SAGES TAVAC Safety and Effectiveness Analysis – DaVinci Surgical System (Intuitive Surgical, Sunnyvale, CA)

This statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Jul 2015.

SAGES daVinci Safety and Effectiveness Subcommittee

Chair: Shawn Tsuda, MD
TAVAC Committee Chair: Dmitry Oleynikov, MD

Jon Gould, MD
Dan Azagury, MD
Bryan Sandler, MD
Matthew Hutter, MD
Sharona Ross, MD
Eric Haas, MD
Fred Brody, MD
Richard Satava, MD

Technology Overview

The da Vinci® Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is a computer-assisted (robotic) surgical system designed to enable and enhance minimally invasive surgery. The Food and Drug Administration (FDA) has cleared computer-assisted surgical systems for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures.

The da Vinci® Surgical System is not technically a robot but is a computer-assisted telemanipulator. A robotic device is a “powered, computer-controlled manipulator with artificial sensing that can be reprogrammed to move and position tools to carry out a wide range of surgical tasks.” [1] Conversely, computer-assisted devices are not true robots because they lack independent motions or preprogrammed actions. The term telemanipulator, or telesurgery, implies that there is a distance interposed between the surgeon and the patient.

When using the da Vinci® Surgical System, the surgeon sits at a console remote from the patient and manipulates controls for the surgical instruments. The computer enhances the interaction between the surgeon and the bedside robotic device by eliminating tremor and scaling all motions to a selected degree. This makes fine and precise movements of the surgical instruments possible. In addition, the robotic instruments are multi-articulated and capable of a full range of motion enabling complex maneuvers that would be difficult with standard laparoscopic instruments. High-definition, three-dimensional visualization provides image detail and depth. A robotic arm manipulates the camera, providing a steady view that is directed by the operating surgeon. The surgeon’s hand and instrument tip movements are synchronous.

The da Vinci® Surgical System consists of the control console, vision system cart, and the patient-side cart. The surgeon sits at the control console, separated from the operative table but typically in the same room. This console is designed to provide the surgeon with an ergonomically comfortable position in which he or she can manipulate the “masters,” or controls. The vision system cart includes the processor, video monitor, light source, and other equipment related to the endoscopic camera. The cart receives input from the camera and displays the resulting live video on the video monitor and at the surgeon console. The patient-side cart provides two or three robotic arms (depending on the version and options) and one camera-manipulating arm that execute the surgeon’s commands. There are currently more than 50 different detachable instruments (needle drivers, graspers, etc.) that can be attached to the manipulator arms and exchanged as needed during a procedure. Additional options include a dual console that enables surgeons to work in tandem, Firefly™ imaging (near-infrared imaging of vasculature achieved by tracking a fluorescent dye), and single-port surgery capability (recently cleared by the FDA for laparoscopic cholecystectomy).

Technology Significance

The advantages of minimally invasive surgery when compared to an open approach have been well documented in many surgical specialties and for many different procedures [2-4]. These differences include decreased duration of hospital stay, less pain, fewer wound infections and hernias, quicker return of bowel function, and less time to resume normal activities. In certain disciplines, most notably urology and gynecology (prostatectomy made up 31% and hysterectomy 41% of all daVinci® procedures in 2011), robotic surgical systems have enabled increased adoption of minimally invasive techniques by surgeons and a move away from open surgery. When compared to open prostatectomy, minimally invasive robotic prostatectomy has been demonstrated to be associated with better urinary continence and erectile function recovery, lower rates of positive surgical margins, and better perioperative outcomes [5-7]. However, when an established laparoscopic approach to an operation exists, the benefits of robotic surgery when compared to laparoscopy have not been demonstrated to be superior [8,9].

