Best Practice & Research Clinical Gastroenterology 28 (2014) 225–232

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Best Practice & Research Clinical Gastroenterology

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Robotics: The next step? Ivo A.M.J. Broeders, MD, PhD, Professor, Dr a, b, * a

Department of Surgery, Meander Medical Centre, Utrechtseweg 160, 3818 ES Amersfoort, The Netherlands Twente University, Technical Medicine, Carre Building CR 3629, Drienerlolaan 5, 7522 NB Enschede, The Netherlands b

a b s t r a c t Keywords: Endoscopic Surgery Robotic da Vinci

Robotic systems were introduced 15 years ago to support complex endoscopic procedures. The technology is increasingly used in gastro-intestinal surgery. In this article, literature on experimental- and clinical research is reviewed and ergonomic issues are discussed.

Methods: literature review was based on Medline search using a large variety of search terms, including e.g. robot(ic), randomized, rectal, oesophageal, ergonomics. Review articles on relevant topics are discussed with preference. Results: There is abundant evidence of supremacy in performing complex endoscopic surgery tasks when using the robot in an experimental setting. There is little high-level evidence so far on translation of these merits to clinical practice. Discussion: Robotic systems may appear helpful in complex gastrointestinal surgery. Moreover, dedicated computer based technology integrated in telepresence systems opens the way to integration of planning, diagnostics and therapy. The first high tech addons such as near infrared technology are under clinical evaluation. Ó 2014 Elsevier Ltd. All rights reserved.

Introduction The concept of remote surgery was initially explored to facility surgery at the battlefield from a safe location. Collaboration between National Air and Space Administration (NASA) and the Stanford Research Institute (SRI) resulted in the Green telemanipulator, a four degrees of freedom robotic * Department of Surgery, Meander Medical Centre, Utrechtseweg 160, 3818 ES Amersfoort, The Netherlands. Tel.: þ31 33 8501167. E-mail address: [email protected]. 1521-6918/$ – see front matter Ó 2014 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.bpg.2013.12.001

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system that enabled manipulation of surgical instruments over distance using cables for data transfer. Intuitive Surgical Inc. commercialized this prototype. At that time, Computer Motion Inc. had already launched their Easop robotic arm for voice controlled steering of rigid endoscopes. Computer Motion expanded their concept to the Zeus robotic telemanipulator, a remote surgery system that held three separate arms. The competitor bought the system and at this point of time the Intuitive Surgical da Vinci system is the only commercial robot available for endoscopic surgery. The first procedure after market approval was performed in 1998. The system was initially launched to enable minimally invasive cardiac bypass surgery. This turned out to be challenging, especially in combination with remote on-pump cardiac surgery using groin-inserted cooling systems. Robotic beating heart surgery didn’t reach the assumed market potential either because the gain to burden ratio, compared to mini thoracotomy, was not explicit enough. The breakthrough was forced some six years later when urologists started using the da Vinci system at large scale for radical prostatectomy. This led to interest among gynaecologists, ENT specialists and finally general surgeons. Up to now 1.5 million procedures have been performed worldwide with over 2600 systems installed. The essence of telemanipulation is the introduction of advanced computer technology at the OR table. This enables surgical support, advanced imaging and data analysis. The inherent drawbacks of endoscopic surgery are dealt with by reversing the tip response of the instruments, and by introducing scaling to lower the fulcrum effect. Two degrees of freedom are added to the instrument tip to enable refined and complex dissection and suturing tasks. The surgeon also steers the camera by pressing a foot pedal. Whilst pressing this pedal, the surgical instruments hold their position, and the joysticks are used to adapt the field of view. One can move in all directions and rotate and also control focus. When releasing the foot pedal the camera immediately stabilized and the joysticks return to instrument control. Such a correction of the camera position takes 1–3 s. The endoscope is completely stable during surgery, and a high level 3-D view is provided by a double optical channel-double camera image chain. The surgeon controls three arms to operate with two and assist with one. Usually one extra trocar is placed, and surgery is performed with one dedicated OR nurse only. The surgeon can adapt the position of the chair, the arm- and head rests to work in an ergonomically favourable position. A drawback is the complete absence of haptic feedback in combination with loss of direct contact with the instruments. This is of less importance in refined work, but is an issue to deal within case larger forces are exerted. Telemanipulation surgery separates the surgeon from the sterile field. This implies loss of direct control at the OR table. There are also substantial differences between the surgeon and the OR nurse in vision, horizon dependency, instrument handling and body position. This demands extensive collaboration between dedicated team members. Users of the current robotic systems should aim at complex endoscopic surgery, from a technical and financial perspective. The main target areas in general surgery in the upper body are trans axillary thyroidectomy, pulmonary surgery with lymph node dissection and thoracic extended oesophagectomy. In the upper abdomen one should focus on giant hernia, redo surgery for reflux and achalasia, oesophagectomy, pancreas and biliary surgery. Surgery for distal rectal cancer and transanal or perineal approaches to rectal cancer may also benefit from this technique. This article deals with ex vivo experiments, clinical results, ergonomic aspects and future perspectives of robot-assisted endoscopic surgery. Ex vivo experiments with robotic surgery systems for endoscopic surgery The system is designed to enable complex tasks in endoscopic surgery. This should lead to better functional outcome and expansion of routine use of the minimally invasive approach. Performance in endoscopic surgery is easier to measure due to the inherent use of trocars. The fulcrum point blocks sideward movements and may serve as source for data acquisition. The da Vinci system has been compared to standard endoscopic surgery repetitively in an experimental setting. Box trainers, the Promis trainer, animal intestine- and live porcine models have been

