but two patients were clinically expected to have stage I disease, the other two and para-aortic regions up to the left renal vein, followed by an infra- or supracolic patients were expected to have stage II disease. All histological types of ovarian cancers omentectomy (using a vessel sealing technique). A hysterectomy was not routinely were included. Patient characteristics are shown in Table 1. performed. The non-involved ovary, when unsuspicious on visual inspection, was left in-situ in fertility sparing procedures, in which case a wedge biopsy was taken. Table 1. Patient characteristics Number Learning curve Patients 25 To asses the effect of increasing experience, of the surgeon in the laparoscopic staging procedure, the patients were arranged in chronological order based on the date of their Mean Age in years (range) 49.7 (18 - 79) staging surgery. The patients were divided in equal groups according to three periods.

BMI in kg/m2 (range) 24.6 (17.4 - 36.5) Group I (n=9) had surgery in 2001-2003, group II (n=8) had surgery in 2004-2006 and group III (n=8) had surgery in 2007-2009. The groups were compared for surgical Histological Types outcomes: operating time, estimated blood loss, number of lymph nodes harvested, adenocarcinoma 16 clear cell 4 complications and hospital stay. bordeline 4 other 1 Literature search FIGO stage (before staging) A PubMed search was performed to retrieve all articles concerning laparoscopic staging IA 12 procedures in women with ovarian cancer between 1980 and January 2010. Search terms IB 1 used included: ‘ovarian cancer’, ‘early ovarian cancer’, ‘early-stage ovarian cancer’, ‘ovarian IC 9 IIC 2 carcinoma’, ‘ovarian neoplasm’s’, ‘adnexal tumor’, ‘fallopian tube neoplasm’s’, ‘fallopian unknown 1 tube cancer’, ‘laparoscopy’, ‘laparoscopic surgery’, ‘staging’, ‘staging surgery’ and ‘laparoscopic staging’. The relevant studies we found were compared to our series on the Tumorgrade grade 1 10 basis of above parameters. grade 2 7 grade 3 5 Statistical Analysis unknown 3 To analyse non-continuous variables we used the Kruskal Wallis test. p-values < 0.05 were Procedures at initial surgery considered significant. Statistic analysis was performed using the statistical software cystectomy 3 package SPSS 15.0 (SPSS Inc, Chicago, IL). adnectomy 11 bilateral adnectomy 5 hysterectomy + adnectomy 1 hysterectomy + bilateral adnectomy 4 Results no initial surgery 1 A total of 25 patients underwent laparoscopic staging for presumed early stage ovarian Laparoscopic staging procedure cancer. Most patients (n=24) had a secondary staging (restaging) procedure after All patients were operated by the same surgeon, using the same technique. Four trocar referral, one patients was primarily staged. Patient’s characteristics are outlined in ports were used. The first 11mm trocar was inserted into the umbilical area, one 10mm Table 1. The surgical outcome is outlined in Table 2. The median operation time was 235 trocar above the symphysis, one 10mm at the left upper quadrant and a 5mm trocar at minutes (range 100-285, mean 224). Intra operative complications were two arterial the right upper quadrant of the lower abdomen. A thorough exploration of all pelvic and bleedings. One patient lost 1000 ml of blood, the other patient 1500 ml and required a abdominal organs and peritoneal surface was conducted. Cytological washings of the blood transfusion during surgery. No conversion to laparotomy was needed. peritoneal cavity were taken and any suspicious lesion was biopsied next to random Postoperative complications were two port site haematoma’s in different patients, which

116 117 Increasing experience in laparoscopic staging of early ovarian cancer Chapter 7 resolved spontaneously. In 19 patients pelvic lymph nodes were collected (median 8.0, Table 2. Surgical outcome mean 12.2) and in 24 patients para-aortic lymph nodes were collected (median 6.0, mean Variable 5.8). The median number of total lymph nodes harvested was 8.0 (range 3-31, mean 12.2). Operation time (min) 235 (100-285) The operating time and total number of lymph nodes collected are shown in a scatter plot chronologically arranged by date of surgery (Figure 1). The operating times are widely Estimated Blood Loss (ml) 100 (10-1500) spread, but the total number of lymph nodes harvested show an increase during time. Total LNN* 8.0 (3-31) Based on final pathological assessment, eight patients were upstaged. From presumed pelvic lymph nodes (n=19) 6.0 (2-12) para-aortic lymph nodes (n=24) stage IA, two patients were upstaged to stage IC, one to stage IIB, one to stage IIC, one 8.0 (3-31) to stage IIIA, two patients were upstaged from presumed stage IC to stage IIIC and one overall (n=24) patient was upstaged from IIC to stage IIIC. Eleven patients didn’t need adjuvant Time between operations (days) 54 ± 21 chemotherapy; all other patients received adjuvant chemotherapy. These patients all had stage IC or higher or a grade 3 tumour. Mean duration of follow up was 43 months. Five Upstaging, (n) 8 (32%) patients had a recurrence. One mucinous borderline tumour (2001 FIGO stage IC, no Intraoperative complications, (n) 2 (8%) lymph node dissection) and four carcinomas recurred. In two patients recurrence appeared as carcinomatous pleuritis or peritonitis. Both these patients were completely Postoperative complications (n) 2 (8%) staged and had a clearcel carcinoma (2003 FIGO IIC and 2006 FIGO stage IC), they died Postoperative hospital stay (days) 4.0 (2-6) from the disease. The other patients are all alive without disease. To demonstrate a possible learning curve over time the patients were divided into three Time to adjuvant chemotherapy (days) 21 (± 10.3) groups and compared with respect to operating time, estimated blood loss, hospital stay Follow up (months) 43 (± 31.5) and number of pelvic and para-aortic lymph nodes. Median operating time, estimated blood loss and hospital stay did not show a significant difference between the three Data are expressed as median (range), mean ± standard deviation or number (%). * in those patients where a groups. But there was a significant increase in the total number of lymph nodes collected pelvic and/or para-aortic lymphadenectomy was performed (P=0.003) (Table 3). Table 4 shows an overview of the original literature regarding the laparoscopic staging procedure in early ovarian cancer. We added the present study in Table 3. Surgical outcome in time this table. Group I Group II Group III (first period) (second period) (third period) p-value n=9 n=8 n=8 Figure 1. Operating time and number of lymph nodes Operative time (min) 225.0 (100-260) 245.0 (145-285) 207.5 (181-270) 0.095 300 40 EBL (ml) 50.0 (10-1000) 50.0 (20-200) 100.0 (20-1500) 0.682

250 30 Total number lymph nodes* 6.5 (3-17) 8.0 (3-21) 21.0 (7-31) 0.003 Pelvic* 7.5 (1-12) 3.0 (1-13) 13.0 (4-19) 0.023 10 Para-aortic* 5.5 (2-7) 4.0 (2-8) 9.0 (3-12) 0.017 20 Hospital stay (days) 3.0 (2-5) 4.0 (3-6) 3.5 (3-6) 0.069 Operating time (min) 150 10

otal number of lymphnodes Data expressed as medians with range; * in those patients where a pelvic and/or para-aortic lymphadenectomy T was performed. 100 R Sq Linear = 0,083 0 R Sq Linear = 0,473 0 5 10 15 20 25 0 5 10 15 20 25

Laparoscopic staging prodecure (n) Laparoscopic staging prodecure (n)

Surgical procedures in chronological order operating time (n=25) and total number of lymph nodes (pelvic + para-aortal (n=24) (scatter plot).

118 119 Increasing experience in laparoscopic staging of early ovarian cancer Chapter 7 0 0 1 0 1 0 0 NA 0 2 NA 0 1 NA NA NA NA 0 0 0 NA 0 M, ( n ) 2 Discussion

3 1 1 0 2 1 0 NA NA 5 NA 2 1 NA NA NA NA 0 0 4 NA NA R ( n ) 5 We expected that with increase of the surgeon’s experience in performing laparoscopic staging procedures, the effect would be a shorter operating time and a higher number of pelvic and para-aortal lymph nodes harvested. However we did not find a decrease in op- 56 20 (7-38) 10 (2-39) (2-40) 17 19 (5-56) (1-61) 24.7 16 (4-33) NA NA 54 (8-116) 32 46 (2-72) 38 (2-89) NA NA NA NA (1-44) 23 ( 5-61) 14 60 (32-108) NA NA Mean up Follow (months) 43 (1-116) erating time as a function of the surgeon’s experience in laparoscopic staging. This might be due to the relatively limited number of cases. We did find a significant increase in the amount of lymph nodes harvested. The variation in operating time may be due to differ- 4 (11.1%) 1 (3.7%) 1 (4.2%) 2 (10.5%) 2 (11.8%) 2 (10%) 2 (6.7%) 0 11(19%) 4 (7.5%) 4 (16%) 1 (4.1%) 1 (3.7%) 0 2 (20%) 2 (14.3%) 0 9 (27.3%) 7 (36.8%) 8 (42.1%) 2 (7%) NA Compl ( n , %) 4 (16%) ences in the extent of surgery performed during laparoscopic staging. In the relatively small group we were unable to correct for these differences. Depending on what is done at initial surgery, the staging procedure for early ovarian cancer should be completed at 7 (19.4%) 7 (26%) 10 (41.7%) 4 (21.1%) 1 (5.9%) 4 (20%) 4 (26.7%) NA 8 (13.8%) 8 (19%) 7 (36%) NA 6 (21%) NA NA 8, 57% 0% 7 (21.2%) 6 (31.6%) 6 (31.6%) NA 8(47%) Upstaging ( n , %) 8 (32 %) the second operation (restaging). In our series all patients had an omentectomy, which was usually performed infracolicly. In nine patients a unilateral and in three patients a bilateral salpingo-oophorectomy was performed, four patients had an ovarian excision (to preserve fertility) and in nine patients a bilateral salpingo-oophrectomy had already been 195 (25-500) 200 (100-700) ± 170.9 567.0 240 ± 228 ± 117.9 231.2 NA 250 (50-1000) ± 138 235 ± 128 171.9 NA 271(50-1500) NA NA NA NA NA <300 568 ± 451 505.3 ± 279.8 400(150-1000) ± 208 367 352.8 ± 415.0 EBL (ml) 193 (10-1500) performed during the initial surgery. In six patients (four carcinoma’s and two borderline tumours, all before 2004) there was no pelvic lymphadenectomy performed. In the earlier years less emphasis was laid on the role of pelvic lymphadenectomy and during the years the guidelines changed.. In one patient, with a borderline tumour, a para-aortic 12.23 (0-53) 12.23 NA 11.0 ± 5.8 6.6 ± 6.2 8.9 ± 7.1 11.3 (7-23) 6.5 ± 3.9 L:2.9 ± 1.7 R:3.8 ± 1.8 L: 5.3 ± 3.3 R: 5.0 ± 3.4 20 (7-40) NA 19.6 (5-35) (5-40) 19.7 NA 8.8 (6-12) NA 8.6 (5-17) 8.8 ± 8.1 6.4 ± 3.9 7 ± 4.5 L:4.8 ± 4.2 R:4.4 ± 2.8 L: 4.6± 2.6 R: 4.4± 2.7 PALN ( n ) 5.8 (2-12) lymphadenctomy was not performed. In one patient a hysterectomy was performed, and two patients had an appendectomy because of a mucinous tumour. A laparoscopic procedure including a hysterectomy takes longer. Childers et al found a mean operating time of 149 minutes in patients who did not undergo a hysterectomy during their laparoscopic 14.84 (0-45) 14.84 NA 22.5 ± 8.9 ± 9.7 27.2 ± 5.6 13.7 18 (14-21) 25.2 ± 9.3 L:5.8 ± 2.9 R:6.5 ± 3.9 L: 9.0 ± 6.0 R: 9.6 ± 5.2 (4-27) 14 NA 19.8 (14-29) (4-27) 13.7 NA (3-13) 7.1 NA NA 33.9 ±14.5 19.3 ± 10.1 ± 5.8 25.1 ± 4.3 L:7.1 ± 3.8 R:7.6 L: 8.2 ± 5.0 9.9 R:9.14± PLN ( n ) 13.8 (1-31) staging, and a mean operating time of 196 minutes in patients who did undergo a hysterectomy.9 We do not routinely perform a full hysterectomy in a laparoscopic staging procedure. In view of the lack of evidence that the uterus may be involved when the tumour 2.37 (1-5) 2.37 3 (2-7) 10.6 ± 4.0 8.9 ± 6.1 9.4 ± 4.1 3.2 (1-7) 3 (2-12) ± 0.7 3.1 3.35 ± 5.10 (1-5) 3.1 2 (1-8) 7 (5-12) 3.3 (1-6) (1-2) 1.75 (2-8) 4.75 1.6 (0-3) 2.8 (1-5) ± 5.6 14.5 ± 4.2 14.1 7 (4-14) 5.8 ± 2.6 ± 9.3 7.31 Hospital stay (days) 3.8 (2-6) (seemingly) does not extend beyond the ovaries, it is not justifiable to routinely include such, potential harmful, operation.24-25 However in a case of endometroid ovarian carcinoma we perform an endometrial curettage. We did not find recurrences in a retained NA 6.8 (2-9) NA 19 (7-34) 35.8 (2-11.4) 4.7 8 (5-14) NA NA 8.3 ± 4.8 NA 12 (4-21) 8.3 (2-26) NA NA NA NA 13 (9-16) 32 NA NA NA Delay (weeks) 7.3 (3.1-13.3) 7.3 uterus, confirming that it is safe to leave the hysterectomy. Regarding fertility sparing surgery in early ovarian cancer several authors reported that it seems to be safe to leave the uterus and the remaining ovary.15 Despite the fact that we couldn’t find a decrease in operating time, it is likely that the increase of lymph nodes harvested demonstrates a learning curve in the laparoscopic management of women with early stage ovarian carcinoma. 229 (59-386) 180 (130-300) ± 65.7 253.7 221 ± 83 303.8 ± 84.9 (180–320) 223 ± 47 377 321 ± 64 ± 59.8 187.9 (120-370) 238 201 (90-350) (102-306) 176 ± 67.5 230 290 (190-335) 313 (120-240) 149 (130–360) 227 ± 63 275 290 ± 121 ± 81 272 ± 68 276 218 ± 73 OR-time (min) 224 (100-285) This aspect of the learning curve was also found by Eltabbakh et al. In this study, a laparoscopic assisted vaginal hysterectomy with bilateral salpingo-oophorectomy and pelvic lymph node sampling was performed in patients staged for endometrial cancer. Next to a 9/25 27/0 5/19 7/12 6 / 11 7/13 5/10 13/7 58/0 42/11 0/19 11/13 25/3 3/1 10/0 5/9 9/0 NA NA NA NA NA Restaging/ Primary staging 24/1 significantly reduced operating time, the authors describe a significant increase in the 36 27 24 19 17 20 15 20 58 53 19 24 28 4 10 14 9 33 19 19 30 17 N 25 amount of pelvic lymph nodes harvested with gaining experience.23 17 17 18 18 10 13 20 14 16 9 21 21 11 11 27 19 7 Although there are studies proving laparoscopic staging to be accurate and feasi- 15 22 12

8 8 8,10-12,14,16-18,21

Overview of literature for the laparoscopic staging procedure in early stage ovarian cancer ble, many gynaecologic oncologists are still reluctant to adopt laparoscopic staging of ovarian cancer. Apart from inexperience with minimal invasive surgery, reluc- tance seems mainly based on doubts about the adequacy of the procedure. In particularly Muzii 2009 Jung 2009 Kim 2008 Park, Bae 2008 Park, 2008 Colomer Ghezzi 2007 Chi, 2005 Spirtos, 2005 Leblanc, 2004 Krivak, 2004 2004 Tozzi Leblanc, 2000 Amara 1996 1995 Pomel, Childers,1995 Querleu, 1994 Laparotomy Kim 2008 Park, Bae 2008 Park, Ghezzi 2007 Chi, 2005 Spirtos, 2005 Laparoscopy Present series Nezhat, 2009 Delay: between initial OR and staging, PLN: pelvic lymph nodes, PALN: para-aortic lymph nodes, EBL: estimated blood loss, Compl: complications, R: Recurrence, complications, R: Recurrence, para-aortic lymph nodes, EBL: estimated blood loss, Compl: Delay: between initial OR and staging, PLN: pelvic lymph nodes, PALN: M: Mortality. (Depending on what authors describe NA= not available, (-)= range, ± = Standard Deviation) M: Mortality. Table 4. Table

120 121 Increasing experience in laparoscopic staging of early ovarian cancer Chapter 7 the number of lymph nodes obtained, possible risk of port-site metastases, lack of tactile however be weighted against the patients benefit from a less traumatic technique, quick- sensation and risk of intra operative mass rupture have been questioned.8,11,12,16-18,22 er recovery, shorter hospitalisation, and the opportunity to start chemotherapy earlier. 10 Several studies found similar numbers of lymph nodes obtained during laparoscopic and In the literature, postoperative stay for laparoscopic staging ranges from 2 to 10.6 days. 12,30 laparotomic staging.11,21 The overall number of lymph nodes obtained in our study is low- We found a median of 4.0 (range 2-6) days. Jung et al found a mean postoperative stay of er than in other studies. This could be due to the fact that we describe the learning curve 10.6 days, which is substantially longer than in the most other studies. The postoperative from the first case. In other studies the surgeons are already experienced in the laparo- stay in the laparotomic control groups ranges 5.8 to 14.5 days.8,17 scopic staging procedure and completed their learning curve before the series they de- In our series, four complications occurred. The complication rate for the laparoscopic scribe. This is substantiated by the fact that the mean number of lymph nodes in the last staging procedure in early stage ovarian cancer found in the literature ranges from 4.2%12 8 patients (group 3) is indeed comparable with other authors. Besides we do not routine- to 37.5%.7 The complication rate in laparoscopy is similar to or even less compared with ly perform a full lymph node dissection, but rather a sampling. In retrospect, the number laparotomy.8,11 of lymph nodes harvested in the first periods were too low. Future surgeons can avoid this by learning the procedure from a gynaecologic surgeon who already performed many lymph node dissections. Another concern is the risk of port site metastases due to direct Conclusion wound contamination or implantation by instruments.17 Nagarsheth et al demonstrated the risk of port site metastases (ranging from 0% to 2.3%) is comparable to the inci- This study is primarily focused on the effect of increasing experience of a single surgeon dence of implantation metastases observed after conventional laparotomy.18,26 The risk (‘learning curve’) in the laparoscopic staging of women with early ovarian cancer. We seems to be higher in patients with recurrent ovarian cancer or primary peritoneal malig- demonstrated a significant learning curve for the laparoscopic full staging procedure in nancies in the presence of ascites.16-26 In our study no port site metastases were seen. early ovarian cancer. In our study the effect of the increased experience of the surgeon is Intra-operative mass rupture in the primary laparoscopic staging procedure of early stage mainly reflected in the increased number of lymph nodes harvested and not by the total ovarian cancer is also been thought to be a risk.27 However in secondary staging operating time. Minimal invasive surgery requires a high level of skill and delicate dissec- procedures there is no risk of intra-operative mass rupture, since the tumour has already tion, and many gynaecologic oncologists have not yet been trained in this procedure. The been removed in the first procedure. Intra-operative mass rupture leads to subsequent laparoscopic staging procedure is a complex procedure and should best be learned un- contamination of the peritoneal cavity with tumour cells and upstages the unexpected der direct supervision of a skilled gynaecologic laparoscopic surgeon. If more gynaeco- ovarian cancer from stage IA to stage IC. Upstaging of the tumour can create the need logic oncologists would develop their experience with laparoscopic staging, this could for adjuvant chemotherapy in patients with potentially curable disease.18 A multivariate have a great impact on applying laparoscopic surgery on a wider scale among women analysis showed that capsular rupture caused by the surgeon did not significantly affect with early stage ovarian cancer. the prognosis in stage I and II ovarian cancer.28 In contrast to many others, Vergote et al reported in a larger multivariate analysis that tumour rupture during surgery has a negative effect on prognosis.29 However, whether or not tumour rupture has a prognostic effect, it should not be considered specific to the laparoscopic procedure. The incidence of iatrogenic rupture of ovarian cancer cysts is similar in the laparoscopy and laparotomy groups.17,19 The rate of upstaging (having a higher stage after secondary staging procedure then presumed after the initial operation) found in this study is 32%, percentages found in other studies range between 0% (only 9 patients described)20 and 41.7%. 12 The high percentage of 41.7% found by Jung et al is not entirely comparable to percentages found in other studies because they included a relatively high percentage of primary staging procedures. Our upstaging percentage is similar to upstaging rates in laparotomic staging ranging from 21.2% 17 to 47% [. 21 The mean operation time in our series is comparable to the operating times reported by other authors; ranging from 149 to 377 minutes.9,11 The operating times found in studies with a laparotomy control group range from 218 to 290 minutes. 18-21 The operation time for the laparoscopic procedures is generally longer than for a laparotomy. This should

122 123 Increasing experience in laparoscopic staging of early ovarian cancer Chapter 7

References 23. Eltabbakh GH (2000) Effect of surgeon’s experience on the surgical outcome of laparoscopic surgery for women with endometrial cancer. Gynecol Oncol. 78(1):58-61 1. Muzii L, Angioli R, Zullo M, Panici PB (2005) The unexpected ovarian malignancy found during operative 24. Schlaerth AC, Chi DS, Poynor EA, Barakat RR, Brown CL (2009) Long-term survival after fertility-sparing laparoscopy: incidence, management, and implications for prognosis. J Minim Invasive Gynecol. 12(1):81-89 surgery for epithelial ovarian cancer. Int J Gynecol Cancer. 19(7):1199-1204 2. Engelen MJ, van der Zee AG, de Vries EG, Willemse PH (2006) Debulking surgery for ovarian epithelial 25. Zanetta G, Chiari S, Rota S, Bratina G, Maneo A, Torri V, Mangioni C (1997) Conservative surgery for cancer performed by a gynaecological oncologist improved survival compared with less specialised stage I ovarian carcinoma in women of childbearing age. Br J Obstet Gynaecol. 104(9):1030-1035 surgeons. Cancer Treat Rev. 32(4):320-323 26. Nagarsheth NP, Rahaman J, Cohen CJ, Gretz H, Nezhat F (2004) The incidence of port-site metastases 3. Mayer AR, Chambers SK, Graves E, Holm C, Tseng PC, Nelson BE, Schwartz PE (1992) Ovarian cancer in gynecologic cancers. JSLS. 8(2):133-139 staging: does it require a gynecologic oncologist? Gynecol Oncol. 47(2):223-227 27. Tozzi R, Schneider A (2005) Laparoscopic treatment of early ovarian cancer. Curr Opin Obstet Gynecol. 4. Trimbos JB, Vergote I, Bolis G, Vermorken JB, Mangioni C, Madronal C, Franchi M, Tateo S, Zanetta G, 17(4):354-358 Scarfone G, Giurgea L, Timmers P, Coens C, Pecorelli S (2003) Impact of adjuvant chemotherapy and 28. Kodama S, Tanaka K, Tokunaga A, Sudo N, Takahashi T, Matsui K (1997) Multivariate analysis of surgical staging in early-stage ovarian carcinoma: European Organisation for Research and Treatment of prognostic factors in patients with ovarian cancer stage I and II. Int J Gynaecol Obstet. 56(2):147-153 Cancer-Adjuvant ChemoTherapy in Ovarian Neoplasm trial. J Natl Cancer Inst. 95(2):113-125 29. Vergote I, De BJ, Fyles A, Bertelsen K, Einhorn N, Sevelda P, Gore ME, Kaern J, Verrelst H, Sjovall K, 5. Winter-Roach BA, Kitchener HC, Dickinson HO (2009) Adjuvant (post-surgery) chemotherapy for early Timmerman D, Vandewalle J, Van GM, Trope CG (2001) Prognostic importance of degree of stage epithelial ovarian cancer. Cochrane Database Syst Rev. 3):CD004706 differentiation and cyst rupture in stage I invasive epithelial ovarian carcinoma. Lancet. 357(9251):176-182 6. Benedet JL, Bender H, Jones H, III, Ngan HY, Pecorelli S (2000) FIGO staging classifications and clinical 30. Krivak TC, Elkas JC, Rose GS, Sundborg M, Winter WE, Carlson J, MacKoul PJ (2005) The utility of hand- practice guidelines in the management of gynecologic cancers. FIGO Committee on Gynecologic assisted laparoscopy in ovarian cancer. Gynecol Oncol. 96(1):72-76 Oncology. Int J Gynaecol Obstet. 70(2):209-262 7. Amara DP, Nezhat C, Teng NN, Nezhat F, Nezhat C, Rosati M (1996) Operative laparoscopy in the management of ovarian cancer. Surg Laparosc Endosc. 6(1):38-45 8. Chi DS, bu-Rustum NR, Sonoda Y, Ivy J, Rhee E, Moore K, Levine DA, Barakat RR (2005) The safety and efficacy of laparoscopic surgical staging of apparent stage I ovarian and fallopian tube cancers.Am J Obstet Gynecol. 192(5):1614-1619 9. Childers JM, Lang J, Surwit EA, Hatch KD (1995) Laparoscopic surgical staging of ovarian cancer. Gynecol Oncol. 59(1):25-33 10. Colomer AT, Jimenez AM, Bover Barcelo MI (2008) Laparoscopic treatment and staging of early ovarian cancer. J Minim Invasive Gynecol. 15(4):414-419 11. Ghezzi F, Cromi A, Uccella S, Bergamini V, Tomera S, Franchi M, Bolis P (2007) Laparoscopy versus laparotomy for the surgical management of apparent early stage ovarian cancer. Gynecol Oncol. 105(2):409-413 12. Jung US, Lee JH, Kyung MS, Choi JS (2009) Feasibility and efficacy of laparoscopic management of ovarian cancer. J Obstet Gynaecol Res. 35(1):113-118 13. Leblanc E, Querleu D, Narducci F, Chauvet MP, Chevalier A, Lesoin A, Vennin P, Taieb S (2000) Surgical staging of early invasive epithelial ovarian tumors. Semin Surg Oncol. 19(1):36-41 14. Leblanc E, Querleu D, Narducci F, Occelli B, Papageorgiou T, Sonoda Y (2004) Laparoscopic restaging of early stage invasive adnexal tumors: a 10-year experience. Gynecol Oncol. 94(3):624-629 15. Muzii L, Palaia I, Sansone M, Calcagno M, Plotti F, Angioli R, Panici PB (2009) Laparoscopic fertility- sparing staging in unexpected early stage ovarian malignancies. Fertil Steril. 91(6):2632-2637 16. Nezhat FR, Ezzati M, Chuang L, Shamshirsaz AA, Rahaman J, Gretz H (2009) Laparoscopic management of early ovarian and fallopian tube cancers: surgical and survival outcome. Am J Obstet Gynecol. 200(1):83-86 17. Park JY, Kim DY, Suh DS, Kim JH, Kim YM, Kim YT, Nam JH (2008) Comparison of laparoscopy and laparotomy in surgical staging of early-stage ovarian and fallopian tubal cancer. Ann Surg Oncol. 15(7):2012-2019 18. Park JY, Bae J, Lim MC, Lim SY, Seo SS, Kang S, Park SY (2008) Laparoscopic and laparotomic staging in stage I epithelial ovarian cancer: a comparison of feasibility and safety. Int J Gynecol Cancer. 18(6):1202- 1209 19. Pomel C, Provencher D, Dauplat J, Gauthier P, Le BG, Drouin P, udet-Lapointe P, Dubuc-Lissoir J (1995) Laparoscopic staging of early ovarian cancer. Gynecol Oncol. 58(3):301-306 20. Querleu D, Leblanc E (1994) Laparoscopic infrarenal paraaortic lymph node dissection for restaging of carcinoma of the ovary or fallopian tube. Cancer. 73(5):1467-1471 21. Spirtos NM, Eisekop SM, Boike G, Schlaerth JB, Cappellari JO (2005) Laparoscopic staging in patients with incompletely staged cancers of the uterus, ovary, fallopian tube, and primary peritoneum: a Gynecologic Oncology Group (GOG) study. Am J Obstet Gynecol. 193(5):1645-1649 22. Tozzi R, Kohler C, Ferrara A, Schneider A (2004) Laparoscopic treatment of early ovarian cancer: surgical and survival outcomes. Gynecol Oncol. 93(1):199-203

124 125 Part II Robotic Surgery Robotic Surgery 8

Henk W.R. Schreuder René H.M. Verheijen

BJOG: An International Journal of Obstetrics and Gynaecology 2009;116:198-213 Robotic Surgery Chapter 8

Introduction Abstract The use of robots is rapidly increasing with a market growth worldwide from less than 5 Over the last decade there has been an exponential growth of robot assisted billion in 2000 to an expected 25 billion in 2010.1 Robotic technology offers the unique procedures and of publications concerning robotic assisted laparoscopic surgery. opportunity to control the operational process outside the actual location, with the skilled From a review of the available literature it becomes apparent that this technology is and often expert operators not necessarily being physically present. Probably more im- safe and allows more complex procedures in many fields of surgery, be it at relatively portant than the tele-operating features are opportunities for extremely precise, high costs. Although randomized controlled trials in gynaecology are lacking, controlled and fatigueless acts of the robot. This will make it possible to replace human available evidence suggests that particularly in gynaecology robotic surgery might movements that are limited both in time and in space in order to make complicated not only reduce morbidity but also be cost effective if performed in high volume processes more secure and safe. Interestingly, until recently robotic technology was centers. Training in robotic surgery and programs for safe and effective implementa- mainly applied in manufacturing processes, but is now becoming increasingly important tion are necessary. in machines for personal use. It is expected that after the current surge in the public domain the medical field will also start to make increasing use of robotics. In this paper we review the use of surgical robots in laparoscopy applied in different subspecialties and in gynaecology in particular. An inventory of the current applications is made on the basis of published series. The efficacy, costs, training and future developments are discussed.

Search Strategy

Over the last 2 decades the number of publications on robotic surgery has risen exponentially (Figure 1). A computer-aided and manual search for systematic reviews of randomized controlled trials, prospective observational studies, retrospective studies and case reports published between 1970 and 2008, assessing robotic surgery was carried out defined by search strings including “robotics” or “robot” or “robot-assisted” or “da Vinci”. Different searches were performed for each of the specific subspecialties.

Data sources We searched the following computerized bibliographic databases, from 1970 to 2008: MEDLINE, Embase, the Cochrane Database of systematic reviews, the Cochrane controlled trials register, the specialist register of trials maintained by Cochrane Effective Practice and Organisation of Care Group, NHS Economic Evaluation Database, Database of Abstracts on Reviews and Effectiveness (DARE).

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Figure 1. Publications about robotics in www.embase.com (search terms robot or robotics) Table 1. Robotic surgery in time 1400 1985 First robot used for stereotactic brain surgery204 1989 PROBOT, first robot used for prostatectomies205 206 1200 1992 ROBODOC use for hip replacement 1993 AESOP First commercially available robot approved by the FDA207,208 1996 ARTREMIS, master slave manipulator system209 1000 1996 EndoAssist, robot camera holder210 1998 Zeus robotic system commercially available211 800 2000 Da Vinci robotic system FDA approved

600

Figure 2. Da Vinci S HD robotic system (surgeons console, patient side card with robot arms, InSite® vision

Number of articles 400 system) (Image provided by Intuitive Surgical, Inc.)

200

0 1980 1990 1995 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year

Methods

The search was performed with the limits English and reports published between 1-January-1970 to July-2008. Full reports of each study likely to be relevant were then assessed including the reference lists. First randomized controlled trials were searched and subsequently prospective case controlled studies, prospective cohort studies, retro spective studies and case reports were assessed. Finally, we included all different types of relevant clinical research because little (randomized) data were available.

History

The first concept of surgical robotics was developed in the late 1980s at the National Aeronautics and Space Centre (NASA).2 Together with the Stanford Research Institute, virtual reality and surgical robotics were integrated and the first steps toward telepresence Description of technique surgery where made. The commercialization of robotic surgery started in the early nineties. The next step was the development of complete robotic systems. The Zeus robotic system The da Vinci robotic system (Intuitive Surgery, Mountain View, CA) has three major (Computer Motion, Goleta, CA) and the da Vinci robotic system (Intuitive Surgery, components (Figure 2). The first component is the surgeon console. The surgeon sits Mountain View, CA) were introduced in the late 1990s. Both systems have remote ergonomically behind the console and controls the robotic system remotely. The console manipulators that are controlled from a surgical work station; in less than twenty time can be placed anywhere in, or even outside the operating room. While operating, the there had been a major development in robotic surgery (Table 1). In 2003 Computer Mo- surgeon is viewing a stereoscopic image projected in the console and controls the robotic tion was taken over by Intuitive Surgery and today the Zeus system is no longer commer- arms with hand manipulators and food pedals. The position provides an optimal cially available. The da Vinci platform is the only telerobotic system currently commercially hand-eye alignment. The surgeon has limited haptic feedback, so one should rely on available. The da Vinci system was approved for general surgery by the Food and Drug Ad- visual feedback. ministration (FDA) in 2000, for the use in urology in 2001 and for gynaecology in 2005.

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The second component is the Insite Vision System® (Figure 3). A three-dimensional view Figure 4. EndoWrist® instrument, seven degrees of freedom, just like the human wrist. (Image provided by is created with the use of two camera control units and two light sources, built in the Intuitive Surgical, Inc.) unit. A 12 mm endoscope (0° or 30°) is used. The viewer gives a 6 -10 times magnification of the operating field. Because of the three dimensional view the visual feedback is excellent, and allows the surgeon to work very precisely, even without haptic feedback. High definition vision is available in the robotic visualisation system, providing higher resolution and improved clarity and detail. Finally, the digital zoom reduces the interference between endoscope and instruments.

The third component is the patient side cart with the robotic arms. The first series of da Vinci systems had three robotic arms, the new series all have four robotic arms. Attached to the robotic arms are the EndoWrist® instruments. These instruments are one of the key components of the system. The wrist has a total of 7 degrees of freedom, similar to the human hand (Figure 4). The surgeon’s hand (fingertip) movements are translated by the computer to the same movements of the instruments. Motion scaling (up to 1:10) is making it possible to perform very precise tasks. The computer also filters out normal physiological hand tremor and avoids the reverse-fulcrum effect which occurs in traditional laparoscopy. Depending on the type of surgery to be performed, there are various instruments available (Figure 5). The software is important, not only for the functioning of the robot, but also to provide safety features, such as a multi-input display allowing an integrated view of patient critical information, and the built-in telestration for proctoring and team communication.