The daVinci® Surgical System has evolved since the original version was released in 2000 at the time of FDA approval. In 2006, the S version was released, followed by the Si in 2009 and the Si-e in 2010 (Si-e is a more basic version of the Si with three robotic arms rather than four). On April 1, 2014, the newest Intuitive system, the da Vinci® Xi, was cleared by the FDA (Xi has an overhead arm and thinner arms which allow greater range of motion and placement of any instrument or the camera thru any port). According to the 2012 Intuitive Surgical Annual Report, there were 2585 da Vinci® Surgical Systems installed worldwide, including 1878 in the U.S., 416 in Europe, and 291 in the rest of the world [10]. In 2013, approximately 523,000 surgical procedures were performed with the da Vinci® Surgical System, up 16% compared to approximately 450,000 procedures performed in 2012. The growth in overall 2013-procedure volume was driven by the growth in U.S. general surgery procedures, U.S. gynecologic procedures, and urology procedures outside of the USA [11].

The 2013 list price of a da Vinci® Si system (without dual console, single site platform, Firefly™, or simulator) was $1.75 million. The annual service fee is approximately $150,000 and the estimated added consumable cost per procedure is $1600 compared to open surgery.[1] Insurance companies generally provide coverage and reimbursement for robotic procedures at the same rate as conventional laparoscopic surgery. In order to recoup the added expense of robotic surgery, cost savings through length of stay reductions and decreased complications must theoretically be coupled with high caseloads. The cost-effectiveness of robotic surgery has not yet been shown.

Clinical Evidence Summary

Data has been published for multiple general and gastrointestinal surgeries with robotic surgery, including cholecystectomy, esophagectomy, fundoplication, Heller myotomy, gastrectomy, splenectomy, pancreatectomy, liver resection, colectomy, sleeve gastrectomy, and Roux-en-Y gastric bypass.

Foregut Surgery

Use of the da Vinci® Surgical System in operations involving the foregut comprises some of the largest data sets for robotic gastrointestinal surgery, mainly in Nissen fundoplication and Heller myotomy [12-15].

A robotic assisted laparoscopic Heller myotomy (RALHM) was first reported in 2001 followed by a small case series [16-18]. An academic robotic surgery group, comprising surgeons from Ohio State University, Johns Hopkins University, and the University of Illinois at Chicago, prospectively collected data on 104 robotic Heller myotomies without any perforations. Both laparoscopic and robotic techniques were safe and associated with low occurrence of complications. However, no clear benefit was seen in the robotic group. Some studies have demonstrated a lower incidence of esophageal perforation with the use of robotic assistance than reported for conventional laparoscopic techniques. Melvin et al. demonstrated the feasibility of robotic assistance for 104 patients, with a mean operative time of 140 min, no esophageal perforations, and only one conversion to an open procedure [29]. In the series by Galvani et al., 54 patients underwent RALHM with no esophageal perforations, minimal blood loss, and an average hospital stay of 1.5 days [30]. The average operative time was 162 min, and 93% of the patients had no dysphagia during an average follow-up period of 17 months. Iqbal et al. demonstrated a 7.8% esophageal perforation rate with the standard laparoscopic technique and no esophageal perforations in the 19 patients undergoing RALHM [31]. Horgan et al. reported an esophageal perforation rate of 16% in their LHM group compared with 0% for the RALHM patients [32]. Similar results regarding the robotic telesurgical approach were obtained in three subsequent published series comparing robotic Heller myotomy with laparoscopic Heller myotomy [20,21].

Melvin et al. reported a comparison case series of gastroesophageal fundoplication performed by standard laparoscopy or with robotic telesurgical assistance [19]. Several randomized studies have examined the utility of robotic Nissen fundoplication for treatment of gastroesophageal reflux disease (GERD) [22-23]. These studies compared robotic Nissen fundoplication (RF) to laparoscopic Nissen fundoplication. Both studies quoted increased operative times for patients within the robotic groups.

The short-term outcomes of robotic paraesophageal hernia repair (RPEH) are not well reported in the literature [24,25]. Several studies had reported that RPEH is not associated with statistically significant increases in operative times when compared with RF [26]. It has been suggested that technically superior hiatal repairs can be achieved with RPEH, although in long-term follow-up comparisons to a laparoscopic PEH cohort this has not been shown [27,28].