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used to explore speed, precision, tissue damage learning curves and surgeon’s preference [1–12]. Table 1 summarizes the results of 12 studies. The number of participants varied from three to 34, and a wide variety of tasks were performed. These range from moving beans [12] to aortic replacement [6]. Suturing and not tying was the most often explored. In the vast majority of studies, performance with the robotic system was faster and better. The quality of sutures was better in all but one [12], and better outcome with regard to tissue damage and leakage was demonstrated by three studies that explored this parameter [1,2,7]. On the other hand, Ruurda et al found more suture tears in the robotic group [6] and Anderberg [11] concluded that lack of force feedback influenced outcome in dedicated tasks. Two studies, both with novices only, investigated participant preference. Robotic support was favoured in these ex vivo experiments. The results on learning curves were less reconciled, and conclusions on differences in learning curves varied widely. This is probably due to the differences is study model and the variation between inexperienced and expert participants. Two studies used a live porcine model to imitate human surgery as close as possible. Eisenberg compared suturing of a gastrotomy [2]. 34 non-experienced subjects had to place three interrupted sutures to close the defect. The subjects in the robotic group were faster (459 versus 595 seconds) and made less mistakes per knot (0 versus 1,2). The robotic group subjects estimated the task easier on the NASA-TLX scale (57 versus 99). Ruurda et al studied the quality of anastomosis in a retroperitoneal abdominal aortic replacement model [9]. The three subjects were experienced surgeons without extensive training in endoscopic vascular suturing. The quality and speed was investigated in 20 pigs, ten in each group. Suturing and clamping time was shorter in the robotic group and there was less blood loss. All pigs in the robotic group had a patent and anastomosis compared to 8/10 in the standard group. All sutures lines in the robotic group and 8/20 suture lines in the standard group were adequate.

Table 1 Performance in experimental setting: robot-assisted- versus standard endoscopic task performance (N ¼ novice, E ¼ expert, NA ¼ not assessed). Author

Participants

Time

Quality

Damage

Learning curve

Preference

Stefanidis

Faster

Better

Less tissue damage

Robot yes Standard no

Robot

Faster

Better

No versus 90% leaks

NA

NA

N faster E not

NA

N robot no N standard yes

NA

Faster

N better E pathlength only NA

NA

Robot yes Standard yes

NA

Faster

Better

NA

NA

Robot

Faster

Better

NA

Standard steeper

NA

Equal

Better

NA

NA

Faster

Better

NA

NA

Faster

Better

Robot more suture tears 20% persistent leaks in laparoscopy group NA

NA

NA

Faster

Better

NA

NA

NA

Anderberg

34 N Live procine model 5E Porcine bowel single incision 20 N 9E Promis simulator 4N 4E Box trainer 16 N box trainer 8N Box trainer 5E Procine bowel 3E Live porcine aorta model 10 E Promis simulator 6E Box trainer 20 N