Figure 3. InSite® vision system, three dimensional view, with console master. (Image provided by Intuitive Sur- Robotics in non-gynaecological surgery gical, Inc.) Urology Radical prostatectomy has been the fastest growing application of robotic surgery in urology and becoming standard procedure in many centres in the United States.3 Robot assistance is also applied for cystectomy, pyeloplasty, adrenalectomy,4,5 renal surgery,6 radical nephrectomy,7 donor nephrectomy,8 urogynaecology and paediatric urology.9 Since the first da Vinci robot assisted radical prostatectomy was published in 200010 multiple large prospective trials (300-2652 cases) have been published.11-15 Reviewing these data, Box et al. concluded that the robot assisted radical prostatectomy is superior in preventing excessive blood loss, major surgical complications and the development of venous thromboembolic events. Oncologic outcomes suggest that in experienced hands the percentage of positive surgical margins in the robot assisted procedure is equivalent or better compared to the open radical prostatectomy. Continence rates achieved with the robot assisted procedure are excellent and the return of sexual function is very good.16 Other reviews draw almost the same conclusions.3,17,18 The technique of the robot assisted radical prostatectomy is described in detail by Tewari and Menon.19,20 The adoption of the robotic assisted radical prostatectomy on a large scale in Europe is slower then in the USA. This could be a related to the high level of experience in conventional laparoscopy already available in Europe. Also, Europeans are more expectant for more evidence to

134 135 Robotic Surgery Chapter 8 show the advantage above conventional laparoscopy. The high costs of setting up a General surgery robotic program could also be a burden for centres. Randomized clinical trials comparing Robotic assisted laparoscopy is used for Nissen fundoplications, cholecystectomies, the open with the robot technique are unlikely to take place and other tools of assess- gastric bypass surgery,40,41 colectomies,42 mediastinal lymphadenectomy and esophagec- ment are needed.21 Randomized clinical trials between different robot assisted procedures tomy,43,44 mediastinal parathyroidectomy and thymectomy.45 In 1997 the first robot assist- are more likely to take place.22 In 2008 Lam et al started to write a Cochrane review about ed Nissen fundoplications for gastro-oesophageal reflux were performed.46 Notably this the surgical management of prostate cancer. This review will also address the issues con- is the only robotic procedures in which proper randomized trials are published. Four, cerning robot surgery.23 Cystectomy is mainly used for the treatment of bladder cancer. relatively small, randomized trials found no differences in terms of feasibility and out- The first robot assisted laparoscopic radical cystectomy was described in 2003.24 Since come, but the costs of the robot assisted procedure were higher.47-50 However, in contrast then several other authors have published their initial experiences with this procedure.25-28 to primary procedures, repeat fundoplications are often more demanding and could ben- The procedure is safe with acceptable operating times and good short term functional efit by robot assistance.51 The first studies addressing the robot assisted cholecystectomy and oncological results.29-32 Recently Elhage et al. described their surgical technique and were done using the Zeus robotic system,52-54 and later studies with the da Vinci robotic looked at the financial aspect from a British perspective.33 Another difficult laparoscopic system.55-58 Based on these studies there is not enough evidence for routine use of the procedure in urology is the ureteropelvic junction reconstruction (pyeloplasty). Although robot for this procedure.56 A Cochrane review concerning robotic surgery for the short term results seem to be similar to those of the conventional laparoscopic cholecystectomy is under way.59 pyeloplasty34-37 and open repair,38 for experienced laparoscopists there was no significant clinical advantage using robot assistance.39 Other subspecialties Robot assistance is used in cardiovascular surgery for mitral valve repair, atrial fibrillation Figure 5. EndoWrist® instruments belonging to the da Vinci Robotic system (Image provided by Intuitive surgery, coronary revascularisation, left ventricular lead placement and congenital heart Surgical, Inc.) disease surgery.60-62 In 2005 the FDA approved the da Vinci robot for mitral valve surgery and it has become an accepted procedure.63 The da Vinci robot is also used for aorto- bifemoral bypasses64 and aorto-ileac reconstruction.65 The use of robotics in paediatric surgery is rapidly growing and it is now used in the field of general surgery, urology and cardiothoracic surgery.66-68 A pilot randomized controlled trial between robot and conventional laparoscopic fundoplication in children was performed.49 A recent overview of the current status of robot-assisted surgery in children is given by Sinha et al.69 Other areas where the da Vinci system has been used include otolaryngeal surgery (FDA approval is expected this year); endocrine surgery, where the first cases have been described70,71 and neurosurgery, where results are not yet published.72 One of the major problems for these robots is the different types of tissue, bone and soft tissue to be han- dled. Different robots are used in neurosurgery for microscopy, navigation, instrumen tation, optics and imaging.73-75 The da Vinci system is not used in orthopaedics but different robots are used.76

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Robotics in Gynaecology General gynaecology Although robot assistance in general gynaecology is most widely used for hysterectomy , Reproductive surgery no randomized trials have been reported. The first robot assisted hysterectomy was Tubal reanastomosis published in 2001.81 The first series of the robot assisted hysterectomy for various Although this microsurgical operation seems to suit the features of robotic surgery, there indications was described in 2002 by Diaz-Arrastia et al., who performed the procedure is not much literature available. The first complete robotic assisted tubal anastomosis in in 11 patients including a 10 hour case of full staging for ovarian cancer where reposition- humans was performed in 1997 with the Zeus robotic system in Cleveland, USA.77 In ing of the robot was needed twice.90 Three years later, Beste et al. published their first 2003 Falcone et al. compared the robotic assisted procedure with conventional laparo- 10 cases, with an operative time similar to the standard laparoscopic hysterectomy; they scopic procedure. The operation time was two hours longer with the robot and there reported that the robot has unique advantages for knot tying, suturing and adhesiolysis.91 were no significant differences in tubal patency and clinical pregnancy rates.78 The tubal In the same year Marshal et al. published 30 cases (18 benign and 12 endometrial cancer anastomosis by robotic assistance was compared with minilaparotomy by Rodgers et al. stage I). The mean set-up time for the robot was 30 min, the mean operative time was They performed 26 robot assisted cases and 41 minilaparotomy cases. Mean anaesthesia 185 min and the mean robot use time was 120 min. There was no morbidity related to the time and surgical time were 283 minutes and 229 minutes respectively for the robot robotic system.92 Twenty cases were described in 2006 by Fiorentino et al. Mean operative group compared with 205 minutes and 181 for the minilaparotomy group. There were no time was 200 min, mean blood loss 81 ml and hospital stay 2 days. There were two differences in hospital stay, pregnancy rates and ectopic pregnancy rates. Costs were conversions due to poor visualization.93 Sixteen cases of a robot assisted laparoscopic significantly higher in the robot group and return to normal activity was significantly hysterectomy were published by Reynolds et al. Their mean operative time was 242 min. shorter in the robot group.79 The first reanastomosis with the da Vinci robotic system (170-432) and mean hospital stay was 1,5 day.94 The details of their technique have been were published by Degueldre et al. After a feasibility series of eight patients,80 they described separately.95 Robot assistance can be particular of help in difficult cases, to evaluated 28 patients in 2001. The mean operating time for bilateral anastomosis was overcome the surgical limitations of conventional laparoscopy. Six cases with scarred or 122 minutes, and there were no complications. Median hospital stay was 1 day (1-2).81 obliterated anterior cul-de-sac underwent a robot assisted hysterectomy without conversion with satisfactory outcome.96 Nezhat et al. described his first experience in Myomectomy robot assisted surgery in a diverse case series of 15 patients (hysterectomy, endo A laparoscopic approach to myomectomy results in less postoperative pain and faster metriosis, lysis of adhesions and cystectomy). The visualization, great surgical precision, recovery compared with laparotomy.82 There is no significant difference between decreasing fatigue and tension tremor of the surgeon and added wrist motion appeared laparotomy and laparoscopy concerning pregnancy rates, miscarriage rates, preterm an advantage. The costs, added operating time and the bulkiness of the equipment were delivery or Caesarean section.83 Laparoscopic myomectomy is an advanced procedure considered a disadvantage.97 A large prospective study of 91 patients was published by which needs multilayer laparoscopic suturing, resulting in a long learning curve. This Kho et al. Robot assisted laparoscopic hysterectomy took a mean operating time of 128 could be the main reason laparotomy still remains the primary access route to surgical min, with a mean console time of 73 min. As expected, console time decreased with treatment of intramural and subserosal fibroids. Nevertheless, the robot could be very experience and was significantly associated with uterine weight and adhesiolysis. Mean helpful with enucleation and suturing. The first experience with robot assisted laparo- blood loss was 79 mL and the mean hospital stay was 1.3 day. There were no conversions, scopic myomectomy was published in 2004.84 In a case series of 35 patients this was no bladder or urethral injuries occurred, but one enterotomy was repaired robotically. Six presented as a promising new technique which may overcome the surgical limitations of patients were re-admitted post surgically, because of ileus, pneumonia, vaginal cuff conventional laparoscopy. A second series by the same author was a retrospective case abscess, colitis and two for pain control. From this large series it can be concluded that matched (age, body mass and myoma weight) analysis of 58 patients treated with robot- robot assisted laparoscopic hysterectomy can be performed safely and effectively with assisted laparoscopy and laparotomy.85 The robotic approach had less blood loss, shorter acceptable operating times. The robot overcomes many limitations of the conventional hospital stay and lower complication rates, but was more expensive. The technique of the laparoscopy.98 Recently, an equally large retrospective comparison between 100 patients robotic-assisted laparoscopic myomectomy used in these two studies is explained in who underwent a total laparoscopic hysterectomy and 100 patients who underwent a detail.86 A case of a robot assisted enucleation of a large myoma is described by Mao et robot assisted laparoscopic hysterectomy was published. Overall, the operating time was al.87 Sroga et al. described 15 patients in whom they performed a robot assisted 27 min longer in the robot group. But the last 25 robotic cases compared with the myomectomies, and found operative time to range from 159–389 min, with an average conventional laparoscopy cohort had a significant shorter operating time of 79 min vs 92 bloodloss of 160 mL.88 In a retrospective matched control study of 15 cases comparing min. The mean blood loss was significantly less in the robot group (61 mL vs 113 mL), the robot assisted laparoscopic myomectomy and laparoscopic myomectomy , no difference mean length of hospital stay significantly shorter (1.1 day vs 1.6 day), while the incidence in blood loss, hospital stay and postoperative complications was found. The robot of adverse events was the same. The conversion rate in the robot group was lower (4% vs procedure took little, but significantly, longer (234 min. vs 203 min.).89 138 139 Robotic Surgery Chapter 8

9%). Others have also found that once the learning curve is completed there is a reduced detailed overview of their set-up protocol including patient positioning, trocar placement, operative time, reduced blood loss and a reduced hospital stay in patients treated and instruments used, they also included video material in the online publication. Such robotically.99 visual presentations can certainly help others to shorten their learning curve. For all Other procedures performed successful with robot assistance are ovarian trans patients in whom the robotic procedure could be completed the median total time position.100 A recent innovative and promising application is abdominal cerclage for skin-to-skin time was 257 min. (159-380). The average time from entering the theatre to cervical insufficiency.101 incision was 45 min, the average time from incision to docking robot was 25 min, the time for the hysterectomy with bilateral salpingectomy was 86 min, and the time for the Pelvic Surgery (urogynaecology) pelvic and aortic lymphadenectomy was 45 min each. When comparing the first 10 cases Robot-assisted surgery with the da Vinci robot is used in vesicovaginal fistula repair, with the last 10 there was a significant improvement, with shortening in time at all sacrocolpopexy and rectovaginopexy. Laparoscopic repair of vesicovaginal fistulas is different stages of the procedure. The conversion rate was rather high (9.86%), mean rarely done, because of its technical difficulty and there are few case reports reporting blood loss 75 ml and mean hospital stay 1 day. Veljovich et al recently published their first robot assisted repair.102,103 A case series of 5 was performed with a mean operative time of year experience, performing 118 robot assisted oncology procedures for different gynae- 233 min and a blood loss of less than 70 mL, with a 100% closure rate.104 Robot assisted cologic oncologic conditions. They compared their robot procedures with open and laparoscopic sacrocolpopexy was first described in 2004.105,106 In 20 patients the mean conventional laparoscopic procedures. They found less blood loss, shorter hospital stay operative time was 210 min, but in a subsequent series of 31 patients the same author and longer operating time in the robot procedures (but operating time significantly reported exactly the same mean operative time of 210 min, suggesting that the learning decreasing with experience).118 The technique of the robotic retroperitoneal para-aortic curve requires approximately 20 cases.107 At 1 year follow up, 4 out of 30 of these cases lymphadenectomy has recently been described by Vergrote et al.119 had recurrence of prolapse or extrusion of mesh.108 Ayav et al. described 18 consecutive The first radical hysterectomy in cervical cancer with robot assistance was described by cases of pelvic organ prolapse successfully operated with the da Vinci robotic system. Sert et al.120 They concluded that radical dissection could be done much more precise They concluded that using the da Vinci robotic system is feasible, safe and effective for than with conventional laparoscopy. In 2007 they described 15 patients with early stage the treatment of pelvic organ prolapse.109 Robot-assisted rectovaginopexy was recently cervical cancer as a pilot case control study and compared robotic-assisted laparoscopic described in 15 patients by Draaisma et al.110 Median set-up robot time was 10 min, and radical hysterectomy with conventional total laparoscopic radical hysterectomy. There median skin-to-skin operating time was 160 min, median blood loss less than 50 mL and was a significant difference in mean operating time (241 minutes in the robot group and median hospital stay was 4 days. Two other small series of 6 and 10 patients also showed 300 minutes in the conventional group). No difference in the number of lymph nodes the feasibility of this procedure.111,112 and size of parametrial tissue was found. In the robot group there was significant less bleeding and shorter hospital stay.121 A prospective analysis of 27 patients with early stage Gynaecological oncology cervical cancer undergoing a robotic radical hysterectomy was done by Margina et al., Laparoscopy can be safely and adequately used in the treatment of endometrial, ovarian and a comparison was made with matched patients operated by conventional laparo and cervical cancer.113 The initial experience and the first publications of robot assistance scopy and laparotomy. They concluded that operating times for robot surgery and in gynaecological oncology date from recent years. Reynolds et al performed 7 staging laparotomy were similar and significantly shorter compared to laparoscopy (189, 166 and procedures in ovarian and endometrial cancer patients, with a mean operating time of 220 minutes, respectively). Blood loss and length of hospital stay were similar in robotics 257 minutes.114 Twelve hysterectomies for endometrial cancer (Stage I) were performed by and laparoscopy and significantly longer in laparotomy. At a mean follow up of 31 months the group of Marshal et al.; robotic surgery was safely performed and had a major there were no recurrences at all.122 Kim et al. performed robotic radical hysterectomy and advantage for the surgeon’s ergonomics.92 A series of 20 diverse procedures in gynae pelvic lymphadenectomy in 10 cases and found a mean operating time of 207 min. The cological oncology has been described by Field et al.115 Boggess presented 43 robotic vs mean docking time was 26 min, but this was reduced significantly with experience (from 101 laparoscopic staging procedures for endometrial cancer at the American College of 35 to 10 min.).123 Kowalski compared 14 robotic versus 17 open radical hysterectomies. Surgeons. There were no conversions in the robotic group versus 3% in the laparoscopic Their mean operating time was significantly longer in the robot group (204 vs 121 group. In the robot group the operative time was significantly shorter (163 vs 213 min.), min.).124 These small series, however, do not report the outcome of surgery in terms of significantly more nodes were received (30 vs 23), there was significantly less blood loss lymph node yield and radicality and also lack sufficient oncological follow up. Boggess (63 vs 142 ml) and shorter hospital stay (1 vs 1.2 days). Notably, surgeons were better found no difference in the operating time (242 vs 240 min.).116 He performed 13 robot able to perform comprehensive staging on obese women with the robot.116 A large series assisted radical hysterectomies and compared them with 48 open radical hysterectomies. was published by Seamon et al.117 Seventy patients with endometrial cancer underwent a Significantly more lymph nodes were collected in the robot group (33 vs 22). All the robot assisted hysterectomy with pelvic and para-aortic lymphadenectomy. Next to a very robotic patients were discharged within 24 hours. He also describes how to set up a

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robotic programme in gynaecological oncology. A robotic radical hysterectomy in twenty costs of €557 or $745 (including material and time).130 For tubal anastomosis the increase patients was recently described by Fanning et al. Operating console time reduced from was $1,446.79 For myomectomy,85 pyeloplasty,39 cholecystectomy56,131 and Nissen fun 8.5 to 3.5 hours in 20 cases. Less blood loss and shorter hospital stay was found. There diplication50,132 higher costs were also found for robot assisted procedure. Most, if not all were no recurrences at a median follow-up of two years.125 There are currently no cost-effectiveness analyses do not or only partly take into account indirect costs. Morgan randomized trials concerning robotic surgery in gynaecological oncology, and none of the et al compared all “in hospital” costs for the use in cardiac surgery. When leaving out the published studies provides information on long term effects, such as survival, lymph initial capital investment for the robotic system there was no significant difference in oedema, continence and sexual function. costs between the robot procedure and the sternotomy procedure.133 Most cost analyses have been performed for radical prostatectomy. The cost of the open, conventional laparoscopic and robot assisted radical prostatectomy have been compared by different Robotics and anesthesia groups. Burgess et al. found significantly higher operative costs for the robot assisted procedure, although these costs decreased after the learning curve was completed.134 The Danic et al. describe anaesthetic considerations in 1500 radical prostatectomies.126 Some intra operative costs were higher in the robot assisted procedure but the shorter hospital special arrangements have to be made when performing robot assisted surgery in the stay in the laparoscopic/robot procedure should be taken into account.135 In relation to pelvis. Preoperatively there is no need for a full bowel preparation, but it is advisable to this it is important to realize that the costs of hospital beds vary between hospitals, use a laxative on the day before surgery. During the operation special attention must be especially between community hospitals and academic medical centres. So a robotic given to the positioning of the patient. Cushioned stirrups should be used to place the program will be most competitive in a high cost hospital combined with a high volume of patient in lithotomy position. During the operation 45° steep Trendelenburg position is cases.136 An extensive cost analysis for pyeloplasty by experienced surgeons excluding the used and the patient is prone to slip of the table. One can use a chest binding in an “x” learning curve showed cost effectiveness if operating time is less then 130 minutes and like pattern over the aromia to prevent this, paying attention to pressure areas. The most the yearly cases are above 500.137 Steinberg also concluded that after the initial learning common anaesthesia related complication (3% of the cases) was corneal abrasion, curve a program of robot assisted radical prostatectomy the procedure can be profitable, despite the use of eye tape. This could be significantly reduced with the use of eye but that one should maintain a high volume to pay for the robot and its service.138 The

patches. Constant positive airway pressure of 5 cmH2O preserves arterial oxygenation costs of the initial learning curve are high and can vary widely. A theoretical model of the during prolonged pneumoperitoneum.127 Recently Baltayian published a comprehensive expenses of the learning curve was made by including 8 series. The costs of the initial overview of anaesthetic considerations and detailed anaesthetic management for robot learning curve varied from $49,613 to $554,694 with an average of $217,034. To overcome assisted radical prostatectomy. This could be of help for centres starting a robotic these high costs the concept of high volume centres is of great importance. In such program and where the anaesthetists are not familiar with the specific measures for centres the learning curve can be rapidly traversed and costs minimized.139 these type of procedures.128

Training and education in robotics Costs effectiveness With the implemention of robot assisted laparoscopic surgery there is also an increasing An important issue in robotic surgery are the higher costs compared to regular surgery. need for training. Conventional laparoscopic surgery requires different skills and training Several costs comparisons have been made in the last few years. We will only discuss the compared to open surgery. Basic laparoscopic skills can be obtained in a box trainer, in a costs for the use of the da Vinci robotic system since this is the only robotic platform cadaver or with virtual reality.140 Training for specific procedures is possible in a cadaver available at this moment. The latest robotic da Vinci S system will cost approximately €1.5 or in a virtual reality environment. In conventional laparoscopy the surgeon has a two million in Europe, plus €150.000 yearly for maintenance. Instruments are available at dimensional view, while in robotic surgery the view is three dimensional, allowing tasks approximately €250 per instrument used, however price changes are expected with to be performed quicker and more efficiently.141-143 In contrast to open surgery, the basic current currency fluctuations. Finally, extra costs for training, delay in set-up and extra laparoscopic and robotic skills can improve significantly in a relatively short intensive operative time during the learning curve should be anticipated. A recent description of course.144 Question are how to maintain this improvement after a course, and whether the cost patterns using a robotic system is given by Prewitt et al. They analyzed 224 this improvement translates to better surgery? Robot assisted surgery can be learned in procedures in different subspecialties in a single institution and found $1470 greater different ways than conventional laparoscopy. Training on human cadavers still gives the direct costs for the use of the robotic system.129 Analyses of costs for different procedures best anatomic training, but fresh human cadavers are not always available. Coordination are made: for robot assisted laparoscopic rectopexy there was an increase in operative for multiple cadaver use increases the availability of human material and is advisable.145

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The advantage of using fresh tissue models (like porcine intestine) is obvious in develop- Figure 6. SEP da Vinci robotic simulator (Image provided by SimSurgery) ing delicate tissue handling. A complex sewing task, like a robotic sutured intestinal anastomosis, can be reproduced successfully by residents.146 For vascular surgery a standardized and reproducible training module, using pigs and rats, was developed.147 Robotic surgery is specifically suitable for virtual reality training, as the operation itself is computer guided. Different companies are developing virtual reality simulators for robotic surgery and this is likely to be the training of choice for the surgeons of tomorrow.148 The dV-Trainertm robotic simulator (Mimic Technologies, Inc, Seattle, WA) has modules for system training and for skills training.149 Face, content and construct validity for the virtual reality dV-Trainer were recently established.150,151 Another virtual reality trainer is the SEP Robottm simulator (SimSurgery, Oslo, Norway) (Figure 6).152 Training on basic robot assisted suturing skills using this simulator equalled training using a mechanical simulator.153 At the University of Nebraska a virtual reality trainer using da Vinci instruments and training task platform (dry lab) has been developed. This 3D virtual reality program can be projected inside the actual console of the da Vinci robot. Some tasks were adequately simulated but others need improvement in the complexity of the virtual reality simulation.154 The same group developed a more complex robotic surgical task, mesh alignment, in virtual reality. There were no great differences between the actual and the virtual environment, and a virtual reality environment projected inside the console was found to mimic more than any other surgical training system the actual environment.155 At the University of Hong Kong a comprehensive computer-based simulator for the da Vinci robotic system is being developed. The simulator reproduces the behaviour of the da Vinci system by implementing its kinematics and thus providing a promising tool for training and a way to plan operations.156 Students of today easily and readily adopt virtual reality as part of their regular training program.157 The new generation of medical students has grown up in the Special attention should be given to the training of residents and fellows. In the early age of computer technology and it has been shown that prior videogame experience can days the exposure of residents to robotic training was low.165 In 2003 the interest of shorten the time to learn basic skills in virtual reality simulation for minimal invasive general surgery residents in robotic training was 57%.166 In 2006 already 75% of the surgery, 158 except for robotic suturing, where prior videogame experience had a negative residents surveyed would pursue a fellowshi p robotic surgery. 167 A growing interest is impact on robotic performance.159 New developments are the use of a mentoring console. noticeable and more attention is given to robotic training of residents and fellows. The prototype of the da Vinci mentoring system was tested by Hanly et al. It facilitates A systematic approach should be used, starting as table site assistant and followed by a collaboration between the mentor and the resident during robotic surgery. It improves step wise approach of the actual surgery as a console surgeon.168 Unlike open surgery, performance of complex three handed tasks. This feature can also contribute to the robotic surgery provides safe and easy opportunity to divide the operation into smaller patient’s safety in hospitals with robotic surgical training programs. On the other hand it segments, enabling participation as a console surgeon depending on the experience of improves resident participation and resident education.160 Other new developments in the resident or fellow. It is advisable to develop a structured training program in advance. training robotics are the use of augmented visual feedback to enhance robotic surgical In this way a complex operation can be incorporated in a residency or fellow training training.161 The use of 3-D telestration technology during an actual operation not only pro- program and has less influence on the total operating time and patient safety.169 The vides immediate feedback, but it is also safer for the patient through immediate guidance surgical margins and blood loss are not negatively affected when using a systematically of the surgeon by a more experienced mentor.162 Together with the approval of the FDA, stepwise training approach.170 the manufacturer of the da Vinci robotic system (Intuitive Surgery, Mountain View, CA ) Another aspect of training is the learning curve. The term “learning curve” is used to was demanded to provide comprehensive training for all teams and surgeons planning to describe the process of gaining knowledge and skills in the field of surgical technology. use the robot clinically. The registered training centres, located all over the world, can be As a minimum, reporting of learning should include the number and experience of the found on their website. Today 23 official training centres are noted.163 The first training cur- operators and a detailed description of data collection.171 There is a difference between riculum for robotic surgery was developed at the East California University, California.164 the learning curve of conventional laparoscopy and robot surgery. Suturing and dexterity

144 145 Robotic Surgery Chapter 8 skills can be performed quicker in robot assisted laparoscopy than in conventional profitable, where one could think of recruitment or training of new surgeons working laparoscopy.172 The 3D view in robotic surgery improves surgical performance and together with other subspecialties.184 Very importantly, there is a need for a dedicated learning compared with the traditional 2D view laparoscopy.173 The learning curve for theatre team.185 Transforming an existing high volume conventional laparoscopic program robotic surgical techniques is therefore relatively short, and may be even shorter for a to a robot assisted program for radical prostatectomy can be achieved while maintaining new generation as residents have a greater ability to interact with the new robotic reasonable profits. However, equal profit is not possible without a substantial increase of instruments.174 Several studies addressed the issue of how learning of robotic skills best caseload.138 All the above programs were launched in the United States. The situation in can be assessed. It is important to identify objective variables for quantifying the extent Europe is different from country to country because of different health care systems and of proficiency. Hernandez et al demonstrate a rapid learning curve for suturing with the insurance systems. For the UK some general implications, similar to those for the US, for da Vinci robotic system. Besides time and Open Structured Assessment of Technical adoption of a robotic surgery program are described by Goldstraw et al.21 Skills (OSATS),175 they used motion analysis and found this a useful tool.176 Other variables used to show the rapid learning curve in robotic tasks are bimanual coordination and muscular activation.177 Recently a computerized assessment system (ProMIS®) was Litigation and ethical issues used to demonstrate the faster and more precise performance of the robotic system compared with conventional laparoscopy.178 An overview of assessment of simulation The increasing complexity of modern surgical technology will require more stringent based surgical skills training was recently published in the Journal of Surgical guidelines for operation and practice, similar to the discipline exercised in aviation. Using Education.179 The learning curve for robot surgical procedures varies widely. Factors of a surgical robot implies that the surgeon is no longer in direct physical of visual contact influence are experience and expertise of the surgeon, type of surgery, volume of the with the patient. The surgeon not only operates through computer commands, but there surgery. There are various variables which can be used to define the end point of the is also a physical distance to the assistants attending the operation table. Unfortunately, learning curve.180 Most data concerning the learning curve in robotic surgery come from the current systems lack a satisfactory way to communicate between the operator and the the radical prostatectomy. They show a relatively short learning curve, if volume is high assistants. As with many new technological advances, communication might appear the enough.181 The learning curve for robot assisted radical prostatectomy seems to be simi- Achilles’ heel of robotic surgery. More appropriate equipment of communication and lar for a fellowship trained surgeon and a laparoscopically naïve experienced surgeon of more strict discipline in follow up of the commands from the primary responsible person, open radical prostatectomies.182 In gynaecology, the issue of the learning curve has not the surgeon, will be essential for a safe and successful procedure. yet been properly described. However, from the small series that describe reduced With the possibility of telemedicine and robotics new legal and ethical issues arise. docking times and console time with increased experience it can be concluded that Telemedicine makes cross border treatment possible. How to deal with liability and learning curves are as steep as in other types of surgery.98 Finally the relatively large series licensure across borders? Cross border care should not change usual medical ethics, but from Seaman et al. clearly show a significant effect of experience with gynaecological makes treatment possible of patients in areas the specialist cannot reach in person. In operations.117 this way underserved regions and countries could be helped. But the technology could also aggravate migration of specialists from poor to rich areas/countries.186 Also, the security of the transmitted data between the surgeon and the (distant) robot is at stake. Setting up a robotic program Should data be treated the same way as written medical records? Who is responsible if complications arise due to transmission cuts, a breakdown of the system or instability of With the growing interest in robotic surgery and the promising results there is a the software? Malfunction of the robotic system will occur more frequently with its increasing need for information how to set up a robotic program. Palmer et al. describe increasing use; fortunately, it appeared that less than 5% of device failures resulted in 5 essential phases to set up a successful robotic program. The first step is the develop- patient complications. In addition, the rate of open conversions due to device ment of a business plan, defining the initial robotic program and arrange proper admin- malfunction decreased from 94% in 2003 to 16% in 2007.187 Although robots seem to act istrative support. The second phase is the implementation, in which one must think of autonomously all their movements and actions are operated by the surgeon and as such the theatre design, the theatre team, the purchase of a robotic system, sterilisation do not differ from any other surgical equipment. Nevertheless, as with any complex facilities, marketing and an expert lead surgeon.183 The third phase is the execution of the system, safety precautions will be more essential than with the use of simple instruments. program. Followed by a phase of maintenance. In this fourth phase one should have a Local as well as national and international guidelines will need to be developed to proper data system for quality control and efficiency, and outcomes as well as patient address specific issues. In 2007 the first policy guidelines for the robot assisted satisfaction should be registered. A structured program for training and education of prostatectomy were suggested in an editorial by Valvo et al.188 The Society of American fellow’s/residents should be available. The last phase is growth to make the program Gastrointestinal and Endoscopic Surgeons (SAGES) and the Minimally Invasive Robotic

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Association (MIRA) believed that guidelines for the use of robotics were lacking. To over- that wider availability of such systems will lead to more and more conventional laparo- come this gap they recently published a consensus statement on robotic surgery includ- scopic procedures to be performed with robot assistance. ing guidelines for training and credentialing.189 The World Medical Association (WMA) made a statement on the ethics of telemedicine on their last meeting in Copenhagen Figure 7. Procedures worldwide performed with the da Vinci robotic system until the end of week 21 2008 (October 2007). Included are principles for the patient-physician relationship and (source: Intuitive Surgical, Inc). confidentiality, the responsibilities of the physician and the quality of care. The WMA is encouraging the development of national legislation and international agreements on 140000 132,454 telemedicine.190 120000

100000 Pros and Cons 85,447 80000 The robotic surgical system has some clear advantages compared with conventional laparoscopy. A summary of the advantages and disadvantages of robot assisted laparoscop- 60000 ic surgery is given in table 2. 49,038 40000 Number of procedures Table 2. Advantages and disadvantages of robotic surgery 26,809 20000 16,228 Advantage Disadvantage 9,500 5,057 2,478 Surgical system advantages High costs 127 321 1,031 ® 0 - better InSIte vision (three dimensional) - robotic system 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 - digital camera zoom - maintenance system - camera stability - start up Year - greater degrees of freedom (Endowrist®) - improved dexterity Bulky size of the robotic system - elimination of fulcrum effect - Sometimes difficult access to patient In this respect it should also be appreciated that the next generations of doctors will have - better ergonomics for surgeon - Separation surgeon from the operating field - motion scaling been raised with computer technology as part of daily life and will therefore more readily -elimination of physiological hand tremor No tactile feedback adopt computer guided surgical techniques. Apart from more compact systems the first adaptations to be expected are the development of tactile feedback and the use of Telesurgery possible Chance of breakdown cardanic transmission that will allow even more precise tissue handling. Also, fusion with 192 Telementoring possible Use of 8 mm ports imaging techniques like CT and MRI are likely to be introduced allowing more precise and safer surgery and thus more radical oncologic surgery with minimal trauma. As the Monopoly of single market leader first MRI compatible robot was introduced in neurosurgery in 2007,193 it may also be expected to be introduced in pelvic and abdominal surgery.194,195 Although robotic technology was initially developed to allow telesurgery to be performed in areas difficult Future of robotics in gynaecology or dangerous to access, this has not yet fully been implemented. The first trans-Atlantic operation was reported in 2001 when surgeons in New York performed a cholecystectomy Considering the development of robotics in general and assisted surgery in particular, it in Strasbourg, but the main problem appeared to be the limitation and delay over the is to be expected that the application of this technology will only increase.191 The exponen- satellite transmission.195,196 Further research on long distance telesurgery is being carried tial growth of the da Vinci robotic surgical system worldwide, with over 867 systems sold out by NASA in the NASA Extreme Environment Mission Operations project, starting at up to march 2008,163 will lead to an exponential growth of procedures performed (Figure NEEMO 9.197 The first robotic system in a space station has recently been established for 7). As with every innovation that introduces new technology, initial scepticism with remote emergency surgery.198 Further future developments will focus on mobile in-vivo respect to necessity, applicability and affordability will mean a delay in wider introduction. robots to support minimal invasive surgery in remote locations (battlefield, space). For In the near future the robotic systems will become smaller and easier to handle. Whereas example, the in-vivo robots can be placed in the abdominal cavity during surgery and they now constitute stand alone systems, it is expected that they will become integrated perform wireless imaging or task assistance.199 Together with the Jet Propulsion in minimal invasive operating theatres, e.g. attached to the sealing. It may be expected 148 149 Robotic Surgery Chapter 8

Laboratory, NASA is developing a robot assisted microsurgery system (RAMS), for eye, References ear, nose, throat, face, hand, and cranial surgery.200 For the more complicated procedures it may be possible to make use of either multiple robotic arms, or even multiple robots. 1. Robonexus (www.robonexus.com/roboticsmarket.htm). accessed 20 June 2008. 2. Fisher SS, McGreevy MM, Humphries J. Proceedings of the workshop on Interactive 3-Dimensional So called swarm robots act co-ordinated and simultaneously. Such systems may be Graphics. 1986;1-12. trained to perform certain tasks independently and automatically if continuously trained 3. Rassweiler J, Hruza M, Teber D, Su LM. Laparoscopic and robotic assisted radical prostatectomy--critical by the computer by e.g. neurological networks.201 It remains fully speculative when this analysis of the results. Eur Urol 2006;49:612-624. would eventually lead to certain (parts of) operations being performed autonomously by 4. 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28. Rhee JJ, Lebeau S, Smolkin M, Theodorescu D. Radical cystectomy with ileal conduit diversion: early 53. Nio D, Bemelman WA, Busch OR, Vrouenraets BC, Gouma DJ. Robot-assisted laparoscopic prospective evaluation of the impact of robotic assistance. BJU Int 2006;98:1059-1063. cholecystectomy versus conventional laparoscopic cholecystectomy: a comparative study. Surg Endosc 29. Abraham JB, Young JL, Box GN, Lee HJ, Deane LA, Ornstein DK. Comparative analysis of laparoscopic 2004;18:379-382. and robot-assisted radical cystectomy with ileal conduit urinary diversion. J Endourol 2007;21:1473-1480. 54. Zhou HX, Guo YH, Yu XF, Bao SY, Liu JL, Zhang Y, et al. Zeus robot-assisted laparoscopic 30. Hemal AK, Kolla SB, Wadhwa P, Dogra PN, Gupta NP. Laparoscopic radical cystectomy and cholecystectomy in comparison with conventional laparoscopic cholecystectomy. Hepatobiliary Pancreat extracorporeal urinary diversion: a single center experience of 48 cases with three years of follow-up. 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187. Andonian S, Okeke Z, Okeke DA, Rastinehad A, Vanderbrink BA, Richstone L, et al. Device failures associated with patient injuries during robot-assisted laparoscopic surgeries: a comprehensive review of FDA MAUDE database. Can J Urol 2008;15:3912-3916. 188. Valvo JR, Madeb R, Gilbert R, Nicholson C, Oleyoeryk G, Perrapato S, et al. Policy guidelines suggested for robot-assisted prostatectomy. J Robotic Surg 2007;1:173-176. 189. Herron DM, Marohn M. A consensus document on robotic surgery. Surg Endosc 2008;22:313-325. 190. World Medical Assocation (www.wma.net/e/policy/t3.htm). accessed 20 June 2008. 191. Berlinger NT. Robotic surgery--squeezing into tight places. N Engl J Med 2006;354:2099-2101. 192. Gassert R, Burdet E, Chinzei K. MRI-Compatible Robotics. IEEE Eng Med Biol Mag 2008;27:12-14. 193. Sutherland GR, Latour I, Greer AD, Fielding T, Feil G, Newhook P. An image-guided magnetic resonance- compatible surgical robot. Neurosurgery 2008;62:286-292. 194. Hashizume M. MRI-guided laparoscopic and robotic surgery for malignancies. Int J Clin Oncol 2007;12:94-98. 195. Melzer A, Gutmann B, Remmele T, Wolf R, Lukoscheck A, Bock M, et al. INNOMOTION for percutaneous image-guided interventions: principles and evaluation of this MR- and CT-compatible robotic system. IEEE Eng Med Biol Mag 2008;27:66-73. 196. Marescaux J, Leroy J, Gagner M, Rubino F, Mutter D, Vix M, et al. Transatlantic robot-assisted telesurgery. Nature 2001;413:379-380. 197. NEEMO (www.nasa.gov/mission_pages/NEEMO). accessed 20 June 2008. 198. Anvari M. Telesurgery: remote knowledge translation in clinical surgery. World J Surg 2007;31:1545-1550. 199. Rentschler ME, Platt SR, Berg K, Dumpert J, Oleynikov D, Farritor SM. Miniature in vivo robots for remote and harsh environments. IEEE Trans Inf Technol Biomed 2008;12:66-75. 200. NASA project RAMS (www-robotics.jpl.nasa.gov/systems/system.cfm?System=9). accessed 20 June 2008. 201. Swarm Robots (www.swarm-robotics.org). accessed 20 June 2008. 202. Dasgupta P. Robotics in urology. Int J Med Robot 2008;4:1-2. 203. Advincula AP. 2007 World Robotic Gyn Symposium: the dawn of a new age in minimally invasive gynecologic surgery. J Robotic Surg 2008;1:177-178. 204. Kwoh YS, Hou J, Jonckheere EA, Hayati S. A robot with improved absolute positioning accuracy for CT guided stereotactic brain surgery. IEEE Trans Biomed Eng 1988;35:153-160. 205. Davies BL, Hibberd RD, Ng WS, Timoney AG, Wickham JE. The development of a surgeon robot for prostatectomies. Proc Inst Mech Eng [H ] 1991;205:35-38. 206. Paul HA, Bargar WL, Mittlestadt B, Musits B, Taylor RH, Kazanzides P, et al. Development of a surgical robot for cementless total hip arthroplasty. Clin Orthop Relat Res 1992;57-66. 207. Mettler L, Ibrahim M, Jonat W. One year of experience working with the aid of a robotic assistant (the voice-controlled optic holder AESOP) in gynaecological endoscopic surgery. Hum Reprod 1998;13:2748-2750. 208. Sackier JM, Wang Y. Robotically assisted laparoscopic surgery. From concept to development. Surg Endosc 1994;8:63-66. 209. Schurr MO, Buess G, Neisius B, Voges U. Robotics and telemanipulation technologies for endoscopic surgery. A review of the ARTEMIS project. Advanced Robotic Telemanipulator for Minimally Invasive Surgery. Surg Endosc 2000;14:375-381. 210. Aiono S, Gilbert JM, Soin B, Finlay PA, Gordan A. Controlled trial of the introduction of a robotic camera assistant (EndoAssist) for laparoscopic cholecystectomy. Surg Endosc 2002;16:1267-1270. 211. Boehm DH, Reichenspurner H, Detter C, Arnold M, Gulbins H, Meiser B, et al. Clinical use of a computer-enhanced surgical robotic system for endoscopic coronary artery bypass grafting on the beating heart. Thorac Cardiovasc Surg 2000;48:198-202. 211. Boehm DH, Reichenspurner H, Detter C, Arnold M, Gulbins H, Meiser B, et al. Clinical use of a computer-enhanced surgical robotic system for endoscopic coronary artery bypass grafting on the beating heart. Thorac Cardiovasc Surg 2000;48:198-202.