Other data has looked at operative time and cost comparing robotic fundoplication to laparoscopic fundoplication. Several randomized trials were conducted comparing robotic and laparoscopic fundoplication, which demonstrated short-term outcomes were similar in both groups, with increased hospital cost seen in the robotic group [33-35]. Most recently, Owen et al. with Oleynikov at the University of Nebraska Medical Center analyzed 12,079 patients from the University Health System Consortium and found for Nissen fundoplication similar outcomes between robotic and laparoscopic approaches except for increased cost (US$10,644 +/-6041 vs. US$$12,766 +/-13,982, p < 0.05) [51].

Robotics in the management of gastric cancer has been employed, first reported by Giulianotti in 2003 [36]. There are comparison series between robotic and laparoscopic gastrectomy [37-46]. Some of the results are: the overall conversion rate is between 0–10%, mean operating time ranges from 293.8 to 656 min, and there is a noticeable decrease in time for robotic system set up as registered over 2 years. Estimated mean blood loss ranged from 65 to 300 ml. Specific morbidity ranges from 9 to 30% in the literature. Mortality varies between 0 and 9% [47-49]. There is additional data looking specifically at oncologic outcomes in robotic versus laparoscopic or open surgery. Kim et al. provided comparison-effectiveness information regarding robotic surgery versus laparoscopic or open gastrectomy for the treatment of gastric cancer [50]. The authors compared the results of robotic gastrectomy using the da Vinci® Surgical System with those for 11 laparoscopic and 12 open gastrectomies. The total number of lymph nodes retrieved was used as a quality control measure in gastric, colorectal, and other cancers and did not differ significantly among the groups. Robotic surgery was associated with significantly less blood loss and a shorter postoperative hospital stay.

Overall studies suggest that robotic foregut surgery is safe; however, no improvement in outcomes has been shown and costs are increased.

Bariatric Surgery

The use of robotic technology has been increasingly reported in bariatric surgery, including five systematic reviews [52-56]. The only procedure studied in any volume is the Roux-en-Y gastric bypass. A totally robotic laparoscopic RYGBP procedure using the da Vinci® surgical system has been described as a safe and effective alternative to open or laparoscopic techniques.

The published reviews report non-inferiority of the robotic approach when compared to standard laparoscopy. However, they fail to demonstrate superiority, pointing to the lack of high quality data. A single randomized trial exists showing equivalent outcomes [57]. Other large trials include case control studies with up to 400 patients per group or case series (one including over 1000 robotic RYGB) [58-69]: These studies all confirm non-inferiority of the robotic approach, and most demonstrate some benefit when compared to laparoscopy in reduction of gastro-jejunal (GJ) leak rates, reduced strictures rates, or reduced length of stay. Data also consistently shows longer operative times in the robotic groups. Reported rates of complications after stapling at the GJ are 1.1–6.0% leak rate, 2.9–27.1% stricture rate, and 1.6% rate of intraluminal bleeding [70-72].

Robotic approaches can facilitate hand-sewn GJ creation that offers several advantages to the bariatric surgeon compared to laparoscopy. The most important advantage is that the added degrees of freedom of the needle driver allow for precise, ambidextrous forehand and backhand suture placement [73]. The angles encountered in the creation of the laparoscopic GJ are sometimes awkward and can make the anastomosis technique challenging. With robotic surgery, this additional challenge is potentially minimized. A completely handsewn robotic gastrojejunal anastomosis appears to be feasible and although it may even be less technically challenging then a pure laparoscopic hand sutured approach, there is no data. However, since the standard is a stapled anastomosis there appears to be no difference in either safety or outcomes between laparoscopic and robotic approaches.

Hepatobiliary/Pancreatic Surgery

The use of the daVinci® Surgical System to perform liver resection has been described by several authors in a variety of case series for both benign and malignant hepatic resections [74-85]. The challenge in fully evaluating this technology for this application is that no randomized, controlled data exist to compare robotic-assistance with conventional laparoscopy for hepatic resections.

