Robotic surgery

DOI: 10.1111/j.1471-0528.2008.02038.x

Review article

www.blackwellpublishing.com/bjog

Robotic surgery HWR Schreuder, RHM Verheijen Department of Women and Baby, University Medical Centre Utrecht, Utrecht, the Netherlands Correspondence: Prof RHM Verheijen, Department of Woman and Baby, University Medical Centre Utrecht, PO Box 85500, Room F05-126, 3508 GA, Utrecht, the Netherlands. Email [email protected] Accepted 12 October 2008.

Over the past decade, there has been an exponential growth of robot-assisted procedures and of publications concerning roboticassisted laparoscopic surgery. From a review of the available literature, it becomes apparent that this technology is safe and allows more complex procedures in many fields of surgery, be it at relatively high costs. Although randomised controlled trials in gynaecology are lacking, available evidence suggests that

particularly in gynaecology robotic surgery might not only reduce morbidity but also be cost effective if performed in high-volume centres. Training in robotic surgery and programs for safe and effective implementation are necessary. Keywords Gynaecology, laparoscopy, robotics, robotic surgery,

training.

Please cite this paper as: Schreuder H, Verheijen R. Robotic surgery. BJOG 2009;116:198–213.

Introduction The use of robots is rapidly increasing with a market growth worldwide from less than 5 billion in 2000 to an expected 25 billion in 2010.1 Robotic technology offers the unique opportunity to control the operational process outside the actual location, with the skilled and often expert operators not necessarily being physically present. Probably, more important than the teleoperating features are opportunities for extremely precise, controlled and fatigueless acts of the robot. This will make it possible to replace human movements that are limited both in time and in space to make complicated processes more secure and safe. Interestingly, until recently robotic technology was mainly applied in manufacturing processes but is now becoming increasingly important 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.

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 computerised 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.

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

Search strategy Over the past two decades, the number of publications on robotic surgery has risen exponentially (Figure 1). A computer aided and manual search for systematic reviews of randomised controlled trials, prospective observational studies,

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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

ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology

Robotic surgery (efficacy, costs and training)

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

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Figure 1. Publications about robotics in www.embase.com (search terms robot or robotics).

and surgical robotics were integrated and the first steps towards telepresence surgery were made. The commercialisation of robotic surgery started in the early 1990s. The next step was the development of complete robotic systems. The Zeus robotic system (Computer Motion, Goleta, CA, USA) and the da Vinci robotic system (Intuitive Surgery, Mountain View, CA, USA) were introduced in the late 1990s. Both systems have remote manipulators that are controlled from a surgical workstation; in less than 20 years’ time, there had been a major development in robotic surgery (Table 1). In 2003, Computer Motion was taken over by Intuitive Surgery and today the Zeus system is no longer commercially available. The da Vinci platform is the only telerobotic system currently commercially available. The da Vinci system was approved for general surgery by the US Food and Drug Administration (FDA) in 2000, for the use in urology in 2001 and for gynaecology in 2005.

Description of technique The da Vinci robotic system (Intuitive Surgery) has three major components (Figure 2). The first component is the surgeon console. The surgeon sits ergonomically behind the

Table 1. Robotic surgery in time 1985 1989 1992 1993 1996 1996 1998 2000

First robot used for stereotactic brain surgery3 PROBOT, first robot used for prostatectomies4 ROBODOC use for hip replacement5 AESOP, first commercially available robot approved by the FDA6,7 ARTREMIS, master slave manipulator system8 EndoAssist, robot camera holder9 Zeus robotic system commercially available10 da Vinci robotic system FDA approved

console and controls the robotic system remotely. The console can be placed anywhere in or even outside the operating room. While operating, the surgeon is viewing a stereoscopic image projected in the console and controls the robotic arms with hand manipulators and food pedals. The position provides an optimal hand–eye alignment. The surgeon has limited haptic feedback, so one should rely on visual feedback. The second component is the Insite Vision System (Figure 3). A three-dimensional (3D) view is created with the use of two camera control units and two light sources, built in the unit. A 12-mm endoscope (0 or 30) is used. The viewer gives a six to ten times magnification of the operating field. Because of the 3D 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, and 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 df 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 reversefulcrum effect that 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.