158 159 From open radical hysterectomy to robot assisted laparoscopic radical hysterectomy for early stage cervical cancer: aspects of a single institution learning curve9

Henk W.R. Schreuder Ronald P. Zweemer W. Marchien van Baal Jonas van de Lande Jan C. Dijkstra René H.M. Verheijen

Gynecological Surgery 2010;7 :253-258 Learning curve for robot assisted laparoscopic surgery Chapter 9

Introduction Abstract For the surgical treatment of stage Ib1 cervical cancer, open radical hysterectomy with We analysed the introduction of the robot assisted laparoscopic radical pelvic lymph node dissection has been the gold standard for over 100 years and has hysterectomy in patients with early stage cervical cancer with respect to patient undergone little modification since it was first described by Wertheim1 and later by benefits and surgeon related aspects of a surgical learning curve. Meigs.2 Techniques for laparoscopic radical hysterectomy and lymph node dissection A retrospective review of the first 14 robot assisted laparoscopic radical were developed in the early 1990’s3,4 and considerable experience has been gained since hysterectomies and the last 14 open radical hysterectomies in a similar clinical with over 1000 cases reported in literature. 5 setting with the same surgical team was conducted. Patients were candidates for a After initial experience with robotic systems that are no longer available, the introduction laparoscopic sentinel node procedure, pelvic lymph node dissection and open of the da Vinci Surgical Robotic system (Intuitive Surgery, Mountain View, Ca, USA) and radical hysterectomy (RH) before August 2006 and were candidates for a subsequent FDA approval for gynaecological use in 2005,6 has made the laparoscopic laparoscopic sentinel node procedure, pelvic lymph node dissection and robot as- approach to complex radical gynaecologic operations more feasible. The robotic system sisted laparoscopic radical hysterectomy (RALRH) after August 2006. has an advantage over the traditional laparoscopic approach regarding improved Overall blood loss in the open cases was significantly more compared with the articulation of instruments, stereoscopic vision, tremor reduction and motion down robot cases. Median hospital stay after RALRH was 5 days less than after RH. The scaling.7 These features suggest that a shorter learning curve may be achieved compared median theatre time in the learning period for the robot procedure was reduced to conventional laparoscopy.8 Robot assisted laparoscopic surgery is used in gynaecology from 9 hours to less that 4 hours and compared well to the 3h45min for an open for benign hysterectomy, myomectomy, tubal reanastomoses, radical surgery, lymph procedure. Three complications occurred in the open group and one in the robot node dissections and sacrocolpopexias.9,10 Robot assisted laparoscopic radical group. hysterectomy (RALRH) for cervical cancer has been recently introduced. A total of 313 RALRH is feasible and of benefit to the patient with early stage cervical cancer by a cases in 11 reports have now been published.11-20 These early reports describe operation reduction of blood loss and reduced hospital stay. Introduction of this new tech- time, blood loss, hospital stay, lymph node count and complications, but the aspect of nique requires a learning curve of less than 15 cases that will reduce the operating the learning curve is not well described. One report describes the aspect of the learning time to a level comparable to open surgery. curve more in detail.21 In the present study we compare 14 open radical hysterectomies (RH) with 14 RALRH’s including sentinel node detection. We analysed patient related aspects (blood loss, operating time, radicality of surgery (lymph node count), hospital stay and follow-up) and surgeon related aspects (operating time) of the learning curve of the surgical team in the transition from open to robot assisted laparoscopic radical hysterectomy.

Material and Methods

A total of 14 cases underwent an open RH between July 2004 and July 2006, and subsequently 14 patients were operated with the use of the da Vinci robot between August 2006 and January 2008 at the VU University Medical Centre in the Netherlands. In one case from the Robot group a sentinel lymph node showed metastatic disease and the radical hysterectomy was abandoned. The patient received chemo-radiation therapy. This case was excluded from further analysis. One case in the Robot group consisted of a stage IIb endometrial cancer. In the Netherlands we introduced the laparoscopic pelvic lymph node dissection (LPLND) with sentinel node (SN) detection for the surgical treatment of FIGO Ia2-IIa cervical cancers in 2000.22 When the SN contains a metastasis, the procedure is abandoned and the patient subsequently receives chemo-radiotherapy. The aim of this

162 163 Learning curve for robot assisted laparoscopic surgery Chapter 9 approach is to reduce the number of patients undergoing radical hysterectomy followed Figure 1. Four arm da Vinci robot (Intuitive Surgery, Mountain View, CA, USA) by chemo-radiation as this leads to substantially more morbidity than either treatment alone, without obvious better survival.23-24 Our surgical team first obtained experience with the da Vinci robot system in a training facility; consequently experience was broadened on pelvic lymphadenectomy and sentinel node procedures. Also, simple hysterectomies were performed with the system while continuing to perform radical hysterectomies by laparotomy. We subsequently started to perform robotic radical hysterectomies, using da Vinci Robotic system with 4 robotic arms (Figure 1), in August 2006. Before and after this date the last open procedures and the first robotic procedures by the same team were compared with respect to number of lymph nodes retrieved (as a marker for radicality of surgery), theatre time, blood loss, hospital stay and complications. Technically the robot assisted procedure starts with the injection of Tc99-nanocol the day prior to surgery and a scintigram is made to detect and localise the SN’s. On the day of surgery, immediately prior to the procedure 2 ml patent blue (Patent Blue V, 2.5% solution, Laboratoire Guerbet, Roissy, France) is injected in the cervix around the tumour. A three-way urinary catheter is introduced. A McCartney tube (4.5cm)25 is inserted in the vagina and fixed to the cervix, by means of a suture through the cervix which is attached to the end of the tube. The abdomen is insufflated through a Verres needle just above the umbilicus where an 11mm camera port is introduced. Two 8mm robotic troicarts are introduced at the level of and 10cm laterally to the supra-umbilical incision. The third 8mm robotic port is introduced on the right lower lateral abdomen. A 5th 11 mm port is introduced in the left upper quadrant for the assistant. The patient is then placed in extreme Trendelenburg position and at this point the robot system is attached. The procedure then continues with opening of the retroperitoneum lateral to the external iliac artery and all spaces paravesical and pararectal as well as the obturator fossa are opened in search for the SN, both visually and by use of a laparoscopic radiosensitive probe (Europrobe, Strassbourg, France) (Figure 2). When the SN’s are identified and selectively removed they are sent for frozen section. The LPLND is then systematically completed. If Figure 2. Sentinel node detection after injection of patent blue and with a laparoscopic radiosensitive probe the SN contains no metastasis the radical hysterectomy is started by dissection of the ovarian vessels and uterine artery by bipolar coagulation and selective coagulation and cutting. The ureters are mobilised to the level of the ureteric tunnel. The round ligaments are then coagulated and cut and the bladder dissected downward. The fourth robotic arm is used to manipulate the uterus contra laterally. The posterior peritoneum is then incised and the rectum deflected. The sacrouterine ligaments are cut. The parametria are then cut. The vaginal cuff is identified on the McCartney tube and cut by monopolar coagulation. The specimen can now be removed vaginally with the McCartney tube and the vaginal vault was sutured. All radical hysterectomies were performed at the Rutledge type III level26 both for the open and Robotic procedure. Statistical analysis was done using the statistical software package SPSS 15.0 (SPSS Inc, Chicago, IL). The outcome for robot assisted and open groups were compared using the Chi-square test and Fisher extract test for categorical variables and 2 sample student t-test for continuous variables. A P-value of 0,05 was considered significantly.

164 165 Learning curve for robot assisted laparoscopic surgery Chapter 9

Results Table 1. Patient characteristics, histology and stage Robot Group Open group The mean age in the robot group is 45 years compared to 48 years in the open group. The N=13 N=14 distribution of histology was similar in both groups, squamous cell carcinoma’s Age Median (range) 43 (31-78) 46 (32-68) predominated. In the robot group high grade histology predominated whereas in the open group most cases were graded as moderately differentiated (Table 1). Histology Squamous (%) 10 (77) 11 (79) The median number of lymph nodes removed was slightly higher in the robot group 29 Adeno (%) 2 (15) 3 (21) versus 26 in the open group (not statistically significant) (Table 2). Blood loss was Endometrioid (%) 1(8) 0 (0) calculated by the difference in the total amount of suctioned and irrigated fluids. Median Grade blood loss in the open group was 2000ml (range 1000-4600ml). For the Robot group 1 0 0 median blood loss was 300ml (range 50-1000ml). In both groups blood loss for 2 9 6 3 4 8 SN+LPLND and radical hysterectomy was combined. Hospital stay for the radical hysterectomy in the open group was at a median of 9 days (range 7-16 days). In the robot group Stage (FIGO) Cervical the median hospital stay was 4 days (range 3-14 days). Three complications occurred in Ib1 11 12 the open group. One cystotomy lesion was managed conservatively. One temporary ure- Ib2 1 (after neoadjuvant chemotherapy) 1 teric obstruction occurred post operatively and the hydronefrosis was decompressed by Endometrial cancer IIB 1 percutaneous drainage. After removal of this drain the patient recovered well. A vault abscess was drained in a third patient. In the robot group one complication occurred: an accessory ureter was cut requiring percutaneous drainage and re-anastomosis in a second procedure. Theatre times are represented in real theatre-time-spent and are Table 2. Comparison of the theatre time, lymph nodes removed, blood loss, hospital stay, complications, and calculated from the start of anaesthetic preparations. Theatre time ends when the patient recurrences for radical hysterectomy patients. leaves the operating table. For the open group the median theatre time for the radical Robot Group (n=13) Open Group (n=14) P-value hysterectomy was 3h:45min (range 2:50 - 5:30). For the robot group this was 7h:23min Theatre time (min) 434 (264-610) 225 (170-330 ) < 0,001 (range 4:24 - 10:10) and includes the SN+LPLND in 10 of 13 cases. In the remaining three Median (range) cases the SN+LPLND was performed in a separate surgical session, and the console time LN removed (n) 29 (19-76) 26 (10-41) 0,064 of the SN+LPLND was added to the total theatre time of the radical hysterectomy. The Median (range) theatre times are decreasing dramatically over time in the Robot group whereas theatre time in the open group has obviously remained stable (Figure 3). Blood loss (ml) 300 (50-1000) 2000 (1000-4600) < 0,001 Median (range) In a median follow-up of 42 months (range 31-54) for the open group one pelvic sidewall recurrence occurred 7 months after the radical hysterectomy. The robot group has a Hospital stay (days) 4 (2-14) 9 (7-16) < 0,001 mean follow-up of 26 months (range 17-32) in which two recurrences occurred. One Median (range) pelvic sidewall recurrence and a port metastasis occurred 12 moths after primary surgery. Complications (n) 1 3 0,61 This was treated with excision of the port metastasis and chemoradiation on the pelvis. Number The second recurrence occurred 17 months after primary surgery and was located in the Follow-up (months) 26 (17-32) 42 (31-54) rectum, a posterior exenteration was performed. All but one patient received single Median (range) < 0,001 modality treatment. In one patient from the open group post-operative radiotherapy was Recurrences (n) 2 1 0, 59 required due to a narrow vaginal margin. Number

166 167 Learning curve for robot assisted laparoscopic surgery Chapter 9

Comment theatre time with approximately one hour.28 A dedicated surgical and anaesthesiological In this study we could confirm the findings of previous authors describing the RALRH for team tremendously increases efficiency and reduces the time spent in this phase of the the treatment of cervical cancer.11,13-18,20 They also conclude that this technique is feasible procedure. Anaesthesiological aspects of robotic surgery should be well appreciated and could be of benefit to the patient regarding reduction of blood loss and reduction of before embarking on robotic surgery.29-30 Interestingly anaesthesiological complications hospital stay. We found a significant reduction of blood loss and hospitalisation was did not occur despite prolonged surgical times with the patient in extreme Trendelenburg reduced by 5 days in the robotic group indicating significant quicker recovery compared position.There is still a lack of literature about the learning curve for robot assisted to open surgery. The complication rate was lower in the robot assisted group, this is gynaecological procedures. In urology the aspect of the learning curve for radical consistent with the data described by other authors.11,12,14,15 One aspect of quality of prostatectomies is well described and compared to conventional laparoscopy the surgery is the number of pelvic lymph nodes removed. In this study lymph node counts learning curve for robotic surgery is significantly shorter.31-32 Recently the learning curve of were higher in the robotic group, although this was not statistically significant. Most the robot assisted sacrocolpopexy was described, a reduction of operative time of 25% other authors could not find a statistically significant difference in lymph node counts after ten cases was found, again suggesting a relatively short learning curve.32-33 Two other compared with open surgery, but there seems to be a trend towards a higher lymph node studies have specifically looked at learning curves in benign gynaecology. Lenihan et al retrieval in patients operated with robot assistance.14,15,17 An explanation could be that the performed 113 robot assisted procedures (mainly hysterectomies, but also myomectomy, studies were too small to show a statistically significant difference. Recent larger reports sacrocolpopexy and oophorectomy). With the use of a dedicated team they where able tot concerning the RALRH confirm this trend and found a statistically significant higher set up the robot for surgery in 45 minutes after 20 cases and in 35 minutes within 50 lymph node count in the robotic group.11,12 It is likely that this may be attributed to cases. Robot console times and total operative times were consolidated after instrument articulation, 3D view and motion downscaling, allowing a very selective approximately 50 cases at about 50 minutes for console time and 90 minutes for total dissection in robot assisted surgery. operative time.34 Forty cases of benign gynaecologic procedures by a single surgeon are In addition, we showed that theatre time may rapidly be reduced to the level of an open described by Pitter et al.35 After 20 cases a statistical improvement in operative time is radical hysterectomy. A learning curve of 14 cases reduced the team’s total theatre time reached. Both studies do not differentiate between the procedures performed. by 48%. Our learning curve is comparable with the only other published detailed learning In conclusion, robotic assisted surgery is rapidly growing and has a high potential. Our curve for the RALRH described by Fanning et al.21 We plotted their learning curve of the data suggest a relatively short learning curve with quick improvement of patient and first 14 robotic cases together with our learning curve in Figure 3. Their reduction in surgeon related parameters. This is a great advantage in the implementation in daily theatre time is 35% after 14 cases and 59% after 20 cases. This is suggesting a relatively practice. short learning curve for robotic procedures. Person et al. reported their skin to skin time for the RALRH (with or without sentinel node) and found also a rapid decrease of surgery 19 Figure 3. Theatre time for the Radical Hysterectomy (Open procedure and Robot procedure) also plotted the time. The learning curve for the robot hysterectomy with pelvic and para-aortic learning curve from Fanning et al21 lymphadenectomy for endometrial cancer is described in detail by Seamon et al. They Open procedure conclude the learning curve for this procedure seems to be approximately 20 cases; 700 however efficiency continues to improve after the first 20 cases.27 Our team gradually Robot procedure 600 introduced the use of the Robot and had experience in laparoscopic oncological surgery Fanning et al. robot and open radical surgery for many years. When a more rapid transition to robotic surgery 500 is chosen the learning curve may be longer. In our study we purposely measured real-the- 400 atre-time as it is our experience that a significant amount of time may be lost inpreparing Minutes and positioning of the patient as well as positioning and introducing the Robotic system. 300 This is also stated by Seamon et al who looked in detail at theatre time, skin to skin time, 200 and console times for the robotic hysterectomy with lymphadenectomy for endometrial cancer. In their study console time is approximately half of the total theatre time.27 100 Measuring pure console time, as is done in many other studies on robotic surgery, does 0 not reflect the effort of the whole team’s learning curve and may therefore not represent a 1 2 3 4 567 8 9 10 11 12 13 14 true comparison with open surgery. In our study the theatre time may be longer than in Case number other centres. This is mainly due to the SN technique where the anatomical spaces are all opened before starting the lymph node in search of the SN. This procedure increases

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References 27. Seamon LG, Cohn DE, Richardson DL, Valmadre S, Carlson MJ, Phillips GS, et al. Robotic hysterectomy and pelvic-aortic lymphadenectomy for endometrial cancer. Obstet Gynecol 2008;112:1207-1213. 1. Wertheim E. The extended abdominal operation for carcinoma uteri. Am J Obstet Gynecol 1912;7:169-232. 28. Buist MR, Pijpers RJ, van LA, van Diest PJ, Dijkstra J, Kenemans P, et al. Laparoscopic detection of 2. Meigs J. The Wertheim operation for carcinoma of the cervix. Am J Obstet Gynecol 1945;40:542-543. sentinel lymph nodes followed by lymph node dissection in patients with early stage cervical cancer. 3. Canis M, Mage G, Wattiez A, Pouly JL, Manhes H, Bruhat MA. Does endoscopic surgery have a role in Gynecol Oncol 2003;90:290-296. radical surgery of cancer of the cervix uteri? J Gynecol Obstet Biol Reprod 1990;19:921. 29. Baltayian S (2008) A brief review: anesthesia for robotic prostatectomy. J Robotic Surg 2008;2:59-61. 4. Nezhat CR, Burrell MO, Nezhat FR, Benigno BB, Welander CE. Laparoscopic radical hysterectomy with 30. Danic MJ, Chow M, Alexander G, Bhandari A, Menon M, Brown M. Anesthesia considerations for paraaortic and pelvic node dissection. Am J Obstet Gynecol 1992;166:864-865. robotic-assisted laparoscopic prostatectomy: a review of 1,500 cases. J Robotic Surg 2008;1:119-123. 5. Zakashansky K, Bradley WH, Nezhat FR. New techniques in radical hysterectomy. Curr Opin Obstet 31. Artibani W, Fracalanza S, Cavalleri S, Iafrate M, Aragona M, Novara G, et al. Learning curve and Gynecol 2008;20:14-19. preliminary experience with da Vinci-assisted laparoscopic radical prostatectomy. Urol Int 6. Food and Drug Association. www fda gov/fdac/features/2005/405_computer html. Accessed 2009 May 20 2008;80:237-244. 7. Camarillo DB, Krummel TM, Salisbury JK, Jr. Robotic technology in surgery: past, present, and future. Am 32. Ficarra V, Cavalleri S, Novara G, Aragona M, Artibani W. Evidence from robot-assisted laparoscopic J Surg 2004;188(4A Suppl):2S-15S. radical prostatectomy: a systematic review. Eur Urol 2007;51:45-55. 8. Blavier A, Gaudissart Q, Cadiere GB, Nyssen AS. Comparison of learning curves and skill transfer 33. Akl MN, Long JB, Giles DL, Cornella JL, Pettit PD, Chen AH, et al. Robotic-assisted sacrocolpopexy: between classical and robotic laparoscopy according to the viewing conditions: implications for training. technique and learning curve. Surg Endosc 2009;23:2390-2394. Am J Surg 2007;194:115-121. 34. Lenihan JP, Jr., Kovanda C, Seshadri-Kreaden U. What is the learning curve for robotic assisted 9. Schreuder HW, Verheijen RH. Robotic surgery. BJOG 2009;116:198-213. gynecologic surgery? J Minim Invasive Gynecol 2008;15:589-594. 10. Visco AG, Advincula AP. Robotic gynecologic surgery. Obstet Gynecol 2008;112:1369-1384. 35. Pitter MC, Anderson P, Blissett A, Pemberton N. Robotic-assisted gynaecological surgery-establishing 11. Boggess JF, Gehrig PA, Cantrell L, Shafer A, Ridgway M, Skinner EN, et al. A case-control study of robottraining criteria; minimizing operative time and blood loss. Int J Med Robot 2008;4:114-120. assisted type III radical hysterectomy with pelvic lymph node dissection compared with open radical hysterectomy. Am J Obstet Gynecol 2008;199:357.e1-357.e7. 12. Estape R, Lambrou N, Diaz R, Estape E, Dunkin N, Rivera A. A case matched analysis of robotic radical hysterectomy with lymphadenectomy compared with laparoscopy and laparotomy. Gynecol Oncol 2009;113:357-361. 13. Kim YT, Kim SW, Hyung WJ, Lee SJ, Nam EJ, Lee WJ. Robotic radical hysterectomy with pelvic lymphadenectomy for cervical carcinoma: a pilot study. Gynecol Oncol 2008;108:312-316. 14. Ko EM, Muto MG, Berkowitz RS, Feltmate CM. Robotic versus open radical hysterectomy: a comparative study at a single institution. Gynecol Oncol 2008;111:425-430. 15. Lowe MP, Hoekstra AV, Jairam-Thodla A, Singh DK, Buttin BM, Lurain JR, et al. A comparison of robot- assisted and traditional radical hysterectomy for early-stage cervical cancer. J Robotic Surg 2009;3:19-23. 16. Lowe MP, Chamberlain DH, Kamelle SA, Johnson PR, Tillmanns TD. A multi-institutional experience with robotic-assisted radical hysterectomy for early stage cervical cancer. Gynecol Oncol 2009;113:191-194. 17. Magrina JF, Kho RM, Weaver AL, Montero RP, Magtibay PM. Robotic radical hysterectomy: comparison with laparoscopy and laparotomy. Gynecol Oncol 2008;109:86-91. 18. Nezhat FR, Datta MS, Liu C, Chuang L, Zakashansky K. Robotic radical hysterectomy versus total laparoscopic radical hysterectomy with pelvic lymphadenectomy for treatment of early cervical cancer. JSLS 2008;12:227-237. 19. Persson J, Reynisson P, Borgfeldt C, Kannisto P, Lindahl B, Bossmar T. Robot assisted laparoscopic radical hysterectomy and pelvic lymphadenectomy with short and long term morbidity data. Gynecol Oncol 2009;113:185-190. 20. Sert B, Abeler V. Robotic radical hysterectomy in early-stage cervical carcinoma patients, comparing results with total laparoscopic radical hysterectomy cases. The future is now? Int J Med Robot 2007;3:224-228. 21. Fanning J, Fenton B, Purohit M. Robot radical hysterectomy. Am J Obstet Gynecol 2008;198:649.e1-649.e4. 22. Verheijen RH, Pijpers R, van Diest PJ, Burger CW, Buist MR, Kenemans P. Sentinel node detection in cervical cancer. Obstet Gynecol 2000;96:135-138. 23. Landoni F, Maneo A, Colombo A, Placa F, Milani R, Perego P, et al. Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer. Lancet 1997;350:535-540. 24. Richard SD, Krivak TC, Castleberry A, Beriwal S, Kelley JL, III, Edwards RP, et al. Survival for stage IB cervical cancer with positive lymph node involvement: a comparison of completed vs. abandoned radical hysterectomy. Gynecol Oncol 2008;109:43-48. 25. McCartney AJ, Obermair A. Total laparoscopic hysterectomy with a transvaginal tube. J Am Assoc Gynecol Laparosc 2004;11:79-82. 26. Piver MS, Rutledge F, Smith JP. Five classes of extended hysterectomy for women with cervical cancer. Obstet Gynecol 1974;44:265-272.

170 171 Validation of a Novel Virtual Reality Simulator for Robotic Surgery10

Henk W.R. Schreuder Jan E.U. Persson Richard G.H. Wolswijk Ingmar Ihse Marlies P. Schijven René H.M. Verheijen

Submitted for publication A novel virtual reality simulator for robotic surgery Chapter 10

Introduction Abstract Since the FDA approval of the da Vinci® Surgical System (dVSS) (Intuitive Surgical, Objective Sunnyvale, CA) for gynaecological surgery, there has been an exponential growth in To establish face- and construct validity of a novel virtual reality simulator (dV-Trainer) robot-assisted gynaecologic surgical procedures.1 The field of robot assisted minimal for the use in training robot assisted surgery with the Da Vinci Surgical System. invasive surgery is still expanding and currently involves many specialties, including urology, general surgery, cardiothoracic surgery, paediatric surgery and gynaecology. Design Current and future developments will further increase the uptake of robot assisted Comparative cohort study procedures for minimal invasive surgery.2 With the increase in robotic procedures there is a concomitant rising demand for training Setting methods for the dVSS. For laparoscopic surgery, the advantages of a ex vivo training 2nd European Symposium on Robotic Gynaecologic Surgery program are well established. Laparoscopic skills can be learned using inanimate box/ video trainers3 and/or virtual reality (VR) trainers.4 The acquired skills can be transferred Population to real operations, leading to a shorter operating time and less errors.5-7 For robotic students, residents and medical specialists surgery the development of training programs has just started and, like in laparoscopy, calls for competence based training programs. Especially in technological highly Methods advanced surgical methods, such as robotic assisted surgery, surgeons should be Participants (n=42) were divided in three groups according to their experience in properly trained before embarking on performing surgical procedures in patients. For robotic surgery: ‘Novices’(n=15): no robotic experience, ‘Intermediates’(n=14): 5-50 robotic surgery, guidelines for training and credentialing were described in a consensus cases performed and ‘Experts’(n=13): more then 70 cases performed. To determine statement in 2007.8 Current robotic training programs for residents may involve dry labs construct validity, all participants performed three different exercises (level two) on with inanimate training, observation, bedside assisting and live surgery training.9 The the simulator twice. Multiple performance parameters were measured. To determine main disadvantages of dry lab training are the lack of objective automated assessment, face validity, participants filled in a questionnaire after completion of the exercises. and extra non-cost-effective training on robotic systems is necessary to be able to familiarize with and master the robot system. To overcome these limitations, VR Main outcome measures simulation could be the solution in training this new surgical technique before embarking Face- and construct validity robotic surgery in patients.10 In 2010, a VR trainer for robotic surgery, the dV-trainer™ (dVT) (Mimic, Technologies, Results Seattle, WA, USA), was introduced. During the development of the system, training on a Experts outperformed novices in most of the measured parameters. The most prototype compared with training on the dVSS provided similar improvement of robotic discriminative parameters were ‘time to complete’ and ‘economy of motion’ skills on the dVSS.11 This assumes VR training could be used for training robotic skills. (P<0.001). Experts outperformed intermediates in these parameters in two of the Before the dVT can be implemented in a gynaecologic training program for robotic three exercises (P<0.05). The training capacity of the simulator was rated 4.6 ±0.5 surgery, the first steps of the validation process (face- and construct validity) must be SD on a 5-point Likert scale. The realism of the simulator in general, visual graphics, established.12 We designed a prospective study to establish face- and construct validity of movements of instruments, interaction with objects and the depth perception were the dVT among a large group of gynaecologist. all rated as being realistic. The simulator is considered to be a very useful training tool for junior residents (4.6 ±0.9 SD), senior residents (4.5±0.9 SD) and fellow’s or medical specialist starting with robotic surgery (4.7±0.6 SD). Methods

Conclusion Participants Face- and construct validity for the dV-trainer could be established. The virtual reali- During the 2nd European Symposium on Robotic Gynaecologic Surgery, held September ty simulator is a useful tool for training robotic surgery. 2010 in Lund, Sweden, participants volunteering to the study were asked to complete three training modules on the VR simulator. The participants (n=42) were categorized, according to their experience with robotic surgery (total amount of robotic cases

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performed), into three groups. Group 1 (n=15), ‘novice’, had no experience in robotic Figure 2. Exercises surgery, Group 2 (n=14), ‘intermediate’, performed more then 5 and less then 50 robotic cases and Group 3 (n=13), ‘expert’, performed more than 70 robotic cases. The novice group consisted of residents, medical specialists and other participants (students and booth personal) . The intermediate and expert group consisted of gynaecologic surgeons with varying robotic experience. Prior laparoscopic experience was stated as the number of Level I-II laparoscopic procedures (diagnostic, sterilization, tubectomy, salpingectomy or cystectomy) and the number of Level III-IV laparoscopic procedures ((radical) hysterectomy, lymphadenectomy or sacrocolpopexy). This according to the guidelines of the European Society of Gynaecologic Endoscopy (ESGE).13

Equipment The dVT is a VR simulator especially designed for training robotic surgery with the dVSS. This simulator consists of a two handed haptic system with grips that emulate the master grips on the surgeon’s console. Together with pedals and a high definition stereoscopic display it simulates the console of the dVSS (Figure 1). The haptic component of the dVT includes an 580 MHz microprocessor and a 100 Mb Ethernet interface for data transfer and networking. The haptic device is networked with a computer that runs the dVT simulation software. The simulation system contains an automated system to measure different parameters of performance. The comprehensive training program of the dVT is subdivided in two sections. The ‘overview and basic skills training’ consists of four modules; surgeons console overview, EndoWrist® manipulation, camera & clutching and Exercises used in this study: ‘Camera targeting’, ‘Thread the rings’ and ‘Pegboard’ (image provided by Mimic trouble shooting. The ‘surgical skills training’ includes the following four modules: needle Technologies, Inc., Seattle, WA) control, needle driving, energy & dissection and games. For this study we used the basic skill exercise ‘Camera Targeting’, the EndoWrist® exercise ‘Peg Board’ and the surgical skill Face validity exercise ‘Thread the Rings’ (Figure 2). All exercises have three levels of difficulty. For the Face validity is defined as the extent to which the simulator resembles the situation in the purpose of this study we used the intermediate level (level 2) for all exercises. real world.12 To investigate this, all participants filled out a questionnaire immediately after performing all three exercises. The first section of the questionnaire contained Figure 1. The dV-Trainer™ several questions about demographics, previous experience with VR trainers, laparo scopy and robotic surgery. The second section contained 28 questions regarding the simulator, the exercises and the training capacity of the simulator. These questions were used for establishing face validity. and were presented on a 5-point Likert scale.14 Finally three general statements concerning training robotic surgery were made. These statements could be answered with ‘yes’, ‘no’ or ‘no opinion’.

