Emerging Technology Briefing Paper on the Use of Robots in Surgery. Paul Sutcliffe Carolyn Czoski-Murray Marc Chattle Lynda Ayiku Gareth Parry

Transcription

1 Emerging Technology Briefing Paper on the Use of Robots in Surgery Paul Sutcliffe Carolyn Czoski-Murray Marc Chattle Lynda Ayiku Gareth Parry April 2006

2 Acknowledgements Correspondence to Richard Wilson (ReBIP Project Manager until December 2005) and Liz Considine (ScHARR) for their valuable support with the early scoping and preparation of the report. Marc Chattle ReBIP Project Administrator Health Services Research School of Health and Related Research University of Sheffield Regent Court, 30 Regent Street Sheffield, S1 4DA Tel: +44 (0) Fax: +44 (0) ; Date completed April

3 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Emerging Technology Briefing Paper on the Use of Robots in Surgery Robots may assist surgeons to carry out repetitive motions automatically and to position tools accurately at specified locations or move them with micromotions or on a complex pathway. Davies (2000) 1 A. Introduction This briefing paper will be presented to the Interventional Procedures Advisory Committee (IPAC) and experts attending a meeting at the National Institute for Health and Clinical Excellence (NICE) on the 24 th May The purpose of this briefing paper is to inform attendees at the NICE meeting about the use of robotic technology in surgery. The report aims to provide an overview of current use of robotic systems in surgical practice in the United Kingdom (UK), including information on the range and type of robotic technology, what these technologies aim to do, the training required to operate them and their cost. The report should not be regarded as a definitive assessment of robotic surgical interventional procedures. The report also provides an overview of what evidence is available concerning robots in surgery. A preliminary scoping review of the literature was conducted, followed by a more comprehensive search of seven medical databases. The structure of the report is based around several key areas: Current pattern of service Clinical and service considerations Evidence base for use of robots Policy context and strategic direction Under each of these sections we aim to address a series of questions that were considered important during the development of the scope for this report. Description There are issues surrounding what constitutes a surgical robot. Based on a review of robotics in surgery by Davies (2000) 1, NICE provided the following statement: For the purpose of this document, a surgical robotic device is defined as a powered device that is programmed and/or externally controlled by a surgeon to position and manipulate tools to undertake surgical tasks. Surgical robotic devices can be broadly classified into three groups: passive, active and master slave telemanipulators. This definition excludes those devices used by surgeons for preoperative planning and intraoperative monitoring." Davies (2000) 1 further defined a surgical robot as: a powered computer controlled manipulator with artificial sensing that can be reprogrammed to move and position tools to carry out a range of surgical tasks. Clarification of what constitutes a surgical robot is necessary. 3

4 Specialist advisors opinions To assist the Review Body for Interventional Procedures (ReBIP) at the University of Sheffield in writing the current briefing paper, an array of organisations and individuals, manufacturers, trusts, clinicians and others was contacted to elicit information and opinions. Two questionnaires were designed to obtain expert opinion and provide a response to a range of pertinent questions. The questionnaires provided information on: i) Current pattern of service: The purpose of this questionnaire was to provide general background information on where these services are currently used particularly in the UK and what they are used for. ii) Clinical and service considerations: The purpose of this questionnaire was to help establish the impact of robotic surgery on the way services are configured and organised in the UK. We will refer to the findings from these questionnaires throughout the report. All the completed questionnaire responses are provided in Appendices 1 and 2. 4

5 B. Current pattern of service In this section we discuss the use of robots and what procedures they are typically used for. We will refer to information obtained from clinicians and manufacturers and from a systematic search of the literature. It is important to emphasise that this report has been written to provide an insight into this wide and rapidly growing area; it should not be considered complete or exhaustive. 1. Where are robots currently being used in England, Wales and Scotland, in both the NHS and private sector for clinical interventions that use a laparoscopic or endoscopic approach? There are several hospitals and academic institutions where robots are being used and researched. A limited amount of information was provided by manufacturers and clinicians. The information obtained is listed below: Hospitals in the UK currently using the da Vinci Surgical System and the surgical specialties in which it is being used include: Addenbrooke s Hospital, Cambridge (Urology) Guys and St. Thomas Hospital, London (General Surgery, Urology) London Clinic (Urology) Princess Grace Hospital, London (Urology) St. Mary s Hospital, London (Cardiothoracic Surgery, Urology) Hospitals in the UK currently using the Aesop System and the surgical specialties in which it is being used include: St. Mary s Hospital, Paddington, London (In the training lab) Great Ormond Street Hospital, London (Paediatric Surgery) The Freeman Hospital, Newcastle upon Tyne (Urology) Leighton Hospital, Crewe (Urology) Clydebank Hospital, Scotland (Urology) Imperial College London has been involved in research to investigate robot assisted knee surgery compared to conventional surgery. 2. What procedures are robots typically used for? A total of nine clinicians replied with twelve questionnaires being completed (see Appendix 1). Six questionnaires were concerned with da Vinci, two Aesop, one Paky-RCM, one computer assisted drilling device, one Pathfinder; one questionnaire was not completed as a device was not installed. The procedures being used with the different robots were: da Vinci: Aesop: Paky-RCM: Computer assisted drilling device: PathFinder: Adrenalectomy Cardiac surgery Cardiomyotomy Colposuspension General surgery Live donor nephrectomy Nephrectomy Nissen s funduplication/heller s myotomy Paediatric surgery Prostatectomy Pyeloplasty Radical cystectomy Radical prostatectomy Rectopexy Totally endoscopic robotically assisted artery Urology Laparoscopic radical prostatectomy Laparoscopic nephrectomy Laparoscopic transplant nephrectomy Radical nephrectomy Telerobotic PCNL using the robot and a kidney model Performing cochleostomy for cochlear implantation Neurosurgery Research 5