Robotics in nongynaecological surgery 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.11 Robot assistance is also applied for cystectomy, pyeloplasty, adrenalectomy,12,13 renal surgery,14 radical nephrectomy,15 donor nephrectomy,16 urogynaecology and paediatric urology.17 Since the first da Vinci robot-assisted radical prostatectomy was published in 2000,18 multiple large prospective trials (300–2652 cases) have been published.19–23 Reviewing these data, Box and Ahlering 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


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Schreuder, Verheijen

Figure 2. da Vinci S HD robotic system (surgeons console, patient side card with robot arms, InSite vision system) (ª[2008] Intuitive Surgical, Inc.).

that in experienced hands, the percentage of positive surgical margins in the robot-assisted procedure is equivalent or better compared with the open radical prostatectomy. Continence rates achieved with the robot-assisted procedure are excellent and the return of sexual function is very good.24 Other reviews draw almost the same conclusions.11,25,26 The

technique of the robot-assisted radical prostatectomy is described in detail by Tewari and Menon.27,28 The adoption of the robotic-assisted radical prostatectomy on a large scale in Europe is slower than in the USA. This could be a related to

Figure 3. InSite Vision, three dimensional view, with console master (ª [2008] Intuitive Surgical, Inc.).

Figure 4. EndoWrist instrument, 7 df, just like the human wrist (ª[2008] Intuitive Surgical, Inc.).

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robotic procedure in which proper randomised trials are published. Four, relatively small, randomised trials found no differences in terms of feasibility and outcome, but the costs of the robot-assisted procedure were higher.55–58 However, in contrast to primary procedures, repeat fundoplications are often more demanding and could benefit by robot assistance.59 The first studies addressing the robot-assisted cholecystectomy were performed using the Zeus robotic system60–62 and later studies with the da Vinci robotic system.63–66 Based on these studies, there is not enough evidence for routine use of the robot for this procedure.64 A Cochrane review concerning robotic surgery for the cholecystectomy is under way.67

Other subspecialties Figure 5. EndoWrist instruments belonging to the da Vinci Robotic system (ª[2008] Intuitive Surgical, Inc.).

the high level of experience in conventional laparoscopy already available in Europe. Also, Europeans are more expectant for more evidence to show the advantage above conventional laparoscopy. The high costs of setting up a robotic program could also be a burden for centres. Randomised clinical trials comparing the open with the robot technique are unlikely to take place and other tools of assessment are needed.29 Randomised clinical trials between different robotassisted procedures are more likely to take place.30 In 2008, Lam et al. started to write a Cochrane review about the surgical management of prostate cancer. This review will also address the issues concerning robot surgery.31 Cystectomy is mainly used for the treatment of bladder cancer. The first robot-assisted laparoscopic radical cystectomy was described in 2003.32 Since then several other authors have published their initial experiences with this procedure.33–36 The procedure is safe with acceptable operating times and good shortterm functional and oncological results.37–40 In 2008 Elhage et al. described their surgical technique and looked at the financial aspect from a British perspective.41 Another difficult laparoscopic procedure in urology is the ureteropelvic junction reconstruction (pyeloplasty). Although short-term results seem to be similar to those of the conventional laparoscopic pyeloplasty42–45 and open repair,46 for experienced laparoscopists, there was no significant clinical advantage using robot assistance.47

General surgery Robotic-assisted laparoscopy is used for Nissen fundoplications, cholecystectomies, gastric bypass surgery,48,49 colectomies,50 mediastinal lymphadenectomy and esophagectomy,51,52 mediastinal parathyroidectomy and thymectomy.53 In 1997, the first robot-assisted Nissen fundoplications for gastroesophageal reflux were performed.54 Notably, this is the only

Robot assistance is used in cardiovascular surgery for mitral valve repair, atrial fibrillation surgery, coronary revascularisation, left ventricular lead placement and congenital heart disease surgery.68–70 In 2005, the FDA approved the da Vinci robot for mitral valve surgery and it has become an accepted procedure.71 The da Vinci robot is also used for aortobifemoral bypasses72 and aortoileac reconstruction.73 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.74–76 A pilot randomised controlled trial between robot and conventional laparoscopic fundoplication in children was performed.57 A recent overview of the current status of robot-assisted surgery in children is given by Sinha and Haddad.77 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 described78,79 and neurosurgery, where results are not yet published.80 One of the major problems for these robots is the different types of tissue, bone and soft tissue to be handled. Different robots are used in neurosurgery for microscopy, navigation, instrumentation, optics and imaging.81–83 The da Vinci system is not used in orthopaedics, but different robots are used.84

Robotics in gynaecology Reproductive surgery Tubal reanastomosis Although this microsurgical operation seems to suit the features of robotic surgery, there is not much literature available. The first complete robotic-assisted tubal anastomosis in humans was performed in 1997 with the Zeus robotic system in Cleveland, USA.85 In 2003, Goldberg and Falcone compared the robotic-assisted procedure with conventional laparoscopic procedure. The operation time was 2 hours longer with the robot, and there were no significant differences in tubal patency and clinical pregnancy rates.86 The tubal anastomosis by robotic assistance was compared with