Construct validity Construct validity is defined as the ability of the simulator to distinguish the experienced form the inexperienced surgeon.12 To investigate construct validity, all participants were asked to perform each of the three exercises twice. Before starting on the simulator, the exercises were briefly explained by the test supervisor, and introduced with an instruction video for each exercise. The first run of each exercise was used for familiarization with the simulator only, and verbal instructions where given whenever necessary. The second run on each exercise was used for validation purposes and data analysis. The first exercise Showing console, grips and pedals (image provided by Mimic Technologies, Inc., Seattle, WA) 176 177 A novel virtual reality simulator for robotic surgery Chapter 10 was ‘Camera Targeting’ (level 2), in which the goal of the exercise is to “accurately Results position the camera while manipulating objects in a large workspace” (Video Clip 1). The second exercise was ‘Thread the Rings’ (level 2), in which the goal is to “develop accuracy Demographics when driving a needle and practice two-handed needle manipulation with hand offs Forty two subjects participated in this study. None of the participants had prior sub between instruments” (Video Clip 2). The third and last exercise was ‘Peg Board’ (level 2) stantial experience with this simulator. Three participants, one in each group, had seen in which the goal is to “improve EndoWrist® dexterity and coordinated two-handed the simulator once before. There was no significant difference between the groups in motion. Practice handling of objects between instruments and learn to avoid unwanted prior experience with other VR simulators (P=0.988). The prior laparoscopic experience collisions of instruments with the surrounding environment and to develop camera of the intermediate and the expert group was not significantly different for level I-II proce- control skills in the context of a pegboard task” (Video Clip 3). For all three exercises, the dures (P=0.756) and level III-IV procedures (P=0.280). In the expert group a wide range outcome parameters were measured during the second run of the participant. The of total robotic cases was performed (70-1200). Demographics are shown in Table 2. outcome parameters and their definition are shown in table 1. Table 2. Demographics Table 1. Parameter definition Total n=42 Group 1 Group 2 Group 3 Exercise and parameters Definition Novice Intermediate Expert (n=15) (n=14) (n=13) Errors (n) If a user receives a 0% score for any metric, this is counted as a n error. Mean Age (range) 39 (28-55) 44 (31-63) 48 (35-61) Drops (n) ‘Camera Targeting’: number of times a stone is dropped outside of a basket or platform and hits the cavity wall. Gender (Male / Female) 11 / 4 11 / 3 13 / 0 ‘Tread the Rings’: number of times the needle is dropped on the floor. ‘Peg Board’: number of times a ring is dropped in the floor. Participants (n) Medical Specialist 3 12 13 Total distance travelled by all Endowrist® tools; measured from the Economy of Motion (cm) Resident 3 2 0 clevis, not the tool tips. Other 9 0 0 Excessive Instrument Force (sec) Total time an applied instrument force exceeds a given force threshold. Videogame experience, > 10 hours (no / yes) 7 / 8 9 / 5 11 / 2 Instrument Collisions (n) Number of times one instruments collides with another instrument Laparoscopic experience (Level I-II procedures) Instrument(s) out of view (cm) Total distance travelled by all instruments when not in view. 0 10 0 0 1-25 2 1 0 Master workspace Range (cm) Combined radius from two spheres that encapsulate the path travelled by 26-100 1 1 3 the master grips. >100 2 12 10 Time to Complete (sec) Total time that begins when the user enters following mode and then end when the user finishes or exits an exercise. Laparoscopic experience (Level III-IV procedures) 0 11 2 0 1-24 2 0 0 Statistics 25-100 2 7 6 >100 0 5 7 A sample size of on average 14 subjects per group allows for detection of between-group differences of 0.85 standard deviations (i.e. Cohen’s D=0.85) with 80% power, using Robotic experience (total cases) alpha = 0.05 and assuming a correlation between scores on the same individual of 0.5. None 15 0 0 The collected data were analyzed using the statistical software package SPSS 15.0 (SPSS 5-9 0 3 0 Inc, Chicago, IL). Differences between the group performances were analyzed using the 10-39 0 6 0 40-49 0 5 0 Kruskal-Wallis test. If there appeared to be a significant difference, then a comparison 70-150 0 0 9 between two separate groups was conducted using the Mann-Whitney-U test for analysis > 150 0 0 4 of non-parametric data. A level of P≤ 0.05 was considered to be statistically significant. Mean estimated total number of robotic cases (range) 0 24 (6-50) 240 (70-1200)

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Face validity Table 3. Face validity (simulator and exercises) All participants completed the questionnaire. The mean scores regarding the simulator Questions Group 1 Group 2 Group 3 Mean and the exercises are shown in Table 3. The realism of the simulator in general, visual Novice Intermediate Expert (n=42) (n=15) (n=14) (n=13) graphics, movements of instruments, interaction with objects and the depth perception were rated as realistic. The lowest score for the simulator in general was given for depth Simulator in general perception and for this item there was a significant difference between the novice group What do you think of the realism of the next issues? and intermediate group (P=0.014). For all exercises, the participants stated that the goal (1=very unrealistic……5=very realistic) of the exercise was surely reached. The training capacity of all separate exercises was Simulator itself (hardware) 3.8 ± 0.8 4.2 ± 0.7 4.2 ± 0.6 4.1 ± 0.7 rated to be ‘(very) good’ by all groups. Compared to the novice group, the expert group Visual graphics 4.3 ± 0.5 4.4 ± 0.7 4.0 ± 1.1 4.3 ± 0.8 rated the training capacity of ‘Thread the Rings’ significantly higher (P=0.041). The Movements of the instruments 3.8 ± 0.9 4.4 ± 0.7 4.2 ± 0.7 4.1 ± 0.8 exercises were rated as ‘moderately difficult’; the ‘Peg Board’ was considered to be the Interaction with objects 3.9 ± 0.9 4.2± 0.7 4.4 ± 0.8 4.2 ± 0.8 Depth perception 3.7 ± 0.9 4.6± 0.5 3.7 ± 1.4 4.0 ± 1.1 easiest exercise. The novice group and the intermediate group rated ‘Camera Targeting’ significantly more difficult than the expert group (resp. P=0.007 and P<0.001). There Exercise 1 ‘Camera Targeting’ were no other significant differences between the three groups Do you think the goal of the exercise is reached? 4.5 ± 0.5 4.57 ± 0.5 4.4 ± 0.5 4.5 ± 0.5 The mean scores regarding training capacity in general are shown in Table 4. The training (1=surely not……5=surely yes) capacity of the simulator in general was rated ‘very good’ (4.7±0.5 SD). The training What is your opinion according to the following capacity for eye-hand coordination (4.5±0.7 SD), camera navigation (4.5±0.9), instrument issues? (1=very bad……5=very good) navigation (4.4±0.8 SD) and use of pedals and clutch (4.60±0.8 SD) were all appreciated Content of the exercise 4.4 ± 0.6 4.2 ± 0.9 4.4 ± 0.8 4.3 ± 0.8 Training capacity of the exercise 4.5 ± 0.6 4.4 ± 0.8 4.5 ± 0.7 4.5 ± 0.7 by the participants. The simulator was rated as a ‘(very) useful’ training tool for junior Difficulty of the exercise 3.3 ± 1.0 3.6 ± 0.8 2.0 ± 1.1 3.0 ± 1.2 residents, senior residents and fellows or medical specialists starting with robotic surgery. The simulator was rated ‘moderately useful’ for training robotic experts (3.3±1.4 Exercise 2 ‘Thread the Rings’ SD). The participants thought the simulator to be less useful for warm-up before surgery Do you think the goal of the exercise is reached? 4.3 ± 1.0 4.2 ± 0.89 4.6 ± 0.7 4.4 ± 0.9 or for retention of skills. (1=surely not……5=surely yes)

At the end of the questionnaire, three general statements about training robotic surgery What is your opinion according to the following were given. Almost everyone agreed on the statement that surgeons starting with robot- issues? (1=very bad……5=very good) ics should first start training on a virtual system (no=1, yes=39, no opinion=2). Most of Content of the exercise 4.5 ± 0.6 4.5 ± 0.7 4.5 ± 0.7 4.5 ± 0.6 the participants (86%) think it is time for a competence or proficiency based training Training capacity of the exercise 4.3 ± 0.6 4.6 ± 0.6 4.9 ± 0.4 4.6 ± 0.6 curriculum for robotic surgery (no=1, yes=36, no opinion=5). And the majority (74%) Difficulty of the exercise 3.5 ± 0.9 3.3± 1.1 3.0 ± 1.0 3.3 ± 1.0 agreed that such a curriculum should be mandatory (no=6, yes=31, no opinion=5). Exercise 3 ‘Peg Board’ Do you think the goal of the exercise is reached? 4.3 ± 0.9 4.2 ± 0.58 4.6 ± 0.5 4.4 ± 0.7 (1=surely not……5=surely yes)

What is your opinion according to the following issues? (1=very bad……5=very good) Content of the exercise 4.4 ± 0.7 4.2 ± 0.6 4.4 ± 0.7 4.3 ± 0.7 Training capacity of the exercise 4.3 ± 0.8 4.3 ± 0.8 4.5 ± 0.7 4.4 ± 0.8 Difficulty of the exercise 2.9 ± 0.9 2.9 ± 0.9 2.5 ± 1.2 2.7 ± 0.9

Values expressed in mean on a 1 to 5 Likert scale ± SD.

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Table 4. Face validity (training capacity)

Group 1 Group 2 Group 3 Mean Questions Novice Intermediate Expert (n=42) (n=15) (n=14) (n=13)

Training capacity simulator in general 4.7 ± 0.5 4.8 ± 0,4 4.5 ± 0.5 4.6 ± 0.5 (1=very bad……5=very good)

Training capacity simulator regarding … (1=very bad……5=very good) Eye-hand coordination 4.5 ± 0.5 4.5 ± 0.9 4.5 ± 0.7 4.5 ± 0.7 Significant difference (P < 0.05) 1>2 P=0.020, 1>3 P=0.002 1>2 P=0.041, 1>3 P<0.001, 2>3 P=0.003 1>3 P=0.015 1>3 P=0.015 1>3 P<0.001, 2>3 P=0.001 1>2 P=0.026, 1>3 P<0.001 1>2 P=0.023, 1>3 P=0.002 1>2 P=0.023, 1>2 P=0.014, 1>3 P=0.006 1>2 P=0.014, 1>2 P<0.001, 1>3 P<0.001 1>3 P=0.037 1>3 P=0.002, 2>3 P=0.025 1>2 P=0.007, 1>3 P<0.001, 2>3 P=0.017 1>2 P=0.007, Camera navigation 4.3 ± 1.1 4.5 ± 0.7 4.6 ± 0.9 4.6 ± 0.9 Instrument navigation 4.1 ± 1.1 4.6 ± 0.5 4.5 ± 0.5 4.4 ± 0.8 Use of pedals and clutch 4.5 ± 1.1 4.6 ± 0.6 4.7 ± 0.5 4.6 ± 0.8

The simulator is useful for training … (1=very un useful……5=very useful) Junior residents (post graduate year 1-3) 4.5 ± 1.1 4.5 ± 1.2 4.9 ± 0.3 4.6 ± 0.9 Group 3 Expert (n=13) 0.54 ± 1.11 0.00 ± 268.21 ± 69.69 8.42 ± 29.48 0.46 ± 1.13 18.04 ± 47.49 10.61 ± 1.62 106.60 ± 44.59 0.46 ± 0.88 0.38 ± 0.65 292.28 ± 74.42 3.69 ± 4.20 3.38 ± 4.81 0.74 ± 1.30 0.74 8.27 ± 1.24 8.27 146.15 ± 39.65 146.15 0.15 ± 0.38 0.15 0.15 ± 0.38 0.15 293.20 ± 73.08 0.12 ± 0.30 0.12 0.46 ± 0.66 1.25 ± 3.40 9.66 ± 1.51 90.08 ± 26.72 Senior residents (post graduate year 4-6) 4.5 ± 0.6 4.4 ± 1.2 4.6 ± 0.8 4.5 ± 0.9 Fellow’s and regular consultants 4.5 ± 0.7 4.9 ± 0.4 4.7 ± 0.6 4.7 ± 0.6 (starting robotics) Robotic experts 3.2 ± 1.3 3.4 ± 1.3 3.2 ± 1.5 3.3 ± 1.4

The simulator is useful for … (1=very un useful……5=very useful) Warm-up for robotic surgery 3.9 ± 1.3 3.6 ± 1.5 2.7 ± 1.5 3.4 ± 1.4 Group 2 Intermediate (n=14) 1.00 ± 1.62 0.00 ± 353.78 ± 99.20 353.78 11.36 ± 24.26 1.21 ± 2.16 10.06 ± 23.67 11.72 ± 2.02 11.72 164.59 ± 64.24 1.07 ± 1.54 1.07 0.29 ± 0.61 308.03 ± 101.40 5.50 ± 8.52 3.86 ± 4.15 3.34 ± 9.18 8.46 ± 1.77 158.17 ± 45.39 158.17 0.14 ± 0.36 0.14 0.36 ± 0.50 342.35 ± 71.12 0.39 ± 0.99 0.71 ± 0.83 0.71 0.37 ± 1.08 0.37 9.51 ± 1.57 114.46 ± 23.80 114.46 Retention of robotic skills 3.8 ± 1.1 4.0 ± 1.1 2.9 ± 1.6 3.6 ± 1.3 Values expressed in mean on a 1 to 5 Likert scale ± SD.

Construct validity All participants completed the three exercises on the dVT. For all parameters, the results and significant differences of the second run are shown in Table 5. Two important Group 1 Novice (n=15) 2.33 ± 1.45 0.20 ± 0.41 469.74 ± 234.53 469.74 22.10 ± 36.92 22.10 2.87 ± 5.17 2.87 27.58 ± 42.76 27.58 12.65 ± 2.11 246.27 ± 131.58 246.27 2.13 ± 1.13 2.13 0.40 ± 0.83 404.60 ± 120.98 9.67 ± 13.15 9.67 6.93 ± 3.54 2.04 ± 3.35 9.08 ± 1.97 256.76 ± 107.70 256.76 0.40 ± 0.63 0.73 ± 0.70 0.73 400.13 ± 109.58 400.13 1.27 ± 3.09 1.27 1.13 ± 1.36 1.13 0.82 ± 2.25 10.91 ± 1.93 157.45 ± 44.05 157.45 parameters showed a significant difference between all three groups; ‘economy of motion’ in exercise 1 and ‘time to complete’ in exercise 3. Comparison between the novice group and the expert group demonstrated the most significant differences. None of the other outcome parameters demonstrated a difference between novices and/or intermediates comparing more experienced colleagues. The performance variability of the most relevant parameters per exercise is shown in box plots. The exercise ‘Camera Targeting’ was most discriminative and showed significant differences in five parameters. There was less variability in the expert group (Figure 3). Four parameters showed significant difference in the exercise ‘Thread the Rings’ (Figure 4). In the ‘Peg Board’ exercise a significant difference was found in three parameters (Figure 5). Exercise and parameters Exercise Exercise 1 ‘Camera Targeting’ 1 ‘Camera Exercise Errors (n) Drops (n) Economy of Motion (cm) Economy Excessive Instrument Force (sec) Instrument Force Excessive Instrument Collisions (n) Instrument Collisions Instrument(s) out of view (cm) Master workspace Range (cm) Master workspace Time to Complete (sec) Time to Complete Exercise 2 ‘Thread the Rings’ Exercise Errors (n) Drops (n) Economy of Motion (cm) Economy Excessive Instrument Force (sec) Instrument Force Excessive Instrument Collisions (n) Instrument Collisions Instrument(s) out of view (cm) Master workspace Range (cm) Master workspace Time to Complete (sec) Time to Complete Exercise 3 ‘Peg Board’ 3 ‘Peg Exercise Errors (n) Drops (n) Economy of Motion (cm) Economy Excessive Instrument Force (sec) Instrument Force Excessive Instrument Collisions (n) Instrument Collisions Instrument(s) out of view (cm) Master workspace Range (cm) Master workspace Time to Complete (sec) Time to Complete Construct validity 5. Construct Table Values expressed in mean ± SD. Values

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Figure 3. Exercise ‘Camera Targeting’ Figure 4. Exercise ‘Thread the Ring’

p=0.000 600 700 p=0.002 600 1200 * * p=0.000 p=0.023 p=0.041 500 500 1000 600 p=0.000 p=0.003 400 400 800 p=0.000 500 p=0.001 * 300 300 600 400 * * 200 200 400 Time to complete (sec) Economy of motion (cm) Time to complete (sec) Economy of motion (cm) 300 100 100 200 * 0 200 0 0 Novice Intermediate Expert Novice Intermediate Expert Novice Intermediate Expert Novice Intermediate Expert Group Group Group Group

p=0.002 p=0.000 20 p=0.006 5 25 p=0.015 5 * p=0.026 p=0.014 * * 4 20 4 15

p=0.020 3 15 3 10

2 10 2 Instrument collisions (n) Critical errors (n ) Instrument collisions (n) * Critical errors (n) 5 1 5 1 *

* 0 0 0 0 Novice Intermediate Expert Novice Intermediate Expert Novice Intermediate Expert Novice Intermediate Expert Group Group Group Group

Box plot of the four most important parameters in the exercise. (Bars are medians, boxes show inter quartile Box plot of the four most important parameters in the exercise. (Bars are medians, boxes show inter quartile range, whiskers show range, • are outliers, * are extreme outliers and large horizontal bars indicate statistically range, whiskers show range, • are outliers, * are extreme outliers and large horizontal bars indicate statistically significant differences, specified with P-values). significant differences, specified with P-values).

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Figure 5. Exercise ‘Peg Board’ Discussion p=0.000 p=0.002 250 700 p=0.007 In this study the simulator showed good face validity. The dVT received high ratings on realism of the simulator itself and the separate exercises in all three groups. The training p=0.025 600 capacity of the simulator was rated ‘(very) good’ for residents and gynaecologist starting 200 with robotic surgery, but the simulator was found less useful for training experts. Perhaps p=0.017 the development of complex procedural tasks can add value for training experts who 500 * want to start performing new procedures. Using the dVT as warm-up before surgery (to 150 get familiar with the instruments again) or for retention of skills were not considered as 400 real benefits of the simulator. Regarding the realism of the simulator, a remark should be made regarding the depth perception of the simulator. We noticed participants wearing Time to complete (sec) 100 Economy of motion (cm) multifocal glasses had a slight problem with the depth perception in the dVT. An explana- 300 tion could be the difference in viewing distance in the dVT in contrast to length of this path in the dVSS. When participants changed their distance to the simulator/binoculars 50 200 or did not wear their glasses during their performance, the problem regarding depth Novice Intermediate Expert Novice Intermediate Expert perception mainly declined. Unfortunately, in our questionnaire we did not ask Group Group participants if they wear glasses and therefore could not correlate this observation to results. p=0.037 The simulator was able to differentiate between novices and experts for a number of 4 2 parameters in each exercise (construct validity). ‘Time to complete’ the exercise and ‘economy of motion’ were the two most discriminating parameters. For most parameters there was a significant difference between novices and experts, except for the ‘number of 3 2 drops’ and the distance of the ‘instruments out of view’. A possible cause for the non-significance in the ‘number of drops’ may be due to the relatively easy level of difficulty, which limited the amount of drops in all exercises. According to the non- 2 1 * significance in ‘instrument(s) out of view’, all three groups had (short) periods of time in which instruments were out of view. However, the experts seemed not ‘loosing’ their Instrument collisions (n) Critical errors (n) instruments, as intermediates and in particular novices did. For these less experienced 1 0 participants this might be an explanation for the increased time to complete the exercises compared to their more experienced colleagues. There was less difference between the expert and the intermediate group. An explanation could be that even the level two 0 0 exercises are still to easy to show a difference between these groups. This is supported by Expert Expert Novice Intermediate Novice Intermediate the fact that the most difficult exercise (Camera Targeting) showed a significant difference Group Group for ‘economy of motion’ and ‘time to complete’ between these two groups. Box plot of the four most important parameters in the exercise. (Bars are medians, boxes show inter quartile This is the first study which investigates the validity of the dVT in gynaecology. Previous range, whiskers show range, • are outliers, * are extreme outliers and large horizontal bars indicate statistically small studies in urology were performed during the beta development phase of the significant differences, specified with P-values). simulator, using relatively easy exercises.15-17 Furthermore, the amount of participants (n=42) was never as extensive as in this study and a comparison between three groups (novice, intermediate and expert) was never conducted, since other studies only compared two groups (novice vs expert). The acceptability of the dVT was first addressed by Lendvay et al. In their survey, during a post-graduate training course in paediatric robotic surgery, the majority of participants believed that the dVT trainer could teach robotic skills comparable to a dry lab robotics skills station.18 A study of 19 novices and

186 187 A novel virtual reality simulator for robotic surgery Chapter 10 seven experts validated a prototype of the dVT, demonstrating face- and content validity development of new modules will continue and complete VR procedures, like the of the simulator, but did not show construct validity.17 In a similar study existing of a total hysterectomy, will become available for use in the dVSS or on the stand alone VR of 15 participants with varying degree of urological experience, acceptability and simulator. preliminary face- and content validity was demonstrated. A positive correlation between robotic experience and key performance metrics was found. The authors concluded more research is needed and suggested a prospective study, similar in design to this study, Conclusion could help to determine the utility to integrate this simulator into a robotic training curriculum.16 Kenney et al showed face-, content- and construct validity for the dVT as a In this study face- and construct validity of the dVT was established. The simulator was VR simulator for the dVSS. Nineteen novices and 7 experts completed two endowrist® regarded a useful tool for training robotic surgery for the dVSS. For optimal use the modules and two needle driving modules.15 In our study we found that the dVT was also simulator should be implemented in validated competence based robotic training able to distinguish between three groups of participants with different levels of robotic curricula. Further studies regarding predictive validity need to show if simulator learned experience. Regarding the training capacity of the dVT, Lerner et al found a similar skills are transferable to actual operations in the short run, and if so, weather or not improvement on five exercises comparing a group of novices trained on the actual dVSS positive effects on surgical performance remain on the long run. with a group trained on the dVT.11 Other groups are working on the development of different VR simulators for robotic surgery and reported about their prototypes.19,20 There Acknowledgements is one laparoscopic simulator which can be converted into a robotic simulator and can We like to thank René Eijkemans, Tomas Ragnarsson, Jeff and Andrea Berkley for their train basic robotic skills21, however van der Meijden et al were not able to establish help. We like to thank all the participants for their cooperation in this study. construct validity for this simulator and improvement is necessary before using it in robotic training programs.22 Recently face validity for another VR simulator for robotic surgery was established. Forty five percent rated the Robotic Surgical Simulator (RoSS) very close to the dVSS console. From the participants 38% had also tried the dVT, but no direct comparison was made.23 With the introduction of VR simulators for robotic surgery, a new tool for robotic training and credentialing has become available. Until now, most training programs for robotic surgery consist of didactics, hands-on dry lab training, instructional video’s, assistance at the operating table and then performance of segments of an operation.24 From there, some authors recommend to start with easy procedures to get familiar with the dVSS.25 Virtual reality simulation could be of great value in robotic training programs, and allow surgeons to develop skills and pass a substantial part of their learning curve before operating on humans.26 The VR simulators provide a controlled and pressure free environment with real-time objective measurements of the trainees performance, thereby offering useful feedback for adequate self-assessment. This could eventually improve operating times and patient safety. The recommended way to use a VR simulator as a training tool is to implement it in a competence based training curriculum. Almost all of the participants in our study thought it is time for the development of competence based training curricula for robotic surgery, this instead of the now often used time based curricula. A vast majority of the participants even thought such training should be mandatory before starting robotic surgery. This is important, since we know from laparoscopy that providing expensive simulators to trainees, without implementing them in an obligatory training curriculum, will not motivate them enough to train voluntarily. 27,28 Further development of the dVT software will make it possible to project the VR environment direct into the console of the dVSS. Comparing the same exercise on the dVT and in the dVSS will make it possible to establish content validity for the dVT. The

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References

1. Holloway RW, Patel SD, Ahmad S. Robotic surgery in gynecology. Scand J Surg 2009;98:96-109. 2. Schreuder HW, Verheijen RH. Robotic surgery. BJOG 2009;116:198-213. 3. Ritter EM, Scott DJ. Design of a proficiency-based skills training curriculum for the fundamentals of laparoscopic surgery. Surg Innov 2007;14:107-12. 4. Gurusamy K, Aggarwal R, Palanivelu L, Davidson BR. Systematic review of randomized controlled trials on the effectiveness of virtual reality training for laparoscopic surgery. Br J Surg 2008;95:1088-97. 5. Ahlberg G, Enochsson L, Gallagher AG, Hedman L, Hogman C, McClusky DA, III et al. Proficiency-based virtual reality training significantly reduces the error rate for residents during their first 10 laparoscopic cholecystectomies. Am J Surg 2007;193:797-804. 6. Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C et al. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ 2009;338:b1802. 7. Thijssen AS, Schijven MP. Contemporary virtual reality laparoscopy simulators: quicksand or solid grounds for assessing surgical trainees? Am J Surg 2010;199:529-41. 8. Herron DM, Marohn M. A consensus document on robotic surgery. Surg Endosc 2008;22:313-25. 9. Finan MA, Silver S, Otts E, Rocconi RP. A Novel method for training residents in robotic hysterectomy. J Robotic Surg 2010;4:33-39. 10. Albani JM, Lee DI. Virtual reality-assisted robotic surgery simulation. J Endourol 2007;21:285-87. 11. Lerner MA, Ayalew M, Peine WJ, Sundaram CP. Does training on a virtual reality robotic simulator improve performance on the da Vinci surgical system? J Endourol 2010;24:467-72. 12. McDougall EM. Validation of surgical simulators. J Endourol 2007;21:244-47. 13. ESGE-Standard laparoscopy. Available at: http://esge.org/?p=4&p2=44&id=22 . 2010. Accessed Oct 19, 2010 14. Matell MS, Jacoby J. Is There an Optimal Number of Alternatives for Likert Scale Items? Educational and Psychological Measurement 1971;31:657-67. 15. Kenney PA, Wszolek MF, Gould JJ, Libertino JA, Moinzadeh A. Face, content, and construct validity of dV-trainer, a novel virtual reality simulator for robotic surgery. Urology 2009;73:1288-92. 16. Lendvay TS, Cascale P, Sweet R, Peters C. Initial Validation of a virtual-reality robotic simulator. J Robotic Surg 2008;2:145-49. 17. Sethi AS, Peine WJ, Mohammadi Y, Sundaram CP. Validation of a novel virtual reality robotic simulator. J Endourol 2009;23:503-08. 18. Lendvay TS. VR Robotic Surgery: Randomized blinded study of the dV-trainer robotic simulator. Stud Health Tech Inform 2008;132:242-44. 19. Katsavelis D, Siu KC, Brown-Clerk B, Lee IH, Lee YK, Oleynikov D et al. Validated robotic laparoscopic surgical training in a virtual-reality environment. Surg Endosc 2009;23:66-73. 20. Sun LW, Van MF, Schmid J, Bailly Y, Thakre AA, Yeung CK. Advanced da Vinci Surgical System simulator for surgeon training and operation planning. Int J Med Robot 2007;3:245-51. 21. Halvorsen FH, Elle OJ, Dalinin VV, Mork BE, Sorhus V, Rotnes JS et al. Virtual reality simulator training equals mechanical robotic training in improving robot-assisted basic suturing skills. Surg Endosc 2006;20:1565-69. 22. van der Meijden OA, Broeders IA, Schijven MP. The SEP “Robot”: A Valid Virtual Reality Robotic Simulator for the Da Vinci Surgical System? Surg Technol Int 2010;19:51-58. 23. Seixas-Mikelus SA, Kesavadas T, Srimathveeravalli G, Chandrasekhar R, Wilding GE, Guru KA. Face validation of a novel robotic surgical simulator. Urology 2010;76:357-60. 24. Lee PS, Bland A, Valea FA, Havrilesky LJ, Berchuck A, Secord AA. Robotic-assisted laparoscopic gynecologic procedures in a fellowship training program. JSLS 2009;13:467-72. 25. Ferguson JL, Beste TM, Nelson KH, Daucher JA. Making the transition from standard gynecologic laparoscopy to robotic laparoscopy. JSLS 2004;8:326-28. 26. Al Bareeq R, Jayaraman S, Kiaii B, Schlachta C, Denstedt JD, Paulter SE. The role of surgical simulation an the learning curve in robotic-assisted surgery. J Robotic Surg 2008;2:11-15. 27. Chang L, Petros J, Hess DT, Rotondi C, Babineau TJ. Integrating simulation into a surgical residency program: is voluntary participation effective? Surg Endosc 2007;21:418-21. 28. van Dongen KW, van der Wal WA, Rinkes IH, Schijven MP, Broeders IA. Virtual reality training for endoscopic surgery: voluntary or obligatory? Surg Endosc 2008;22:664-67.

190 191 Training and Learning Robotic Surgery, Time for a more Structured Approach: a systematic review 11

Henk W.R. Schreuder Richard Wolswijk Ronald P. Zweemer Marlies P. Schijven René H.M. Verheijen

BJOG: An International Journal of Obstetrics and Gynaecology In press Training and learning robotic surgery Chapter 11

Introduction Abstract The introduction of robot assisted laparoscopic surgery has revolutionised the field of Background minimal invasive surgery and is growing rapidly in various fields of surgery.1-3 The rapid Robotic assisted laparoscopic surgery is growing rapidly and there is an increasing introduction of robotic procedures necessitates new training methods. Next to the more need for a structured approach to train future robotic surgeons. traditional forms of surgical teaching, the robotic system seems ideal for integrating various forms of simulation.4 While using simulation surgeons can develop their skills Objectives and pass their basic learning curve on a simulator avoiding the medico legal aspects of To review the literature on training and learning strategies for robotic assisted surgical training.5 Implementing simulation has the potential to create high quality, laparoscopic surgery. competence-based robotic training programs. This could shortening the learning curve and thereby ensure patient safety and surgical outcome.6 Next, simulation allows Search Strategy experienced surgeons to develop or familiarise themselves with new instruments in a A systematic search of MEDLINE, EMBASE, the Cochrane Library and the Journal of virtual environment.7 Robotic Surgery was performed. Recently, the Dutch Health Care Inspectorate (IGZ) has published its report “Insufficiently Selection Criteria prepared introduction of robotic surgery”.8 With regard to training, it is stated that “in We included articles concerning training, learning, education and teaching of 50% of the hospitals were insufficient criteria for the surgeon’s competence before robotic assisted laparoscopic surgery in any specialism. starting with robotic surgery”. This is indicative for the growing need for competence based training and assessment criteria. In 2007, an international multidisciplinary Data Collection and Analysis consensus group published a consensus statement on robotic surgery. Training and Two authors independently selected articles to be included. We categorised the credentialing was one of the four main items addressed in this statement.9 included articles into: training modalities, learning curve, training future surgeons, curriculum design and implementation. The aim of this review is to reveal aspects involved with training and learning of robotic assisted laparoscopic surgery and to provide guidelines for optimal construction and Main Results implementation of future structured and competence based training programs. We included 114 full text articles. Training modalities such as didactic training, skills training (dry lab, virtual reality, animal or cadaver models), case observation, bedside assisting, proctoring and the mentoring console can be used for training of ro- Methods botic assisted laparoscopic surgery. Several training programs in general and specific programs designed for residents, fellows and surgeons are described in the Literature search literature. We provide guidelines for development of a structured training program. A systematic literature search was performed regarding training and learning of robotic assisted surgery. The following computerised bibliographic databases were searched: Author’s Conclusions MEDLINE, EMBASE and the Cochrane database of systematic reviews. The search was Robotic surgical training consists of system training and procedural training. System performed within the following limits: English and reports published between January 1st training should be formally organised and should be competence based, instead of 1990 and October 9th 2010. To increase sensitivity, a ‘text word search’ was used.10 The time based. Virtual reality training will play an import role in the near future. assessment of training and/or learning robotic surgery was carried out defined by search Procedural training should be organised in a stepwise approach with objective strings including robot* OR telesurg* AND train* OR learn* OR educat* with all possible assessment of each step. This review aims to facilitate and improve the implemen- extensions. To avoid missing out on recent and not yet indexed papers, MeSH-terms tation of structured robotic surgical training programs. were not included in our search. Subsequently, full articles of each study selected as likely to be relevant were assessed including their respective reference list. Because articles published in the Journal of Robotic Surgery were not yet available in the searched databases, we performed the same search for articles published in this specific journal, on the journal’s homepage.11

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Eligibility criteria Figure 1. Flowchart literature search Relevant articles to be included had to clearly address aspects of training, learning, education, teaching or credentialing for robotic assisted laparoscopic surgery in any Journal of Robotic PubMed data search Cochrane data search Embase data search specialty. Since there are no large randomized trials regarding these issues, all types of Surgery data search n = 2114 n = 164 n = 1355 n = 117 studies were included.