6 A total of six completed manufacturer questionnaires were returned (see Appendix 2). These involved the following surgical robotic devices: Acrobot Sculptor Aesop System Assistive arm for mammotome da Vinci Surgical System / Endowrist Instruments EndoAssist Passive assisting tool for surgery PathFinder Prostate biopsy robot Robotic colonoscope Robots have been utilised in many areas of surgery (Stanoianovici, 2000). 2 In order to provide a more detailed coverage of the types of robotic surgical devices being used worldwide, Table 1 presents an overview of some of the procedures that have been undertaken by specific robotic devices. Table 1: Robotic surgical devices and procedures they undertake Name, company and classification Procedures Intern Replacements (limb positioning, retraction and laproscopic/endoscopic camera holding) AESOP (Computer Motion, US) Laparoscopy, Minimal access surgery camera manipulations (voice controlled) Automated colonoscope Colonoscopy (Nanyang Technological University, Singapore) EndoAssist (Armstrong Healthcare Ltd, High Wycombe) Laparoscopy, Cholecystectomy, Hernia repairs, Fundoplication, Splenectomy, Appendectomy, Hemicolectomy, Sympathectomy, Hysterectomy, Gynaecological laparoscopy Telesurgical systems (access to hard-to-reach areas, access without tremor, surgery on patients remote from the surgeon) da Vinci Surgical Systems Laparoscopy and minimally invasive surgery. Cardiac and vascular Intuitive Surgical Inc, US surgery: Mammary artery dissection, Multi-vessel coronary anastomosis, Mitral and aortic valve repair/replacement, Arterial grafting, Intracardiac surgery, Thoracic and abdominal aneurysms. General/digestive surgery: Cholecystectomy, Inguinal hernia repair. Nissen fundoplication, Colon resection. Gynaecology: ZEUS (Computer Motion, US) Hysterectomy, Bladder neck suspension (*) Endoscopic coronary bypass anastomosis / coronary artery bypass graft in both beating (closed chest) and non-beating hearts. Tubal reanastomosis Navigational Aids (passive manipulator arms that keep track of tools) VectorVision Neuro, spinal and ENT surgery (BrainLab) Viewing Wand Tumour surgery/biopsy (ISS Ltd, Canada) Precise Positioning Systems (powered robot moved to a location, locked off and power removed robot is used passively) NeuroMate Stereotactic brain surgery (Integrated Surgical Systems, US) PathFinder Precision neurosurgical navigation (Armstong Healthcare Ltd, High Wycombe) Precise Path Systems (robot is used actively, interacting with patient) ACROBOT Total knee replacement. Prosthetic knee implantation (Imperial College, London) Ames robot Brain biopsy (NASA, US) CASPAR (Orto Maquet, Germany) Cementless hip replacement. Implantation of knee and shoulder prostheses and cruciate ligament surgery Probot Transurethral resection of the prostate (Imperial College, London) Roboscope Neurosurgery (Imperial College, London) Robodoc Cementless total hip replacement. Version for total knee (Integrated Surgical Systems, US) SPUD - (Surgeon Programmable Urological Device) (Dornier Asia Medical Systems, NTU, Singapore) arthroplasty Enlargement and cancer of the prostate Note: (*) indicates that additional procedures are listed by Intuitive Surgical in Appendix 3. The above table was adapted from information provided by the National Horizon Scanning Centre, New and Emerging Technology Briefing report concerning Surgical Robots (2000) 3 and from Mckay- Davies et al. (2002). 4 The list of procedures is not exhaustive and does not account for current robotic surgical advances. 6

7 Details of robotic systems The National Horizon Scanning Centre, New and Emerging Technology Briefing report concerning Surgical Robots (2000) 3 provided a useful summary of several robotic systems (see Table 1). In the next section we will provide additional information about each of these robotic systems. We can not confirm whether all the robotic devices are still in use or are currently being used in the UK. Intern Replacements a) AESOP The AESOP uses a single mechanical arm with six degrees of freedom to position an endoscope. The AESOP enables surgeons to position an endoscope through voice-activation (e.g., right, left, in, out ) or manual control. b) EndoAssist The EndoAssist involves a helmet-mounted optical pointer that aims a camera. The coordinated head movements of the surgeon are tracked by the system. The camera can be moved when a footswitch is pressed. Telesurgical Systems a) Zeus The Zeus Robotic Surgical System involves a remote master workstation which allows the surgeon to view a two- or three-dimensional (2-D or 3-D) display. The surgeon is able to manoeuvre two hand-held manipulators to change and position two robotic arms that are attached to the operating table. The operator s hand movements are digitised and translated into motion. A mounted camera on the third arm can be controlled by voice activation (AESOP) or foot-pedal. On a second unit, ( slave unit), there are either three or four robotic arms attached to a mobile cart. In addition to the camera arm, two operative arms and a fourth optional arm for retraction are available. It is possible to grasp, move up/down, in/out, left/right and rotate. There are various Zeus models available (e.g., Zeus Z2P model which incorporates passive eyewear stereovision). b) da Vinci The da Vinci system involves a surgeon s viewing and control console and three surgical arms for insertion into the patient. 3 The surgeon-operated console is located outside the sterile field. One arm is used to hold the endoscope and the other to manipulate and hold the surgical instruments. A series of sensors provide the surgeon with sensory feedback concerning the gripping force. The da Vinci s System provides a stereoscopic 3-D vision of the surgical field. The surgeon s face is positioned in a console in which they view two eyepiece monitors from each of the digital camera channels. Unlike the Zeus system, the surgeon has no external visual cues. Furthermore, the da Vinci s EndoWrist has more degrees of freedom and adjustable grip strength than the Zeus system. The surgeon s master console contains foot controls that enable the surgeon to disengage the master controls from actual movement of the instruments. There appear to be upgrades to the system (e.g., a fourth robotic arm). Precise Positioning Systems a) NeuroMate NeuroMate is an image-guided robotic system for stereotactic neurosurgical procedures. It consists of a single robotic arm and console. The console processes preoperative magnetic resonance images (MRI) or computed tomography (CT) to create a 3-D map of the brain. Based on this information the surgical instruments are orientated, guided and positioned. The system is primarily locked in position whilst the surgeon manually operates, but it does have the capacity to perform more active surgical procedures. b) PathFinder The PathFinder surgical system receives a plan from MRI or CT images during a preoperative stage. The robot then positions the tool holder at the entry point along a straight-line trajectory. Following the surgeon preparing a burr hole, the robot inserts the surgical tool. 7