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minilaparotomy by Rodgers et al. They performed 26 robotassisted cases and 41 minilaparotomy cases. Mean anaesthesia time and surgical time were 283 and 229 minutes, respectively, for the robot group compared with 205 and 181 minutes for the minilaparotomy group. There were no differences in hospital stay, pregnancy rates and ectopic pregnancy rates. Costs were significantly higher in the robot group and return to normal activity was significantly shorter in the robot group.87 The first reanastomosis with the da Vinci robotic system were published by Degueldre et al. After a feasibility series of eight women,88 they evaluated 28 women in 2001. The mean operating time for bilateral anastomosis was 122 minutes, and there were no complications. Median hospital stay was 1 day (1–2).89

Myomectomy A laparoscopic approach to myomectomy results in less postoperative pain and faster recovery compared with laparotomy.90 There is no significant difference between laparotomy and laparoscopy concerning pregnancy rates, miscarriage rates, preterm delivery or caesarean section.91 Laparoscopic myomectomy is an advanced procedure that needs multilayer laparoscopic suturing, resulting in a long learning curve. This could be the main reason laparotomy still remains the primary access route to surgical treatment of intramural and subserosal fibroids. Nevertheless, the robot could be very helpful with enucleation and suturing. The first experience with robot-assisted laparoscopic myomectomy was published in 2004.92 In a case series of 35 women, this was presented as a promising new technique that may overcome the surgical limitations of conventional laparoscopy. A second series by the same author was a retrospective case matched (age, body mass and myoma weight) analysis of 58 women treated with robot-assisted laparoscopy and laparotomy.93 The robotic approach had less blood loss, shorter hospital stay and lower complication rates but was more expensive. The technique of the robotic-assisted laparoscopic myomectomy used in these two studies is explained in detail.94 A case of a robot-assisted enucleation of a large myoma is described by Mao et al.95 Sroga et al. described 15 women in whom they performed a robot-assisted myomectomies and found operative time to range from 159 to 389 minutes, with an average blood loss of 160 mL.96 In a retrospective matched control study of 15 cases comparing robot-assisted laparoscopic myomectomy and laparoscopic myomectomy, no difference in blood loss, hospital stay and postoperative complications was found. The robot procedure took little, but significantly, longer (234 versus 203 minutes).97

General gynaecology Although robot assistance in general gynaecology is most widely used for hysterectomy, no randomised trials have been reported. The first robot-assisted hysterectomy was published

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in 2001.89 The first series of the robot-assisted hysterectomy for various indications was described in 2002 by Diaz-Arrastia et al., who performed the procedure in 11 women including a 10-hour case of full staging for ovarian cancer where repositioning of the robot was needed twice.98 Three years later, Beste et al. published their first ten cases, with an operative time similar to the standard laparoscopic hysterectomy; they reported that the robot has unique advantages for knot tying, suturing and adhesiolysis.99 In the same year, Marchal et al. published 30 cases (18 benign and 12 endometrial cancer stage I). The mean set-up time for the robot was 30 minutes, the mean operative time was 185 minutes and the mean robot use time was 120 minutes. There was no morbidity related to the robotic system.100 Twenty cases were described in 2006 by Fiorentino et al. Mean operative time was 200 minutes, mean blood loss was 81 ml and hospital stay was 2 days. There were two conversions due to poor visualisation.101 Sixteen cases of a robot-assisted laparoscopic hysterectomy were published by Reynolds et al. Their mean operative time was 242 minutes (170–432) and mean hospital stay was 1.5 days.102 The details of their technique have been described separately.103 Robot assistance can be particular of help in difficult cases to overcome the surgical limitations of conventional laparoscopy. Six cases with scarred or obliterated anterior cul-de-sac underwent a robot-assisted hysterectomy without conversion with satisfactory outcome.104 Nezhat et al. described his first experience in robot-assisted surgery in a diverse case series of 15 women (hysterectomy, endometriosis, lysis of adhesions and cystectomy). The visualisation, great surgical precision, decreasing fatigue and tension tremor of the surgeon and added wrist motion appeared an advantage. The costs added operating time and the bulkiness of the equipment were considered a disadvantage.105 A large prospective study of 91 women was published by Kho et al. Robot-assisted laparoscopic hysterectomy took a mean operating time of 128 minutes, with a mean console time of 73 minutes. As expected, console time decreased with experience and was significantly associated with uterine weight and adhesiolysis. Mean blood loss was 79 ml and the mean hospital stay was 1.3 days. There were no conversions, no bladder or urethral injuries occurred, but one enterotomy was repaired robotically. Six women were readmitted postsurgically because of ileus, pneumonia, vaginal cuff abscess, colitis and two for pain control. From this large series, it can be concluded that robotassisted laparoscopic hysterectomy can be performed safely and effectively with acceptable operating times. The robot overcomes many limitations of the conventional laparoscopy.106 In 2008 an equally large retrospective comparison between 100 women who underwent a total laparoscopic hysterectomy and 100 women who underwent a robot-assisted laparoscopic hysterectomy was published. Overall, the operating time was 27 minutes longer in the robot group. But the last 25 robotic cases compared with the conventional



laparoscopy cohort had a significant shorter operating time of 79 versus 92 minutes. The mean blood loss was significantly less in the robot group (61 versus 113 ml), the mean length of hospital stay significantly shorter (1.1 versus 1.6 days), while the incidence of adverse events was the same. The conversion rate in the robot group was lower (4 versus 9%). Others have also found that once the learning curve is completed, there is a reduced operative time, reduced blood loss and a reduced hospital stay in patients treated robotically.107 Other procedures performed successful with robot assistance are ovarian transposition.108 A recent innovative and promising application is abdominal cerclage for cervical insufficiency.109