A systematic review of the literature reports 19 series of robotic-assisted liver resection that included 236 robotic procedures in 219 patients [86]. Both benign and malignant lesion resection were included in the series with tumor size of up to 6.4cm. Robotic-assisted wedge resection or segmentectomy was the most commonly performed procedure (37.7%), followed by right hepatectomy (21.6%), left lateral segmentectomy (20.8%), left hepatectomy (13.1%), and bisegmentectomy (5.1%). Also included in the series were 2 right trisegmentectomies (0.8%), an extended right hepatectomy (0.4%), and a right live donor hepatectomy (0.4%). Liver parenchymal transection was performed using robotic ultrasonic dissection or robotic bipolar electrosurgery after tissue crushing, while vessel transection was performed with clip application, ligature, or with running suture. Conversion to open surgery was performed in 10 cases (4.6%), most commonly for unclear margins or bleeding. No mortality was reported. Morbidity was cited in 20.3% of cases (48/236), the most common being intra-abdominal bile collection/abscess in 6.6% of procedures. Operative duration ranged from 200 to 507 minutes.

A few non-randomized, comparative cohort studies exist, comparing robotic liver resection with laparoscopic and open hepatic surgery [87,88].  A comparative study showed no time difference between robotic and conventional laparoscopic liver resection, while others suggested longer robotic surgical times when compared with laparoscopic or open techniques (253 min vs. 199 min respectively). Estimated blood loss was not significantly different from that of laparoscopic liver resection although direct comparison with laparoscopic hepatectomy showed that the robotic approach allowed for increased percentage of hepatectomies to be completed in a purely minimally invasive fashion (81% vs. 7.1%) [88]. Similar disease-free survival was seen when robotic resection of mixed malignancies were compared with laparoscopic resection [74,76,82]. With a lack of true randomized, controlled data comparing robotic hepatectomy with laparoscopic or open hepatectomy, no significant conclusions can be made comparing the procedures. Robotic hepatectomy is feasible, as demonstrated in several series, but true comparisons, especially to help evaluate oncologic and other patient outcomes, cost-effectiveness, and morbidity and mortality differences cannot be determined with existing data.

Similar to robotic-assisted hepatic procedures, robotic-assisted pancreatic surgery has been described in several case series for both benign and malignant disease [89-90]. Again, no randomized, controlled trials exist comparing robotic pancreatic surgical procedures with laparoscopic or open surgical procedures, but several series have demonstrated safe outcomes in select patients. Pancreatic resections described using robotic assistance include: pancreaticoduodenectomy, distal pancreatectomy, central pancreatectomy, pancreatic enucleation, total pancreatectomy, Appleby resection, and Frey procedure. No direct comparison studies look at open versus laparoscopic versus robotic pancreatectomy in a randomized, controlled, prospective fashion so drawing definitive conclusions about the superiority of a robotic approach in pancreatectomy is not possible.

Multi-port cholecystectomy has been performed with robotic assistance, and is commonly used as a procedure for surgeons to gain comfort with the robotic platform early in their learning curve. There is insufficient data, however, to support robotic cholecystectomy outside of training purposes.

Colorectal Surgery

Adaptation of the da Vinci® system for colorectal procedures was first reported by Weber et al. in 2002 [91]. They found that the robot overcame several of the inherent limitations of conventional laparoscopy, although a much longer operative time was required. Delaney et al. evaluated perioperative outcomes for six matched robotic versus laparoscopic colorectal procedures in 2003 [92]. Their robotic procedures were associated with an increased operative time; however, incision length, blood loss, and length of hospitalization were similar between the groups. Several other authors have also reported their early assessment of da Vinci® robotic colorectal surgery [93-98]. Although some variability exists, the early phases of robotic literature generally revealed similar conclusions showing comparable short-term results compared with laparoscopy with lower blood loss, and increased length of surgery and cost [99, 100].