Study selection After removing duplicate articles, this search resulted in 1905 unique citations. Screening on title (RW) resulted in a total of 508 potentially appropriate citations. Screening on Total hits: n = 3750 abstract (RW) resulted in exclusion of 342 citations. The remaining 166 potentially articles were screened on full text (HS and RW). After exclusion of 62 full text articles, a total Irrelevant titles excluded Duplicates removed n = 1397 n = 1845 number of 104 relevant articles were included. In addition, references of all included articles were screened, which provided another 10 related articles, resulting in a total of Reasons for exclusion: Potentially relevant 114 included full text articles used for this review (Figure 1). Eligibility assessment was - Concerning imaging (unique) studies - Concerning brainsurgery n = 1905 performed independently in an (unblinded) standardized manner by 2 reviewers (HS and - Other robot than dVSS Irrelevant abstracts excluded RW). Disagreements between reviewers were resolved by consensus. - Revalidation (neurology) n = 342 - Not concerning robotic surgery Potentially appropriate Reasons for exclusion: Data collection process - Concerning orthopedics studies, screened by - Technical articles title n = 508 - No full text available We categorized the included articles into: training modalities, learning curve, training - No education - No educational component future surgeons, curriculum design and implementation. Within the main categories, the - Robotics for daily activities - Technical report dVSS articles were subcategorized. Training modalities were categorized in skills-lab, virtual - Non-laparoscopic - Operation-technique speci c - Concerning operating room of Potentially appropriate - Neurologic article reality, animal & cadaver, live case observation, mentoring, serious gaming and the future studies, abstract - Robotics (laparoscopic) not assessment. Learning curves were sub categorized in urology, gynaecology and other. screened n = 166 involved Training future surgeons was subcategorized in residents or fellows, training courses and Irrelevant full text excluded - Non-laparoscopic training centres. Curriculum design and implementation were subcategorized in n = 62 curriculum, implementation and costs. Potentially appropriate Reasons for exclusion (n): studies, full text - No educational component (6) screened n = 104 - Operation-technique speci c (9) Screening related articles - Robotics (laparoscopic) nog n = 10 involved (10) - Case-series or review article, Full text atricles without learning curve (21) n = 114 - Overview article (5) - Implementation, not recent enough (1) - Initial experience (6) - Comment or editorial article (3) - Haptics (1)

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Results Table 2. Training courses in a laboratory setting Author Year Participants Model Evaluation Validation Training modalities Hanly et al53 2004 23 surgeons Standardized hand on Setup time, operating time, no Several training modalities can be used when constructing a training program for robotic dVSS training complications surgery. In general a program starts with knowledge development, followed by skills training Self guided learning in porcine model using a combination of simulation modalities (Table 1), followed by real-life case observation in the operating room. When starting with actual robotic surgery there is a Hernandez et al67 2004 13 surgeons Synthetic bowel OSATS score no role for bedside assisting, proctoring and the mentoring console. Ten training courses for anastomosis Motion analysis robotic surgery in a skills laboratory were identified (Table 2). Ro et al21 2005 4 experts 7 designed drills Calculated performance score construct 17 novices Table 1. Types of simulation Narazaki et al19 2006 7 students 3 designed tasks Time, motion analysis and no muscular activation pattern Simulation Advantages Disadvantages Best use Pelvic trainer (dry lab) Cheap Low fidelity Basic skills Mehrabi et al54 2006 4 trainees with Porcine and rat model Operating time, quality of no Reusable/portable Low face validity Certain discrete skills varying operation, complications Minimal Risk Only basic tasks (suturing, anastomosis) experience Virtual reality trainer Reusable Costs System training Vlaovic et al55 2008 35 urologists 4 exercises including OSATS score no Data capture Maintenance Basic skills suturing and cutting Objective assessment Procedural skills Minimal setup time Marecick et al24 2008 11 residents Porcine intestine for Time and leak pressure no anastomosis Animal model High Fidelity Costs Advanced procedural Procedure simulation Ethical issues knowledge Moles et al22 2009 7 residents Self designed teaching Time and errors no Special facilities Dissection skills model Single use 5 exercises Anatomical differences Finan et al89 2010 16 students 5 designed advanced Time no Fresh human cadaver High Fidelity Costs Advanced procedural drills for hysterectomy Procedure simulation Availability knowledge “True” anatomy Compliance of tissue Dissection skills Chandra et al20 2010 20 novices ProMIS™ Hybrid Time, pathlength and construct 9 experts Surgical Simulator smoothness Adapted from Reznick & MacRae118 dVSS= da Vinci® Surgical System; OSATS = Objective Structured Assessment of Technical Skills Knowledge (didactic) When starting with robotic surgery the trainee/surgeon needs to gain knowledge and Skills laboratory understand the robot technology, device functions, basic troubleshooting, device Just like in laparoscopy, training for robotic surgery can be scheduled in a skills laboratory. parameters and the limitations of the system. The next step will be the development of In such facilities exercises on pelvic trainers and other exercises can be performed. A knowledge for specific surgical procedures. This includes patient selection and skills laboratory usually has the advantage of high accessibility, but a disadvantage is the indications, preoperative preparation, patient and system positioning, port placement, need of an expensive robot for dedicated use in the training facility. With this in mind, procedural steps, complications and their management. To make sure every surgeon most hospitals could probably not afford a separate robot for use in a skills laboratory starting with robotic surgery has a basic level of theoretical knowledge, a theoretical exam only. In these cases the available robot at the OR could be used for training after working on these items could be helpful. hours or on scheduled time when no surgery is performed. Several authors compared conventional laparoscopy with robot assisted laparoscopy in a skills laboratory. Conventional exercises for laparoscopy can be used and can actually be performed faster and more accurate with robotic surgery.12-15 The exercises have a shorter learning curve and are performed more accurately with robot assistance.16,17 Residents without any laparoscopic experience demonstrated the capacity to rapidly learn basic surgical manoeuvres.18-19

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It is important that training exercises are validated and have a proper goal. Several levels Surgical skills training in a virtual environment had a significant learning effect and the of validation can be distinguished (Table 3) Exercises should at least have face validity learned skills are consistent with and transferable to actual robot assisted procedures.33-35 (the simulation resembles the real task) and construct validity (the ability to differentiate However, further research is needed to develop this as an effective and reliable VR between groups with different levels of competence), and translate well to the clinical set- environment.36,37 Sun et al developed a prototype of a computer-based simulator to ting, before they are used in a robotic training program. Unfortunately, there are only a practice simple surgical skills and port placement.38 The SEP Robot™ simulator few reports of validated exercises.20-21 A curriculum, consisting of five tasks for training (SimSurgery AS, Oslo, Norway) is part of a conventional VR trainer for laparoscopy, which basic robotic skills was developed by Moles et al. They were not able to demonstrate a can be converted into a simulator for robotic surgery.39 Direct comparison of both trainer significant learning curve, although there was a trend suggesting that learning had taken modalities showed no significant difference for a standardized suturing task.40 Training of place.22 A portable, reusable, relatively inexpensive pelvic model was developed to a robotic suturing skill on this simulator equalled training on a mechanical simulator41 simulate the dissection phase of the rectum. This model could be used for mounting and practice sessions improved technical performance of novices.42 Concepts of face- and additional exercises and be prepared for other specific surgical procedures.23 Another construct validity for this simulator seem to be present.43 Recently two more advanced model which can be used is animal intestine, which is very suitable to learn suturing simulators were introduced. The Robotic Surgical Simulator (RoSS) (Figure 2)44 skills for an intestinal anastomosis.24 Training of difficult parts of an operation in such demonstrated face validity.45 The development of procedural tasks for the robotic specifically designed models can have a positive impact on the learning curve for complex prostatectomy and robotic hysterectomy are ongoing. The dV-Trainer™ (dVT) is a simula- procedures. Another aspect of skills laboratory training is the transferability of the basic tor which is using the same kinematics as the da Vinci® Surgical System (dVSS) (Figure skills acquisition to real surgical performance.25 Surgeons tend to move slower, make 3).46 During the development phase of this system several validation studies demon more curved movements and use more grip force during human surgery. During robotic strated face-, content- and construct validity.47-50 Training on the dVT improved training it is possible to record objective measures of the robotic instruments. These performance on the robot system equal to training with the robot itself.51 The software of parameters can be used to describe aspects of robotic surgical performance.26 the dVT is suitable to use within the actual robotic console, allowing virtual tasks to be In addition, using real-time augmented visual feedback during training can enhance the performed in a real life environment. actual surgical performance.27-29 Suzuki et al developed a tele-surgery simulation training system for cholecystectomy, Figure 2. Virtual reality training, the Robotic Surgical Simulator™ (image provided by Simulated Surgical which consists of a soft tissue model that reflects the patient’s anatomy and an operation Systems, Buffalo, NY)44 console using an internet connection. The authors aim to apply the system to other surgical procedures in the future.30,31

Table 3. Levels of validity Kind of Validity Description Face validity Opinion of novices and experts about the simulator

Content validity Assessment based on a detailed examination of the simulator content

Construct validity Ability of the simulator to differentiate between novices and experts

Concurrent validity Correlation of training scores with performance on other simulators

Predictive validity Correlation of training scores with performance in the operating room

Virtual reality Virtual reality (VR) training could play an important role in training and learning robotic surgery.32 Since 2006, several, mainly small, studies with respect to virtual reality systems for robotic surgery were published. Studies that address the validation or the learning capacity of the different simulators are summarized in Table 4. Depending on budget and training purpose, several simulators are commercially available, all yet to be validated.

200 201 Training and learning robotic surgery Chapter 11 yes yes no yes no no yes no yes no no Yes No Learning capacity Animal and human cadaver training Animal and cadaver simulation models have the advantage of simulating the human anatomy and these models can be used for procedural training. This kind of training was no no construct no face, content, construct face, content, construct no face, construct no face face, content, construct no face*, construct* Validation Validation considered one of the most important components of a robotic training program52 and has hence been incorporated in several courses.53-55 These courses seem to enable participants to successfully incorporate robot assisted surgery and maintain this technique in clinical practice in the short term and long term.52,56 Although operating on animal models is almost similar to operating on patients, it is expensive and there are ethical concerns (in some countries it is banned).57 However, compared with performance assessment on human cadaver models, assessment in the animal laboratory is usual easier to schedule, cheaper, and more reproducible. An animal laboratory requires a separate robotic system, which will raise costs substantially.

Life Case Observation Evaluation of a robotic training program demonstrated that operating room (OR) observation is an important component.52 There are several ways to implement OR observation in a training program. Watching live surgery and actually being present in the OR or to watch the surgery in another room with the possibility to communicate with the surgeon gives a real life experience. To watch a video registration of an operation together Evaluation with a teacher is another option. The video recording has the advantage that illustrative Difference in number of stitches placed between pre- and posttest Time, instrument tip distance and speed, range of motion (elbow) Time, pathlength, errors completion time, distance travelled, instrument tip speed, range of Task motion (wrist and elbow), EMG time, maximal force, strain, instrument motion, survey, Posttask number of instrument collisions, time out of view, targets reached or missed, total score percentage time for placing first three rings on floor peg, Pre- and posttask survey, of motion, peak ring strain, instrument collisions, economy time master tele-manipulators out of centre time instruments out of view, completion time, travelling distance and speed of instrument tips, Task range of motion (wrist and elbow), EMG time, path length, smoothness, errors survey, Posttask Instrument collisions, time instruments out of time master tele-manipulators out of centre view, survey Posttask TLX time, time instruments out of view, survey, Posttask of motion, instrument collision, time instruments Time, economy peak instrument force, number of targets reached or missed out of view, time, path length Pre- and post task survey, cases are selected in advance and the educational moments can be planned ahead.58

Figure 3. Virtual reality training, the dVT-Trainer™ (image provided by Mimic Technologies, Seattle, WS)46 Surgical System; VR, Virtual reality; VR-environ, VR environment from the Nebraska University; EMG, VR environment VR-environ, Virtual reality; VR, Surgical System; ® Basic suturing skills (inanimate model) bimanual 2 standard tasks: carrying, needle passing with increasing 5 suturing tasks difficulty 1 standard advanced surgical task: mesh alignment 2 endowrist modules and 2 needle-driving modules 1 ring transfer module bimanual 2 standard tasks: carrying, needle passing Suture-knot tying 3 standard exercises 2 standard exercises 3 standard exercises 5 standard exercises 1 suturing task Model Participants 26 medical students 5 experienced users 10 surgical novices 2 experts 9 subjects with no or limited prior dVSS experience 7 experts 19 novices 15 course enrollees in urology with varying experience 8 novices experts 14 49 non-experts 10 students 15 experts 9 intermediates 6 novices 5 experts 15 novices 11 minimal robotic experienced subjects 12 novices 7 MIS experts 9 MIS novices Trainer; RoSS, Robotic Surgical Simulator; TLX, NASA Task Load Index questionnaire; NASA,Aeronautics and Space National Task TLX, NASA Surgical Simulator; Robotic RoSS, Trainer; ® VR-trainer SEP-robot vs VR environ dVSS SEP-robot vs VR environ dVSS dVT dVT vs dVSS vs VR-environ dVSS SEP-robot vs (ProMIS or SurgicalSIM) VR-environ RoSS dVT dVT vs dVSS SEP-robot 2006 2007 2008 2008 2008 2008 2009 2009 2009 2009 2009 2010 2010 Year 45 43 42 33 41 34 37 48 47 51 36 50 40 Training using virtual reality Training Fiedler MJ et al Balasundaram I et al Brown-Clerk B et al et al PA Kenney TS et al Lendvay Katsavelis D et al Lin DW et al Mukherjee M et al SA et al Seixas-Mikelas AS et al Sethi Lerner MA et al der Meijden et al Van Halvorsen FH et al Author Electromyography; dVT, da Vinci da dVT, Electromyography; Table 4. Table Vinci SEP-robot, SimSurgery Educational Platform robot; dVSS, da Administration; *, Validity could not be demonstrated Validity Administration; *,

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Proctoring Figure 4. Da Vinci Surgical System™ with separate mentoring console (image provided by Intuitive Surgical Inc)85 Proctoring, i.e. providing direct supervision of an expert, takes place in the initial phase of a learning curve and the proctor is responsible for the assessment of skills and knowledge of the trainee. A review regarding proctoring, underlines the importance for robotic surgery and institutional credentialing, and addresses the medico legal aspects. Although extended proctorship is an expensive way of training, it provides a relatively safe way to introduce a new technique and prevents surgeons to start performing procedures before they have mastered the technique.59 There are different ways of proctoring. Usually the proctor will visit the hospital of the trainee, and surgery is performed together, giving the trainee more responsibilities depending on his or her skills. Sometimes the trainee visits the proctor first to view a certain amount of cases. Proctoring is a very time consuming and expensive way of teaching, so it is interesting to look at alternatives. Modern communication technology, tele-mentoring and tele-procotoring will save time and travelling. Alternatively, a trainee can make a video recording of the performed procedure and sent it to a proctor; the Serious Gaming evaluation can be done by watching the video online together. Surprisingly, after a five-day Previous video game experience shortens the time to learn laparoscopic skills on a intensive robotic course only 37.5% of the attendees used the possibility of proctoring, simulator.63 This association was, however, not found for robotic surgery and prior even at no extra cost. This could be due to the fact that most of the trainees attended as a extensive video game experience was even inversely correlated with the ability to learn ro- team and once returned to their hospital performed surgery together.52 botic suturing. This could be explained by the fact that the robotic system transforms intuitive 3D hand motions into 3D hand movements on a 3D screen. Students who had Mentoring significant experience in activities requiring intuitive hand movements (athletics and Mentoring during actual performance of a robotic operation can be done in several ways. musical instruments) performed better in the robotic tasks.64 Hagen et al confirmed this First of all, the mentor can observe the trainee closely while performing an operation and and showed that there is no correlation between robotic performance and logical think- give verbal instruction and take over the operation when necessary. Another possibility is ing, 3D understanding or general dexterity.65 using the availability of the mentoring console (Figure 4). This is a second console, which facilitates the surgeon to collaborate with the trainee during surgery. The mentoring Assessment of skills training console has two collaborative modes: the ’swap’ mode, which allows the mentor and the There are several options to assess performance of the trainee during skills training. trainee to operate simultaneously and active swap control of the robot arms, and the Objective assessments can be done while using a validated rating scale. Most commonly ‘nudge’ mode, which allows them both to have control over two robot arms. The ‘nudge used is the Objective Structured Assessment of Technical Skills (OSATS).66 Several mode’ seems to be particularly useful for guiding the trainee’s hands during steps of an authors used this method to assess robotic training.55,67 There is no robotic specific rating operation.60 There is also the possibility for the trainee to sit at the mentoring console scale available yet. The Application Programming Interface (API) included in the robotic and passively follow the motions of the telemanipulators of the instructor (haptic system, can provide time and motion analysis of the robot.19 These parameters showed learning).61 an objective and accurate correlation between surgical performance and OSATS score.67 Preliminary studies show that the teaching possibility to draw lines over a motion picture This feature could be used for further development and validation of training exercises. (telestration) seems also possible in robotic surgery and does not negatively impact A non-validated grading system for different steps of a robotic procedure was used to performance.62 objectively demonstrate progression of the trainee, allowing them to proceed to the next step of the procedure.68

Learning curve The ‘learning curve’ refers to the amount of surgical procedures performed before a surgeon reaches an accepted plateau in outcome parameters (operating time, blood loss, complication rate, quality of surgery). More complex procedures have a relatively long learning curve. The length of a learning curve may also vary due to surgeon related

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factors (surgical experience with a similar technology, familiarity with the procedure) or transition from open radical prostatectomy to RALP can however be done without affect- hospital related factors (availability of theatre time, available case load). Many series of ing oncologic patient outcomes.82 Doumerc et al found a flattening of the learning curve robot assisted laparoscopic procedures have been reported upon, but only a minority of after 140 cases and a flattening for larger tumours after 170 cases.83 It is most likely that them addresses the aspect of the learning curve. for other procedures the same principles can be taken into account. Surgeons should With respect to the outcome parameter ‘operating time’, there are the different phases of consider whether they can build enough experience to minimize suboptimal oncological the operation. First, there is the aspect of time needed for the operating team to prepare outcomes, before embarking on or continuing a robotic program.78 and activate the robot system (‘setup time’). Secondly, there is the time phase relating to Until today, most studies in general surgery are case series and only a few studies positioning and installing the robot (‘docking time’). Thirdly, one can differentiate the address the issue of a learning curve.3 These studies present similar results before actual time needed to complete the robotic surgery procedure (‘console time’). Fourthly, achieving proficiency in operating parameters.84 Larger series are necessary to address a there is the whole time span in which the patient is in the theatre (‘theatre time’). proper learning curve and the oncologic quality parameters. Setup-time and docking time can be reduced quickly, when working in a high volume setting with a dedicated team.69,70 Intra-operatively outcome parameters are blood loss, Training future surgeons complication rate, and the conversion rate to open surgery. For the quality of oncologic With the increasing popularity of robotic surgery there is a growing need for sophisticated surgery, parameters like ‘number of lymph nodes’, ‘tumour free margins’ and ‘recurrence training programs for residents, fellows and surgeons. Ideally these training programs rate’ are known to be used. Instead of the learning curve, Sammon et al suggest to use should be competence based. Courses are commonly used to share new information the ‘learning rate’, which is defined as the percentage decrease in operative time (min) and/or learn new skills. Some of them are pure didactic and other mainly consist of skills per doubling of cumulative procedure number.69 training, but many of them combine the two aspects. Several authors addressed the issue of training residents and fellows, and described their training program (Table 5). In Gynaecology contrast to open surgery, robotic skills can improve significantly in a relatively short The learning curve for benign gynaecologic procedures (mainly hysterectomy) in robotic time.53,55 surgery is considered to be around approximately 50 cases.71 A significant improvement in operating time after 20 cases was found for the next 20 cases of hysterectomy and Training centres myomectomy.72 For sacrocolpopexy only small series were published. A 25% reduction of With the approval of the dVSS by the Food and Drug Administration (FDA), the manufac- operative time was found after 10 cases.73 Several authors address the learning curve for turer was demanded to provide a comprehensive robotic training for all surgeons and gynaecologic oncology procedures. Proficiency for performing the robotic hysterectomy their team. The manufacturer has currently engaged 24 training centres located all over with combined pelvic-aortic lymph nodes dissection can be achieved in approximately 20 the world.85 This training comprises of two parts: on-site training, which highlights the cases, but there is a continued gradual improvement in operative time until 50-70 cases. 70 key features of the system, preparation and management in your own hospital, and Similar results were obtained for the radical hysterectomy including pelvic lymphadenec- off-site training, which consists of a course to learn and practice procedural skills. From tomy.2,74,75 However, these series do not address all parameters regarding quality of thereon support of surgical proctoring in the first cases is provided. It is important to oncologic surgery, such as recurrence rate. To achieve proficiency in these parameters the start quickly with regular scheduled cases after completion of a course, since otherwise learning curve probably will be longer (like in urology) and still has to be established. the newly learned skills can fade away. Recommendable is at least one or two cases a week, to overcome the first part of the learning curve. Next to the registered training Other specialties centres there are centres which developed their own training program and in this way Until recently, it was thought that surgeons become proficient for the robot assisted function as a training centre. Mostly these centres focus on specific procedures. laparoscopic radical prostatectomy (RALP) within 40 cases.76 Samadi et al introduced an expert level after achieving proficiency, which is considered to be reached when operating Training residents outcome parameters no longer improve. The learning curve to attain this level is expect- With the expansion of robotic surgery, training for residents during their specialty training ed to be longer and will be in the order of 70 cases.77 The full procedural learning curve has become more and more an issue. In 2006 only 34% of the urology residents thought also includes patient outcome parameters for quality of surgery (positive margins and they will perform robotic surgery after residency.86 A recent survey among residents in recurrence rate). When using these quality parameters much longer learning curves are obstetrics and gynaecology showed that 79% of the residents feel robotic training should recently described.78 For positive margins, proficiency was not reached within 100 cases79 be included in their residency program and 67% feel their training is not adequate at the and to achieve comparable oncologic outcomes to that of an experienced open surgeon, moment.87 A preliminary program for residents to train basic robotic skills consisted of a the learning curve is expected to be 250 to 400 cases.80,81 In a given hospital setting, the tutorial on the use of the robot and was followed by structured skills laboratory training.22 A structured curriculum, to acquire the knowledge and skills for the robot assisted 206 207 Training and learning robotic surgery Chapter 11

hysterectomy is described in detail by Finan et al. The curriculum is divided in familiarisa- tion with the robot itself and console components. The actual procedure is broken down into multiple segments that can be mimicked in a skills laboratory. Five exercises were Approach (n) *** developed: 1) dexterity, 2) bladder flap development, 3) seal and cut the ligaments, 4) stepwise + proctoring stepwise (5) stepwise (3) stepwise (9) mentorship after 12 cases stepwise (5) stepwise (6) stepwise (8) extended mentorship stepwise (11) stepwise (6) stepwise (6) stepwise (5)*** skeletonising the vessels, and 5) suturing the vaginal cuff. During the training period, the residents were bedside assistant and observed a number of robotic surgeries. After completing the program, the residents started step wise with surgery and no training related patient complications were noted. Some residents could not complete the program Bedside Assistant (minimum cases) because of poor eye-hand coordination, these were not allowed to progress to surgery on 15-20 12 10 ND ND ND ND 5-6 ND ND 25 ND patients.88,89 When using a systematic approach, urology residents can safely and effective learn a complex procedure such as the RALP.90 It is possible to divide a procedure into steps with increasing difficulty and only proceed to the next step when proficiency has Skills Module skills lab skills lab + animal lab ND yes Skills lab yes Skills lab + animal lab animal lab ND skills lab + animal lab skills lab skills lab been reached. Performance can be rated using an analogue scale and every step can be recorded and reviewed with the trainee. This system based on appropriate supervision, graduate responsibility, real time feedback and objective measurement could also be used for other procedures.91 Knowledge Module Training fellows yes Intuitive course yes no Intuitive course + image training no course, during bedside assistance yes Intuitive course ND ND two separate intuitive courses yes An increasing number of gynaecologic oncology units incorporate robotic surgery in their practice. A survey among fellows and fellowship directors in gynaecologic oncology showed that 95% of the responded training centres own a robot and are using it.92 However, there is no standardised training curriculum for fellows and official guidelines Procedure N for education of this new technology are lacking. Hoekstra et al describe the transition NA 83 383 50 14 75 21 phase 2. 5-6* (total each) phase 3. 32** (mean each) 124 44 1833 190 period of a gynaecologic oncology fellowship program into a robotic program. They underline the importance of commitment of the whole department during such Procedure type transition. The fellows started with limited observation, animal training, video RALP RALP RALP RALP RALP onc Gyn onc Gyn RALP RALP TECEB RALP Hyst observation and port side assistant training, followed by operating at the console steps of the procedure with increasing difficulty. For the steps vaginal cuff closure, hysterectomy and pelvic lymph node dissection proficiency can be reached after each 5-10 cases. For Trainee N NA 2 5 ? 2 ? 2 6 + 3 4 + 3 2 ? 16 the para-aortic lymph node dissection approximately 10 cases extra were required to reach proficiency.93 A systematic approach was described by Lee et al; their fellow training program included 1) didactic and hands-on training with the robotic system, 2) instructional videos, 3) assistance at the operating table, and 4) performance of segments of Trainee type trainee resident resident + fellow resident urologist fellow fellow urologist + fellow resident + fellow fellow fellow resident several gynaecologic procedures. The conclusion from this study was that the introduction with a systematic approach for training robotic surgery is feasible.94 In urology, an extended proctorship program reported a high take-rate and training satis- urol urol urol urol urol gyn gyn urol urol cardiac surg urol gyn Spec faction.95 A guideline what to look for in a trainee’s progression during the separate steps of the operation can be helpful. Although, training requires more operating time, it does 2006 2006 2007 2008 2008 2009 2009 2009 2009 2009 2009 2010 not appear to diminish patient outcome and seems possible at a high-volume centre.68 In Year 109 95 93 96 contrast to these findings other authors state that the implementation of a training 119 98 91 68 96 88 90

program will not cost extra operative time. All authors reported that fellows can be 97 94 Training approaches for robotic surgery Training trained in a complex procedure with no significant adverse impact on patient clinical outcome.68,96,97 However, a structured and systematic approach to learn robotics in a safe Badani et al Author Rashid et al Schroeck et al Thiel et al et al Yoskioka et al Hoekstra Lee et al Mirheydar et al Davis et al Schachner et al Link et al Finan et al Table 5. Table and effective way is paramount.98 TECEB, Onc, several procedures in gynecologic oncology; Gyn Assisted Laparoscopic Radical Prostatectomy; Robot RALP, Hyst, robot assited laparoscopic hysterectomy; not decribed; NA, totally endoscopic coronary bypass; ND, Robotic not applicable; *,phase 2=trainee assisting the proctor; **,phase 3=trainee being proctored; ***,number of procedural steps 208 209 Training and learning robotic surgery Chapter 11

Costs of training Guzzo et al identified three essential phases in a structured robotic training program: Robotic surgery is still expensive and several authors addressed the aspect of costs1,2,99-101 first the pre-clinical phase, secondly the bedside assistant phase and at last the operative or compared the costs of the robotic procedure with laparoscopic or open surgical console phase.115 In the preclinical phase, trainees should become familiar with the procedures.102-104 Most studies mainly focus on the costs of the robotic system robotic system and learn basic skills through inanimate simulation models. This can be (± $1.800.000) with the additional 10% per year of fixed service costs and instrument achieved in a course of several days consisting of didactic and skills training which costs (± $700 to $1000 per case). should be organised in structured and competence based way.116 In the bedside assistant Rarely addressed are the costs of the learning curve of the surgeon and the surgical team. phase, the trainee functions as a co-surgeon, learning trocar and robot placement, These are substantial costs which are often underestimated. Steinberg et al constructed a instrumentation, troubleshooting and will progressively learn the different steps of the theoretical model to describe the cost associated with the learning curve of a single operation. In the console phase, the trainee starts performing parts of the robotic surgeon for the RALP.101 In this model fixed costs for OR time and anaesthesia services operation. In the ideal situation the operation is divided into multiple steps with were used. The model was then applied to several learning curves described in the increasing difficulty. Optimal proficiency of each step is objectively graded.68 This struc- literature. The learning curves ranged from 13 to 200 cases. Costs associated with the tured approach allows optimal feedback from mentor to trainee. It is recommended to least expensive learning curve were $49.613 and with the most expensive learning curve videotape the procedures, which allows proper reviewing of procedural steps afterwards. were $554.966. The average learning curve was 77 cases at a price of $217.034. Due to the From the urological literature we know a structured training program for RALP will take diversity of the studies it is difficult to determine whether their conclusions are best 55-80 cases to train a future robotic surgeon. First observing 10-20 cases before starting applied to a single surgeon, a group practice or a hospital setting. This study illustrates to participate as a bedside assistant.98 Participation as a bedside assistant in 10-25 cases the high costs which are involved with the learning curve for complex robotic procedures before starting with segments as a console surgeon,77,91,97,98 As a console surgeon it will and underlines the need for sophisticated training programs together with a high case take 20-30 cases before a whole procedure can be performed.98 From there approximately load to overcome the learning curve. 10 cases should be performed under direct supervision of an experienced robotic surgeon.98 To maintain credentialing, a minimum of 20 cases a year is recommended.117 Curriculum design and implementation Regular self assessment of performed cases and complications will help shorting the Pioneers in robotic surgery provided an overview of robotic surgical training, identifying learning curve and provides insight in the quality of surgery. It is most likely that these objective-based curriculum levels for system training and advanced procedure specific issues will be mandatory for future credentialing training.105,106 The importance of team training has been stressed and it was noted that training of the whole surgical team could be one of the highest barriers.106 It is recommendable to start with a cohesive and dedicated OR team and two surgeons, Discussion which need to work closely together during the initial learning curve.52 This team based approach can reduce the learning curve of robotic assisted surgery.107,108 Only when the Based on the literature used in this review, an extraction of the components which could initial team has achieved proficiency, new surgeons can be introduced and a general be used in a structured training program for robotic assisted laparoscopic surgery is strategy should be to avoid multiple learning curves running parallel.109 The team should shown in Table 6. Robotic surgical training consists of two equal parts: system training start with relatively easy cases, to be able to familiarise themselves with patient position- and procedural training. Each part has its own components which should be incorporating, the setup of the robot, trocar and robot positioning, and the robotic instruments.110,111 ed it a structured program. This table could serve as a guideline to adjust existing When these issues are mastered, the team can move on to more complex cases. A large programs when necessary or to design future training programs for robotic surgery. case volume is required to maintain skills, not only for the console surgeon but for Despite formal consensus statements of experts in the field of robotic surgery9,117, the bedside assistant as well.98 A well trained bedside assistant is just as important as the implementation of robotic surgery is not always optimal. As long as there are no official console surgeon and requires a combination of open, laparoscopic and robotic skills.112 guidelines for minimum requirements for hospital and surgeon credentialing, consensus Slow adoption to robotics and prolonged operative times may result from insufficient based statements should be used as a guide before implementing robotic surgery in daily trained bedside assistants.113 practice. Both statements address the issue of training excessively. It is expected that The OR nurses, anaesthesiology nurses and the anaesthetist play also an important role certification of surgeons, also of those already performing robotic surgery, will become a in robotic surgery and should be well trained before starting a robotic program. There are requirement in the near future. many specific perioperative competencies a scrub nurse or a circulating nurse must Implementing a new technology like robotic assisted laparoscopic surgery in a safe and know.114 Training too many nurses at once usually results in inadequate exposure to robot efficient way is demanding. There are many factors which influence a successful procedures and will delay the success of the program. implementation of a robotic training program. Issues like training modalities, longer

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operative times, patient outcomes, cost, case volume, number of robotic cases to Table 6. Guidelines robotic training curriculum

become proficient for operating and patient quality parameters are all items which System training require attention. The exponential growth of robotic surgery however, is not giving the Didactic training Knowledge robotic system and instruments surgical community much time to develop structured training programs for future Test knowledge (exam) robotic surgeons. In the near future an increasing amount of well trained robotic surgeons will be needed. Dry lab How to use robot console How to use camera en instruments How to prepare the system (draping, setup) How to solve common errors Conclusion Practice validated basic skills (competence based) Test skills (exam)

Designing a competence based training curriculum for robotic surgery remains a Virtual Reality Simulation Learning about the system (interactive) challenge, but with the exponential increase of robotic surgery the need for such certified Practice validated basic skills (competence based) Practice procedure specific skills (competence based) curricula is increasing rapidly. There is a lack of validated training tools for robot assisted laparoscopic surgery, and in the near future further research in this field needs to be Animal Laboratory Team training (surgeon and patient side assistant) done. With the increasing quality of virtual reality simulators for robotic surgery it is Cadaver training Team training (surgeon and patient side assistant) expected, that this training modality will play an important role in training future robotic surgeons. Procedural training for robotic surgery needs to be done in a stepwise and Procedural training systematic manner. In this way, introduction of this new technology can be performed in Didactic training Indications, patient selection an efficient and safe way, and without compromising results for our patients. Positioning patient, trocar, robot Complications and their management Test knowledge (exam)

Live-observation / video observation Observe real operations with mentor (live cases or video recordings) Tips, Tricks and complications

Dry lab Practice validated advanced skills (competence based) Practice procedure specific skills (competence based)

Virtual Reality Simulation Practice procedure specific skills (competence based)

Animal Laboratory Practice procedure specific skills (steps of a procedure)

Cadaver training Practice procedure specific skills (steps of a procedure)

Patients First function as a table side assistant Stepwise approach of procedure Proceed to next step after showing proficiency previous step Proctoring or preceptoring (minimum of 10 cases)

Follow-up Evaluation of surgical performance Evaluation of patient outcome (operative and patient quality parameters)

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Initial Experience of Teaching Robot- Gynecologic Oncology Fellowship Programs in the USA: a Survey of Fellows and Fellowship Directors. Assisted Radical Prostatectomy to Surgeons-in-Training: Can Training Be Evaluated and Standardized? Int J Med Robot 2010;6:405-12. BJU Int 2009. 93. Hoekstra AV, Morgan JM, Lurain JR, Buttin BM, Singh DK, Schink JC, Lowe MP. Robotic Surgery in 69. Sammon J, Perry A, Beaule L, Kinkead T, Clark D, Hansen M. Robot-Assisted Radical Prostatectomy: Gynecologic Oncology: Impact on Fellowship Training. Gynecol Oncol 2009;114:168-72. Learning Rate Analysis As an Objective Measure of the Acquisition of Surgical Skill. BJU Int 94. Lee PS, Bland A, Valea FA, Havrilesky LJ, Berchuck A, Secord AA. Robotic-Assisted Laparoscopic 2010;106:855-60. Gynecologic Procedures in a Fellowship Training Program. JSLS 2009;13:467-72. 70. Seamon LG, Fowler JM, Richardson DL, Carlson MJ, Valmadre S, Phillips GS, Cohn DE. A Detailed 95. Mirheydar H, Jones M, Koeneman KS, Sweet RM. Robotic Surgical Education: a Collaborative Approach Analysis of the Learning Curve: Robotic Hysterectomy and Pelvic-Aortic Lymphadenectomy for to Training Postgraduate Urologists and Endourology Fellows. JSLS 2009;13:287-92. Endometrial Cancer. Gynecol Oncol 2009;114:162-7. 96. Schroeck FR, de Sousa CA, Kalman RA, Kalia MS, Pierre SA, Haleblian GE, Sun L, Moul JW, Albala DM. 71. Lenihan JP, Jr., Kovanda C, Seshadri-Kreaden U. What Is the Learning Curve for Robotic Assisted Trainees Do Not Negatively Impact the Institutional Learning Curve for Robotic Prostatectomy As Gynecologic Surgery? J Minim Invasive Gynecol 2008;15:589-94. Characterized by Operative Time, Estimated Blood Loss, and Positive Surgical Margin Rate. Urology 72. Pitter MC, Anderson P, Blissett A, Pemberton N. Robotic-Assisted Gynaecological Surgery-Establishing 2008;71:597-601. Training Criteria; Minimizing Operative Time and Blood Loss. Int J Med Robot 2008;4:114-20. 97. Link BA, Nelson R, Josephson DY, Lau C, Wilson TG. Training of Urologic Oncology Fellows Does Not 73. Akl MN, Long JB, Giles DL, Cornella JL, Pettit PD, Chen AH, Magtibay PM. Robotic-Assisted Adversely Impact Outcomes of Robot-Assisted Laparoscopic Prostatectomy. J Endourol 2009;23:301-5. Sacrocolpopexy: Technique and Learning Curve. Surg Endosc 2009;23:2390-4. 98. Badani KK, Hemal AK, Peabody JO, Menon M. Robotic Radical Prostatectomy: the Vattikuti Urology 74. Fanning J, Fenton B, Purohit M. Robotic Radical Hysterectomy. Am J Obstet Gynecol 2008;198:649-4. Institute Training Experience. World J Urol 2006;24:148-51. 75. Feuer G, Beningo B, Krige L, Alvarez P. Comparison of a Novel Surgical Approach for Radical 99. Boggess JF. Robotic Surgery in Gynecologic Oncology: Evolution of a New Surgical Paradigm. J Robotic Hysterectomy: Robotic Assistance Versus Open Surgery. J Robotic Surg 2009;3:179-86. Surg 2007;1:31-7. 76. Bivalacqua TJ, Pierorazio PM, Su LM. Open, Laparoscopic and Robotic Radical Prostatectomy: 100. Patel HR, Linares A, Joseph JV. Robotic and Laparoscopic Surgery: Cost and Training. Surg Oncol Optimizing the Surgical Approach. Surg Oncol 2009;18:233-41. 2009;18:242-6. 101. Steinberg PL, Merguerian PA, Bihrle W, III, Seigne JD. The Cost of Learning Robotic-Assisted Prostatectomy. Urology 2008;72:1068-72.