Pelvic surgery (urogynaecology) Robot-assisted surgery with the da Vinci robot is used in vesicovaginal fistula repair, sacrocolpopexy and rectovaginopexy. Laparoscopic repair of vesicovaginal fistulas is rarely performed because of its technical difficulty, and there are few case reports reporting robot-assisted repair.110,111 A case series of five was performed with a mean operative time of 233 minutes and a blood loss of less than 70 ml, with a 100% closure rate.112 Robot-assisted laparoscopic sacrocolpopexy was first described in 2004.113 In 20 women, the mean operative time was 212 minutes.114 In a subsequent series of 31 women, the same author reported exactly the same mean operative time of 212 minutes.115 At 1-year follow up, 4 of 30 of these cases had recurrence of prolapse or extrusion of mesh.116 Ayav et al. described 18 consecutive cases of pelvic organ prolapse successfully operated with the da Vinci robotic system. They concluded that using the da Vinci robotic system is feasible, safe and effective for the treatment of pelvic organ prolapse.117 Robot-assisted rectovaginopexy was described in 15 women by Draaisma et al.118 Median set-up robot time was 10 minutes, and median skin-to-skin operating time was 160 minutes, median blood loss less than 50 ml and median hospital stay was 4 days. Two other small series of six and ten women also showed the feasibility of this procedure.119,120

Gynaecological oncology Laparoscopy can be safely and adequately used in the treatment of endometrial, ovarian and cervical cancer.121 The initial experience and the first publications of robot assistance in gynaecological oncology date from recent years. Reynolds et al. performed seven staging procedures in ovarian and endometrial cancer patients, with a mean operating time of 257 minutes.122 Twelve hysterectomies for endometrial cancer (stage I) were performed by the group of Marchal et al.; robotic surgery was safely performed and had a major advantage for the surgeon’s ergonomics.100 A series of 20 diverse procedures in gynaecological oncology has been described by Field et al.123 Boggess presented 43 robotic versus 101 laparo-

scopic staging procedures for endometrial cancer at the American College of Surgeons. There were no conversions in the robotic group versus 3% in the laparoscopic group. In the robot group, the operative time was significantly shorter (163 versus 213 minutes), significantly more nodes were received (30 versus 23), there was significantly less blood loss (63 versus 142 ml) and shorter hospital stay (1 versus 1.2 days). Notably, surgeons were better able to perform comprehensive staging on obese women with the robot.124 A large series was published by Seamon et al.125 Seventy women with endometrial cancer underwent a robot-assisted hysterectomy with pelvic and para-aortic lymphadenectomy. Next to a very detailed overview of their set-up protocol including patient positioning, trocar placement and instruments used, they also included video material in the online publication. Such visual presentations can certainly help others to shorten their learning curve. For all women in whom the robotic procedure could be completed, the median total time skin-to-skin time was 257 minutes (159–380). The average time from entering the theatre to incision was 45 minutes, the average time from incision to docking robot was 25 minutes, the time for the hysterectomy with bilateral salpingectomy was 86 minutes and the time for the pelvic and aortic lymphadenectomy was 45 minutes each. When comparing the first ten cases with the last ten, there was a significant improvement, with shortening in time at all different stages of the procedure. The conversion rate was rather high (9.86%), mean blood loss was 75 ml and mean hospital stay was 1 day. Veljovich et al. published their first year experience, performing 118 robotassisted oncology procedures for different gynaecologic oncologic conditions. They compared their robot procedures with open and conventional laparoscopic procedures. They found less blood loss, shorter hospital stay and longer operating time in the robot procedures (but operating time significantly decreasing with experience).126 The technique of the robotic retroperitoneal para-aortic lymphadenectomy has been described by Vergrote et al.127 The first radical hysterectomy in cervical cancer with robot assistance was described by Sert and Abeler.128 They concluded that radical dissection could be performed much more precise than with conventional laparoscopy. In 2007, they described 15 women with early-stage cervical cancer as a pilot case–control study and compared robotic-assisted laparoscopic radical hysterectomy with conventional total laparoscopic radical hysterectomy. There was a significant difference in mean operating time (241 minutes in the robot group and 300 minutes in the conventional group). No difference in the number of lymph nodes and size of parametrial tissue was found. In the robot group, there was significant less bleeding and shorter hospital stay.129 A prospective analysis of 27 women with early-stage cervical cancer undergoing a robotic radical hysterectomy was performed by Margina et al., and a comparison was made with matched patients operated by