True benefits of robotic colorectal surgery have not been shown. The potential benefits of robotic colorectal surgery may be seen in cases involving rectal and pelvic dissection, but proven benefits have not been demonstrated [101]. There is, however, literature examining the robotic approach for colorectal cases involving rectal and pelvic anatomy [102]. Some have shown positive outcomes for a quality total mesorectal excision (TME) and cylindrical excision for low rectal cancers [103-105]. It has also been suggested that in the obese and male gender, robotic surgery is associated with decreased blood loss and lower rates of conversion. Nearly all studies have shown however, that the robotic platform results in prolonged operative times as well as higher costs compared with laparoscopy. Some surgeons advocate for robotic right colectomy; however, unlike its role in pelvic anatomy, no significant advantages over existing minimally invasive techniques in regard to technical considerations and outcomes have been shown [106,107]. In light of the increased resources required for robotic surgery, its role in non-rectosigmoid procedures is limited at this time.

At present, the greatest utilization for continued advancements with robotic colorectal surgery is centered on techniques and outcomes for total mesorectal excision (TME) [108,109]. Although 45% of colectomies are performed laparoscopically in the USA, less than 10% of rectal resections are performed using a minimally invasive approach. Robotic surgery has been touted as an enabling technology for rectal resections, and it is estimated that nearly half of minimally invasive rectal cases are performed robotically [109]. These procedures involve pelvic anatomy in which critical structures are located in a confined and restricted anatomical location, which is even more pronounced in the male or obese patient. Numerous authors contend that the 3D visualization and wristed instruments afford advantages for mesorectal excision and nerve-sparing over conventional laparoscopic technique [110-112]. The published literature is yet to validate such benefits, with some studies showing advantages and others demonstrating non-inferiority for robotic rectal resection. However, the literature does consistently reveal similar short-term outcomes with longer operative times and higher costs [113,114]. Some early studies have shown trends toward better sexual or bladder function; nevertheless, this has not reached significance and has yet to be proven [115-116]. Currently, randomized control trials are looking to answer these and other questions regarding the widespread role of robotic surgery for rectal cancer [117].

Procedures for benign diseases such as rectal prolapse and complicated diverticulitis have been reported [118-121]. No clear advantage has been shown over laparoscopy. Overall, these studies have shown similar short-term outcomes with lower blood loss at the expense of longer operative times and higher costs similar to the TME data.

Rectal surgery, either by laparoscopy or utilizing the robotic platform, is still considered more technically challenging than open colon resection. As such, some would suggest only employing robotics for the treatment of rectal pathology once the early phase of the learning curve is achieved. There are few studies that have evaluated the learning curve for robotic colorectal surgery. Spinoglio et al. aimed to assess surgical and oncological advantages of robotic colorectal surgery for cancer in 2010 [122]. They noted that operative time decreased as their experience increased (419 minutes in the first 20 cases vs. 346 minutes in the last 30 cases; P = 0.036). In 2011, Bokhari et al. utilized a cumulative sum (CUSUM) methodology to create a three-phase learning curve from a series of 50 consecutive robotic rectal cases [123]. They concluded that the learning phase for robotic rectal surgery was achieved after 15 to 25 cases. Similar observations were noted by Jiménez-Rodríguez et al. and Sng et al. [124,125]. While there is no consensus on the exact number of cases required to overcome the learning curve, it is acknowledged that competency with laparoscopic colectomy is recommended prior to operating the robotic system for rectal procedures [126].

At present, no significant benefits have been realized with regard to operative time or patient-related outcomes following robotic colorectal surgery. Without significant reductions in operative time or length of stay, meaningful cost reductions cannot be realized. Utilization of this platform should be rationalized on a case-by-case basis, especially for cases with pelvic anatomy or unfavorable patient characteristics such as obesity or low rectal tumors. Efforts can be made toward developing improved instrumentation as well as optimizing the approach and lowering or times and costs [127,128]. Until such time, the utilization of the robotic platform for rectal pathology should be reserved for cases and pathologies in which the surgeon feels it affords true benefits that outweigh the increased resources of this approach.