8 Precise Path Systems a) ACROBAT The ACROBAT robotic system is considered to be a hands-on robot that provides the surgeon with a force controlled input handle on the end of the robot. The system enables the surgeon to move a cutter through bone but restricts the amount of cutting and confines the cutting to a specific region. The robot provides additional torque to the cutting motors, which allows more effective slicing of the bone. Imperial College London recently reported that ACROBAT robot assisted knee surgery is significantly more accurate than conventional surgery. Full details of the study are provided at the Imperial College website (see b) Ames The Ames robot has a neural net technology that allows it to distinguish differences. The size of the probe is smaller than previously developed probes and can be inserted at a controlled speed and pressure. These developments enable it to reduce tissue damage and prevent artery penetration. c) CASPAR CASPAR (Computer-Assisted Surgical Planning and Robotics) is an alternative orthopaedic robotically assisted device, can create a bone tunnel for reconstruction of the cruciate ligament and prepare bony surfaces for total knee and hip arthroplasty. d) Probot Probot is considered an active robot which is designed for use with ultrasound 3-D imaging. It provides the surgeon with a computerised image of the area being operated on. Tissue is then cut with diathermy. e) RoboDoc RoboDoc is an active computer-controlled device that can execute a limited procedure independently of the operator. It consists of a preoperative planning computer (OrthoDoc) that uses 3-D computed tomography image data coupled to a 5-axis arm that holds a milling device. Robodoc can create a plan and mill the bone with specialised drill tools. Future developments Some currently used robot assisted systems can feedback on vector force; many do not allow the operator to appreciate other sensations (e.g., pressure, vibration, tension or heat). More recent robotic models are being designed to incorporate software and instrumentation that provide the surgeon with sophisticated real-time, continuous sensory feedback. 5 Future robotic models are likely to be more compact and smaller in size. 6 Advanced cameras with high-performance optics might also provide a wider-angle panoramic view and allow surgeons to have full control of imagery. It is also possible that the new developments in surgical instruments might also offer energy-directed therapy such as thermal ablation, laser, radio-frequency and high-intensity focused ultrasound. 3. How many patients have been treated robotically in England, Wales and Scotland, by year and by procedure? From the clinicians questionnaire responses, in the NHS hospitals, the number of procedures described using the robotic devices over the last 12 months ranged from 2 to 120 (Mean = 35, SD = 37), and in the last 12 to 24 months ranged from 2 to 304 (Mean = 70, SD = 103). The robots were being used both as part and for whole procedures; this varied depending on the robot and the procedure. 8

9 A large number of robotic surgical procedures have been completed both worldwide and in the UK between the years by Intuitive Surgical customers using the da Vinci Surgical System. These include: Urology Number of procedures completed worldwide: 34,302 Number of procedures completed in the UK: 172 General Surgery Number of procedures completed worldwide: 10,412 Number of procedures completed in the UK: 54 Cardiothoracic Surgery Number of procedures completed worldwide: 11,036 Number of procedures completed in the UK: 85 Obstetric and Gynecologic Procedures Number of procedures completed worldwide: 2,892 Number of procedures completed in the UK: None to our knowledge Acrobot Sculptor reported that 13 patients underwent unicompartmental knee replacement as part of a regulated clinical investigation using a procedure that the robotic device is licensed in the UK to provide. 4. What brands and types of machine are in use, and how are they licensed? We received manufacturer questionnaire responses concerning six robotic devices: Aesop System, Acrobot Sculptor, Assistive arm for mammotome, da Vinci Surgical System, EndoAssist and BioXbot. None of the robotic devices were designed for telesurgery. Four robotic devices were licensed in the UK: PathFinder (image guided robot for stereotactic neurosurgical procedures), EndoAssist (robotic camera holder and positioner), Aesop System and da Vinci Surgical System. Intuitive Surgical reported procedures that the robotic device used in addition to those for which it was licensed. The Aesop System has been approved for General Surgery, Urology, Gynaecology, Paediatric Surgery and Cardiac and Thoracic Surgery. Other areas of surgery for future licences are not being pursued at the present time. Furthermore, the da Vinci Surgical System has been approved for General Surgery, Urology, Gynaecology, Paediatric Surgery and Cardiac Surgery. Intuitive Surgical will seek approval for Off-Pump Totally Endoscopic Coronary Artery Bypass surgery in the future. Other areas of surgery for future licences include, but are not limited to, Vascular surgery and Ear, Nose and Throat surgery. None of the remaining manufacturers were seeking additional licences for other procedures for their robotic device in the UK. 5. How many different robots are available, and how many manufacturers supply them? Please refer to Table 1 and Appendices 1 and 2. The information we have provided is not exhaustive. The number and type of robot available currently is unclear as we relied on manufacturers who replied to our survey. 6. What the machines in current use cost (capital and running costs)? In the final section of the questionnaire we asked questions concerning the overall costs. Both PathFinder and EndoAssist provided details. The list price of the PathFinder system, including robot and surgical planning system, is 200,000. Pathfinder also reported that Clinical Partnership Agreements are available, which offer a reduced purchase price to centres wishing to participate in the further development of robotic surgical techniques. The EndoAssist system purchase price is 39,950. A three-year operating lease is available at a cost of approximately 950 per month. Included in purchase price is the installation of the robotic device. PathFinder and EndoAssist reported that maintenance costs to the purchaser of the equipment during the first year are included in the purchase price. In subsequent years the PathFinder maintenance contract costs 6,900 per annum and for 9