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conventional laparoscopy and laparotomy. They concluded that operating times for robot surgery and laparotomy were similar (189 and 166 minutes) and significantly shorter compared with laparoscopy (220 minutes). Blood loss and length of hospital stay were similar in robotics and laparoscopy and significantly longer in laparotomy. At a mean follow up of 31 months, there were no recurrences at all.130 Kim et al. performed robotic radical hysterectomy and pelvic lymphadenectomy in ten cases and found a mean operating time of 207 minutes. The mean docking time was 26 minutes, but this was reduced significantly with experience (from 35 to 10 minutes).131 Kowalski et al. compared 14 robotic versus 17 open radical hysterectomies. Their mean operating time was significantly longer in the robot group (204 versus 121 minutes).132 These small series, however, do not report the outcome of surgery in terms of lymph node yield and radicality and also lack sufficient oncological follow up. Boggess found no difference in the operating time (242 versus 240 minutes).124 He performed 13 robot-assisted radical hysterectomies and compared them with 48 open radical hysterectomies. Significantly more lymph nodes were collected in the robot group (33 versus 22). All the robotic patients were discharged within 24 hours. He also describes how to set up a robotic programme in gynaecological oncology. A robotic radical hysterectomy in 20 women was described by Fanning et al. Operating console time reduced from 8.5 to 3.5 hours in 20 cases. Less blood loss and shorter hospital stay was found. There were no recurrences at a median follow up of 2 years.133 There are currently no randomised trials concerning robotic surgery in gynaecological oncology, and none of the published studies provides information on long-term effects, such as survival, lymph oedema, continence and sexual function.

Robotics and anaesthesia Danic et al. describe anaesthetic considerations in 1500 radical prostatectomies.134 Some special arrangements have to be made when performing robot-assisted surgery in the pelvis. Preoperatively, there is no need for a full bowel preparation, but it is advisable to use a laxative on the day before surgery. During the operation, special attention must be given to the positioning of the patient. Cushioned stirrups should be used to place the patient in lithotomy position. During the operation, 45 steep Trendelenburg position is used and the patient is prone to slip of the table. One can use a chest binding in an ‘x’-like pattern over the acromia to prevent this, paying attention to pressure areas. The most common anaesthesia-related complication (3% of the cases) was corneal abrasion, despite the use of eye tape. This could be significantly reduced with the use of eye patches. Constant positive airway pressure of 5 cmH2O preserves arterial oxygenation during prolonged pneumoperitoneum.135 Baltayian published a comprehensive overview of anaesthetic considera-

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tions and detailed anaesthetic management for robot-assisted radical prostatectomy. This could be of help for centres starting a robotic program and where the anaesthetists are not familiar with the specific measures for these type of procedures.136

Cost-effectiveness An important issue in robotic surgery are the higher costs compared with regular surgery. Several costs comparisons have been made in the past few years. We will only discuss the costs for the use of the da Vinci robotic system since this is the only robotic platform available at this moment. The latest robotic da Vinci S system will cost approximately e1.5 million in Europe plus e150.000 yearly for maintenance. Instruments are available at approximately e250 per instrument used, however, price changes are expected with current currency fluctuations. Finally, extra costs for training, delay in set-up and extraoperative time during the learning curve should be anticipated. A recent description of the cost patterns using a robotic system is given by Prewitt et al. They analysed 224 procedures in different subspecialties in a single institution and found $1470 greater direct costs for the use of the robotic system.137 Analyses of costs for different procedures are made: for robot-assisted laparoscopic rectopexy, there was an increase in operative costs of e557 or $745 (including material and time).138 For tubal anastomosis, the increase was $1,446.87 For myomectomy,93 pyeloplasty,47 cholecystectomy64,139 and Nissen fundiplication,58,140 higher costs were also found for robot-assisted procedure. Most, if not all, cost-effectiveness analyses do not or only partly take into account indirect costs. Morgan et al. compared all ‘in hospital’ costs for the use in cardiac surgery. When leaving out the initial capital investment for the robotic system, there was no significant difference in costs between the robot procedure and the sternotomy procedure.141 Most cost analyses have been performed for radical prostatectomy. The cost of the open conventional laparoscopic and robot-assisted radical prostatectomy has been compared by different groups. Burgess et al. found significantly higher operative costs for the robot-assisted procedure, although these costs decreased after the learning curve was completed.142 The intraoperative costs were higher in the robot-assisted procedure but the shorter hospital stay in the laparoscopic/robot procedure should be taken into account.143 In relation to this, it is important to realise that the costs of hospital beds vary between hospitals, especially between community hospitals and academic medical centres. So, a robotic program will be most competitive in a high-cost hospital combined with a high volume of cases.144 An extensive cost analysis for pyeloplasty by experienced surgeons excluding the learning curve showed cost-effectiveness if operating time is less then 130 minutes and the yearly cases are above 500.145 Steinberg also concluded that after the initial



