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Robot-Assisted Surgery: Health Technology Assessment Robot-assisted surgery: health technology assessment KCE reports 104C Federaal Kenniscentrum voor de Gezondheidszorg Centre fédéral d’expertise des soins de santé Belgian Health Care Knowledge Centre 2009 The Belgian Health Care Knowledge Centre Introduction : The Belgian Health Care Knowledge Centre (KCE) is an organization of public interest, created on the 24th of December 2002 under the supervision of the Minister of Public Health and Social Affairs. KCE is in charge of conducting studies that support the political decision making on health care and health insurance. Administrative Council Actual Members : Gillet Pierre (President), Cuypers Dirk (Deputy President), Avontroodt Yolande, De Cock Jo (Deputy President), Demeyere Frank, De Ridder Henri, Gillet Jean-Bernard, Godin Jean-Noël, Goyens Floris, Maes Jef, Mertens Pascal, Mertens Raf, Moens Marc, Perl François, Van Massenhove Frank (Deputy President), Vandermeeren Philippe, Verertbruggen Patrick, Vermeyen Karel. Substitute Members : Annemans Lieven, Bertels Jan, Collin Benoît, Cuypers Rita, Decoster Christiaan, Dercq Jean-Paul, Désir Daniel, Laasman Jean-Marc, Lemye Roland, Morel Amanda, Palsterman Paul, Ponce Annick, Remacle Anne, Schrooten Renaat, Vanderstappen Anne. Government commissioner : Roger Yves Management Chief Executive Officer a.i. : Jean-Pierre Closon Deputy Managing Director a.i. : Gert Peeters Information Federaal Kenniscentrum voor de gezondheidszorg - Centre fédéral d’expertise des soins de santé – Belgian Health Care Knowlegde Centre. Centre Administratif Botanique, Doorbuilding (10th floor) Boulevard du Jardin Botanique 55 B-1000 Brussels Belgium Tel: +32 [0]2 287 33 88 Fax: +32 [0]2 287 33 85 Email : [email protected] Web : http://www.kce.fgov.be Robot-assisted surgery: health technology assessment KCE reports 104C CECILE CAMBERLIN, ARNAUD SENN, MARK LEYS, CHRIS DE LAET Federaal Kenniscentrum voor de Gezondheidszorg Centre fédéral d’expertise des soins de santé Belgian Health Care Knowledge Centre 2009 KCE REPORTS 104C Title: Robot-assisted surgery: health technology assessment Authors: Cécile Camberlin, Arnaud Senn, Mark Leys, Chris De Laet External experts: Pascal Borry (KUL Leuven), Didier De Cannière (Hôpital Erasme, Brussels), Marie-Luce Delfosse (FUNDP, Namur), Kris Dierickx (KUL Leuven), Patrick Galloo (Socialist Mutualities, Brussels), Guy Lebeer (ULB Brussels), Marleen Temmerman (UZ Ghent), Bertrand Tombal (UCL, Brussels), Rik Vandeursen (GVA Antwerp) External validators: Bruno Holthof (ZNA, Antwerp), Paul Van Cangh (UCL, Brussels), Yolanda van der Graaf (Julius Centre, Utrecht) Acknowledgement: Hans Van Brabant, for his careful rereading of this report Conflicts of interest: Didier De Cannière has performed consultancy for Cardiolife Research and received educational grants from Intuitive Surgical. Rik Vandeursen has received educational grants from Intuitive Surgical. No other potential conflicts of interest were declared. Disclaimer: The external experts collaborated on the scientific report that was subsequently submitted to the validators. The validation of the report results from a consensus or a voting process between the validators. Only the KCE is responsible for errors or omissions that could persist. The policy recommendations are also under the full responsibility of the KCE. Layout: Ine Verhulst Brussels, 9th February 2009 Study nr 2008-10 Domain : Health Technology Assessment (HTA) MeSH : Robotics ; Surgery, computer assisted ; Costs and Cost Analysis ; Technology Assessment, Biomedical NLM classification: WO 505 Language: English Format: Adobe® PDF™ (A4) Legal depot: D/2009/10.273/09 Any partial reproduction of this document is allowed if the source is indicated. This document is available on the website of the Belgian Health Care Knowledge Centre (www.kce.fgov.be). How to refer to this document? Camberlin C, Senn A, Leys M, De Laet C. Robot-assisted surgery: health technology assessment Health Services Research (HSR). Brussels: Belgian Health Care Knowledge Centre (KCE); 2009. KCE reports 104C (D/2009/10.273/09) KCE reports 104C Robot-assisted surgery i Executive summary INTRODUCTION Surgery is by nature invasive. Efforts have been made over time to reduce complications and the trauma inherently associated with surgery, through new instruments, cleverer techniques, and minimally invasive procedures through natural orifices, transcutaneous, or laparoscopically through small artificial holes. Robot-assisted instruments allowing more flexibility, stability and an enhanced vision could be seen as just a further development of this evolution. New technology, however, should be judged on its performance and cost-effectiveness and not only on its technological persuasiveness. The purchase