10 EndoAssist the maintenance contract is 3,950 per annum. Both PathFinder and EndoAssist are typically bought, not leased. Both the Aesop and da Vinci Surgical Systems have had their technology patented in the UK. The Aesop system costs $120,000 (US dollars) and the da Vinci costs 1,200,000 Euros, which includes installation. For both robots the running costs of the system will depend on the usage of the system, the number of procedures performed and the number of instruments used. Endowrist Instruments for the da Vinci Surgical System costs between $1,100 and $4,600 (US dollars) and each instrument can be used for a minimum of 10 procedures and a maximum of 20 procedures. The number of uses is particular to the type of instrument. The Aesop System has a one year warranty. In the event of malfunction, spare parts are available, otherwise there is complete replacement of the system. There is no preventive maintenance programme available with the system. The maintenance cost for the da Vinci Surgical System is $129,000 per year (US dollars). The costs of Aesop training provided within the standard da Vinci training varies according to the type of programme and the involvement of surgeon instructor. For the Aesop and da Vinci Surgical System training, programmes cost between $6,000 to $7,000 (US dollars) for a team of two surgeons for two days. The cost of a one-day programme is between $3,000 and $3,500 (US dollars). 10

11 C. Clinical and service considerations In this section we will summarise the manufacturer and clinician responses in relation to the number of staff required and training needed for the operating robotic surgical equipment. 7. How are robots being used by clinicians (e.g., for whole or part of a procedure)? The clinicians surveyed reported some variation in the use of robots for whole or part of the surgery. As expected, this depended on the procedure. Prostatectomy could be performed entirely by robots, while they might only be partially employed for a laproscopic nephrectomy. Cardiac procedures could be either complete or partial, but we are unable to provide further details from the responses. 8. What members of the clinical team need to be available to support the use of robots, and how are they deployed? In terms of how the robot impacts on the staff workload, there was a range of clinical team members needed by many robots as support. Several clinicians reported that no more staff than normal were needed. However, one clinician reported two extra staff were needed and one stated that an extra anaesthetist, surgeon and nurse were required. It is unclear to what extent the addition of the robot impacts on the traditional number of theatre and support staff required. With regard to the manufacturers recommendations as to the composition of the clinical team, Acrobot Sculptor was designed to be operated by the same staff composition as in conventional procedures. Similarly, PathFinder made no specific recommendations regarding the composition of the clinical team, which appeared to be unchanged from traditional methods. In contrast, EndoAssist removes the need for an assistant, allowing "solo surgery", but in more complex laparoscopic procedures (e.g., mitral valve repair, radical prostatectomy) one or more assistants are still required. BioXbot recommend a surgeon, radiologist (optional) and a nurse (optional) are trained to use the device. Aesop System recommend one surgeon is needed to use this device. For the da Vinci Surgical System the clinical team is a critical component to the success of a robotic case. There is a console surgeon who is the primary surgeon performing the procedure. Assisting the console surgeon should be either a Physician's Assistant or another surgeon (the role of this person is in changing instruments and assisting in surgery, retraction, countertraction. suction, irrigation, etc). There is usually a scrub nurse and sometimes a circulating nurse as well. An anaesthetist is present for all procedures and in cardiac surgery cases a perfusionist will be present as well. Therefore, a team for the da Vinci Surgical System generally consists of four to six people depending on the type of surgery. 9. Are robots used remotely either by clinicians working remotely in the same hospital or remotely from other sites? Five clinicians used their robots remotely and six clinicians reported their robots were not being used remotely in the same hospital. One clinician reported the remote use of the PAKY-RCM robot under direction of a research team at Johns Hopkins in Baltimore. 10. What impact do robots have on clinical training? A range of staff had attended training in order to use the robotic device: Anaesthetist Nurses Surgeons Surgical team Theatre nursing staff Technical staff Scrub nurses Consultants SPRS 11