learning curve, a program of robot-assisted radical prostatectomy, the procedure can be profitable, but that one should maintain a high volume to pay for the robot and its service.146 The costs of the initial learning curve are high and can vary widely. A theoretical model of the expenses of the learning curve was made by including eight series. The costs of the initial learning curve varied from $49,613 to $554,694 with an average of $217,034. To overcome these high costs, the concept of high-volume centres is of great importance. In such centres, the learning curve can be rapidly traversed and costs minimised.147

Training and education in robotics With the implementation of robot-assisted laparoscopic surgery, there is also an increasing need for training. Conventional laparoscopic surgery requires different skills and training compared with open surgery. Basic laparoscopic skills can be obtained in a box trainer, in a cadaver or with virtual reality.148 Training for specific procedures is possible in a cadaver or in a virtual reality environment. In conventional laparoscopy, the surgeon has a two-dimensional (2D) view, while in robotic surgery, the view is 3D, allowing tasks to be performed quicker and more efficiently.149–151 In contrast to open surgery, the basic laparoscopic and robotic skills can improve significantly in a relatively short-intensive course.152 Question is how to maintain this improvement after a course and whether this improvement translates to better surgery? Robot-assisted surgery can be learned in different ways than conventional laparoscopy. Training on human cadavers still gives the best anatomic training, but fresh human cadavers are not always available. Coordination for multiple cadaver use increases the availability of human material and is advisable.153 The advantage of using fresh tissue models (like porcine intestine) is obvious in developing delicate tissue handling. A complex sewing task, like a robotic-sutured intestinal anastomosis, can be reproduced successfully by residents.154 For vascular surgery, a standardized and reproducible training module, using pigs and rats, was developed.155 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.156 The dV-trainer robotic simulator (Mimic Technologies, Inc., Seattle, WA, USA) has modules for system training and for skills training.157 Face, content and construct validity for the virtual reality dV-Trainer were established.158,159 Another virtual reality trainer is the SEP robotic surgery simulator (SimSurgery, Oslo, Norway, USA)160 (Figure 6). Training on basic robot-assisted suturing skills using this simulator equalled training using a mechanical simulator.161 At the Uni-

Figure 6. SEP da Vinci robotic simulator (ª[2008] SimSurgery).

versity 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.162 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.163 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.164 Students of today easily and readily adopt virtual reality as part of their regular training program.165 The new generation of medical students has grown up in the age of computer technology and it has been shown that prior videogame experience can shorten the time to learn basic skills in virtual reality simulation for minimal invasive surgery,166 except for robotic suturing, where prior videogame experience had a negative impact on robotic performance.167 New developments are the use of a mentoring console. The prototype of the da Vinci mentoring system was tested by Hanly et al. It facilitates collaboration between the mentor and the resident during robotic surgery. It improves performance of complex three-handed tasks. This feature can also contribute to the patient’s safety in hospitals with robotic surgical training programs. On the other hand, it improves resident participation and resident education.168 Other new developments in training robotics are the use of augmented visual feedback to enhance robotic surgical training.169 The


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use of 3D telestration technology during an actual operation not only provides immediate feedback but it is also safer for the patient through immediate guidance of the surgeon by a more experienced mentor.170 Together with the approval of the FDA, the manufacturer of the da Vinci robotic system (Intuitive Surgery) was demanded to provide comprehensive training for all teams and surgeons planning to use the robot clinically. The registered training centres, located all over the world, can be found on their website. Today 23 official training centres are noted.171 The first training curriculum for robotic surgery was developed at the East California University, California.172 Special attention should be given to the training of residents and fellows. In the early days, the exposure of residents to robotic training was low.173 In 2003, the interest of general surgery residents in robotic training was 57%.174 In 2006, already 75% of the residents surveyed would pursue a fellowship robotic surgery.175 A growing interest is noticeable and more attention is given to robotic training of residents and fellows. A systematic approach should be used, starting as table site assistant and followed by a stepwise approach of the actual surgery as a console surgeon.176 Unlike open surgery, robotic surgery provides safe and easy opportunity to divide the operation into smaller segments, enabling participation as a console surgeon depending on the experience of the resident or fellow. It is advisable to develop a structured training program in advance. In this way, a complex operation can be incorporated in a residency or fellow training program and has less influence on the total operating time and patient safety.177 The surgical margins and blood loss are not negatively affected when using a systematically stepwise training approach.178 Another aspect of training is the learning curve. The term ‘learning curve’ is used to describe the process of gaining knowledge and skills in the field of surgical technology. As a minimum, reporting of learning should include the number and experience of the operators and a detailed description of data collection.179 There is a difference between the learning curve of conventional laparoscopy and robot surgery. Suturing and dexterity skills can be performed quicker in robotassisted laparoscopy than in conventional laparoscopy.180 The 3D view in robotic surgery improves surgical performance and learning compared with the traditional 2D view laparoscopy.181 The learning curve for robotic surgical techniques is therefore relatively short and may be even shorter for a new generation as residents have a greater ability to interact with the new robotic instruments.182 Several studies addressed the issue of how learning of robotic skills best can be assessed. It is important to identify objective variables for quantifying the extent of proficiency. Hernandez et al. demonstrate a rapid learning curve for suturing with the da Vinci robotic system. Besides time and open structured assessment of technical skills,183 they used motion analysis and found this a useful