Single-port robotic colorectal surgery has been performed but has not been evaluated outside of small series and initial experiences [129-131]. Use of the da Vinci® platform has also been extended for use in transanal surgery, with several authors demonstrating safety and feasibility in combination with transanal minimally invasive surgery (TAMIS) [132-134]. This is early data and further studies will need to be performed to know if there is any benefit to this approach.

Single-Incision Robotic Cholecystectomy

With the introduction of the single-incision Da Vinci® robotic platform, several institutions have described their experience with this technology for robotic cholecystectomy [135-145]. It appears that, with adequate experience, the use of this technology for single-incision robotic-assisted cholecystectomy is safe and feasible. In addition to the use of a novel robotic platform, this technology also has the capability of fluorescent imaging using an integrated near infrared camera following indocyanine green (ICG) administration for real-time visualization of biliary anatomy. This has been advocated by some groups to help facilitate bile duct visualization during the procedure in efforts to reduce biliary injury [146]. The real-time visualization of a patient’s biliary anatomy requires a simple push of a button to swap between the white-light and the near infrared camera filter feature built into the most recent robotic system.

While convenient for deciphering obscure anatomy quickly, the true reliability of this single-incision robotic surgery approach awaits further clinical trials. Similar to hepatic and pancreatic surgery, no randomized, controlled trials exist comparing robotic single-incision cholecystectomy with either traditional 4-trocar laparoscopic cholecystectomy or conventional single-incision laparoscopic cholecystectomy and any advantages that the robotic system offers must await this analysis before definitive conclusions can be made. There are also ample data that the costs are higher with the robotic approach. Robotic cholecystectomy cannot, therefore, be recommended currently as a modality to be used for routine cholecystectomy.

Ongoing Trials

A review of clinicaltrials.gov (accessed 2/19/2014) was performed to identify current clinical studies regarding robotic surgery:

  • Robotic Versus Laparoscopic Resection for Rectal Cancer: This study at the University of California, Irvine aims to compare two different surgical procedures for the treatment of Rectal Cancer: Laparoscopic Surgery and Robotic Assisted Laparoscopic Surgery. The ROLARR study is for participants with cancer of the rectum for whom a laparoscopic operation has been recommended by their surgeon.
  • Efficacy Study of Robotic Surgery for Rectal Cancer: This study from the National Cancer Center, Korea aims to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.
  • Robotic Assisted Versus Laparoscopic Cholecystectomy – Outcome and Cost Analyses of a Case-Matched Control Study: This study from the University of Zurich, is a case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy. These patients are matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and surgical experience.
  • A Trial to Assess Robot-assisted Surgery and Laparoscopy-assisted Surgery in Patients With Mid or Low Rectal Cancer: This study from Kyungpook National University will assess the safety and benefit of robotic resection compared with conventional laparoscopy-assisted resection for curative treatment of patients with cancer of the mid or low rectum.
  • Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomized Clinical Trial: This study from Kyungpook National University is a randomized controlled trial designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.
  • Clinical and Health Economic Impact of Robot-assisted Surgery vs Conventional Laparoscopy : the Case of Gastric Bypass: This study from IHU Strasbourg aims to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass). This monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, and post-operative complication incidence. It will also provide information on direct and indirect costs of surgery.
  • Laparoscopic “da VINCI®” Robot Assisted Abdominal Wall Hernia Repair: This study from Assistance Publique – Hôpitaux de Paris aims to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias. In this monocentric randomized controlled trial, the use of the DA VINCI® robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.
  • Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy: This study from IHU Strasbourg looks at different techniques that have been proposed to prevent bile duct injury.
  • Cosmesis, Patient Satisfaction and Quality of Life After da Vinci® Single Site and Multiport Laparoscopic Cholecystectomy: This study by Intuitive Surgical is a prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci® Single Site Instruments™ to multi-port (four ports) laparoscopy.
  • The Clinical Study of Making the Evidence With Application of Da Vinci® Robot-Assisted Low Anterior Resection in Rectal Cancer: This study from Yonsei University investigates evidence with application of Da vinci® robot-assisted low anterior resection in rectal cancer.
  • Fluorescence Imaging on the da Vinci® Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks postoperatively): This study by Intuitive Surgical hypothesized that the da Vinci® Fluorescence Imaging Vision System provides real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.