12 Training was provided by the manufacturing company in the majority of cases (see Appendix 4). We have no evidence of surgical deskilling due to the use of robots. 11. What impact do robots have on use of theatre time and theatre staff compared with their use for equivalent procedures carried out non-robotically? In terms of the impact of the robotic device on theatre time compared to the equivalent procedure performed non-robotically a range of responses was provided. The majority of responses claimed that the robotic surgery takes longer. Some clinicians claimed robotic surgery takes much longer with 20 to 60 minutes being required for setting up the system before commencing the procedure. However, some claimed the use of a robot adds only a short period of time onto the traditional procedure (e.g., 5-10 minutes). 12. Do robots affect the length of hospital stay compared with length of stay for equivalent procedures carried out non-robotically? Several clinicians reported that by using of robots in surgery it might be possible to reduce the length of hospital stay in some patients (e.g., by 2-5 days or half to one third the time ). Three clinicians reported no change. 13. What is the impact (if any) of robots on related patient services and facilities? There were mixed views about the impact of the robotic device on related patient services. Five clinicians reported that their robotic device did not have an impact; the remaining clinicians who responded reported that there was an additional need for sterile drapes and other more expensive disposables. One clinician reported that robotic surgery resulted in increased theatre time and staff time for preparation. 12

13 D. Evidence base for use of robots In this section of the report, we will discuss the evidence base concerning robots in surgery. Rapid review of literature A scoping search of the literature was conducted during November 2005 in the Medline database with terms of robotic surgery and computer enhanced surgery. Appendix 5 provides a summary of the scoping search. Using a randomised controlled trial (RCT) filter, 16 possible RCTs were found. It should be noted that these were not evaluated for relevance. Literature search In order to provide a more up-to-date and comprehensive search of the literature, a second search was conducted in March Seven electronic databases were searched (BIOSIS [SilverPlatter], Cochrane Library [CDSR, CENTRAL, DARE, HTA, NHS EED], CRD Databases [University of York, Centre for Reviews and Dissemination: DARE, HTA, NHS EED], Embase [Ovid Online], Medline [Ovid Online], Medline in Process [Ovid Online], OHE HEED [Online version], Science Citation Index [ISI, Web of Knowledge]) providing coverage of the biomedical and grey literature and current research. In addition, the National Research Register, Current Controlled Trials and Clinical Trials.gov websites were searched. Sensitive keyword strategies using free-text and, where available, thesaurus terms were developed to search the electronic databases. The search strategies performed on each of the databases mentioned above are provided in Appendix 6. A methodological filter was also used to provide additional information on results of RCTs in the searches of Medline and Embase. Date limits were not used on any database. The literature search was restricted to English language publications. The full literature search produced a total of 9034 references. The RCT filter produced 208 RCTs. Due to time limitations these searches were not quality assessed or data extracted. Furthermore, due to the general scoping question, it was not possible to assess the relevance of each reference. In searching the database for manufacturer brands, support was found for the scoping search, in that the most reported manufacturer brand was da Vinci (294 references) with similar numbers of references being found as in the scoping searches for the remaining manufacturer brands. Overall, our comprehensive search of the literature concerning robotic surgery uncovered a wealth of published and unpublished literature. Due to the large number of previous reviews we will list some of the reviews published during January 2005 to March 2006 (see Table 2). 13

14 Table 2: List of existing reviews published in concerning robotics in surgery Authors Journal/Report Topic of review Australian Safety and Efficacy Register of New Interventional (2005) 7 Stepney: ASERNIP-S Report No. 48 Safety or efficacy outcomes of TLRP or EERP or RALP compared to open RRP or RPP (*) Cepolina et al. (2005) 8 Journal of Endourology Various types of robotic surgical devices Dasgupta et al. (2005) 9 British Journal of Urology International Robot-assisted urologic procedures Espat et al. (2005) 10 Cancer Journal Laparoscopic/thoracoscopic esophagectomy to telesurgical esophagectomy Finley & Nguyen (2005) 5 Current Surgery Robotic surgery in: urology, gynecology, cardiothoracic, pediatric, otolaryngology, neurosurgery, gastrointestinal, colorectal and more general surgery Hegarty & Kaouk (2006) 11 Canadian Journal of Urology LRP, open RRP and RALP Hoznek et al. (2005) 12 Current Opinion in Urology Laparoscopic and robotic radical prostatectomy Kariv & Delaney (2005) 13 Minerva Chirurgica Robotics in colorectal surgery Kaul & Menon (2005) 14 Minimally Invasive Therapy & Allied Robot-assisted urologic procedures (*) Technologies Kumar et al. (2005) 15 British Journal of Urology International Robotic renal and adrenal surgery Lunca et al. (2005) 16 Romanian Journal of Gastroenterology Gastrointestinal robot-assisted surgery Marescaux & Rubino (2005) 17 European Surgery - Acta Chirurgica Clinical and experimental applications of Austriaca Supplement robotics-assisted surgery Nathoo et al. (2005) 18 Neurosurgery Robotic technology in neurosurgery Rassweiler et al. (2006) 19 European Urology LRP and RALP (*) Rassweiler et al. (2005) 20 Minimally Invasive Therapy & Allied Technologies Robot-assisted urologic procedures Shah et al. (2005) 21 Current Urology Reports Review and describe the procedure of robotic-assisted laparoscopic radical cystectomy with urinary diversion Tewari et al. (2006) 22 Expert Review of Anticancer Therapy Robotic prostatectomy (*) Varkarakis et al. (2005) 23 Urology Robotic surgery and telesurgery in urology Note: All references indicated with (*) are systematic reviews. Key: LRP TLRP RRP RALP EERP RPP ASERNIP-S Laparoscopic radical prostatectomy Transperitoneal laparoscopic radical prostatectomy Retropubic radical prostatectomy Robot-assisted laparoscopic radical prostatectomy Extraperitoneal endoscopic radical prostatectomy Radical perineal prostatectomy Australian Safety and Efficacy Register of New Interventional Procedures - Surgical The above table summarises the recent reviews, systematic reviews and editorials on a range of robotic surgical procedures. It is beyond the scope of this briefing paper to evaluate the studies of individual procedures documented in these reviews. This would be the purpose of further systematic reviews. List of studies included in the review Due to the large number of areas in which robotic surgery is currently being used, we have presented some of the recent studies investigating a selection of surgical areas: general surgery; gastrointestinal surgery; colorectal surgery and urology (see Appendix 7 and 8). A recent review provides a comprehensive coverage of trials in many areas of robotic surgery (Finley & Nguyen, 2005). 5 This review is useful for consideration of other areas involving robotic surgery (e.g., cardiothoracic, paediatric, otolaryngology and neurosurgery). Validity and generalisability of the studies We aimed to provide a general overview of the range of recent reviews and studies concerning robotic surgery. The report has not quality assessed or undertaken an assessment of the level of evidence (e.g., RCT, case series). It is clear, however, that the amount of published literature in this area is growing. A series of systematic reviews with specific focus on individual procedures would assist in evaluating the validity and generalisability of the studies presented in this report. 14