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tool.184 Other variables used to show the rapid learning curve in robotic tasks are bimanual coordination and muscular activation.185 A computerised assessment system (ProMIS) was used to demonstrate the faster and more precise performance of the robotic system compared with conventional laparoscopy.186 An overview of assessment of simulationbased surgical skills training was published in the Journal of Surgical Education.187 The learning curve for robot surgical procedures varies widely. Factors of influence are experience and expertise of the surgeon, type of surgery and volume of the surgery. There are various variables that can be used to define the end-point of the learning curve.188 Most data concerning the learning curve in robotic surgery come from the radical prostatectomy. They show a relatively short learning curve if volume is high enough.189 The learning curve for robot-assisted radical prostatectomy seems to be similar for a fellowship-trained surgeon and a laparoscopically naı¨ve experienced surgeon of open radical prostatectomies.190 In gynaecology, the issue of the learning curve has not yet been properly described. However, from the small series that describe reduced docking times and console time with increased experience, it can be concluded that learning curves are as steep as in other types of surgery.106 Finally, the relatively large series from Seamon et al. clearly show a significant effect of experience with gynaecological operations.125

Setting up a robotic program With the growing interest in robotic surgery and the promising results, there is an increasing need for information how to set up a robotic program. Palmer et al. describe five essential phases to set up a successful robotic program. The first step is the development of a business plan, defining the initial robotic program and arrange proper administrative support. The second phase is the implementation in which one must think of the theatre design, the theatre team, the purchase of a robotic system, sterilisation facilities, marketing and an expert lead surgeon.191 The third phase is the execution of the program. Followed by a phase of maintenance. In this fourth phase, one should have a proper data system for quality control and efficiency and outcomes as well as patient satisfaction should be registered. A structured program for training and education of fellow’s/residents should be available. The last phase is growth to make the program profitable, where one could think of recruitment or training of new surgeons working together with other subspecialties.192 Very importantly, there is a need for a dedicated theatre team.193 Transforming an existing high-volume conventional laparoscopic program to a robot-assisted program for radical prostatectomy can be achieved while maintaining reasonable profits. However, equal profit is not possible without a substantial increase of caseload.146 All the above programs were launched in the USA. The situation in Europe is different



from country to country because of different healthcare systems and insurance systems. For the UK, some general implications, similar to those for the USA, for adoption of a robotic surgery program are described by Goldstraw et al.29

Litigation and ethical issues The increasing complexity of modern surgical technology will require more stringent guidelines for operation and practice similar to the discipline exercised in aviation. Using a surgical robot implies that the surgeon is no longer in direct physical of visual contact with the patient. The surgeon not only operates through computer commands but there is also a physical distance to the assistants attending the operation table. Unfortunately, the current systems lack a satisfactory way to communicate between the operator and the assistants. As with many new technological advances, communication might appear the Achilles’ heel of robotic surgery. More appropriate equipment of communication and more strict discipline in follow up of the commands from the primary responsible person, the surgeon, will be essential for a safe and successful procedure. With the possibility of telemedicine and robotics new legal and ethical issues arise. Telemedicine makes cross-border treatment possible. How to deal with liability and licensure across borders? Cross-border care should not change usual medical ethics but makes treatment possible of patients in areas the specialist cannot reach in person. In this way, underserved regions and countries could be helped. But the technology could also aggravate migration of specialists from poor to rich areas/countries.194 Also, the security of the transmitted data between the surgeon and the (distant) robot is at stake. 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 the software? Malfunction of the robotic system will occur more frequently with its increasing use; fortunately, it appeared that less than 5% of device failures resulted in patient complications. In addition, the rate of open conversions due to device malfunction decreased from 94% in 2003 to 16% in 2007.195 Although robots seem to act autonomously, all their movements and actions are operated by the surgeon and as such do not differ from any other surgical equipment. Nevertheless, as with any complex system, safety precautions will be more essential than with the use of simple instruments. Local as well as national and international guidelines will need to be developed to address specific issues. In 2007, the first policy guidelines for the robot-assisted prostatectomy were suggested in an editorial by Valvo et al.196 The Society of American Gastrointestinal and Endoscopic Surgeons and the Minimally Invasive Robotic Association believed that guidelines for the use of robotics were lacking. To overcome this gap, they published a consensus statement

on robotic surgery including guidelines for training and credentialing.197 The World Medical Association (WMA) made a statement on the ethics of telemedicine on their last meeting in Copenhagen (October 2007). Included are principles for the patient–physician relationship and confidentiality, the responsibilities of the physician and the quality of care. The WMA is encouraging the development of national legislation and international agreements on telemedicine.198