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102. Curet MJ, Solomon H, Lui G, Morton JM. Comparison of Hospital Charges Between Robotic, Laparoscopic Stapled, and Laparoscopic Handsewn Roux-En-Y Gastric Bypass. J Robotic Surg 2009;3:75-8. 103. Joseph JV, Leonhardt A, Patel HRH. The Cost of Radical Prostatectomy: Retrospective Comparison of Open, Laparoscopic, and Robot-Assisted Approaches. J Robotic Surg 2008;2:21-4. 104. Prewitt R, Bochkarev V, McBride CL, Kinney S, Oleynikov D. The Patterns and Costs of the Da Vinci Robotic Surgery System in a Large Academic Institution. J Robotic Surg 2008;2:17-20. 105. Chitwood WR, Jr., Nifong LW, Chapman WH, Felger JE, Bailey BM, Ballint T, Mendleson KG, Kim VB, Young JA, Albrecht RA. Robotic Surgical Training in an Academic Institution. Ann Surg 2001;234:475-84. 106. Nifong LW, Chitwood WR, Jr. Building a Surgical Robotics Program. Am J Surg 2004;188:16S-8S. 107. Sim HG, Yip SK, Lau WK, Tan YH, Wong MY, Cheng CW. Team-Based Approach Reduces Learning Curve in Robot-Assisted Laparoscopic Radical Prostatectomy. Int J Urol 2006;13:560-4. 108. Trabulsi EJ, Zola JC, Gomella LG, Lallas CD. Transition From Pure Laparoscopic to Robotic-Assisted Radical Prostatectomy: a Single Surgeon Institutional Evolution. Urol Oncol 2010;28:81-5. 109. Schachner T, Bonaros N, Wiedemann D, Weidinger F, Feuchtner G, Friedrich G, Laufer G, Bonatti J. Training Surgeons to Perform Robotically Assisted Totally Endoscopic Coronary Surgery. Ann Thorac Surg 2009;88:523-7. 110. Ferguson JL, Beste TM, Nelson KH, Daucher JA. Making the Transition From Standard Gynecologic Laparoscopy to Robotic Laparoscopy. JSLS 2004;8:326-8. 111. Jayaraman S, Davies W, Schlachta CM. Robot-Assisted Minimally Invasive Common Bile Duct Exploration: a Canadian First. Can J Surg 2008;51:E93-E94. 112. Kumar R, Hemal AK. The ‘Scrubbed Surgeon’ in Robotic Surgery. World J Urol 2006;24:144-7. 113. Steers WD, LeBeau S, Cardella J, Fulmer B. Establishing a Robotics Program. Urol Clin North Am 2004;31:773-80, x. 114. Zender J, Thell C. Developing a Successful Robotic Surgery Program in a Rural Hospital. AORN J 2010;92:72-83. 115. Guzzo TJ, Gonzalgo ML. Robotic Surgical Training of the Urologic Oncologist. Urol Oncol 2009;27:214-7. 116. Benson AD, Kramer BA, Boehler M, Schwind CJ, Schwartz BF. Robot-Assisted Laparoscopic Skills Development: Formal Versus Informal Training. J Endourol 2010;24:1351-5. 117. Valvo JR, Madeb R, Gilbert R, Nicholson C, Oleyourryk G, errapato S, Ricottone A, Roberts W, Eichel L. Policy Guidelines Suggested for Robot-Assisted Prostatectomy. J Robotic Surg 2007;1:173-6. 118. Reznick RK, MacRae H. Teaching Surgical Skills--Changes in the Wind. N Engl J Med 2006;355:2664-9. 119. Yoshioka K, Hatano T, Nakagami Y, Ozu C, Horiguchi Y, Yonou H, Tachibana M, Coughlin G, Patel VR. Robotic-Assisted Laparoscopic Radical Prostatectomy:Initial 15 Cases in Japan. J Robotic Surg 2008;2:85-8.

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Discussion objective outcome assessment and the possibility to simulate complete surgical procedures and various trouble shooting scenarios. Primum no nocere: first of all, do no harm. Every surgeon should keep this phrase in mind An optimally designed skills curriculum should contain a variety of training models to and close at heart before starting to operate on a patient. In modern surgery, based on address to the specific scenario needs. Depending on the financial resources and the the sound foundation of patient safety, the classic Halstedian teaching model of see one, goal of the curriculum, different simulators may be introduced, as long as they are do one, teach one is no longer valid. As in aviation, where every pilot is well trained and properly validated. There should be a good, human instruction focusing on how to use has to demonstrate competence in a flight simulator before flying an air plane; a surgeon the simulator and a demonstration of the skills to be acquired. Effective, on-site should be proven competent in certain skills before being allowed to operate on patients. instruction facilitates skills acquisition, prevents unwanted or even counterproductive Especially, since the tools for proper training and assessment of individual competence skills development and motivates trainees, thus leading to more efficient learning. The on performance of minimally invasive laparoscopic surgical procedures are available. demonstration is best given by a laparoscopic expert (teacher), but if this is not possible, Still, many difficulties are encountered in developing training programs incorporating digital media content (video, e-learning) may serve as a valid alternative. Every training such tools, and above all, in implementing these training programs optimally. scenario should have a proper and clearly defined goal which is communicated to the In the last decade many authors have addressed the issue of training for minimally trainee. Competence levels for every phase of training should be well defined. If applicable invasive laparoscopic surgery. This thesis describes several training tools for minimally the trainee should also be able to identify possible ‘hurdles’ in the competency invasive surgery and identified items which are important for the development and acquisition. The simulators used in a skills curriculum should provide a variety of implementation of a structured training program. In this chapter, the most important different exercises with increasing levels of difficulty, since this will enhance training. The aspects of training and learning minimally invasive conventional laparoscopic surgery trainee has to start with basic exercises to develop basic skills before progression to more and robot assisted laparoscopic surgery are discussed. complex exercises or complete procedures can be made. Multiple studies for a variety of simulators demonstrate the effectiveness of simulators Building a curriculum for skills training for minimally invasive laparoscopic skill development. Although a simulator may be Any valid training program for minimally invasive surgery must be one following a properly validated for the purpose of its use, it is eventually the broader context of the structured step-by-step concept and contain several crucial items. Although these depend entire curriculum that dictates trainee’s clinical progress. Several theories describe on the goal of training, essential items are: knowledge development, skills training optimal pathways for trainees to acquire skills underpinning clinical progress. (including the definition of various skills and scenario’s to be mastered for specific tasks In a structured training program, skills training should be competence based instead of or procedures) and objective competence testing on meaningful outcome parameters. time based. Traditionally, procedural end-time or the amount of repetitions needed to Ideally, a laparoscopic training program should start with a knowledge module combining complete the exercise successfully have been used for skills training. However, training normal physiology, fundamental laparoscopic knowledge and associated technical based on these endpoints does not correlate well to the level of the acquired skills, since knowledge (e.g. electrosurgery, instruments, robot console etc.). This module could be there is a wide variety in time or in the amount of repetitions between trainees before the best accompanied with basic skills training, since the direct application of knowledge needed skills are acquired.2 A well-designed, tailored curriculum will identify trainees into practice will improve the retention of the information compared with didactics early in their learning process and will facilitate in the appropriate training possibilities. alone.1 The newly gained knowledge should best be verified through an exam. Some trainees need additional training to reach a preset level before they can be allowed Next, the trainee should learn the required basic skills needed to start performing to start performing laparoscopy in the operating room. Other trainees acquire the needed laparoscopic surgery. For skills training several simulation modalities may be used. skills faster and could use their time for various training scenario’s or other activities. In Available models are box or video trainers, virtual reality trainers and (in)animate models competence based training, the trainee has to reach preset performance based end- (e.g anesthetized live animal models and human cadaveric models). The goal of points. These are clearly defined training goals and every trainee has to train to a uniform simulator based training is to provide the best possible level of skill to trainees before level of competence. In general, this type of training results in a good and faster skills starting surgery on patients. For basic skills training there is no need for animal or human acquisition, and provides a better retention of the learned skills. Essentially, competence cadaver training. These modalities should be reserved for advanced procedure specific based simulator training improves operative performance. 3,4 training. Due to legal, ethical and financial considerations, access to live animal model After reaching the preset set level of competence the newly learned skills should be training is limited and increasingly being replaced by inanimate simulation models. Box maintained, otherwise the skills will fade away.5 This can be done while performing trainers and virtual reality trainers complement each other and may not be considered regular surgery or with regular skills training using box- or virtual reality trainers. To interchangeable. Box trainers have the advantage of providing realistic haptic feedback prevent the loss of skills the trainee should thus demonstrate competence with a regular and the use of real instruments. Virtual reality trainers have the advantage of automated interval. For example, providing a skills test every 6 or 12 months would make the trainee

222 223 Discussion, conclusions and future perspectives Chapter 12 aware of maintaining their skills. for a simulator. These studies are able to proof in a randomized way that it is possible to Finally, organizing multiple training sessions has been demonstrated to result in a higher transfer skills learned on a simulator to real operations, leading to less errors and level of skills acquisition and skills retention when compared to offering training all at reduced operation time.4 This will eventually lead to cost effective and safe surgery. once, during only one training session.6 This may be attributed to a better retention and Ultimately only simulators showing predictive validity should be incorporated in consolidation of the learned skills during the inactive periods. In addition, multiple short structured training programs for minimally invasive surgery. However studies to training sessions lead to less physical and mental fatigue. determine predictive validity are, mainly due to ethical reasons, difficult to organize.

Feedback in skills training Facilities for skills training Feedback is an important part of skills development and moreover, indispensible for When bringing a surgical skills curriculum into practice, an appropriate environment effective learning strategies, and may be provided in a variety of ways and at different such as a skills laboratory is essential. A skills laboratory for minimally invasive laparo- points during training. Feedback can be given after completion of the training to scopic surgery provides a safe and reproducible environment for training and assess- document course completion (summative feedback), but essential for the learning ment outside the operating room. Before setting up a skills facility it is important to process is feedback which is provided during practice sessions (formative feedback). The define the mission of the facility. Definition of the purpose(s) and identification of the latter means that feedback is provided continuously during practice sessions with the users (e.g. one specialty or more specialties) and resources are important early on in its focus on correcting mistakes and identifying areas for improvement. development. The personnel, space resources and equipment purchased should be In minimally invasive skills training courses formative feedback is often given by faculty tailored by the curricular needs.8 Unfortunately, several skills facilities have been built surgeons, who provide ongoing tips and provide valuable instructions during practice. without an existing or implemented curriculum. This can result in an expensive skills lab- Many virtual reality simulators have incorporated components to provide automated oratory which is rarely used and leads to a disappointed staff to run it. Important factors feedback, such as video demonstrations, tutorials, anatomical overlays or markers to to make a skills facilities for training minimal invasive surgery efficient and successful guide the trainee. Thus these simulators may be used with minimal reliance of human are; sufficient financial resources to build, equip and maintain the facility; the presence of resources. However, in virtual reality training the presence of a laparoscopic expert is a box and/or virtual reality trainer, and the presence of a mandatory curriculum. Taking valuable as well. Feedback should be provided in the appropriate amount and at the right these aspects into account, and using the facility with different surgical specialties may time, since too little feedback can lead to frustration of the trainee and to much feedback improve the overall quality. will interfere with the quality of learning. Assessment of skills training Validation of skills training In skills training the assessment of improvement is essential to the development and im- A simulator used in a training program for minimally invasive surgery must be reliable plementation of surgical simulators and curricula. There are several methods of assess- and valid. The reliability of a simulator refers to the precision and consistency of the ment which can be used in skills training. These can be classified as observational and simulator. A simulator can not be reliable unless it is proven to be valid for the domain it non-observational tools. The observational tools which can be used for laparoscopic is supposed to train. Regarding the validation of simulators, several levels of validation skills training are the Objective Structured Assessment of Technical Skills (OSATS)9 and apply. Before implementing a simulator into a training program it should at least contain the Global Operative Assessment of Laparoscopic Skills (GOALS)10, which are both glob- face- and construct validity. Face validity means that the simulation resembles the real al rating scales. These rating scales, both extensively studied and validated, are suitable task. Construct validity means that the simulation has the ability to differentiate between for the assessment of complete procedures or of a part of a procedure. Both rating scales groups with different levels of competence. In this thesis we performed several validation have their shortcomings, since they still rely on subjective assessment. This makes them studies to establish face and construct validity of different simulators. With respect to only suitable for formative assessment and not for summative assessment or credential- box trainers, any box or video trainer can be used as long as the exercises performed ing.11 To asses a certain procedure, it is possible to modify these rating scales in order to within the box are valid. Unfortunately, there are not many validated, reproducible or highlight specific skills needed for that particular procedure. Before using a modified commercially available exercises published for box training. For virtual reality trainers rating scale a validation study must be performed.12 however there are many publications with respect to the validity of the simulator. Examples of non-observational tools are the measurement of metrics and motion Most virtual reality simulators show face- and construct validity, but only a few meet the analysis. In skills training for minimally invasive surgery the measurement of metrics is criteria for further levels of validation.7 These next levels are concurrent validity and widely used. Most commonly used parameters are time and error rate. Decreased time to predictive validity. Predictive validity is the capacity of the simulator to predict future perform the exercise may indicate progression, while a recording of errors assures that surgical performance in the operating room and is the highest achievable level of validity efficacy is not obtained with reduced accuracy. To use these parameters optimally, they

224 225 Discussion, conclusions and future perspectives Chapter 12 should be both incorporated in a total score. Incorporating several different errors in a program to all involved and should create allocated training time during working hours, total score gives the developer (teacher) the possibility to weigh the errors depending on rather than expecting that trainees would train by themselves in their off-duty hours. It their seriousness. This type of assessment is very suitable for box training since there is should be clear what is expected from trainees and staff. Furthermore, staff must agree usually no automated system in these type of trainers. This means a trainer should be on the issue not to allow residents to operate on patients unless they have reached the present to asses the trainee, usually using a stopwatch to record time and watch to preset level of competence. The dedication and quality of staff regarding training record errors. Ideally, simulators should have the ability to record and analyze metrics minimally invasive surgery could be of decisive importance for the success of a training real-time, which makes it possible to provide immediate feedback. These features are one program. The institutional board must facilitate the initiative in terms of offering space of the main advantages of virtual reality simulators, since they use a computer interface and resource for the initiative. The government, at last, through defining rules and to record metrics and are capable to create automated assessment reports. This makes checking the current status of implementation, is key in enforcing timely action on the them suitable for self-directed learning and the acquisition of proficiency. Due to their proper implementation of proposed nationwide curricula and those institutes lacking to computerized measurements, it is possible to measure several other metrics for assess- do so. ment, such as instrument path length, economy of motion, quantified measurement of tension or pressure to structures and many others. However, not all metrics are equally Costs of skills training important, so a weighted and validated scoring system is necessary. Nowadays, several Nowadays, cost is an important factor in health care. The establishment of skills training virtual reality simulators can be used for summative assessment.11 In a research setting facilities, with simulators and personal can be expensive. When there is no allocated other methods of assessment can also be used. Options are measuring electro money for training the chances to successfully implement a skills curriculum are reduced myographic parameters, eye movement parameters or hand tracking. significantly. A training facility should be adjusted or equipped based on the needs of the people working near to it, the demands of the institute, and the skills curricula set by the Implementation of skills training different medical specialties. In this way skills training for minimally invasive surgery can Simulators should not be used on their own, but should be incorporated in a structured be cost-effective.15 To reduce costs and to optimize the use of the skills facility the competence based laparoscopic training curriculum, using criteria set by the professional development of skills centers should be monitored and training directors should have a community, and enforced by the hospital board or government. Several authors clear insight in what is where available. Next to the larger regional training centre there demonstrated that providing a simulator for skills training to trainees by itself will not should be an easy accessible smaller facility in every hospital. This can be a dedicated lead to voluntarily training.13,14 To make trainees start to train, the training program itself room in the hospital, but can also be a simulator in the register room. In this way, training must be mandatory with consequences upon not completing the training. The capacity can be adjusted to the training needs. This will increase the efficacy of skills responsible curriculum director (laparoscopic expert) should monitor the trainee’s facilities which will reduce the overall costs. Besides, training by itself can reduce costs, progress to ensure that the trainee will indeed reach the preset, validated learning since structured and competence based skills training leads to faster operating objectives. Trainees can be stimulated by making the results transparent or creating a performance and less operating errors.4 This will eventually improve patient safety, skills competition. For example, a competition can be created between trainees. It is also meaning less complications and increased efficacy in the operating room. Both reducing possible to create an online national or international competition. A portfolio should be hospital and society costs. used, which gives insight in the progression to the teacher and trainee and thus motivates the trainee to fill the portfolio. Robot assisted laparoscopic surgery and skills training To implement such a curriculum, good cooperation between institutional board, program The necessity of a structured training program is even more acute for robot assisted director, department chair, medical staff and trainees is essential. Crucial factors for a laparoscopic surgery than for conventional laparoscopy. Although there are some specific solid implementation of a training curriculum are funding, motivation and commitment. issues, a curriculum for robot assisted surgery should essentially be similar to that for Once the funding of the program has been agreed other issues can arise. Facilities are conventional laparoscopy. not always properly equipped, teaching staff is not always willing or able to teach such a First of all, robotic assisted surgery is a relatively new surgical modality. This implies, curriculum, and residents are often too occupied with daily practice core activities to that standards and outcome parameters should still be set. Issues like training train. Perhaps most crucial is, thus, the human factor. Different viewpoints on proposed modalities, longer operative times, patient outcomes, cost, case volume, number of national curricula are of course important but on the other side, cause serious delay in robotic cases to become proficient for operating and patient quality parameters are all implementation. A better approach would be to start the implementation once agreed items which require more attention. Also, there is an inherent lack of experienced users. upon by the respective societies, and sharpen the curricula using careful and timely Secondly, in robot assisted laparoscopic surgery the trainee needs to, next to the evaluation. Department chairs and program directors should communicate the skills procedure, master the robotic system itself. Basically, one could say robotic surgical

226 227 Discussion, conclusions and future perspectives Chapter 12 training consists of two equal parts: system training and procedural training. Each part Netherlands.16 It has been concluded that training in minimally invasive surgery was has its own components which should be incorporated it a structured training program. inadequately structured and implemented. A need for national standardized training Next to the simulation modalities used for conventional laparoscopy (e.g. dry-lab programs was stressed and recommendations were made. In reaction, working groups of training, virtual reality training and in(animate) models, one could use the separate the Dutch Society of Surgery, the Dutch Society Obstetrics and Gynecology and the Dutch mentoring console for procedural training. Unlike in conventional laparoscopy, there is a Society of Urology each developed structured training programs for minimally invasive lack of validated training modalities for robot assisted laparoscopic surgery. However, laparoscopic surgery to be implemented in daily practice. Requirements for skills training with the increasing quality of virtual reality simulators for robotic surgery it is expected were defined and hospitals were obliged to implement these requirements in their that this training modality will have more validated training modules in the near future. training programs. The next step would be to establish pan-disciplinary agreements with These validated training modules will address system training and procedural training regard to training and skills assessment in minimally invasive surgery.17 The Dutch and should be implemented in a structured training curriculum. Procedural training for Society for Simulation in Healthcare (DSSH) is providing a platform for networking and robotic surgery needs to be done in a stepwise and systematic manner. This can be done sharing of experiences, by bringing engineers and medical educators in contact with the by dividing the procedure in several steps, with increasing difficulty. Before progressing medical specialists and simulator industry to thrive initiatives.18 This could accelerate a to the next step, competence for the previous step must be achieved. In procedural nationwide implementation of competence-based training curricula. Recently, the Dutch training there is also an important role for life-case observation or video observation, and Society of Endoscopic Surgery19 published such a multidisciplinary guideline regarding all proctoring. In this way, introduction of this new technology can be performed in an aspects of minimally invasive surgery in the Netherlands.20 In this guideline efficient and safe way, and without compromising the safety of our patients. recommendations are made for the implementation of training and skills assessment in Thirdly, robotic surgery relies heavily on optimal team performance and collaboration. daily practice. Every resident in surgical training should pass a knowledge module and a Training should therefore involve all members of the team, including the surgical, validated skills module to demonstrate minimum standards of competence before anesthetic and technical team. Working with dedicated teams, can reduce the learning operating on patients. curve of robotic assisted surgery, which will reduce costs and improve patient safety. Regarding robotic surgery, the Dutch Health Care Inspectorate (IGZ) published another Designing a competence based curriculum for robotic surgery remains a challenge, but report entitled “Insufficient prepared introduction of robotic surgery” in 2010.21 With with the exponential increase of robotic surgery the need for such certified training respect to training, the report stated that “in 50% of the hospitals insufficient criteria curricula is increasing rapidly. where set for the surgeons competence before starting with robotic surgery”. This is surprisingly since several international expert groups provided guidelines for the Learning curve in surgical skills training introduction of robotic surgery and addressed aspects of training and competence. The The simulator learning curve ends when the trainee reaches a preset level of competence, Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the usually defined as a preset expert level, based on mean performance of experts. From this Minimally Invasive Robotic Association (MIRA) assembled in 2007 an international moment, depending on the curriculum, the trainee can usually start performing surgery multidisciplinary consensus group (the SAGES-MIRA Robotic Consensus Group) to draft on patients under close observation of a trained surgeon. Depending on the procedure a official consensus statement regarding robotic surgery. Training and credentialing is this can be as a either first or as a second surgeon. This is where the surgical learning one of the four main items in this statement and full credentialing guidelines for robotic curve starts. The surgical learning curve is reflected by several outcome parameters, such surgery were provided.22 An international expert group of urologist published consensus as operating time, blood loss, complication rate and quality of surgery (e.g. tumor free based guidelines for appropriate training and credentialing of robot assisted surgery.23 margins, recurrence rate for oncologic procedures). A learning curve could have multiple Despite these formal consensus statements the implementation of robotic surgery in the plateaus. The plateau for operating time is usually reached before the plateau for tumor Netherlands was stated to be insufficient in several occasions. As long as there are no free margins or recurrence rate. The only way to go through the surgical learning curve is official guidelines for minimum requirements for hospital and surgeon credentialing, the to perform multiple procedures. A well-designed and competence based training consensus based statements should be used as a official guide before implementing program can reduce the surgical learning curve substantially. robotic surgery in daily practice.

Guidelines and credentialing for skills training Providing guidelines for training minimally invasive laparoscopic surgery are a necessary step in improving the quality of training and surgery. In 2007, the Dutch Inspectorate for Healthcare published a report entitled “Risks minimally invasive surgery underestimated”, expressing its concern regarding endoscopic surgery and patient safety in the

228 229 Discussion, conclusions and future perspectives Chapter 12

General conclusions and recommendations Future Perspectives

- There is a learning curve inherent to every -minimally invasive laparoscopic- surgical For training conventional laparoscopy, further development will be in the field of box procedure. trainers and virtual reality trainers. Box trainers will be equipped with tools for automated - There is a wide variety of validated training tools for conventional minimally invasive assessment. For virtual reality trainers the main focus will move from basic skills training laparoscopic surgery. to the development of complete surgical procedures, including the further establishment - Box trainers and virtual reality trainers complement each other and should not be of predictive validity. Similar to aviation, a surgeon should first perform the operation in a considered fully interchangeable. virtual environment before operating patients. Furthermore, the newer generation virtual - There is a lack of validated training tools for robot assisted laparoscopic surgery. reality simulators can incorporate real patient data from CT-scan or MRI, thus making a - Skills training for minimally invasive surgery should be implemented in a mandatory, ‘testrun’ on patient data possible. Most likely, a form of virtual reality simulation will be structured and competence based training curriculum. used for credentialing trainees and surgeons. In general, there will be further develop- - Only validated simulators or exercises should be incorporated in a skills training ment of quality criteria and accreditation for the assessment of skills facilities and skills curriculum. curricula. - Essential items in a training curriculum are knowledge development, skills training and “Serious gaming” is entering the field of medical education and the gaming industry is assessment of competence. more and more interested in designing serious games for health care purposes. Serious - Crucial factors for a successful and solid implementation of a training curriculum are games that can be used for training the skills necessary for conventional minimally funding, motivation and commitment of trainer and trainee. invasive surgery are underdevelopment. Most likely, it will be a matter of time till games - There should be a transparent and allocated budget for surgical skills training in all for training robot assisted surgery will be developed. Further development of e-learning hospitals. modules for minimally invasive surgery will provide tools to master and asses the - Residents must be facilitated to train during their regular working week in specifically knowledge necessary for laparoscopic surgery. allocated trainings hours With the ever developing technology it is most likely that robotic surgery is here to stay. - Just like in aviation, surgeons should show competence of surgical skills on well- The past decade has shown how fast a new technology like this can grow. Several major validated trainings curricula before being allowed to operate on patients. technical innovations are expected that will not only make robot assistance more versatile (e.g. smaller systems, robot mounted to the ceiling, integration of imaging techniques), but which also provide better and safer training modalities (e.g. mentoring console, virtual reality simulation). Validated virtual reality training tools will be incorporated in the robotic systems and provide a safe way for the growing demand for training robot assisted surgery. Flexible endoscopes, including to steerable instruments are already available, but these will most likely develop in flexible robotic arms. Since these flexible endoscopes are almost to difficult for a human to maneuver. Putting a robot between the surgeon and the instrument will help overcome these problems. This probably will lead to a growth of “It’s not practice that makes perfect, but it’s perfect practice that makes perfect” single port surgery and Natural Orifice Transluminal Endoscopic Surgery (NOTES) using Vince Lombardi 1913-1970 one flexible robotic endoscope. All these technologies will use virtual training systems for training since their computerized platforms are very suitable for virtual reality.

230 231 Discussion, conclusions and future perspectives Chapter 12

References

1. Stefanidis D, Heniford BT. The formula for a successful laparoscopic skills curriculum. Arch Surg 2009;144:77-82. 2. Schijven MP, Jakimowicz JJ. The learning curve on the Xitact LS500 laparoscopy simulator: profiles of performance. Surg Endosc 2004;18:121-127. 3. Stefanidis D, Korndorffer JR, Markley S, Sierra R, Heniford BT, Scott DJ. Closing the gap in operative performance between novices and experts: Does harder mean better for laparoscopic simulation training. J Am Coll Surg 2007;205:307-313. 4. Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, et al. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ 2009;338:b1802. 5. Maagaard M, Sorensen JL, Oestergaard J, Dalsgaard T, Grantcharov TP, Ottesen BS, Larsen CR. Retention of laparoscopic procedural skills acquired on a virtual-reality surgical trainer. Surg Endosc. 2011;25:722-727. 6. van Dongen KW, Mitra PJ, Schijven MP, Broeders IAMJ. Distributed versus massed training, efficiency of training psychomotor skills. Thesis KW van Dongen Virtual reality training for endoscopic surgery, Gildeprint drukkerijen, Enschede, The Netherlands 2010 ISBN 978-90-365-3062-0 page 71-79. 7. Thijssen AS, Schijven MP. Contemporary virtual reality laparoscopy simulators: quicksand or solid grounds for assessing surgical trainees? Am J Surg 2010;199:529-541. 8. MacRae HM, Satterthwaite L, Reznick RK. Setting up a surgical skills center. World J Surg 2008;32:189- 195. 9. Martin JA, Regehr G, Reznick R, Macrae H, Murnaghan J, Hutchison C, Brown M. Objective Structured Assessment of Technical Skill (OSATS) for Surgical Residents. Br J Surg 1997;84:273–278. 10. Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondré K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg 2005;190:107-113. 11. van Hove PD, Tuijthof GJ, Verdaasdonk EG, Stassen LP, Dankelman J. Objective assessment of technical surgical skills. Br J Surg 2010;97:972-987. 12. Larsen CR, Grantcharov T, Schouenborg L, Ottosen C, Soerensen JL, Ottesen B. Objective assessment of surgical competence in gynaecological laparoscopy: development and validation of a procedure-specific rating scale. BJOG 2008;115:908-916. 13. van Dongen KW, van der Wal WA, Rinkes IH, Schijven MP, Broeders IA. Virtual reality training for endoscopic surgery: voluntary or obligatory? Surg Endosc 2008;22:664-667. 14. Chang L, Petros J, Hess DT, Rotondi C, Babineau TJ. Integrating simulation into a surgical residency program: is voluntary participation effective? Surg Endosc. 2007;21:418-421. 15. Stefanidis D, Hope WW, Korndorffer JR Jr, Markley S, Scott DJ. 2010. Initial laparoscopic basic skills training shortens the learning curve of laparoscopic suturing and is cost-effective.J Am Coll Surg 210:436-440. 16. IGZ: Dutch Health Care Inspectorate. Rapport Risico’s minimaal invasieve chirurgie onderschat, kwaliteitssysteem voor laparoscopische operaties ontbreekt. 2007 Available from www.igz.nl. 17. Stassen LP, Bemelman WA, Meijerink J. 2010. Risks of minimally invasive surgery underestimated: a report of the Dutch Health Care Inspection. Surg Endosc 24:495-498. 18. Dutch Society of Simulation in Healthcare (DSSH). Available from www.dssh.nl. 19. Dutch Society of Endoscopic Surgery ( NVEC). Available from www.nvec.nl. 20. Dutch Society of Obstetrics and Gynaecology (NVOG). Available from www.nvog.nl. 21. IGZ: Dutch Health Care Inspectorate. Rapport onvoldoende zorgvuldigheid bij introductie van operatie robots. 2010 Available from www.igz.nl. 22. Herron DM, Marohn M. A Consensus Document on Robotic Surgery. Surg Endosc 2008;22:313-25. 23. Valvo JR, Madeb R, Gilbert R, Nicholson C, Oleyourryk G, Errapato S, Ricottone A, Roberts W, Eichel L. Policy Guidelines Suggested for Robot-Assisted Prostatectomy. J Robotic Surg 2007;1:173-6.

232 233 Summary Samenvatting 13 Summary Chapter 13

Summary Chapters 3, 4 and 5 describe the validation process of different simulators for minimally invasive surgery. Box trainers have the advantage of being relatively cheap, using standard Minimally invasive techniques in abdominal surgery, also referred to as laparoscopic laparoscopic instruments and providing good tactile feedback. However, box trainers do surgery, are rapidly becoming a standard in many surgical procedures. With a relatively not allow for integrated, objective, performance assessment, and a teacher needs to be short history, laparoscopic surgery is growing fast and this surgical technique should be present for proper assessment. In a cost-effective laparoscopic skills curriculum, box mastered, up to a certain level, by all surgeons. (Chapter 1) Several unique psychomotor trainers can be used alone or in addition to virtual reality trainers and/or animate models. skills are required from the surgeon in order to perform laparoscopic surgery safely. Through the years, many exercises that could be used in box trainers have been These skills include adaptation to the conversion from three dimensional to two developed. Unfortunately, scientific validation of these relatively inexpensive, often dimensional vision, bimanual fine motor skills, handling long instruments with an commercially available exercises, are relatively scarce. A short laparoscopic training amplified tremor, dealing with the fulcrum effect (the need for the surgeon to move his/ course, consisting of six exercises and to be used in any box trainer, was constructed for a her hand in the opposite direction in which the tip of the instrument is intended to go) newly developed set of commercially available exercises. (Chapter 3) In this training and reduced tactile feedback. This thesis describes several advances in the development course, tasktime, the time spent on a specific task, is an important parameter, However and evaluation of training for laparoscopic surgery. Recently robot assisted laparoscopic tasktime alone as a basis of evaluation has limitations. The trainee (surgeon) may cause surgery was introduced and aspects of training for this new type of surgery are addressed serious adverse events when performing too fast in laparoscopy. To overcome this in the second part of this thesis. problem a penalty score for certain mistakes was introduced. The penalty score was intended to keep the trainee more focused, and prevents trainees ‘chasing’ for efficiency Part I Laparoscopy whereas compromising precision. In this study face validity (does the simulation Minimally invasive surgery is very suitable for simulation based training. Moreover, the resemble the real task) and construct validity (the ability to differentiate between groups acquired skills on simulators have shown to be transferrable into the operating room, with different levels of competence) for this training course was established and the leading to improvement of patient safety. To learn the necessary skills different types of mean score of ‘experts’ was set as training target. The total scores appeared to be simulators are available, specifically: animal models, box/video trainers, virtual reality positively correlated with individual’s laparoscopic experience. A comprehensive and trainers and serious games. (Chapter 2) Each type of simulation model has its advantages practical overview of all validated and published exercises for box/video trainers is and disadvantages. It is essential that these simulation models are validated and provided in order to facilitate program directors in the selection of the appropriate incorporated in a competence based training curriculum. This implies that the evaluation training exercises for establishing a training curriculum. of the training is based on the progress of the trainee rather than the time spent on training. In November 2007, the Dutch Inspectorate for Healthcare published a report Virtual reality simulators provide a safe and standardized environment to train minimally entitled “Risks minimally invasive surgery underestimated”, expressing its concern invasive surgery. In addition, these types of simulators have the ability of automated regarding endoscopic surgery and patient safety in The Netherlands. Training in objective performance assessments. Virtual reality training can supplement standard minimally invasive surgery was found to be inadequately structured and implemented. A laparoscopic box training and is at least as effective. Virtual reality simulator training need for nationally standardized training programs for this type of surgery, with strict leads to an overall improvement of laparoscopic surgical skills and is not necessarily criteria, was stressed and firm recommendations were stated. In reaction, various procedure specific. Skills obtained on the virtual reality simulator are transferable to the working groups of the surgical medical specialties (gynecology, surgery and urology) actual laparoscopic operations in animals and in human patients. This will have a started developing training programs. These three front running specialties now each positive effect on operating times and patient safety. Most training programs using have their own program on paper. Unfortunately they all experience problems with the virtual reality simulators focus on basic laparoscopic skills and are suited for junior nationwide implementation of these programs. Facilities are not always properly residents. For continuous training and assessment a more complex training program equipped, teaching staff is not always willing or able to cover the curriculum, and aimed at the more experienced residents and surgeons was needed, focusing on residents are often too occupied with routine daily activities to train. In all programs, bimanual fine motor skills development and precision of instrument handling. A set of simulation based training is stated to be mandatory before the trainee can start minimally five new exercises was developed for the SIMENDO™ virtual reality simulator (Simendo invasive surgery on patients as a first operator. To implement and enforce this, a change B.V., Rotterdam) to train these more advanced laparoscopic skills. (Chapter 4) These in culture of residents and staff is required. Without additional support from the exercises provide a new challenge after the trainee has mastered the basic exercises. They department chair and institution board of the hospital, this is almost impossible. provide increasing levels of difficulty and practice variety, which will improve the retention and transfer of simulator-acquired skills. This study established face- and construct validity for the developed set of exercises for training and assessment of advanced