15 14. What published evidence there is on the use of robots, in total and in comparative studies vs. conventional approaches? This remains a difficult question to accurately answer, due to the large amount of literature published. It is not possible to quality assess the level of all the literature found. Table 3 provides a list of prospective and RCTs on a range of specialist areas. Table 3: Prospective and randomised controlled trials (RCT) comparing a type of robotic surgery vs conventional non-robot surgical procedure First Author Challacombe et al. (2005) 24 Chauhan (2004) 25 Chin et al. (2005) 26 Cobb et al. (2006) 27 Decking et al. (2005) 28 Honl et al. (2003) 29 Kavoussi et al. (1995) 30 Klein (2003) 31 Kondraske et al. (2002) 32 Kopelman (2003) 33 Laine et al. (2000) 34 Luketich et al. (2002) 35 Lum (2002) 36 Martin (2005) 37 Morino et al. (2004) 38 Oberst (2003) 39 Perlick (2004) 40 Picard et al. (2001) 41 Saragaglia et al (2001) 42 Suhm (2003) 43 Suhm (2004) 44 Targarona et al. (2005) 45 Zhou et al. (2006) 46 Design RCT of human vs. telerobotic access to the kidney during percutaneous nephrolithotomy Randomised, prospective trial comparing computer-assisted knee arthroplasty vs. a conventional jig-based technique RCT comparing the radiological outcome of conventional techniques vs. computernavigated surgery for total knee arthroplasty Prospective RCT of unicompartmental knee arthroplasty comparing the performance of the Acrobot system with conventional surgery RCT comparing the alignment after computer-navigated total knee arthroplasty vs. a total knee arthroplasty with the conventional method Prospective study comparing robotic-assisted and manual implantation of a primary total hip replacement RCT comparing robotic vs. human laparoscopic camera control RCT comparing the bleeding complications in patients with atrial fibrillation undergoing cardioversion using transesophageal echocardiographically guided and conventional anticoagulation therapies RCT comparing the surgeon s workload and motion efficiency with robot and human laparoscopic camera control RCT comparing slow pathway catheter ablation of atrioventricular nodal re-entrant tachycardia guided by electroanatomical mapping to the conventional approach RCT comparing the accuracy of pedicle screw insertion with and without computer assistance RCT comparing HERMES-assisted vs. non-hermes-assisted laparoscopic antireflux surgery RCT comparing robot-assisted movement training vs. conventional therapy techniques for the rehabilitation of upper-limb motor function after stroke Prospective comparative study comparing CT-based and CT-free navigation in total knee arthroplasty Prospective RCT comparing robot-assisted vs. laparoscopic adrenalectomy. Prospective RCT comparing CCT analysis of leg alignment after navigated knee prosthesis implantation vs. conventional treatment RCT comparing navigated implantation of total knee endoprostheses in secondary knee osteoarthritis of rheumatoid arthritis patients to conventional technique RCT comparing traditional arthroscopic and computer-assisted navigation techniques Prospective RCT comparing computer-assisted knee arthroplasty with conventional procedure Controlled prospective study comparing fluoroscopy based surgical navitation vs. mechanical guidance system for percutaneous interventions Prospective, controlled clinical study comparing fluoroscopic guidance vs. surgical navigation for distal locking of intramedullary implants Prospective randomised comparison of conventional electrosurgery, bipolar computer-controlled electrosurgery and ultrasonic dissection RCT comparing the Zeus robot-assisted laparoscopic cholecystectomy in comparison with conventional laparoscopic cholecystectomy Note: These references have not been data extracted or quality assessed by the research team. It is possible that these studies may not be considered RCTs on more detailed consideration. Although we were unable to data extract or meta-analyse the RCTs presented above within the scope of this briefing report, it is clear from looking at the findings that mixed conclusions are being reported. For example, one laparoscopic adrenalectomy procedure was found to be superior to robotassisted adrenalectomy in terms of feasibility, morbidity, and cost. 38 In contrast some robotic surgical systems were reported to be better than conventional laparoscopic technique in terms of controlling the operative field, precision and stability. 46 In another case the robot appeared to be slower than human operators to complete insertions (p < 0.001), but was more accurate when compared with human 15