Expert Subcommittee Recommendation

This expert panel convened by the SAGES Technology and Value Assessment Committee finds that:

With regards to safety:

  • The da Vinci® Surgical System for gastrointestinal surgery does not demonstrate increased morbidity or mortality compared with laparoscopic surgery.
  • With proper training, there is enough data to regard the da Vinci® Surgical System as safe. As with any new surgical technology, complications may be more likely without adequate training.

With regards to efficacy:

  • Surgery with the da Vinci® Surgical System is as effective, but not demonstrated to be superior to conventional laparoscopic surgery of the gastrointestinal tract. It appears to have similar benefits to laparoscopic surgery when compared with open.
  • There is insufficient data to know if the oncologic outcomes in surgery using the da Vinci® Surgical System are equivalent or superior to conventional laparoscopic surgery.

With regards to cost:

  • The da Vinci® Surgical System is more costly, including fixed costs for the equipment and servicing, as well as per case cost in terms of OR time, and use of consumables.
  • Published data assessing the value of da Vinci® robotic surgery does not exist, in both the short and long term, taking into account direct and indirect measures of cost and quality. Future analyses should include quality and costs to the health care system as a whole.

Conclusions:

  • Gastrointestinal surgery with the da Vinci® Surgical System is safe and comparable to standard laparoscopic approaches.
  • Surgical outcomes with the da Vinci® Surgical System are not superior to
    laparoscopy.

All studies that have evaluated costs indicate an increase in procedure-related costs, and frequently in OR time-related costs.

  • On the basis of available evidence, this panel concludes that the da Vinci® Surgical System is a clinically acceptable but costly platform for use in selected gastrointestinal procedures such as Heller myotomy, Nissen fundoplication, paraesophageal hernia repair, gastrectomy, liver resection, pancreatic resections, bariatric surgery, and colorectal surgery.
  • Data does not support a role for multi-port robotic cholecystectomy outside of its use for developing familiarity with robotic platforms by surgeons early in their learning curve.
  • There are insufficient data supporting the use of single-port platforms for robotic cholecystectomy.
  • Current data are limited to the da Vinci® Surgical System. Further analyses will be needed as other devices are introduced.

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Disclosures

Dr. Brody is a consultant for Covidien, ViiNetwork, Medtronic, Ethicon, and Cooper Surgical. Dr. Gould is on the advisory committee for Torax Medical. Dr. Oleynikov is a board member for Vitrual Incision Corporation and receives research grant from LifeCell Corporation. Dr. Ross is a speaker for Olympus and consultant for Covidien. Dr. Sandler is a speaker for Bard-Davol, Inc. and Ethicon, Inc., and is a consultant for ValenTx, Inc. Dr. Satava receives a research grant from Institute of Surgical Excellence, and is a consultant for Kingdom of Saudi Arabia – Minister of Health and InTouch. Dr. Tsuda is a proctor for Intuitive Surgical and is a speaker for Acelity. Dr. Azagury, Dr. Haas, and Dr. Hutter have nothing to disclose.

This document was prepared and revised by the SAGES daVinci Safety and Effectiveness Subcommittee of the SAGES Technology and Valuation Assessment Committee

  • Shawn Tsuda
  • Dmitry Oleynikov
  • Jon Gould
  • Dan Azagury
  • Bryan Sandler
  • Matthew Hutter
  • Sharona Ross
  • Eric Haas
  • Fred Brody
  • Richard Satava

This statement was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) on Jul 2015.

SAGES publication #TAVAC002

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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.

Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.