Complex faster Simple equal

NA

Lack of force feedback had impact

NA

Dakin

18 E

Complex equal Simple slower

Complex better Simple equal

NA

Transfer of knowledge from robot to standard NA

Eisenberg

Chandra

Yohannes

Schatte Heemskerk Ruurda Ruurda

Narula Hubens

NA

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In general the quality and the statistical analysis of the experimental studies was sufficient to good. The number of subjects was generally low and most studies lacked a hypothesis based on power calculation. The use on inexperienced subjects is a matter of debate. On one hand it may demonstrate the inherent capacity of the techniques compared. On the other hand it may overestimate its value because training may overcome the drawbacks of the standard technique to some extend. The latter argument is not supported by most studies that included experts, who also appear to perform significantly better when using of the robotic system. The results of experimental studies support the concepts of robotic assistance in endoscopic surgery and serve as a starting point for clinical research. Clinical research in gastro-intestinal robot-assisted surgery Over 3000 articles have been published on the use of robotic systems in endoscopic surgery over a period of 15 years. The vast majority of publications report on early experience, safety and feasibility. Numerous articles can be found on case series, and on comparative studies using cohorts operated before acquisition of robotic systems. In general, safety and feasibility is confirmed and non-inferiority is described in comparison to earlier results on standard endoscopic surgery. Longer OR times are frequently reported in early experience, at higher costs. Most authors conclude that adequate randomized studies are required but few reports at that level are available. This is understandable for two reasons. Wide application of robotic support in gastro-intestinal surgery started just a few years ago, and numbers of highly complex procedures are low. Randomized studies should be based on a strong rationale that supports the use of complex and expensive technology. However, it is attractive to start studies on high volume procedures from the perspective of study management, but this may not serve the case for advanced technology. This is exemplified by randomized studies on Nissen fundoplication and case series on routine colon resection. These are straightforward endoscopic surgical procedures of medium complexity that can be trained well and offer decent to good ergonomics for the surgeon. What expectations could one have? Nissen fundoplication is safe in experienced hands. Outcome is merely related to dysphagia and other side effects, which cause is multifactorial. The surgical technique is probably of much more impact than the choice of surgical instruments. Improvement of long-term durability would require a large study population because there is a few percent gain to win at most. The outcome of colon resection is dominated by anastomotic dehiscence. In endoscopic right hemicolectomy the anastomosis is usually made outside the body with linear staples or running sutures and in sigmoid resection transanal circular stapling is standard of care. There is not much to improve with a high tech dissection and suturing tool. Robot-assisted Nissen fundoplication has been compared to standard endoscopic surgery in seven small randomized trials. These trails have been summarized in five reviews [13–17]. The largest group studied 50 patients, 25 in each group. There were no other outcome parameters than standard perioperative and early postoperative results. Power calculations on clear expectations related to the use of the robotic system were absent. All but one author reported comparable or longer OR times at higher costs. Lower postoperative ppi use was reported in one. No clear advantage of using robotics in standard Nissen fundoplication could be demonstrated in the seven small randomized studies. One non-randomized study focussed on dedicated outcome parameters. Frazzoni et al found lower acid exposure in a study comparing cohorts, but there was a substantial time delay between the groups compared [18]. Currently available literature on colon resection with robotic assistance is limited to case series. Literature has been reviewed and results on perioperative outcome appear comparable to current standards [19,20]. There is no documentation yet on efforts to investigate dedicated robot-related gain in standard colon resection. When searching for robotics in complex gastro-intestinal surgery, and a vast number of publications is found on single cases and small series in any field. Comparative and randomized studies are scarce. The role of robotics has been evaluated in achalasia, with focus on perforations and outcome. Horgan et al found a zero versus sixteen percent perforation rate favouring robotics when comparing prospectively gathered data, and Huffmann described better functional outcome in a comparable study design [21,22]. The role or robotics in transthoracic oesophageal resection with extensive lymph node