236 237 Summary Chapter 13 laparoscopic skills on this virtual reality simulator. The vast majority of participants consensus based list of criteria to evaluate a skills laboratory and a skills curriculum for indicated that the virtual reality simulator is a useful tool for training laparoscopic skills minimal invasive surgery was developed. (Chapter 6) Three quality domains for a skills to residents, urologists, gynecologists and surgeons. Construct validity was demonstrated laboratory were defined; ‘personnel and resources’, ‘trainee motivation’ and ‘training between subjects with varying laparoscopic experience. The expert laparoscopic surgeons curriculum’. A list of consensus based criteria, nine items per domain, was developed. performed significantly faster in exercises which required most intensive cooperation of Expert laparoscopic surgeons from all over Europe rated each item in level of importance the right and left hand. Although construct validity was established, the discriminative on a 0 to 3 scale. In the domain of personnel and resources, the presence of a box trainer, properties of the exercises varied. The new ‘intermediate curriculum’ is especially suitable a laparoscopic expert and the availability of financial resources, were considered most for training senior residents and consultants and to maintain and assess their important criteria. In the domain of trainee motivation, mandatory training supervised by laparoscopic skills. laparoscopic experts was considered the most important criterion. In the domain training curriculum, the presence of a structured skills curriculum, dedicated time for skills In addition to training basic skills, virtual reality simulators can be used to train a part of training, maintenance of skills and an annual evaluation of the progress in laparoscopic a surgical procedure or even complete procedures. The LapSim™ virtual reality simulator skills of the resident were considered the most important. The detailed consensus list (Surgical Science, Göteborg, Sweden) is a virtual reality system designed to simulate can be used when setting up a new skills laboratory, when implementing an existing skills basic and advanced laparoscopic skills or procedures in a virtual environment that closely laboratory into a training curriculum, or for verifying the quality of an existing laboratory resembles an operative field. Surgical procedures like a cholecystectomy (removal of the using the list of items as a checklist. gallbladder) or a removal of an ectopic pregnancy (pregnancy located outside the uterus, in the fallopian tube) can be performed with this virtual reality simulator. The gynecologic For laparoscopic surgery specific surgical skills are required. Once the basic skills have procedure module for this virtual reality simulator consists of three procedures: been mastered, every new procedure for minimally invasive surgery has a new learning sterilization, ectopic pregnancy and suturing of a wound after removing a myoma form curve. This learning curve is the graphical presentation of the changing rate of learning for the uterus. This study established face- and construct validity for four of the basic skill a given surgical procedure, before a surgeon reaches an acceptable plateau in operating exercises and the gynecologic module on this simulator. (Chapter 5) Reasonable face time, blood loss, complication rate and quality of surgery. Complex laparoscopic validity was demonstrated and the majority of participants believed the LapSim™ could procedures have a relatively long learning curve. This is one of the reasons for a relatively become a useful tool in training laparoscopic skills for residents and gynecologists. The slow implementation of minimal invasive techniques in complex gynecologic oncological LapSim™ was able to differentiate between subjects with varying laparoscopic experience. surgery. The laparoscopic staging procedure for early ovarian cancer is a complex Although this study confirmed the construct validity of the LapSim™ there was a procedure but proves to be feasible, accurate and safe in patients while providing the difference in the discriminative properties of the skills. Specifically, not all performance patient with the advantages of minimal invasive surgery. This study describes the learning parameters measured by the LapSim™ system were able to differentiate between curve of a single surgeon in the laparoscopic staging procedure in women with early subjects with different levels of experience. For surgical procedures one could develop a ovarian cancer and the surgical outcome of these patients. (Chapter 7) We retrospectively scoring system based on certain clinically relevant performance parameters. This would analyzed a total of 25 women with apparent early stage ovarian cancer who underwent a make training on a virtual reality simulator more in line with the real procedure in a more laparoscopic staging procedure by the same surgeon. Three time periods, based on date realistic way. The myoma suturing exercise needed to be improved and investigated but of surgery, were compared with respect to operating time, amount of lymph nodes the removal of the ectopic pregnancy was a valid and realistic simulation of this particular harvested and surgical outcome. There was no significant reduction in operation time, virtual reality trainer. estimated blood loss and hospital stay between the three periods. There was however, a significant increase in the number of pelvic and para-aortal lymph nodes harvested. The Many teaching hospitals for surgical specialties have created small or large skills variation in operating time may be due to differences in the extent of surgery performed laboratories, but specific information on how such laboratories should be properly during laparoscopic staging. Depending on what is done at initial surgery, the staging designed and used is often lacking. When setting up a skills laboratory it is essential to procedure for early ovarian cancer should be completed in the second operation (restag- define its purpose and identify resources and stakeholders early in its development. ing). This variety of the procedure influences the operating time substantially. Due to the Unfortunately, the reality is often the other way around and, as a result, many skills relatively small group in this study did not allow for correcting for these differences. The laboratories are not optimally used. Providing advanced simulators or skills laboratories fact that the operating time did not show a significant increase and the amount of lymph to residents is often not enough to encourage residents to voluntarily start training. nodes showed a significant increase probably reflects a relative shortening of the operat- Optimally, the training should be incorporated in a mandatory, competence based ing time. A systematic overview of the available literature regarding the laparoscopic training curriculum and supervised by a laparoscopic expert. In this study an international staging procedure in women with early ovarian cancer between 1980 and January 2010 was provided. The relevant studies found were compared to our series on the basis of the 238 above parameters. 239 Summary Chapter 13

Part II Robotic surgery review of the first robot assisted laparoscopic radical hysterectomies and the last open The use of robots in our society is rapidly increasing and during the last decade medical radical hysterectomies in a similar clinical setting with the same surgical team was robots have found their way into the field of laparoscopic surgery. Robot assisted conducted. (Chapter 9) The radical hysterectomy with pelvic lymph node dissection for laparoscopic surgery is undergoing an exponential growth, which started in the field of the treatment of patients with cervical cancer is a complex procedure. This procedure has urology. For example, the robot assisted laparoscopic radical prostatectomy for cancer of a long learning curve for conventional laparoscopy, and is therefore mainly performed by the bladder has become the standard procedure in most centers in the United States and laparotomy (open surgery). With the introduction and the advantages of robot assisted a significant growth in Europe and Asia is anticipated. Nowadays robotic assisted surgery surgery it is possible to perform this procedure by laparoscopy on a larger scale, giving is performed in almost every surgical specialty. Within the field of gynecology robot the patients the advantages of minimally invasive surgery. In this study we analyzed assisted laparoscopic surgery is performed within most subspecialties; general patient related aspects (blood loss, complication rate, radicality of surgery (lymph node gynecology, reproductive surgery, urogynecoloy and oncology. (Chapter 8) The da Vinci® count) and hospital stay) and surgeon related aspects (operating time) of the learning surgical system (Intuitive Surgical, Mountain View, CA) is the only telerobotic system curve were analyzed. Blood loss and hospital stay were significantly reduced in the robot currently commercially available for laparoscopic surgery. This system consists of three group. There was no significant difference in complication rate or radicality of surgery major components: the surgical console, the Insite Vision System® and the patient side (reflected in total lymph node count). A learning curve of 14 cases reduced the team’s cart with the robotic arms. The surgical console can be placed anywhere in, or even total theatre time by 48 percent. The median theatre time in the learning period for the outside the operating room. While operating, the surgeon is viewing a stereoscopic robot procedure was reduced from nine hours to less that four hours and compared well image projected in the console and controls the robotic arms with hand manipulators to the three hours and 45 min for an open procedure. Our data suggest the feasibility and and food pedals. The position provides an optimal hand-eye alignment. The surgeon has a relatively short learning curve for this robot assisted laparoscopic procedure with quick limited haptic (force) feedback, so one should rely on visual feedback. In the Insite Vision improvement of patient and surgeon related parameters. System® a three-dimensional high definition view is created and the viewer gives a six to ten times magnification of the operating field. Because of the three-dimensional view the With the increase in robot assisted procedures there is a concomitant rising demand for visual feedback is excellent, and allows the surgeon to work very precisely. The first da training methods for the da Vinci® surgical system. Current robotic training programs Vinci® system had three robotic arms. The more recent series all have four robotic arms. usually involve dry labs with inanimate training, observation, bedside assisting, animal Attached to the robotic arms are the EndoWrist® instruments. These instruments are one and live surgery training. The main disadvantages of dry lab training are the lack of of the key components of the system. The wrist has a total of seven degrees of freedom, objective assessment, and substantial costs associated with an extra robotic system in a similar to the human hand. The surgeon’s hand (fingertip) movements are translated by skills laboratory. To overcome these limitations, virtual reality simulation could be applied the computer to the same movements of the instruments. Very precise movements of to train in this new surgical technique before applying robotic surgery on patients. In the robotic instruments are possible because the computer filters out normal 2010 a virtual reality simulator for robotic surgery, the dV-Trainer™ (Mimic, Technologies, physiological hand tremor, avoids the reverse-fulcrum effect which occurs in traditional Seattle, WA, USA), was introduced. To establish face- and construct validity of the dV- laparoscopy and has the opportunity for motion scaling. In this way several disadvantages Trainer™ for the use i n training robot assisted surgery with the da Vinci® surgical system of conventional laparoscopy are eliminated, which results generally in a shorter learning a comparative cohort study was performed. (Chapter 10) Forty-two participants curve for robot assisted laparoscopy than for conventional laparoscopy. The main performed three exercises twice on the virtual reality simulator and filled in a disadvantage of robotic assisted laparoscopic surgery are the high costs. The costs are questionnaire. Based on their robotic experience, participants were categorized into three mainly reflected in the purchase and maintenance of the robotic system, together with groups: novice, intermediate and experts. The realism of the simulator in general, visual the costs of the learning curve. The costs of the initial learning curve for the surgeon can graphics, movements of instruments, interaction with objects and the depth perception vary widely, depending on the surgeon, the operating team and the case volume. To were rated as being realistic (face validity). The training capacity of the simulator was overcome these high costs the concept of high volume centres is of great importance. In rated ‘(very) good’ for residents and gynecologist starting with robotic surgery, but the such centres the learning curve can be rapidly traversed and costs minimized. When simulator was found less useful for training experts. The simulator was able to leaving out the initial capital investment for the robotic system and extra costs during the differentiate between novices and experts on a number of parameters in each exercise learning curve there is not much difference compared with conventional laparoscopy or (construct validity). ‘Time to complete the exercise’ and ‘economy of motion’ were the open surgery regarding the costs. two most discriminating parameters. For most parameters there was a significant difference between novices and experts. Based on this study the dV-Trainer™ is When implementing a new surgical technique in a medical practice it is important to considered to be a useful training tool for junior- and senior residents, as well as fellow’s compare the new technique with the old (currently used) technique. A retrospective or medical specialists starting with robotic surgery.

240 241 Summary Chapter 13

Robot assisted laparoscopic surgery is one of the main future directions of minimally invasive laparoscopic surgery. Guidelines for training and credentialing were described in an international consensus statement in 2007. However until today there are no official guidelines for training and competence. Several suggestions for training and learning robot assisted laparoscopic surgery are described in the literature. However, with the rapid growth of robotic surgery a more structured approach to training and learning robotic surgery is desirable. A systematic review evaluating all aspects of training and learning of robot assisted laparoscopic surgery on the da Vinci® surgical system was performed. (Chapter 11) The literature regarding different training modalities, including didactic training, skills training (dry lab, virtual reality, and animal or cadaver models), case observation, bedside assisting, proctoring and the mentoring console was reviewed. Literature regarding training programs for robot assisted surgery in general and programs designed for residents, fellows and surgeons were all included. A comprehensive overview of all training modalities, training programs and recommendations for training of robotic surgery was provided. Robot surgical training consists of two equally important parts: system training and procedural training. System training should be formally organized and should be competence based, rather than time based. Virtual reality simulation will soon play an import role in training robotic surgery. For procedural training a stepwise approach with an objective assessment of each step of the surgical procedure is recommended. The use of structured training programs seems to make it possible to train future robotic surgeons without affecting patient outcomes. Training should be organized preferably in high volume centers through the implementation of a systematic and structured competence based training program. This review of training and learning robotic assisted laparoscopic surgery can guide program directors and surgeons who want to start robotic surgery. In addition, it can be used for the development of structured training programs or to adjust existing training programs. A growing number of studies show that the next generation of surgeons should be trained in this new technique. Residents, fellows and colleague surgeons need to master the robot.

Learning and training minimally invasive surgery sounds easy, but in reality the development and implementation of a competence based training program is a difficult road to travel. Many factors influence the success of a training program. In the discussion and conclusions section (Chapter 12) the conclusions of this thesis are placed in a broader perspective and suggestions and recommendations for a successful training program are made. Suggestions for future developments and further research are provided.

242 243 Samenvatting Chapter 13

Samenvatting faciliteiten zijn echter niet overal niet adequaat uitgerust, specialisten zijn niet altijd in staat om het trainingsprogramma te onderwijzen en de assistenten komen er veelal niet Laparoscopische chirurgie, de ‘kijkoperatie’ in de buik, wordt in snel tempo de standaard aan toe om voldoende te trainen. Tevens wordt niet in alle ziekenhuizen een dergelijk voor veel chirurgische ingrepen. Deze snel groeiende vorm van minimaal invasieve programma omarmd, omdat er bijvoorbeeld al locale initiatieven lopen of omdat er soms chirurgie heeft een relatief korte geschiedenis. Elke chirurg moet deze vorm van chirurgie weerstand bestaat tegen de inhoud van een ‘van buitenaf bedacht’ programma. Om de tot op een zeker niveau beheersen. (Hoofdstuk 1) Om een laparoscopische operatie goed afspraken over training te implementeren is een cultuuromslag van de specialisten in open veilig uit te voeren moet de chirurg, afhankelijk van de gebruikte techniek, over leiding en medisch specialisten noodzakelijk. Zonder extra hulp van de afdelingsleiding specifieke vaardigheden beschikken. Een aantal unieke psychomotorische vaardigheden en het ziekenhuisbestuur is dit haast onmogelijk. is vereist, zoals het kunnen omschakelen van een driedimensionale werkomgeving naar het opereren vanaf een monitor (tweedimensionaal beeld), het beschikken over een fijne Hoofdstuk 3, 4 en 5 beschrijven het validatieproces van verschillende simulatoren voor motoriek en coördinatie van beide handen, het kunnen gebruiken van lange instrumenten laparoscopische chirurgie. Boxtrainers hebben als voordeel dat ze relatief goedkoop zijn. waardoor een versterkte tremor ontstaat, het omgaan met het ‘fulcrum effect’ (door het Ze geven goede tactiele feedback en maken gebruik van standaard laparoscopische werken om een draaipunt -de buikwand- maken de punten van de instrumenten in de instrumenten. Echter tot op heden hebben boxtrainers geen geïntegreerde en objectieve buik een tegengestelde beweging ten opzichte van de handen buiten de buik) en het evaluatiemogelijkheden, waardoor de docent aanwezig moet zijn voor een goede omgaan met het verminderde gevoel bij het werken met lange instrumenten. Het eerste beoordeling. Dit maakt de controle op training arbeidsintensief. In een effectief deel van dit proefschrift beschrijft een aantal nieuwe ontwikkelingen om vaardigheden trainingscurriculum kunnen boxtrainers alleen worden gebruikt. Daarnaast kunnen zij voor conventionele laparoscopie op een valide en gestructureerde wijze aan te leren en te samen met virtual reality simulatoren en/of diermodellen worden ingezet. De laatste evalueren. In het tweede deel van dit proefschrift worden aspecten van het leren van decennia zijn verschillende oefeningen voor boxtrainers ontwikkeld. Helaas is de robotgeassisteerde laparoscopische chirurgie besproken. wetenschappelijke validatie van deze relatief goedkope oefeningen beperkt. Een laparoscopie training, bestaande uit zes oefeningen voor een nieuwe commercieel Deel 1 Laparoscopie verkrijgbare set van laparoscopieoefeningen werd ontwikkeld. Deze oefeningen kunnen Op simulatie gebaseerde training is zeer geschikt voor het leren van de specifieke in elke box/video trainer worden geplaatst. (Hoofdstuk 3) In de ontwikkelde laparoscopie vaardigheden, noodzakelijk om minimaal invasieve chirurgie verantwoord te kunnen training is taaktijd een belangrijke parameter. Echter taaktijd als parameter alleen heeft verrichten. Het is aangetoond dat de op een simulator verworven vaardigheden zijn beperkingen. ‘Te snel’ werken bij laparoscopie kan leiden tot fouten en mogelijk tot overdraagbaar zijn naar de operatiekamer en op deze manier kunnen leiden tot een complicaties. Men kan immers snel foutieve handelingen verrichten. Om dit te verbetering van de kwaliteit van de operatie en de patiëntveiligheid. Om de noodzakelijke voorkomen is bij elke oefening ook een strafscore geïntroduceerd. Hierdoor blijft de vaardigheden te leren zijn verschillende simulatiemodellen beschikbaar: box/video leerling gefocust, wordt precisie beloond en ‘te snel’ werken bestraft. In deze studie werd trainers, virtual reality trainers, diermodellen en serious games. (Hoofdstuk 2) Elk de facevaliditeit (lijkt de simulatie op de werkelijkheid) en de constructvaliditeit (het simulatiemodel heeft zijn eigen voor- en nadelen. Het is essentieel dat simulatiemodel- vermogen van de simulatie om onderscheid te maken tussen beginners en experts) van len worden gevalideerd en worden opgenomen in een op competenties gericht deze training bepaald. Er was een duidelijke correlatie tussen de totaalscore en de curriculum. Dit betekent dat het eindpunt van de training is gebaseerd op de vooruitgang laparoscopie-ervaring van de deelnemers. Op basis van de resultaten werd de gemiddelde van de leerling in plaats van op de hoeveelheid tijd besteed aan training. In 2007 heeft de score van experts in laparoscopie als einddoel voor deze training vastgesteld. Dit Inspectie voor de Gezondheidszorg (IGZ) haar bezorgdheid geuit over de patiëntveilig- hoofdstuk bevat tevens een literatuuroverzicht van gevalideerde oefeningen voor heid bij laparoscopieën (rapport “Risico’s minimaal invasieve chirurgie onderschat”). boxtrainers. Het overzicht kan een hulpmiddel zijn bij het samenstellen van een De training voor minimaal invasieve chirurgie bleek onvoldoende gestructureerd en trainingscurriculum voor laparoscopie. geïmplementeerd te zijn. De behoefte aan landelijke gestandaardiseerde trainingseisen met uniforme criteria werd door de IGZ onderstreept en duidelijke aanbevelingen werden Virtual reality simulatoren voorzien in een veilige en gestandaardiseerde omgeving voor gedaan. Als reactie hierop startten werkgroepen van de specialismen gynaecologie, laparoscopietraining. Deze simulatoren beschikken over geautomatiseerde objectieve chirurgie en urologie met het ontwikkelen van nieuwe trainingsprogramma’s. Deze drie evaluatie. Het is aangetoond dat virtual reality training leidt tot een toename van de specialismen ontwikkelden elk een eigen trainingsprogramma, maar ondervinden allen algemene laparoscopische vaardigheden en dat de verworven vaardigheden problemen bij de landelijke implementatie hiervan. In alle trainingprogramma’s is op overdraagbaar zijn naar echte laparoscopische operaties. Dit heeft een positieve invloed simulatie gebaseerde training verplicht voordat de specialist in opleiding als eerste op de patiëntveiligheid en op de duur van de operatie. Virtual reality training kan samen operateur kan beginnen met het uitvoeren van laparoscopieën bij patiënten. Trainings met boxtraining worden gebruikt en is op zijn minst even effectief. De meeste virtual

244 245 Samenvatting Chapter 13 reality trainingprogramma’s richten zich op dit moment nog op het verwerven van basale samen met de toekomstige gebruikers vast te stellen. Helaas gebeurt dit nog wel eens vaardigheden en zijn daardoor meer geschikt voor beginnende specialisten in opleiding. andersom, met als gevolg dat de ruimte niet optimaal gebruikt wordt. Het beschikbaar Voor de continuïteit van training en evaluatie zijn meer complexe trainingprogramma’s stellen van dure simulatoren en ruimten voor training leidt er namelijk niet altijd toe dat noodzakelijk. Deze moeten zich onder andere focussen op de bimanuele fijne motoriek de doelgroep vrijwillig en zelfstandig gaat trainen. In het optimale scenario is de training en de precisie van de instrumentmanipulatie. dan ook in gealloceerde werktijd geïncorporeerd in een verplicht- en op competentie Een trainingsprogramma van vijf nieuwe oefeningen voor het trainen van geavanceerde gericht trainingscurriculum, dat wordt gesuperviseerd door een laparoscopie-expert. vaardigheden werd ontwikkeld voor de SIMENDO™ virtual reality simulator (SIMENDO Een op consensus gebaseerde lijst met criteria voor de evaluatie van skills laboratoria en B.V., Rotterdam). (Hoofdstuk 4) De oefeningen voorzien in een trainingscontinuüm trainingscurricula werd samengesteld. (Hoofdstuk 6) Drie kwaliteitsdomeinen voor skills nadat de specialist in opleiding het beginnerscurriculum heeft doorlopen. De nieuwe laboratoria werden gedefinieerd: ‘personeel en middelen’, ‘trainingsmotivatie’ en oefeningen hebben een oplopende moeilijkheidsgraad en voorzien in trainingsvariabiliteit, ‘trainingscurriculum’. Een internationaal panel van laparoscopie-experts beoordeelde elk waardoor de overdracht en retentie van de geleerde vaardigheden toeneemt. In dit item, negen per domein, op relevantie. Dit werd gedaan op een 0 tot 3 schaal. Binnen het onderzoek werd de face- en constructvaliditeit voor de ontwikkelde oefeningen op deze kwaliteitsdomein ‘personeel en middelen’ werden de aanwezigheid van een boxtrainer, simulator bepaald. Bijna alle deelnemers gaven aan dat de virtual reality simulator een een laparoscopie-expert bij de training en de beschikbaarheid van financiële middelen als geschikt middel is voor het trainen van laparoscopische vaardigheden van specialisten in meest belangrijk beoordeeld. Binnen het domein ‘trainingsmotivatie’ was het verplicht opleiding en specialisten. stellen van de training gesuperviseerd door een laparoscopie-expert het belangrijkste criterium. Binnen het domein ‘trainingscurriculum’ werd de aanwezigheid van een Naast het trainen van basale vaardigheden kunnen virtual reality simulatoren gebruikt gestructureerd curriculum met gealloceerde tijd voor training samen met het worden voor het trainen van delen van een operatie of zelfs van complete operaties. De onderhouden van de vaardigheden en een jaarlijkse beoordeling van de voortgang als LapSim™ virtual reality simulator (Surgical Science AB, Göteborg, Zweden) is een meest belangrijk gezien. De gedetailleerde consensuslijst kan worden gebruikt bij het simulator, ontwikkeld voor het trainen van zowel basale als geavanceerde vaardigheden. opzetten van een nieuw skills laboratorium of voor het implementeren van een bestaand Daarnaast kunnen complete procedures worden uitgevoerd. Operaties zoals het skills laboratorium in een nieuw trainingscurriculum. De lijst kan tevens worden gebruikt verwijderen van de galblaas, de blindedarm en het verwijderen van een voor een kwaliteitscontrole van bestaande skills laboratoria voor minimaal invasieve buitenbaarmoederlijke zwangerschap kunnen worden verricht. De gynaecologiemodule chirurgie. simuleert een aantal operaties: de sterilisatie, het verwijderen van een buitenbaarmoederlijke zwangerschap en het hechten van de baarmoeder na het Voor laparoscopische chirurgie zijn speciale chirurgische vaardigheden vereist. Wanneer verwijderen van een vleesboom. In dit onderzoek werd de face- en constructvaliditeit de basale vaardigheden voor laparoscopische zijn verworven, heeft elke laparoscopische voor vier basale oefeningen en de gynaecologiemodule bepaald. (Hoofdstuk 5) Er werd operatie een nieuwe leercurve. De lengte van de leercurve wordt in het algemeen bepaald een redelijke facevaliditeit aangetoond en het merendeel van de deelnemers is van door het aantal procedures dat moet worden verricht voordat de chirurg een acceptabel mening dat deze simulator nuttig is voor het trainen van specialisten in opleiding en plateau bereikt voor parameters zoals operatietijd, bloedverlies, complicaties en kwaliteit gynaecologen. De simulator was in staat te differentiëren tussen deelnemers met van de operatie. Complexe laparoscopische operaties hebben een relatief lange leercurve verschillende laparoscopische ervaring. Hoewel constructvaliditeit kon worden - of misschien beter gezegd ‘ervaringscurve’ - men opereert immers daadwerkelijk. Dit is aangetoond, is er wel een verschil in de onderscheidende eigenschappen van de mogelijk een van de redenen voor de relatief langzame implementatie van complexe verschillende oefeningen. Niet alle parameters die gemeten worden door de simulator laparoscopische operaties binnen de gynaecologische oncologie. De laparoscopische laten een verschil zien tussen de deelnemers. Voor de procedurele oefeningen is een stadiëringsoperatie bij vrouwen met een vermeend laag stadium van eierstokkanker is scoringssysteem gebaseerd op klinische relevantie nodig. Dit zou het trainen op een een voorbeeld van een complexe laparoscopische operatie. virtual reality simulator nog meer in lijn met de werkelijkheid brengen. Het verwijderen In dit onderzoek wordt de leercurve van een gynaecoloog voor deze operatie met van de buitenbaarmoederlijke zwangerschap is een valide en realistische oefening, maar betrekking tot de chirurgische uitkomst beschreven. (Hoofdstuk 7) Retrospectief werden de hechtoefening van de baarmoeder moet worden verbeterd. de resultaten van de behandelingen van 25 vrouwen met een vermeend vroeg stadium van eierstokkanker geanalyseerd. Alle vrouwen ondergingen een laparoscopische De meeste opleidingsklinieken hebben kleine of grote ruimten voor het trainen van stadiëringsoperatie door dezelfde gynaecoloog. De operaties werden ingedeeld in drie laparoscopische vaardigheden opgezet (skills laboratoria). De kennis van de inrichting en groepen en wel op basis van het jaar waarin de operatie werd verricht. Er werd gekeken het gebruik van deze ruimten is echter niet altijd toereikend. Bij het opzetten van een naar de operatietijd, het aantal verwijderde lymfeklieren en de chirurgische uitkomst. Uit skills laboratorium is het belangrijk vooraf het doel te bepalen en de financiële middelen het onderzoek bleek geen significante reductie van de operatietijd, het bloedverlies of de

246 247 Samenvatting Chapter 13 duur van de ziekenhuisopname. Er was wel een significante toename in het aantal biedt tot ‘motion scaling’ (hierbij wordt bijvoorbeeld 10 cm beweging van de chirurg om lymfeklieren dat werd verwijderd. De variatie in operatietijd kan worden verklaard door de gezet in 1 cm beweging van het robotinstrument). Op deze manier worden verschillende wisselende omvang van deze laparoscopische ingreep. De uitgebreidheid is namelijk nadelen van conventionele laparoscopie opgeheven, wat over het algemeen leidt tot een afhankelijk van wat er tijdens een eerdere operatie is gedaan, omdat de laparoscopische korte leercurve. Het belangrijkste nadeel van robot geassisteerde chirurgie zijn de hoge operatie dient ter completering van de stadiëring, waarvan dus al onderdelen uitgevoerd kosten. De aanschaf, het onderhoud en de leercurve van de operateurs zijn kunnen zijn. Door het relatief kleine aantal patiënten was het niet mogelijk om voor deze verantwoordelijk voor deze hoge kosten. De kosten voor de leercurve zijn weer afhankelijk verschillen te corrigeren. Het feit dat er geen significante toename is van de operatietijd, van de chirurg, het operatieteam en het operatievolume. Om de kosten van de leercurve maar wel een significante toename van het aantal verwijderde lymfeklieren duidt mogelijk zo laag mogelijk te houden is hoogvolume chirurgie van belang. Bij hoogvolume chirurgie op een relatieve afname van de operatietijd als onderdeel van de leercurve. De resultaten kan de leercurve snel worden doorlopen, waardoor de kosten hiervoor tot een minimum uit deze studie werden vergeleken met een systematisch overzicht van de literatuur over worden beperkt. Wanneer men aanschaf, onderhoud en leercurve-kosten niet in dit onderwerp. ogenschouw neemt, is er niet veel verschil in prijs per operatie vergeleken met ‘open’ chirurgie en conventionele laparoscopische chirurgie. Deel II Robot geassisteerde chirurgie Het laatste decennium hebben operatierobots hun intrede gedaan binnen de Bij de implementatie van een nieuwe chirurgische techniek is het belangrijk deze eerst te laparoscopische chirurgie. Robot geassisteerde laparoscopische chirurgie maakt vergelijken met de oude (standaard) techniek. Retrospectief werden de eerste robot momenteel een exponentiële groei door. Zo is bijvoorbeeld in de Verenigde Staten het geassisteerde laparoscopische radicale baarmoederverwijderingen vergeleken met de verwijderen van de prostaat met behulp van een operatierobot bij mannen met laatste open procedures (via een grote snede in de buik). (Hoofdstuk 9) Deze complexe prostaatkanker de standaard behandeling geworden. Naar verwachting zal deze groei radicale operatie (inclusief het verwijderen van de lymfeklieren in het bekken) wordt zich ook in Europa en Azië voortzetten. Tegenwoordig maakt vrijwel elk snijdend toegepast bij vrouwen met baarmoederhalskanker. Omdat de leercurve voor deze ingreep specialisme gebruik van robot geassisteerde chirurgie. met behulp van conventionele laparoscopische chirurgie erg lang is, wordt deze ingreep Binnen de gynaecologie wordt robot geassisteerde chirurgie toegepast binnen de meeste meestal nog via een snede in de buik verricht. Door de introductie van de robot subspecialisaties zoals: algemene gynaecologie, voortplantingsgeneeskunde, geassisteerde laparoscopische chirurgie is het mogelijk geworden deze ingreep bij een urogynaecologie en oncologie. (Hoofdstuk 8) De da Vinci® operatierobot (Intuitive toenemend aantal vrouwen laparoscopisch uit te voeren. De ingrepen in dit onderzoek Surgical, Mountain View, CA, USA) is momenteel het enige commercieel verkrijgbare werden verricht door hetzelfde chirurgische team. Verschillende variabelen, zoals de telerobotische systeem voor laparoscopische chirurgie. Dit systeem bestaat uit drie operatietijd, het bloedverlies, de complicaties, het aantal verwijderde lymfeklieren en de hoofdcomponenten: de operatieconsole, het InSite Vision® systeem en het statief met de duur ziekenhuisopname werden met elkaar vergeleken. Er was significant minder robotarmen. De operatieconsole voor de chirurg kan overal in de operatiekamer of zelfs bloedverlies en de ziekenhuisopname was significant korter in de robotgroep. Er was daarbuiten worden geplaatst. Tijdens het opereren kijkt de chirurg naar een geen significant verschil tussen beide groepen in het aantal complicaties en het aantal stereoscopisch beeld dat wordt geprojecteerd in de console en bedient hij de robotarmen verwijderde lymfeklieren. Na 14 robot geassisteerde operaties was de operatieduur met handmanipulatoren en voetpedalen. Op deze manier wordt de oog-hand-werk-as afgenomen van negen naar minder dan vier uur (48%), wat vrijwel vergelijkbaar is met de hersteld, dit in tegenstelling tot conventionele laparoscopie waarbij deze as onderbroken duur van de ‘open’ operatie door hetzelfde team. Deze studie laat zien dat deze operatie is. Bij het werken met de operatierobot is er geen tactiele feedback, hetgeen echter voor goed mogelijk is en qua operatieduur een relatief korte leercurve heeft. Er is een snelle een belangrijk deel wordt overgenomen of gecompenseerd door visuele feedback. Het verbetering van patiënt en chirurg gerelateerde parameters. InSite Vision® systeem zorgt voor een driedimensionaal high definition beeld, met een zes tot tien keer vergroting van het operatieterrein. Hierdoor is de visuele feedback Met de toename van het aantal robot geassisteerde procedures is er een stijgende vraag uitstekend en kan de chirurg zeer precies werken, en zelfs het gevoel hebben te ‘voelen’. naar trainingsmethoden voor de da Vinci® operatierobot ontstaan. Momenteel bestaan De eerste robotsystemen hadden drie robotarmen, maar de huidige systemen beschikken trainingsprogramma’s voor robot geassisteerde chirurgie veelal uit een combinatie van over vier robotarmen. Aan de robotarmen bevinden zich de Endowrist® instrumenten. ‘droog oefenen’, observatie bij operaties, operatieassistentie en oefenen op dier- of Deze instrumenten vormen een wezenlijk onderdeel van het systeem. Elke tip heeft zeven kadavermodellen. ‘Droog oefenen’ heeft als nadeel dat er doorgaans geen objectieve bewegingsvrijheden, vergelijkbaar met een menselijk polsgewricht. De bewegingen van evaluatie plaatsvindt. Daarnaast zijn er extra kosten aan verbonden omdat het de vingertoppen van de chirurg worden direct doorgegeven aan de robotinstrumenten. robotsysteem op dat moment niet gebruikt kan worden voor patiëntenzorg of omdat er Het is mogelijk om zeer nauwkeurig te werken doordat de computer de fysiologische een extra robotsysteem moet worden aangeschaft voor plaatsing in de oefenruimte. Om tremor van de menselijke hand opheft, het ‘fulcrum effect’ opheft en de mogelijkheid deze kosten te voorkomen zou virtual reality training een oplossing kunnen bieden. In

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2010 werd de dV-Trainer™ (Mimic Technologies, Seattle, WA, USA) geïntroduceerd. Dit is aanpak te volgen met objectieve evaluatie van elke stap van de operatie. Door het een losstaande virtual reality simulator die gebruik maakt van dezelfde kinematiek als de invoeren van gestructureerde trainingsprogramma’s is het mogelijk toekomstige da Vinci® operatierobot. Daarnaast is de software beschikbaar voor projectie in de robotchirurgen te trainen zonder dat dit ten koste gaat van de patiëntveiligheid en de robotconsole. kwaliteit van de operatie. Training in deze vorm van chirurgie dient bij voorkeur gegeven In dit onderzoek wordt de face- en constructvaliditeit van deze nieuwe virtual reality te worden in hoogvolume centra. simulator geëvalueerd. (Hoofdstuk 10) Drie oefeningen werden elk twee keer door 42 deelnemers gedaan, achteraf werd een vragenlijst door de deelnemers ingevuld. De Het lijkt eenvoudig om training voor minimaal invasieve chirurgie te organiseren, maar deelnemers werden, op basis van hun ervaring met robot geassisteerde chirurgie, in de werkelijkheid is de ontwikkeling en implementatie van een breed gedragen en ingedeeld in drie groepen. Het realisme van de simulator in het algemeen, de visuele competentie gericht trainingscurriculum een lange weg. Vele factoren beïnvloeden het beelden, de bewegingen van de instrumenten, de interactie met de objecten en de succes van een trainingsprogramma. In de discussie van dit proefschrift (Hoofdstuk 12) diepteperceptie werden als realistisch beoordeeld (facevaliditeit). De deelnemers worden de conclusies van de afzonderlijke studies in een breder perspectief geplaatst en beoordeelden de trainingscapaciteit van de simulator als ‘zeer goed’ voor specialisten in worden suggesties en aanbevelingen voor een succesvol trainingsprogramma gedaan. opleiding en specialisten die beginnen met robot geassisteerde chirurgie. De Tot slot worden de toekomstige ontwikkelingen belicht en suggesties voor toekomstig trainingscapaciteit werd minder geschikt geacht voor het trainen van experts. De onderzoek gegeven. simulator was voor meerdere parameters per oefening in staat om te differentiëren tussen beginners en experts (constructvaliditeit). ‘Tijd om de oefening te voltooien’ en ‘efficiëntie van bewegingen’ waren de meest onderscheidende parameters. Voor het merendeel van de parameters werd een significant verschil tussen beginners en experts gevonden. Gebaseerd op deze resultaten kan de dV-Trainer™ als een nuttig hulpmiddel voor het trainen van robot geassisteerde chirurgie worden beschouwd.