cost is around €1.7 million while the yearly maintenance cost is approximately 10% of this amount. In addition expensive equipment, with limited reusability, is needed for each operation. The scope of this report is robot-assisted minimally invasive surgery using instruments remotely controlled by an operator sitting in the same room as the patient. Telemedicine (with an operator sitting at a distance) is not within the scope of this report and neither does it discuss whether a proposed surgical intervention is indeed the best possible treatment for a specific condition. RESEARCH QUESTIONS AND METHODS The aim of this health technology assessment is to determine the clinical effectiveness and the potential benefit of the currently marketed robotic surgical systems compared to standard interventions, either minimally invasive laparoscopic interventions or conventional open surgery and this for several indications. Additionally, and especially because the use of this technology is expensive, we wanted to assess the cost and cost- effectiveness of this technology compared to standard techniques. Finally, we wanted to determine the current practice in Belgium and abroad, the foreseeable evolutions in this field and the practical, legal and ethical consequences of the implementation of this technology for patients, hospitals and surgeons. For this assessment we conducted a systematic review of the existing literature on the topic. To describe current utilisation in Belgium we additionally questioned the Belgian hospitals currently using surgical robotic systems. For the ethical aspects and patients issues a panel of ethicists was consulted. ROBOTIC SURGICAL SYSTEMS There have been several endeavours to design robotic surgical systems. Apart from some experimental systems there is currently only one company successfully marketing such a system. This system allows for enhanced stereoscopic and enlarged high definition imaging. It has the potential for tremor free precise movements and it uses intracorporeal articulated instruments with multiple degrees of freedom allowing partially overcoming the problem of the fulcrum effect seen with conventional laparoscopy using rigid instruments. Because of its claimed ease of use, the so-called ‘intuitive approach’, it is reported to offer shorter learning curves and ergonomic advantages to the surgeon. The system also has some disadvantages. The lack of force (haptic) feedback is often mentioned as a potential problem when dissecting tissues or performing micro-surgery. Furthermore, the currently limited experience and lack of training with the system needs to be considered. In addition, there is the important issue of cost, not only for the acquisition of the system but also for maintenance and supplies. ii Robot-assisted surgery KCE reports 104C SURGICAL INDICATIONS Historically, robot-assisted surgery has first been used in general abdominal surgery to gather experience. At this moment it is mainly applied in urologic surgery and more specifically for radical prostatectomy. However, the use in gynaecological surgery is increasing rapidly. Thoracic surgery, mainly cardiologic surgery is an example of other potential uses of this system. The evidence base for robot-assisted surgery is growing rapidly with an exponential increase in the number of publications in recent years. Most of this evidence, however, is not gathered through comparative studies, but is based on case series from large centres. It can be questioned how relevant this kind of evidence is for a local hospital performing a limited number of interventions, although this is obviously also true for many other forms of medicine requiring skilled handicraft. In the current literature mainly short-term follow-up outcome data are available. Evidence also shows that performance and outcomes improve with increasing experience of the surgical team. Data for several specific interventions have been gathered in this report. Through this evidence, it can be concluded that robot-assisted surgery is relatively safe and efficient when used by experienced surgical teams. For many indications it is also claimed that robot-assisted surgery is less demanding on the surgeon, both by the reportedly shorter learning curve but also through its ergonomic advantages involving less stress on the surgeon’s body. Most evidence is available for robot-assisted radical prostatectomy, which is also the largest current indication in this country and in the world. There is evidence that peri- operative blood loss is lower than with conventional techniques but evidence for other expected advantages, such as reduced incontinence, reduced erectile dysfunction or shorter length of hospital stay, is less consistent and highly dependent on skill and experience of the surgical team.
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