European Association of Urology GUIDELINES ON LAPAROSCOPY Dedicated to: MJ. Coptcoat. JD. Doublet, G. Janetschek, A. Joyce, A. Mandressi, J. Rassweiller, D. Tolley. TABLE OF CONTENTS PAGE 1. Introduction 3 1.1 Methods of guideline development 3 1.2 Levels of evidence and grade of guideline recommendations 3 1.3 References 4 2. Technical aspects 5 2.1 Introduction 5 2.2 Equipment 5 2.3 Instruments 5 2.3.1 Access to, and development of, working room 5 2.3.2 Dissection 5 2.3.3 Haemostasis 6 2.3.4 Suture technique 6 2.3.5 Retrieval of specimens 6 2.4 Access techniques 6 2.4.1 Retroperitoneoscopy 6 2.4.2 Transperitoneal laparoscopy of the upper tract 8 2.4.3 Transperitoneal access to the pelvis 8 2.4.4 Extraperitoneal access to the pelvis 9 Balloon dissection 9 Finger dissection 10 2.5 Management of complications 10 2.5.1 Introduction 10 2.5.2 Placement of the trocars 10 2.5.3 Insufflation of carbon dioxide 10 2.5.4 Vascular injuries 11 2.5.5 Injuries to organs 11 2.6 Specific training 13 2.7 The difficulty scoring system of laparoscopic procedures 14 2.7.1 Criteria 14 2.7.2 Scoring system 15 2.8 References 16 3 Laparoscopic procedures 18 3.1 Adrenalectomy 18 3.2 Colposuspension 18 3.3 Cryptorchidism treatment 19 3.4 Hernia repair 19 3.5 Nephrectomy 20 3.5.1 Simple nephrectomy (for benign disease) 20 3.5.2 Radical nephrectomy 20 3.5.3 Partial nephrectomy 20 3.5.4 Nephro-ureterectomy 21 3.5.5 Live-donor nephrectomy 21 3.6 Nephropexy 22 3.7 Pyeloplasty 22 3.8 Pelvic lymph node dissection 22 3.9 Radical prostatectomy 22 3.10 Retroperitoneal lymph node dissection (for testicular cancer) 23 3.11 Renal cyst treatment 23 3.12 Ureterolithotomy 23 3.13 Varicocelectomy 24 3.14 References 24 4 Recommendations 37 Abbreviations 38 2 1. INTRODUCTION A group of European urologists, each with a special interest in laparoscopy, has reviewed the published literature in order to provide guidelines for this subspeciality. In considering the role of a particular laparoscopic procedure as an alternative to its open counterpart, it must be stated that there is sometimes minimal evidence to support the use of, what historically has been understood to be, an established open procedure. This group has therefore established new standards of quality. Despite the lack of Level One evidence or Grade A recommendations, the Laparoscopy Working Group of the EAU feels that laparoscopy has a significant role to play in the practice of urology. Indeed, laparoscopy is a surgical field with a tremendous continuing development, both technological and methodological; it means that we are dealing with procedures worthy of particular consideration. In these guidelines, the term ‘laparoscopy’ is used to describe every surgical technique carried out in a closed space, either enlarged or created, regardless of whether or not the technique is performed either inside or outside the peritoneum. The Laparoscopy Working Group has browsed all the literature available on laparoscopy, published between 1990 and 2000, as well as some published in 2001. References are quoted according to the criteria described in Sections 1.1 and 1.2 (see below). 1.1 Methods of guideline development (1) Woolf (1992) described three main methods of guideline development: informal, consensus, formal consensus, and evidence-linked guideline development (2). In informal consensus development, this means that poorly defined often-implicit criteria for decision-making were available to guide the Laparoscopy Working Group. Formal consensus development methods, which are used by many consensus-development conferences and Delphi groups, provide ‘greater structure to the analytical process’ but still fail to provide ‘an explicit linkage between recommendations and quality of evidence’ (2). Evidence-linked guideline development requires the explicit linkage of recommendations to the quality of the supporting evidence (3). This allows the user to make an informed choice about whether to comply with the individual recommendations within the guidelines by taking account of the level of supporting evidence. Clinicians therefore need a very good reason (which should be adequately documented) for choosing not to comply with a recommendation based upon a clinically relevant randomized trial or meta-analysis. However, the clinician has greater flexibility in using recommendations based upon lower levels of evidence. 1.2 Levels of evidence and grade of guideline recommendations The levels of evidence are summarized in Table 1.1, and the grading of guideline recommendations is described in Table 1.2. Table 1.1 Levels of evidence (3) Level Type of evidence 1a Evidence obtained from meta-analysis of randomized trials 1b Evidence obtained from at least one randomized trial 2a Evidence obtained from one well-designed controlled study without randomization 2b Evidence obtained from at least one other type of well-designed quasi-experimental study 3 Evidence obtained from well-designed non-experimental studies, such as comparative studies, correlation studies and case reports 4 Evidence obtained from expert committee reports or opinions or clinical experience of respected authorities 3 Table 1.2 Grades of guideline recommendations (3) Grade Nature of recommendations A Based on clinical studies of good quality and consistency addressing the specific recommendations and including at least one randomized trial B Based on well-conducted clinical studies, but without randomized clinical trials C Made despite the absence of directly applicable clinical studies of good quality 1.3 References 1. Grimshaw J, Eccles M, Russell I. Developing clinically valid practice guidelines. J Eval Clin Prac 1995; 1: 37-48. 