Voor de toekomst van de minimaal invasieve chirurgie is de robot geassisteerde laparoscopische chirurgie een belangrijk onderdeel. Reeds in 2007 werden internationale, op consensus gebaseerde, aanbevelingen voor training en accreditatie van robot geassisteerde chirurgie gedaan. Tot op heden zijn er echter geen officiële richtlijnen voor training en competentie. In de literatuur zijn diverse mogelijkheden om deze vorm van chirurgie te oefenen en te leren gepubliceerd. Gezien de snelle groei van de robot geassisteerde chirurgie is een gestructureerd overzicht van deze trainingsmethoden gewenst. Een systematisch literatuuronderzoek naar alle aspecten van het trainen en leren van robot geassisteerde laparoscopische chirurgie met behulp van de da Vinci® operatierobot werd verricht. (Hoofdstuk 11) De literatuur over de verschillende trainingsmodaliteiten, inclusief didactische training, vaardigheidstraining (‘droog oefenen’, virtual reality training en dier- of kadavermodellen), operatieobservatie, operatieassistentie, proctoring en de robot mentorconsole werd geëvalueerd. Tevens werd de literatuur over trainingprogramma’s voor specialisten in opleiding en medisch specialisten geëvalueerd. Dit alles resulteerde in een systematisch overzicht van trainingsmethoden, trainingsprogramma’s en aanbevelingen. Training voor robot geassisteerde laparoscopische chirurgie bestaat uit twee gelijke delen: robotsysteemtraining en operatietraining. Robotsysteemtraining zou formeel georganiseerd moeten worden en de training zou, in plaats van tijd gerelateerd, competentiegericht moeten zijn. Het is aannemelijk dat virtual reality training snel een belangrijke rol zal spelen bij de training van robot geassisteerde chirurgie. Voor operatietraining is het raadzaam een stapsgewijze

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Acknowledgements - Dankwoord List of publications 14 Curriculum Vitae Grants Chapter 14

Manual skills training Appendices Manual skills training Chapter 14

Manual validated laparoscopic skills training exercises Exercise 1: ‘Post and Sleeve’

Introduction The training course consists of six different exercises (3-Dmed®): Goal: 1. Post and Sleeve Moving the colored sleeves 2. Loops and Wire from side to side 3. Pea on a Peg 4. Wire Chaser (one hand) 5. Wire Chaser (two hands) 6. Zig-Zag Loop

The goal of the different exercises is to train hand-eye coordination, manual dexterity, depth perception and interaction of the dominant and non-dominant hand. Material: The overall score is based on time and precision which is calculated by adding the - Six colored sleeves completion time to a penalty score. A lower score correlates with better performance. - Pegboard with 12 pegs

The trainee should train to the expert level. Starting position: - The board is placed in the box trainer with the peg rows in a vertical position The exercises can be done in any laparoscopic box- or video trainer. The exercises were (from left to right: 4 - 2 - 2 - 4) validated in a 42 x 32 x 24 cm box trainer with a fixed camera (Covidien® Surgical Box). - The six sleeves are positioned over the 6 pegs on the right side of the board. Two reusable laparoscopic graspers (Karl Storz®) were used to perform the exercises. A digital cooking timer was used to measure the time. The exercises are available on Procedure: www.3-Dmed.com - Start the time when the participant takes the first sleeve with the left hand - Pass the sleeve to the right hand when it is taken from the peg The validation of the exercises is described in chapter 3 of this thesis. - Place the sleeve on the other side of the pegboard over the mirrored peg Next you find a description of the six different exercises separately. - After the six sleeves have been moved successfully to the other side, the exercise is repeated in opposite direction, starting with the right hand.

Finishing position: - The task is finished when all sleeves are again in the starting position

Penalty: - Per dropped sleeve 10 penalty points are counted. When a sleeve falls from the pegboard it will not be used anymore and 20 penalty points are counted

Score: - Time in seconds + penalty points

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Exercise 2: ‘Loops and wire’ Exercise 3: ‘Pea on a peg’

Goal: Goal: Placing the pipe cleaners in Put the beads on the 14 pegs a straight line through the loops

Material: Material: - Two pipe cleaners - Pegboard with 14 pegs (different heights) and a cup with 25 wooden beads. - Pegboard with four rows of loops. Starting position: Starting position: - The board is positioned with the cup containing the beads in front. - The board is positioned with four loops in front, the pipes are lying in front. Procedure: - Start time when the first bead is taken Procedure: - Take 14 wooden beads one by one out of the cup and place them on pegs of - Start time when the first pipe cleaner is taken. Introduce the first pipe cleaner different height. from the right; the next pipe cleaner from the left. - The left side of the pegboard has to be done with the left hand, the right side - Pass two pipe cleaners through the first two rows of four loops, changing hands with the right hand. as it progresses. Finishing position: Finishing position: - The task is finished when 14 beads are succesfully placed on all pegs. - The task is finished when both pipe cleaners are successfully placed through the two rows of loops. Penalty: - Ten penalty points are counted when a bead is dropped; twenty penalty points Penalty: are counted when a bead falls from the pegboard. - If the pipe cleaner is passed besides a loop during the procedure, 10 penalty - When a bead is dropped besides the pegboard, it can not be used anymore points are counted. - When a bead falls on the pegboard it has to be picked up again to be successfully placed on a peg Score: - Time in seconds + penalty points Score: - Time in seconds + penalty points

This exercise has a maximum time of 10 minutes

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Exercise 4: ‘Wire Chaser’ one hand Exercise 5: ‘Wire Chaser’ two hands

Goal: Goal: Moving the three rings from Moving the three rings from one side to the other side one side to the other side

Material: Material: - Wireboard (one hand) - Wireboard (two hands) - Three rings with decreasing diameter (increasing difficulty) - Three rings with decreasing diameter (increasing difficulty)

Starting position: Starting position: - The board is positioned with the text “one hand” in front. - The board is positioned with the text “two hands” in front. - The rings are at the side of the dominant hand - The rings are placed at the right side of the board

Procedure: Procedure: - Start time when the first ring is taken - Start time when the first ring is taken - Bring the three rings, with decreasing diameter, one by one to the other side of - Bring the three rings, with decreasing diameter, one by one to the other side of the wire using the dominant hand the wire using the left and right hand alternately. - Both hands are used and hands need to change after each curve in the ring. Finishing position: - The task is finished when the three rings are moved to the other side of the Finishing position: board - The task is finished when the three rings are moved to the other side of the board Penalty: - If a ring is lost by the instrument, 10 penalty points are counted Penalty: - If a ring is lost by the instrument, 10 penalty points are counted Score: - Time in seconds + penalty points Score: Time in seconds + penalty points

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Exercise 6: ‘Zig-Zag loop’ Construct Validity (Total Time + Penalty points) Exercises Group 1 Group 2 Group 3 Novices (n=18 ) Intermediates (n=14) Experts (n=10) Goal: Passing the rope in a zigzag Mean score (range) Mean score (range) Mean score (range) pattern through the loops Post and sleeve 299 (159-602) 161 (91-307) 120 (78-232)

Loops and wire 176 (111-298) 108 (59-176) 86 (61-121)

Pea on a peg 771 (345-1450) 404 (186-768) 313 (203-552)

Wire chaser 195 (60-417) 113 (31-306) 69 (23-182) (one hand)

Wire chaser 317 (191-503) 166 (78-371) 127 (74-248) Material: (two hands) - White rope with red end on one side Zig-Zag loop 134 (69-219) 70 (29-136) 48 (28-82) - Pegboard with four rows with loops. Overall Score 1891 (1102-2683) 1022 (621-2030) 763 (523-1199) Starting position: Assessment: - The board is positioned with four loops in front, the rope is lying in front. - We recommend to use the total score (which includes both time and penalty points) as described in the manual. Procedure: - In the construct validity table the mean score of the expert group should be used as a target score. - Start time when the rope is taken at the red side of the rope. - A regular stopwatch or cooking timer can be used to measure time. Total time is expressed in seconds. - Pass the rope alternately through the four loops of the first and second row of the loop-board, resulting in a zigzag pattern. - Use both hands

Finishing position: - The task is finished when the rope is passed through the last loop

Penalty: If the pipe cleaner is passed besides a loop during the procedure, 10 penalty points are counted.

Score: Time in seconds + penalty points

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Notes on co-authors Appendices Notes on co-authors Chapter 14

Notes on co-authors Ingemar Ihse, MD, PhD, FRCS, ASA, FACS is Professor of Surgery at the Lund University Hospital, Lund, Sweden. He is director of the “Practicum - Lund Clinical Skills Center”, Marchien van Baal, MD, PhD is a gynaecological oncologist at the Flevo Hospital, Lund University, Lund, Sweden. Almere, The Netherlands. Her main fields of interest are education and minimally invasive surgery. Juliënne Janse, MD is a registrar in Obstetrics and Gynaecology in the Sint Antonius Hospital, Nieuwegein and a PhD student at the Department of Obstetrics and Caroline van den Berg, MD is a registrar in Obstetrics and Gynaecology in the Meander Gynaecology, University Medical Center Utrecht, Utrecht, The Netherlands. Medical Center, Amersfoort, The Netherlands. She conducted research in her sixth year of Medical School at the University of Utrecht. Frank Willem Jansen, MD, PhD is Professor of Clinical evaluation of minimally invasive surgical instruments at the University of Leiden and the Delft University of Technology, Jan Borleffs, MD, PhD is an internist and Professor of Medical Education and Dean of The Netherlands. He is a gynaecologist at the Leiden University Medical Center. He has Education at the University Medical Center Groningen and the University of Groningen, monitored several PhD students on the issue of training minimally invasive surgery. The Netherlands. He is Editor-in-Chief of the Dutch Journal of Medical Education. Diederick van Hove, MD is a PhD student at the Department of BioMechanical Ivo Broeders, MD, PhD is a surgeon in the Meander Medical Center, Amersfoort, The Engineering, Delft University of Technology and the department of Surgery, Reinier de Netherlands and Professor of Minimally Invasive Surgery and Robotics at the Faculty of Graaf Hospital, Delft, The Netherlands. He is conducting research in the field of training Science and Technology, Institute Technical Medicine at the University of Twente, The for minimally invasive surgery. Netherlands. He is board member of the Minimally Invasive Robotic Association (MIRA) Jonas van de Lande, MD is a gynaecologist at the Kennemer Gasthuis, Haarlem, The Jenny Dankelman, PhD is Professor at the Department of BioMechanical Engineering, Netherlands. He is conducting a PhD regarding aspects of minimally invasive treatment Delft University of Technology, The Netherlands. She is head of the MISIT (Minimally for cervical cancer. Invasive Surgery and Interventional Techniques) group of the Delft University of Technology. She is involved in the development of instruments and training tools for Mario Maas, MD, PhD is a radiologist in the Academic Medical Center of Amsterdam. He minimally invasive techniques. also is chair of the board of Medical School Faculty of University of Amsterdam and member of the IT council and chair of section of IT innovation in education. Koen van Dongen, MD, PhD is a senior registrar in General Surgery at the TweeSteden Hospital, Tilburg, The Netherlands. In 2010 he completed his thesis “Virtual Reality Guid Oei, MD, PhD is a gynaecologist in the Máxima Medical Center and Professor of training for endoscopic surgery” at the University of Twente, The Netherlands. Fundamental Perinatology at the Eindhoven University of Technology.

Jan Dijkstra, MD, PhD is a gynaecological oncologist who worked in the Sint Lucas Thyrza Pattij, MS is a sixth year medical student at the University of Utrecht, The Andreas Hospital, Amsterdam and in the VU Medical Center, Amsterdam, The Netherlands. She is conducting research in her fifth and sixth year of Medical School at Netherlands. He retired in 2010. the University of Utrecht.

Eric Hazebroek, MD, PhD is a general surgeon in the Sint Antonius Hospital, Nieuwegein, Jan Person, MD, PhD is Associate Professor of Gynecologic Oncology at the Lund The Netherlands. He is an expert in laparoscopic gastrointestinal surgery. University Hospital, Lund, Sweden. He is Director of Minimally Invasive and Robotic Surgery. He is board member of the Society of European Robotic Gynaecological Surgery Ellen Hiemstra, MD is a registrar in Obstetrics and Gynaecology at the Leiden University (SERGS). Medical Center and a PhD Student at the department of Obstetrics and Gynecology at the University Medical Center Leiden, The Netherlands. She is conducting research in the Susan Roeleveld, MD is a general practitioner in Utrecht. She conducted research in her field of training for minimally invasive surgery. sixth year of Medical School at the University of Utrecht.

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Marlies Schijven, MD, PhD, Msc is a surgeon in the Academic Medical Center of Thesis review committee Amsterdam, the Netherlands. She holds a Master in Health Education and a PhD in virtual reality simulation for laparoscopy. She has monitored several PhD students on the issue of simulation in medicine. She is president of the Dutch Society in Healthcare.

Laurents PS Stassen, MD, PhD is Professor of Surgery, chief of Surgical training and director of Continuous Medical Education at the Maastricht Medical Centre, Maastricht, The Netherlands. He is an expert in the field of training and learning minimally invasive surgery and has monitored several PhD students on the issue of training minimally invasive surgery.

Anne Stiggelbout, PhD is Professor at the Department of Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands.

René Verheijen, MD, PhD is Professor of gynaecological oncology at the University Medical Center Utrecht, The Netherlands. In the Netherlands he was the first to perform a robot assisted laparoscopic radical hysterectomy and a (laparoscopic) sentinel node procedure for cervical cancer. He is founding council member of the Society of European Robotic Gynaecological Surgery (SERGS), and currently serves as the vice-president of the European Society of Gynaecological Oncology (ESGO).

Richard Wolswijk, MD is a registrar in General Surgery in the Gelderse Vallei Hospital, Ede, The Netherlands. He conducted research in his sixth year of Medical School at the University of Utrecht.

Ronald Zweemer, MD, PhD is a gynaecological oncologist at the University Medical Center Utrecht. He is performing minimally invasive robotic assisted surgery for treatment of gynecologic malignancies.

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Thesis Review Committee

Prof. Dr. Ivo A.M.J. Broeders Meander Medical Center, Amersfoort, The Netherlands Department of Surgery

University of Twente, Enschede, The Netherlands Faculty of Science and Technology Institute Technical Medicine

Prof. Dr. Richard van Hillegersberg University Medical Center Utrecht, Utrecht, The Netherlands Division of Surgical Specialties Department of Surgery

Prof. Dr. Frank Willem Jansen Leiden University Medical Center, Leiden, The Netherlands Department of Obstetrics and Gynaecology

University of Technology, Delft, The Netherlands Faculty of Mechanical, Maritime and Materials Engineering Department of BioMechanical Engineering

Prof. Dr. Jan P.J. van Schaik University Medical Center Utrecht, Utrecht, The Netherlands Imaging Division Department of Radiology

Prof. Dr. David C. van der Zee Wilhelmina Children’s Hospital University Medical Center Utrecht, Utrecht The Netherlands Division of Surgical Specialties Department of Pediatric Surgery

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Acknowledgements - Dankwoord

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Dankwoord / Acknowledgements Prof. Dr. L.P.S. Stassen, beste Laurens, samen met jou het nieuw laparoscopie curriculum voor de Simendo virtual reality simulator ontwikkelen was een waar genoegen. De Bij het schrijven van dit proefschrift heb ik van veel mensen hulp gekregen. Iedereen die kruisbestuiving tussen de chirurgie en gynaecologie leidt tot mooie dingen. heeft bijgedragen aan het tot stand komen van dit boek, wil ik heel hartelijk bedanken. Graag wil ik een persoonlijk woord richten tot: Prof. Dr. J. Dankelman, beste Jenny, de tripjes naar de TU Delft waren een belevenis. Het was heel verhelderend om nu eens vanuit de technische en wiskundige kant naar het Prof. Dr. R.H.M. Verheijen, promotor, beste René, dank dat je na je komst in het UMC ontwikkelen van simulatieprogramma’s te kijken. Utrecht dit proefschrift hebt willen omarmen. De snelheid en zorgvuldigheid waarmee jij werkt zijn bewonderenswaardig. Dank voor je laagdrempelige en altijd aanwezige Prof. Dr. F.W. Jansen, beste Frank-Willem, laparoscopie en chirurgische training liggen jou bereidheid tot het geven van advies en ondersteuning. Jouw kritische blik op tal van nauw aan het hart. Ik hoop dat ons eerste gezamenlijke artikel de start zal zijn van een zaken heeft mij enorm geholpen. Jouw gezelligheid en jouw voorliefde voor een goede verdere samenwerking op het gebied van de chirurgische training binnen de gynaecologie. dis hebben het overleg over dit boek altijd plezierig gemaakt. Ik kijk uit naar al onze Dank dat je wilde plaatsnemen in de beoordelingscommissie. toekomstige projecten. Prof. Dr. R. van Hillegersberg, beste Richard, als expert in de robotgeassisteerde Dr. M.P. Schijven, co-promotor, beste Marlies, jij bent onmisbaar geweest bij het tot slokdarmchirurgie weet je als geen ander wat er allemaal komt kijken bij het leren van stand komen van dit proefschrift. Het fijne overleg en de snelle correcties hebben er deze vorm van chirurgie. Ik kijk uit naar het gezamenlijk verder vormgeven van de mede voor gezorgd dat de trein snel bleef rijden. Dank voor jouw betrokkenheid, robottraining in het UMC Utrecht. Dank dat je voorzitter van de beoordelingcommissie gezelligheid en oprecht luisterend oor. Onze samenwerking en vriendschap zijn een wilde zijn. solide basis voor de toekomst. Prof. Dr. D.C. van der Zee, beste David, jouw enthousiasme voor de minimaal invasieve Dr. R.P. Zweemer, co-promotor, beste Ronald, dank voor jouw bijdrage aan dit chirurgie is niet te stuiten. Het prachtige Endoscopisch Centrum in het Wilhelmina proefschrift. Jouw rustige houding en relativerende kijk op de zaken hielpen mij tijdens Kinderziekenhuis is hiervan een goed voorbeeld. Het belang van goede training weet je moeilijke momenten. Met respect kijk ik naar de manier waarop jij basaal en klinisch als geen ander te onderstrepen en je stond mede aan de basis van het skillscentrum in onderzoek binnen de gynaecologische oncologie combineert. het UMC Utrecht. Dank dat je wilde plaatsnemen in de beoordelingcommissie.

Prof. Dr. A.M.P. Heintz, beste Peter, aan jou heb ik veel te danken. Jij was het die mij Prof. Dr. J.P.J. van Schaik, beste Jan, een onderwijskundig proefschrift kan natuurlijk niet mede aannam voor de opleiding tot gynaecoloog en aanzette tot specialisatie in de zonder een onderwijskundig hoogleraar. Dank dat je met jouw expertise in onderwijs en gynaecologische oncologie. Hierna kreeg ik de mogelijkheid om een tijd in Australië te opleiding wilde plaatsnemen in de beoordelingscommissie van mijn proefschrift. werken. Als jouw laatste fellow, wil ik je bedanken voor de goede opleiding die ik heb gekregen. Tijdens onze wekelijkse fietstochten samen met Ciel wist je alles altijd weer Ass. Prof. Dr. M.J.C. Eijkemans, beste René, dank voor de prettige samenwerking en de goed te relativeren. Je bent een inspirerende persoonlijkheid, een zeer kundige operateur hulp bij de statistische vraagstukken. Jouw snelle en duidelijke antwoorden hebben mij en onze vriendschap ligt mij nauw aan het hart. Dank dat je wilt plaatsnemen in de enorm geholpen. promotiecommissie. Drs. J. Janse, beste Juliënne, in het 5e jaar van je geneeskundestudie kwam je langs om te Prof. Dr. I.A.M.J. Broeders, beste Ivo, jij staat mede aan de basis van dit proefschrift. kijken of er een project bij de gynaecologie was. Inmiddels hebben we samen drie Nadat jij het virtual reality skillscentrum in het UMC Utrecht had opgezet, zijn we artikelen geschreven, ben je aan de slag als assistent gynaecologie en begonnen met een begonnen met onderzoek. Samen met de enthousiaste onderzoekers van de Heelkunde promotietraject op het gebied van hysteroscopiesimulatie. Jouw inzet is er een zonder maakte ik gretig gebruik van het grootste virtual reality skillscentrum van Europa. De grenzen en met jou samenwerken is altijd plezierig. combinatie met de robotchirurgie was natuurlijk een schot in de roos. Na jouw vertrek naar Amersfoort, zijn we elkaar nooit uit het oog verloren. Dank voor alles wat ik van je Drs. P.D. van Hove, beste Diederick, dank voor je hulp vanuit het technisch bolwerk geleerd heb en dank dat je wilde plaatsnemen in de beoordelingscommissie van mijn ‘TU Delft’. De samenwerking met jou was uitstekend en we mogen trots zijn op het proefschrift. resultaat. Succes met de afronding van jouw proefschrift.

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Drs. C.B. van den Berg, beste Caroline, als wetenschapsstudent heb je vele uren door Dear Becky and Bob, we met at the AAGL 2009 and this was the start of a successful gebracht in het skills lab op de assistentenkamer gynaecologie. Mede dankzij jouw collaboration. Thank you for your believe and support. I’m curious what will be next… precisie en enthousiasme hebben de assistenten nu een prachtig gevalideerde skillsset voor in de boxtrainer. Dear Jan and Ingmar, thank you for your contribution and making it possible to conduct our study at the 2nd SERGS symposium in Lund, Sweden. I will remember the “Practicum Drs. T.O.S. Pattij, beste Thyrza, enthousiast, vrolijk en altijd vol energie. Na je keuzestage - Lund Clinical Skills Centre”, Lund University, Sweden as a great example how a skills in het 5e jaar, zijn we nu met een groter project begonnen. Ik weet zeker dat je dit ook tot center should be. een goed einde weet te brengen. Beste Phil en Bertus, IT team divisie Heelkundige specialismen, dank voor jullie hulp bij Drs. S.J. Roeleveld, beste Susan, jij was de eerste wetenschapsstudent uit CRU ’99 die ik het onderhoud van het virtual reality skills lab in het UMC Utrecht. Zonder jullie was het begeleidde. Dank voor je hulp en ik weet zeker dat je als huisarts een aanwinst voor niet mogelijk geweest dit lab te laten voortbestaan. Utrecht zal zijn. Beste Tessa, Ingrid en Ellis, dank voor jullie enthousiasme en alle hand en spandiensten Drs. E. Hiemstra, beste Ellen, beiden hebben we een passie voor wielrennen en tijdens een die jullie voor het tot stand komen van dit boek hebben verricht. van de fietstochten van de VFGN werd het idee van ons project geboren. Je weet inmiddels als geen ander dat het krijgen van een kleine, een fulltime baan en promoveren geen Beste onderzoekers, in jullie uitvindersbolwerk vond ik altijd een warm welkom. Tussen makkelijke combinatie is. Jouw boek is nu bijna af en je mag er met recht trots op zijn. de bedrijven door liep ik vaak bij jullie binnen om even iets te vragen of te checken. Dank voor al jullie tips en trics. Dr. K.W. van Dongen, Dr. J.P. Ruurda en Dr. W.A. Draaisma, beste Koen, Jelle en Werner, samenwerken met jullie is een waar genoegen. De brainstormsessies met een bakkie Beste Barbara, dank voor de vormgeving van dit proefschrift. Op de meest onverwachte pleur in jullie bolwerk achter de eerste hulp waren altijd een welkome afwisseling. tijden, tussen de dagelijkse werkzaamheden door, liep ik bij je binnen. We mogen trots Inmiddels zijn jullie allen gepromoveerd en opgeleid tot chirurg. zijn op het resultaat.

Dr. E.J.P van Santbrink, beste Evert, wat een genoegen dat wij samen de laparoscopie Alle gynaecologen, chirurgen, urologen, arts-assistenten, co-assistenten en medisch trainingen voor assistenten in het cluster Utrecht en Rotterdam hebben kunnen opzetten. studenten die deelgenomen hebben aan een van de studies. Dank voor jullie tijd en Op deze manier hebben we het laparoscopiecurriculum gestructureerd en vorm gegeven. enthousiasme. Zonder jullie deelname en feedback waren de studies niet mogelijk Jouw nuchtere kijk en daadkrachtige aanpak weten mij altijd te inspireren. geweest.

Beste Joeri en Mark, de fijne samenwerking met jullie heeft geleid tot mooie dingen. Beste René, Eleonora en Ronald, veel dank voor de ruimte die jullie mij hebben gegeven Onder het genot van een espresso hebben we vele zaken aan de eetkamertafel besproken. om dit proefschrift af te maken. Jullie enthousiasme en kijk op chirurgische training werkt stimulerend. Ik ben er van overtuigd dat we in de toekomst nog meer leerzame programma’s samen ontwikkelen. Beste gynaecologen van het UMC Utrecht, dank voor jullie interesse en steun tijdens de het tot stand komen van dit boek. Promoveren naast het werk als fulltime gynaecoloog is Dear Mattias, Thomas, Roland and the Surgical Science team, our collaboration goes een uitdaging, maar zeker ook een verrijking. Dank voor jullie ondersteuning en de fijne back a long time. Working with you is always a pleasure, and I’m sure many exciting new samenwerking. developments are lying ahead of us. Thank you all for your believe and support. Thomas, I hope to join you next year for a round on the Barsabäck course. Beste Steven, we kennen elkaar vanuit de opleiding tot gynaecoloog. Onze vriendschap is in de loop der jaren steeds sterker geworden en je hebt me op veel fronten gesteund. Dear Jeff, Andrea, Gordon and Jan, the cooperation with the Mimic team was fantastic. Regelmatig hebben we onder het genot van een goed glas wijn de totstandkoming van dit Thank you for your great effort in Sweden and the memorable round of golf in Wolf Creek. boek besproken. Dank voor je bemoedigende woorden en waardevolle inbreng. Ik ben Gordon, thanks for your help by designing the cover of this thesis. Look forward too heel blij dat je op 2 november als paranimf naast me wil staan. further exiting developments of virtual reality simulation for robot assisted laparoscopic surgery.

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Beste Paul, wij kennen elkaar al ruim 30 jaar en hebben veel samen meegemaakt. College Hageveld, studeren in Amsterdam, wijnreizen, vakanties, etc. Het zijn stuk voor stuk belangrijke en onvergetelijke gezamenlijke herinneringen. Dit alles heeft ons gemaakt tot vrienden voor het leven. Ik ben trots dat je naast me wil staan als paranimf. Volgend jaar ga ik zeker weer met je mee op wijnreis.

Lieve familie en vrienden, dank voor jullie steun en belangstelling voor mijn onderzoek. Ik ben weer terug en ik verheug me op heel veel gezellige BBQ’s en andere Bourgondische momenten.

Beste Gerrit, lieve zwager, dank voor je hulp bij het ontwerpen van de voorkant van dit proefschrift. Jouw creativiteit kent geen einde, evenals je toverkunsten met de computer.

Lieve Bu en Jans, lievere en gezelligere schoonouders had ik me niet kunnen wensen. Zonder jullie onvoorwaardelijke steun was dit boek nooit afgekomen. Jullie hulp thuis, samen met de oppasdagen voor Anna, hebben er mede voor gezorgd dat dit boek geschreven kon worden.

Lieve Maarten and Lynn, lieve broer en schoonzus, dank voor jullie taalkundige hulp bij diverse hoofdstukken van dit proefschrift. Ik hoop jullie nu snel weer te komen bezoeken in Portland, Oregon en kijk er naar uit om Otillia en Charlotta weer te zien.

Lieve Ruud en Gisela, lieve pap en mam, dank voor de onbezorgde jeugd en alles wat jullie voor mij hebben gedaan. Dankzij jullie heb ik alle kansen gehad. Pap, ik weet zeker dat je toekijkt. Mam, nu kom ik weer wat vaker naar Heemstede om samen wat leuks te doen.

Lieve Marieke en Anna, jullie zijn mijn twee grootste schatten. Marie, dank voor jouw onvoorwaardelijke steun en vertrouwen in mij. Jouw kritische blik en geduld hebben mij enorm geholpen. Veel bewondering heb ik voor de manier waarop jij je staande hebt gehouden in deze hectische tijden. Ik ben trots op je en hou heel veel van je. Anna, dit boek draag ik op aan jou. Jouw glimlach en vrolijkheid maken van elke dag een feestje. Jij bent het wonder dat in ons leven is gekomen waar ik heel dankbaar voor ben. Het is gelukt het manuscript naar de beoordelingscommissie te sturen, voordat jij ging lopen.

Voor jou

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List of publications Appendices List of publications Chapter 14

List of publications Schreuder HWR, Oei G, Maas M, Borleffs JC, Schijven MP. Implementation of simulation Schreuder HWR, Wolters FL, Vries G, Wetsteyn JC. Prospective in-vivo study of in daily practice: why has minimally invasive surgery taken the lead? The Dutch viewpoint. chloroquine resistance of Plasmodium falciparum in Zambian under-fives. Trop Geogr Med Teach 2011;33:105-15. Med 1993;45:15-7. van Hove PD, Schreuder HWR, Janse JA, Stassen LPS, Dankelman J. Face- and Construct Schreuder HWR, Visser DM, Zuithoff-Rijntjes JGM. The sweat-test as diagnostic aid for Validity of a Virtual Reality Curriculum for Intermediate Laparoscopic Surgeons. Surg cystic fibrosis: a comparison between the classic Gibson-Cooke method and the Endosc 2011;25:S52. Macroduct Analyser. Ned Tijdschr voor Kindergeneeskd 1995;63:157-61. van Bommel ACM, Schreuder HWR, Schellekens PPA. Vulva reconstruction after pelvic Janse JA, Witteveen PO, Jürgenliemk-Schulz IM, van Dorst EBL, Schreuder HWR. exenteration, using a unique combination of two flaps. BMJ Case Reports 2011; Baarmoederhalskanker tijdens de zwangerschap: een dilemma? Ned Tijdschr Obstetrie & doi:10.1136/bcr.01.2011.3717. Gynaecologie 2008;121:238-241 Janse JA, Sie-Go DMDS, Schreuder HWR. Ovarian metastasis in a transposed ovary ten Zaal A, Kocken M, Louwers J, Schreuder HWR, Verheijen RHM. Het Humaan years after primary cervical cancer: the importance of histological examination and review Papillomavirus van alle kanten bekeken. Up to Date 2009;21:40-43. of literature. BMJ Case Reports 2011; doi:10.1136/bcr.04.2011.4155.

Schreuder HWR, Verheijen RHM. Robotic Surgery. BJOG 2009;116:198-213. Schreuder HWR, Pattij TOS, Zweemer RP, van Baal WM, Verheijen RHM. Increasing experience in laparoscopic staging of early ovarian cancer. Gynecol Surg 2011. [Epub Zweemer RP, Schreuder HWR, Verheijen RHM. Commentary, use of Da Vinci system in ahead of print Jul 14] doi:10.1007/s10397-011-0692-6. gynaecologic oncology. Gynecol Surg 2009;6:287-294. Schreuder HWR, van Hove PD, Janse JA, Verheijen RHM, Stassen LPS, Dankelman J. An Schreuder HWR, van Dongen KW, Roeleveld, Schijven MJ, Broeders IAMJ. Virtual reality ‘Intermediate Curriculum’ for Advanced Laparoscopic Skills Training using Virtual Reality laparoscopic simulator, face- and construct validity for the use in gynecology. Am J Obstet Simulation. J Minim Invasive Gynecol 2011. [Epub ahead of print Jul 21] doi;10.1016/j/ Gynecol 2009;200:e1-e8. jmig.2011.05.017.

Verheijen RHM, Schreuder HWR. Robotgeassisteerde laparoscopie in de oncologische Schreuder HWR, MD CB van den Berg CB, MD, EJ Hazebroek EJ, Verheijen RHM, gynaecologie. Reproductieve geneeskunde, gynaecologie en obstetrie anno 2009. Slager Schijven MP. Laparoscopic skills training using inexpensive box-trainers: which exercises E, 2009 ISBN 978-90-811646-5-8 2009:342-350. to choose when constructing a validated training course. BJOG 2011 in press

Schreuder HWR, van Santbrink E, Verheijen RHM. Developing and Implementing a Schreuder HWR, Oei G, Maas M, Borleffs JC, Schijven MP. Implementation of simulation laparoscopy Curriculum for Residents in the Netherlands. J Minim Invasive Gynecol for Training Minimally Invasive Surgery. Tijdschrift voor Medisch Onderwijs 2011 in press 2009;16:S57-S58. Schreuder HWR, Wolswijk R, Zweemer RP, Schijven MP, Verheijen RHM. Learning and Schreuder HWR, Zweemer RP, van Baal WM, van de Lande J, Dijkstra JC, Verheijen RHM. Training Robotic Surgery; Time for a more Structured Approach: a systematic review. From open radical hysterectomy to robot-assisted laparoscopic radical hysterectomy for BJOG 2011 in press early stage cervical cancer: aspects of a single institution learning curve. Gynecol Surg 2010;7:253-258. Hiemstra E, Schreuder HWR, Stiggelbout AM, Jansen FW. Grading surgical skills curricula and training facilities for minimally invasive surgery. 2011 submitted Jürgenliemk-Schulz IM, Toet-Bosma MZ, de Kort GAP, Schreuder HWR, Roesink JM, Tersteeg JHA, van der Heide UA. Internal motion of the vagina after hysterectomy for Schreuder HWR, Persson JEU, Wolswijk R, Ihse I, Schijven MP, Verheijen RHM. Validation gynaecological cancer. Radiother Oncol 2010;98:244-8. of a novel virtual reality simulator for robotic surgery. 2011 submitted

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Curriculum Vitae

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Curriculum Vitae Next to his work in the hospital he is currently board member of the Dutch Society for Simulation in Healthcare (DSSH) and board member of the Dutch postgraduate education committee for Obstetrics and Gynaecology (CCO). During his fellowship and the years thereafter his interest in teaching grew. In 2009 he qualified for a senior degree in ‘Teaching at the University’. His interest in minimally invasive surgery and teaching were combined in the completion of this thesis.

Henk Schreuder is married to Marieke Cats and together they have a lovely daughter Anna.

Henk Schreuder was born on the 19th of October 1966 at the Maria Stichting in Haarlem, the Netherlands. He grew up in a busy home practice as a son of a general practitioner in Haarlem. After finishing primary school at the Montessori School in Haarlem he attended secondary school at the Hageveld College in Heemstede. In 1986 he started Medical School at the University of Amsterdam.

In 1994 he finished Medical School. To master the basic principles of surgery he started for one year as a resident in general surgery at the Regional Hospital of Hilversum (Dr. J.H. Kroesen). In 1995 he started his career in Obstetrics and Gynaecology as a resident in the Spaarne Hospital in Haarlem (Dr. P.F. Wiesenhaan). The next year he worked as a resident in Obstetrics and Gynaecology at the University Medical Center Utrecht in Utrecht. From 1997 to 2003 he completed his specialist training at the department of Obstetrics and Gynaecology at the University Medical Center Utrecht (Prof. Dr. A.M.P. Heintz and Prof. Dr. G.H.A. Visser) and at the department of Obstetrics and Gynaecology at the TweeSteden Hospital in Tilburg (Dr. H.C.L.V. Kock and Dr. H.J.H.M. van Dessel).

During his training he developed major interest in gynaecologic surgery. This lead to the opportunity to work in 2002 as a fellow at the department of Gynaecologic Oncology in the Mercy Hospital for Women, Melbourne, Australia (Dr. Peter Grant and Prof. Dr. David Allen). This was the start of his career as a gynaecologic oncologist. After completing his specialist training in 2003, he worked as a fellow in gynaecological oncology at the department of Obstetrics and Gynaecology at the University Medical Center Utrecht (Prof. Dr. A.P.M. Heintz). In 2006 he completed his fellowship and was officially registered as a Gynaecological Oncologist by the Dutch Society of Obstetrics and Gynaecology. Since then he is working as a gynaecological oncologist at the department of gynaecological oncology (Prof. Dr. R.H.M Verheijen), Division of Woman and Baby (Prof. Dr. B.C.J.M. Fauser) at the University Medical Center Utrecht, The Netherlands.

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Grants

Publication of this thesis was supported by

3-Dmed® Bayer Schering Nederland BMA BV (Mosos) Covidien Nederland BV Division of Woman & Baby, UMC Utrecht Dutch Society for Simulation in Healthcare (DSSH) Ferring B.V. GlaxoSmithKline Ipsen Farmaceutica B.V. Johnson & Johnson Medical BV Krijnen Medical Innovations B.V. Medical Dynamics Memidis Pharma b.v. Merck Sharp & Dohme B.V. Mimic Technologies Inc. Nederlandse Vereniging voor Endoscopische Chirurgie (NVEC) Nycomed bv Olympus Nederland B.V. Raadgevers Kuijkhoven Sigma Medical Simendo BV Skills Meducation Stöpler Instrumenten en Apparaten Surgical Science Sweden AB Toshiba Medical Systems Nederland Van Beek Medical bv. Welmed B.V. ZekVinos

I would like to thank everyone who supported the publication of this thesis and who expressed their interest in surgical training.

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