16 operators as it made fewer attempts (88% robotic vs. 79% human first attempt success; p = 0.046). 24 Careful data extraction of information concerning the type of robot and type of procedures being investigated is needed to be able to evaluate the benefits of robotic surgery in comparison to conventional surgery. 15. What are the rationale and advantages of using robots, by procedure? Table 4 summarises the strengths and weaknesses of robots in comparison to humans when performing surgery. Table 4: Advantages and disadvantages of human and robot technology Surgeons Robots Advantages Task versatility Repeatability Judgment experience Stable and untiring Hand-eye coordination Resistant to ionising radiation Dexterity at millimetre-to-centimetre scale Use of diverse sensors in control (e.g., chemical, force, acoustic) Many sensors with seamless data fusion Optimized for particular environment Quickly integrate extensive and diverse qualitative information Spatial hand-eye transformations handled with ease: improved dexterity Rudimentary haptic abilities Manage multiple simultaneous tasks Good judgement 3-D visualisations Easy to instruct and debrief Good degrees of freedom May be sterilised Good geographical accuracy Disadvantages Tremors Expensive Fatigue Cumbersome Limited dexterity No judgement Limited geometric accuracy Absence of haptic sensation Imprecision Large Variability in skill, age, state of mind Inability to process qualitative information Inability to process quantitative information easily Not versatile Ineffective at sub-millimetre scale Technology still in infancy Limited sterility More evidence of effectiveness needed Susceptible to radiation and infection Limited to simple procedures Large operating room space required Difficult to construct and debug The above table was adapted from information provided by Stoianovici (2000), 2 Lanfranco et al. (2003), 47 and Camarillo et al. (2004). 48 It was not possible to evaluate the advantages and disadvantages of each individual procedure. Overall, robots appear to have potential advantages over humans in performing specific types of tasks that require accuracy and repeatability. However, a major weakness of robots is that they are not adaptable; this would be problematic if an emergency situation developed during the course of surgery. 16

17 16. Do robots have a different safety and/or efficacy profile from equivalent procedures carried out non-robotically? Safety is a major concern for the use of robots in surgery. However, there is no absolute measure of safety. A recent review by Phee et al. (2005) 49 discussed the safety aspects of medical robots in the treatment of diseases of the prostate. They chose to differentiate between passive and active mechanisms. Passive mechanisms (i.e., manually operated) are generally safer than active mechanisms since the surgeon is in full control at all times. Some of the safety considerations raised in this review were concerned with: position sensors (these confirm position of various parts of robot); velocity sensors (these ensure tools move along correct path); mechanical stoppers and limit switches (these restrict movement to a pre-defined area); and an emergency switch (this stops any movements). The review recognises that many people are still unaware of the advantages of robots over surgeons when considering accuracy, speed and robustness. Surgeons themselves are often reluctant to let a robot perform tasks that they have been trained to complete. In a recent assessment of intraoperative safety in transoral robotic surgery, Hockstein et al. (2006) 50 reported that transoral robotic surgery on a human cadaver with the da Vinci Surgical System demonstrated a safety profile similar to conventional transoral surgery. In conventional transoral surgery with laryngoscope procedures specific risks range from minor lip and tooth damage to more severe injury to the face, jaw and eye. In addition, the position of the patient can make them vulnerable to cervical spinal injury. The human cadaver study by Hockstein reported here demonstrated that the forces generated by the da Vinci Surgical System were not sufficient to cause severe injury under intentionally reckless conditions. Sterility has been raised as a concern, since robots can become contaminated. Robotic devices need to be designed to prevent ingress of material and the individual components may need to be autoclaved or enclosed in sterile bags. 3 Other safety issues have been reported (e.g., monitoring of force, predefined cutting boundaries, emergency override, sterility, prevention of false activation). 3 Two questions might be considered when addressing the efficacy of robots in surgery: Why should we use robots in surgery? Do robots improve surgical outcomes? 17. What economic evaluations of the use of robots are available? Several published papers have provided economic evaluations concerned with the use of robots in surgery. Table 5 presents three of the more recent published papers. Table 5: Economic evaluations of the use of robots First Author Bhayani et al. (2005) 51 Scales et al. (2005) 52 Lotan et al. (2004) 53 Design Compared with 13 patients who underwent purely laparoscopic pyeloplasty (LP) The cost of equipment and capital depreciation for both procedures, as well as assessment of room set-up time, takedown time, and personnel was analysed Investigated the sensitivity of robot assisted prostatectomy and traditional radical retropubic prostatectomy inpatient costs to variations in length of stay, local hospitalization costs and robotic case volume in the specialist and generalist settings Evaluated the costs components of laparoscopic and robot assisted prostatectomy, and compared their costs to those of open radical retropubic prostatectomy Scales et al. (2005) 52 investigated local cost structures and economics of robot assisted radical prostatectomy (RRP) and robot assisted prostatectomy (RAP). The authors developed a model of RAP vs RRP costs in specialist and generalist settings using published data on operative time and length of stay, and cost data from our academic medical centre. All inpatient cost centres were included: postoperative care, professional fees, surgery costs, robotic equipment and service. The base 17