2. Woolf SH. Practice guidelines, a new reality in medicine. II. Methods of developing guidelines. (Review.) Arch Intern Med 1992; 152: 946-952. 3. Agency for Health Care Policy and Research. Clinical Practice Guidelines Development, Methodological Perspectives. US Department of Health and Human Services, Public Health Service, Washington DC,1992, pp. 115-127. 4 2. TECHNICAL ASPECTS 2.1 Introduction Laparoscopy is a surgical technique that allows surgical procedures to be performed while minimizing trauma to the body. The following are indispensable for carrying out any laparoscopic procedure: • Basic mandatory equipment • Specific basic instruments • Basic access techniques • Complication management • Specific training. 2.2 Equipment (1-3) The view of the surgical field is provided by a video-camera, which represents the eye of the surgeon. It goes without saying that a proper video armamentarium is of paramount importance. The basic, indispensable equipment for videoing is as follows: • At least one CCD (charge-coupled device), but preferaby three CCD video-cameras • At least one, but preferably two, video-monitors • Video-recorder cart. In addition, equipment should also include: • High-flow insufflator • Xenon-light source • High-frequency generator, both mono- and bipolar • Suction and irrigation device. (Other devices for dissecting and for controlling bleeding may be useful, such as an ultrasonic dissector or a radio-frequency coagulator.) 2.3 Instruments (1-3) As well as having instruments to enable access to, and development of, working room, the surgeon requires state-of-the-art instruments for optimal performance of laparoscopic procedures, including: • Dissection • Haemostasis • Suturing • Retrieval of specimens. 2.3.1 Access to, and development of, working room Indispensable instruments for accessing and developing the working space include: • Veress needle (for transperitoneal access only) • Hasson trocar • 10 mm trocar with safety sheath • 10 mm trocars with ventile valve and reducer to 5 mm • 0° and 30° 10 mm telescopes. An optional instrument is a: • Balloon dilator (for extraperitoneal access only). Basically, there are no major differences between performing transperitoneal or extraperitoneal laparoscopic surgery. However, since the peritoneum is already an existing cavity, it is only necessary to inflate the peritoneum to create a working space. However, since the retroperitoneum and pelvis are not a cavity, it is first necessary to dissect the fat which fills the retroperitoneal space to create a working room. Thus, in the case of a transperitoneal approach, the abdomen is insufflated by use of a Veress needle followed by puncture with a 10 mm trocar with a safety shield or using an open Hasson technique. The retroperitoneoscopic approach is begun by making an open canal (15-20 mm wide in diameter) down to the retroperitoneal space, followed by finger dissection (with or without balloon dissection). A Veress needle is not required. 2.3.2 Dissection The basic indispensable instruments for laparoscopic dissection are: • Endoscopic curved scissors with rotatable blades 5 • Endoscopic curved dissector • Suction-irrigation probe. An optional but useful instrument is: • An ultrasonic dissector. Several dissection techniques may be applied: • Blunt and sharp dissection with endoshears • Blunt dissection with endo-peanuts • Blunt dissection with right-angle dissector (5 mm, 10 mm). • Blunt dissection with the tip of the suction-irrigation probe • Sharp dissection with an ultrasonic scalpel. 2.3.3 Haemostasis Haemostasis is one of the main issues of any surgical procedure. In laparoscopic surgery, there are several guidelines that can assure bloodless dissection. It is of major importance to dissect widely with optimal exposure of the organ rather than a deep dissection. To minimize blood loss, it is better to handle beforehand the vascular supply of an organ to be removed, rather than dissecting it all around and leaving dissection of the vessels as the last surgical step. The basic indispensable instruments for laparoscopic haemostasis are: • 5 mm monopolar coagulation forceps/dissector • 5 mm bipolar forceps • 10 mm endoclip-applicator • Endo-GIA® stapler (for large veins only) • Optional instruments • Bipolar coagulation forceps/dissector • Ultrasonic dissector • Radio-frequency coagulating 5 mm probe. 2.3.4 Suture technique Laparoscopic suture requires specific training, as it is rather different to open-surgery for both stitching and knotting.