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dissection is currently investigated in a randomized controlled trial [23]. Robotic systems are also used increasingly in pancreatic surgery. Data at best are available in comparative studies. Four studies compare robotic surgery to open surgery, another to endoscopic surgery. For now, there is the suggestion that robotic support may lead to increased preservation of the spleen [24]. Robotics in liver and biliary surgery seems promising as described in case series but higher level of evidence is not yet available [25]. Scientific interest in complex gastro-intestinal surgery at this point of time primary focuses on treatment of rectal cancer. The rationale is based on high incidence, the challenging nature of endoscopic resection of low rectal cancers, the high percentage of postoperative functional disorders and the bad ergonomics of traditional endoscopic surgery. There is no level 1 evidence available yet, but results from case series and comparison between consecutive cohorts merit further research. Patriti et al found shorter OR times (166 versus 210 min) and lower conversion rates [26]. Beak et al reported on 2% conversion in 47 patients operated with the robot compared to 16% conversion in 37 patients operated with standard techniques [27]. Meta-analysis on results up to 2011 confirms shorter conversion rates and suggests better postoperative outcome [28,29]. A large number of confounders may influence the results of these comparative studies and the meta-analysis. High-level evidence is expected within a few years, together with reports on dedicated approaches such as transanal microsurgery and perineal mesorectal resection. The international multicentre ROLARR trial, initiated by the University of Leeds is the leading initiative in this field. The current system incorporated high tech computer based analysis that could be of substantial value in rectal surgery. The so-called Firefly technology uses near infrared to search for hidden vessels, and tissue vascularization or lymph node involvement is explored when combining Firefly technology with intravenous agents. Additionally, a linear stapler is introduced that measures tissue thickness after parallel beak compression. In case tissue thickness is not in line with staple height, stapling is blocked. Large scale clinical use of robotics is hindered by costs. Acquisition takes around 1.8 million euros and one needs to amortize this amount in eight years. An 10% yearly is required for maintenance, repair and upgrades. The annual costs to run a robotic system are therefore 405,000 Euros. Extra costs per procedure relate to drapes and semi-reusable instruments. Costs vary and are related to the number of instruments used. One should count on an average of 1300 Euros. This implies that extra costs strongly relate to the number of procedures that are performed with the system annually. 100 procedures means 5300 Euros extra costs, 400 procedures leads to an extra 2300 Euros. Five hundred cases per year with one system are achievable with excellent planning and efficient use. This usually implies multidisciplinary use and a high volume practice with complex endoscopic surgery. Ergonomics in robot-assisted surgery Growing experience in robot-assisted surgery paralleled widespread introduction of complex endoscopic surgery. Surgeons started complaining on bad ergonomics and resulting injury due to more and longer exposure. In a recent survey among 317 experienced endoscopic surgeons, 87% reported work related physical complaints with direct relation to case load, and this is just one of the many articles published on this topic [30]. This study also revealed lack of knowledge among surgeons on ergonomics and body posture in endoscopic surgery. With today’s knowledge one can get the best out of any situation when preparing well [31,32]. This may allow acceptable to good body posture for surgery in the upper abdomen and the flanks. Pelvic surgery is bound to be troublesome even under optimal preparation. The surgeon is forced to work aside the working axis, resulting in unnatural strain of arms, shoulders back and legs. It is possible to return to the ideal working axis when sitting above the patient’s head. This may sound awkward but a dedicated chair has been developed and commercialized to achieve this goal. A workload score of 32 in standard position was reduced to 14 when seated on the Ethos SurgicalÔ chair. The researchers also investigated a telemanipulation concept and reported a score of 5 when using the da Vinci workstation [33] (Fig. 1).

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Fig. 1. Use of the da Vinci robotic system during pelvic floor reconstruction at the Meander Medical Centre.

In the challenging sequel to validate expensive tools, the surgeon’s interest in ergonomics has become more apparent. Complex endoscopic procedures demand for very skilled surgeons and the road to reach the requested level is known to be long. It is most undesirable, both from personal and societal perspective, to lose experienced surgeons due to work related hernia’s and other musculoskeletal injuries. Telepresence surgery offers the opportunity to deal with the necessity of direct contact between surgeon and surgical instruments. The ergonomics of endoscopic surgery can be reinvented by positioning the surgeon behind a workstation that brings target area, hands and eyes back in the ideal working axis. Reports on this subject are promising. Schatte Olivier found less mental stress, better ergonomics and better performance in an experimental set-up among 16 interns [5]. Better ergonomics and less physical strain was confirmed by Lee et al, using the validated JSL and RULA upper extremity scores [34]. Improved body posture may result in less pain. This was investigated by Bagrodia et al in a survey among urologic endoscopic surgeons. They reported pain after performing pelvic surgery in 50% after laparotomy, in 56% after endoscopic techniques and in 23% after working from behind a surgical workstation [35]. The currently available workstation may require adaptations to reach ideal ergonomics. This is supported by results form a small study from Lawson et al comparing standard endoscopic to robot-assisted gastric bypass surgery. The interesting aspect of this study is the fact that bypass surgery is performed from between the legs, which provides allows a much better body posture that e.g. pelvic surgery. They found improvement in strain for arms and thorax when using the robot, but better ergonomics for neck and trunck when standing at the OR table [36]. There is much to learn from other disciplines that use advanced videoscopic technology in the OR, especially from those using binocular microscopes. Lux et al published a most useful state of the art paper on da Vinci workstation ergonomics with worthy advice for daily robotic surgery practice [37]. Future perspectives Robotic systems guide the road towards new age surgery, where computer technology is an inherent part of surgical procedures. It is important to keep focussing on the potential of computerbased technology, instead of solely judging the merits by investigating today’s clinical parameters. This review shows that technical supremacy is proven in experimental set-up, but that high level clinical evidence is scarce. There are many reasons for this, but the surgical community will no less have to work on solid prove to guide robotics through the next years. Next to that, one can explore the capacity and options of the digital capacity or robotic systems. For now these are e.g. motion scaling, computer guided pressure sensing in stapling and near infrared technology in tissue and vessel discrimination. The next generation robotics will allow further integration of planning, diagnostics and intervention, and thereby consolidate their unique position in future operating theatres.