Pros and cons The robotic surgical system has some clear advantages compared with conventional laparoscopy. A summary of the advantages and disadvantages of robot-assisted laparoscopic surgery is given in Table 2.

Future of robotics in gynaecology Considering the development of robotics in general and assisted surgery in particular, it is to be expected that the application of this technology will only increase.199 The exponential growth of the da Vinci robotic surgical system worldwide, with more than 867 systems sold up to march 2008,171 will lead to an exponential growth of procedures performed (Figure 7). As with every innovation that introduces new technology, initial scepticism with respect to necessity, applicability and affordability will mean a delay in wider introduction. In the near future, the robotic systems will become smaller and easier to handle. Whereas they now constitute stand-alone systems, it is expected that they will become

Table 2. Advantages and disadvantages of robotic surgery Advantage Surgical system advantages Better InSIte vision (3D) Digital camera zoom Camera stability Greater df (Endowrist) Improved dexterity Elimination of fulcrum effect Better ergonomics for surgeon Motion scaling Elimination of physiological hand tremor Telesurgery possible

Disadvantage High costs Robotic system Maintenance system Start up Bulky size of the robotic system Sometimes difficult access to patient Separation surgeon from the operating field No tactile feedback Chance of breakdown Use of 8 mm ports Monopoly of single market leader

Telementoring possible


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robot procedures

Number of procedures

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120 000 100 000 85447

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49038

40 000 26809

20 000 0

127

321

1031

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16288

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

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Figure 7. Procedures worldwide performed with the da Vinci robotic system until 2008 (the end of week 21).

integrated in minimal invasive operating theatres, for example attached to the sealing. It may be expected that wider availability of such systems will lead to more and more conventional laparoscopic procedures to be performed with robot assistance. In this respect, it should also be appreciated that the next generations of doctors will have been raised with computer technology as part of daily life and will therefore more readily 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 cardanic transmission that will allow even more precise tissue handling. Also, fusion with imaging techniques like computed tomography and magnetic resonance imaging (MRI) are likely to be introduced200 allowing more precise and safer surgery and thus more radical oncologic surgery with minimal trauma. As the first MRI compatible robot was introduced in neurosurgery in 2007,201 it may also be expected to be introduced in pelvic and abdominal surgery.202,203 Although robotic technology was initially developed to allow telesurgery to be performed in areas difficult 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 in Strasbourg, but the main problem appeared to be the limitation and delay over the satellite transmission.203,204 Further research on long-distance telesurgery is being carried out by NASA in the NASA Extreme Environment Mission Operations project, starting at NEEMO 9.205 The first robotic system in a space station has been established for remote emergency surgery.206 Further future developments will focus on mobile in vivo robots to support minimal invasive surgery in remote locations (battlefield, space). For example, the in vivo robots can be placed in the abdominal cavity during surgery and perform wireless imaging or task assistance.207 Together with the Jet Propulsion Laboratory, NASA is developing a robot-assisted microsurgery system for eye, ear, nose, throat, face, hand, and cranial surgery.208 For the more com-

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plicated procedures, it may be possible to make use of either multiple robotic arms or even multiple robots. So-called swarm robots act coordinated and simultaneously. Such systems may be trained to perform certain tasks independently and automatically if continuously trained by the computer by, for example neurological networks.209 It remains fully speculative when this would eventually lead to certain (parts of) operations being performed autonomously by robots. The exponential growth of robotic surgery, for example in urology, with an increase in robot-assisted radical prostatectomies of more than 60% in 2007–2008210 is promising, as such high-cost robotic systems are affordable by high-volume centres. Thus, randomised studies will be possible to establish more reliably the role of these new techniques. In gynaecology, robot-assisted surgery is also rapidly growing. In April 2007, the first World Robotic Symposium in Gynaecology was organised in Michigan, heralding a bright future.211 At the same time, the new Journal of Robotic Surgery was introduced. The challenges in robotic surgery are exciting and we are standing at the beginning of a new and inevitable phase in minimal invasive surgery.

Disclosure of interests For both authors, there is no financial interest.

Contribution to authorship Both authors meet the criteria to qualify for authorship.

Details of ethics approval Not applicable.

Funding None. j

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