18 case model demonstrated a cost premium for RAP vs RRP of USD $783 and $195 in the specialist and generalist settings, respectively. It was concluded that while RAP may be cost competitive with RRP at high cost hospitals or high volume RAP specialist centers, this procedure would exist at a cost premium to RRP in other practice settings. In a similar study, Lotan et al. (2004) 53 developed a model to compare the costs of treatment with laparoscopic robot assisted prostatectomy (LRP), RAP or RRP. The cost of the robot was estimated at $1,200,000 with a $100,000 (US dollars) yearly maintenance contract. It was assumed that the robot would be used across different specialties for a total of 300 cases yearly in a 7-year period. RRP appeared to be the most cost-effective approach with a cost advantage of $487 and $1,726 (US dollars) over LRP and RAP, respectively. LRP cost more than RRP; this was primarily due to equipment costs ($533 US dollars) since the shorter hospital stay (1.3 vs. 2.5 days) was compensated for by longer operative time (200 vs 160 minutes). The costs of new technology tend to be higher in the first years of use and RAP is no exception with high robot costs for maintenance, purchase and operative equipment overshadowing savings gained by shorter length of stay. It was concluded that while RRP appears to be lower in cost, LRP is also similar in overall cost, whereas RAP might require a significant decrease in the cost of the device and maintenance fees. Overall, a limited amount of published information was available concerning the economic evaluation of robots in surgery, and further research would be beneficial. 18

19 E. Policy context and strategic direction We undertook a separate search of the literature to investigate whether any published literature had been reported concerning policy and robotic surgery. The search strategy used is reported in Appendix 9. Only one document was found concerning the strategic future use of robots for surgery in the NHS. 18. What UK policy and clinical groups have considered or are considering the strategic future use of robots for surgery in the NHS? In June 2005 NICE issued an Interventional Procedure Guidance report concerned with totally endoscopic robotically assisted coronary artery bypass grafting. The Institute's Interventional Procedures Advisory Committee considered the available evidence and the views of Specialist Advisors, who were consultants with knowledge of the procedure. The Advisory Committee made provisional recommendations about totally endoscopic robotically assisted coronary artery bypass grafting. At the time the report was written the evidence on the safety and efficacy of totally endoscopic robotically assisted coronary artery bypass grafting did not appear adequate for this procedure to be used without special arrangements for consent and for audit or research. It was also recommended that clinicians wishing to undertake totally endoscopic robotically assisted coronary artery bypass grafting should take the following actions: Inform the clinical governance leads in their Trusts. Ensure that patients understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. Use of the Institute's information for the public is recommended. Enter all patients having totally endoscopic robotically assisted coronary artery bypass grafting onto the UK Central Cardiac Audit Database ( The Institute may review the procedure upon publication of further evidence. As part of compiling this report we were able to speak to the President of the Royal College of Surgeons (Edinburgh). He reported that a paper had been prepared recently for the surgical specialties board which detailed the current position of robots in urology. This paper concluded that although the technology was available to be used, there were many issues unresolved which included the length of time to set up for surgery, the longer time it often took to carry out the procedure and the capital investment required. The Royal College of Surgeons agreed that this was an interesting new technology which should be developed further in a research environment. 19. What policy documents have been prepared, e.g., by the Department of Health, that might influence the future uptake and use in the NHS? No additional policy documents were found. We contacted the Department of Health directly to update our information. We were informed that there was no existing strategy or plans for implementing policies relating to robot assisted surgery. 20. What external pressures there are to adopt their use, including future trends and comparisons to other countries? There is considerable interest in the use of robotic surgery in the United States. This is exemplified by the large number of training courses available for specific surgical procedures across the United States, in particular for the da Vinci Surgical System. In relation to the questionnaire responses, five manufacturers reported that future robotic devices were being developed and one said, not at the moment. 19

20 F. Summary of issues for consideration by NICE In this final section we aim to provide a summary of issues which have been raised during the writing of this report. Definition There appear to be different definitions being used to describe robotics in surgery. This needs to be addressed and a clear definition recognised. It has been noted that some patients are not comfortable with the term robot. The terms computer controlled instrument or monitored safety frames may be more acceptable. 3 How do we assess the safety and efficacy of robots in surgery? In order to evaluate the effectiveness of robots in surgery we need to be clear about: What type of robotic device is being evaluated? What patient population? What is the type of interventional procedure? What is the comparator? What are the outcomes? Traditionally the benefits of robotic surgery have been compared relative to conventional procedures. However it has been claimed, rather, that the use of robots should be justified over computer assisted surgery (CAS). 1 What robotic devices are in use in the UK and for what type of surgery? From the available evidence, reports from manufacturers and questionnaire responses from clinicians we are unable to state reliably the robotic surgical systems currently being used in the UK. Different types of device available? The report has summarised a range of robotic surgical systems which have been documented in the literature and from questionnaire responses. There is considerable uncertainty surrounding which devices are currently in use in the UK, as surgical systems are being rapidly updated and revised. Which procedures are of most importance? A large amount of literature appears to have focussed on urological procedures. A greater number of publications appear to have been reported concerning the use of the da Vinci robotic system. Costs With the advances in robotic surgical devices, one must consider the differences in costs across robots. The updating and modification of surgical devices also needs to be recognised. At present it would be difficult to establish which robotic device is most clinically effective, since there is a lack of RCT evidence comparing robotic systems. There is still uncertainty surrounding other costs such as the time to set up the system, operating time and hospital stay; these varied across robotic systems and procedures. It is important to recognise that some studies reported that system setup time decreased as the experience of the operating team increased, emphasising the importance of training. Patient outcomes Several studies have reported no differences in post-operative morbidity compared with conventional procedures related to their robotic system. Greater consideration of patient outcomes in terms of quality of life is needed. A number of studies have confirmed the safety and feasibility of robotassisted surgery. Large-scale, multi-centre, RCTs might be useful to determine the benefits of robotic surgical systems across the wide range of areas of surgery as compared with the technology currently in use. 20