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Research agenda - Randomized studies have to be conducted of disease with moderate to high incidence e.g. oesophageal and rectal cancer. - Robotic surgery on relatively rare procedures such as pancreatic resection and biliary reconstruction should be documented prospectively. - Research should focus on dedicated parameters related to robotic technology.

Practice points  Robotic systems should be used in complex endoscopic procedures that required delicate dissection and fine endoscopic suturing.  The use of robotics should be considered in lasting endoscopic procedures with unfavourable ergonomics.  Cost-efficient use of robotics requires a high annual volume of complex endoscopic surgical procedures. Multidisciplinary use is usually mandatory.  Robotic systems will evolve for electromechanical surgical instrument to computer based integral diagnostic and therapeutic platforms.

Conflict of interest statement The author declares that there is no conflict of interest. There is no funding source related to this review article. References [1] Stefanidis D, Wang F, Korndorffer Jr JR, Dunne JB, Scott DJ. Robotic assistance improves intracorporeal suturing performance and safety in the operating room while decreasing operator workload. Surg Endosc 2010;24:377–8. [2] Eisenberg D, Vidovszky TJ, Lau J, Guiroy B, Rivas H. Comparison of robotic and laparoendoscopic single-site surgery systems in a suturing and knot tying task. Surg Endosc 2013;27:3182–6. [3] Chandra V, Nehra D, Parent R, Woo R, Reyes R, Hernandez-Boussard T, et al. A comparison of laparoscopic and robotic assisted suturing performance by experts and novices. Surgery 2010;147:830–9. [4] Yohannes P, Rotariu P, Pinto P, Smith AD, Lee BR. Comparison of robotic versus laparoscopic skills: is there a difference in the learning curve? Urology 2002;60:39–45. [5] van der Schatte Olivier RH, Van’t Hullenaar CD, Ruurda JP, Broeders IA. Ergonomics, user comfort, and performance in standard and robot-assisted laparoscopic surgery. Surg Endosc 2009;23:1365–71. [6] Heemskerk J, van Gemert WG, de Vries J, Greve J, Bouvy ND. Learning curves of robot-assisted laparoscopic surgery compared with conventional laparoscopic surgery: an experimental study evaluating skill acquisition of robot-assisted laparoscopic tasks compared with conventional laparoscopic tasks in inexperienced users. Surg Laparosc Endosc Percutan Tech 2007;17(3):171–4. [7] Ruurda JP, Broeders IA, Pulles B, Kappelhof FM, van der Werken C. Manual robot assisted endoscopic suturing: time-action analysis in an experimental model. Surg Endosc 2004;18:1249–52. [8] Ruurda JP, Wisselink W, Cuesta MA, Verhagen HJ, Broeders IA. Robot-assisted versus standard videoscopic aortic replacement. A comparative study in pigs. Eur J Vasc Endovasc Surg 2004;27:501–6. [9] Narula VK, Watson WC, Davis SS, Hinshaw K, Needleman BJ, Mikami DJ, et al. A computerized analysis of robotic versus laparoscopic task performance. Surg Endosc 2007;21:2258–61. [10] Anderberg M, Larsson J, Kockum CC, Arnbjörnsson E. Robotics versus laparoscopy – an experimental study of the transfer effect in maiden users. Ann Surg Innov Res 2010;4:1164–8. [11] Hubens G, Coveliers H, Balliu L, Ruppert M, Vaneerdeweg W. A performance study comparing manual and robotically assisted laparoscopic surgery using the da Vinci system. Surg Endosc 2003;17(1):595–9. [12] Dakin GF, Gagner M. Comparison of laparoscopic skills performance between standard instruments and two surgical robotic systems. Surg Endosc 2003;17:574–9. [13] Hambraeus M, Arnbjörnsson E, Anderberg M. A literature review of the outcomes after robot-assisted laparoscopic and conventional laparoscopic Nissen fundoplication for gastro-esophageal reflux disease in children. Int J Med Robot 2013 [Epub ahead of print]. [14] Markar SR, Karthikesalingam AP, Hagen ME, Talamini M, Horgan S, Wagner OJ. Robotic vs. laparoscopic Nissen fundoplication for gastro-oesophageal reflux disease: systematic review and meta-analysis. Int J Med Robot 2010;6:125–31.

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Robotics: The next step?

Robotic systems were introduced 15 years ago to support complex endoscopic procedures. The technology is increasingly used in gastro-intestinal surger...
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