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SAGES DaVinci review

SAGES: No difference lap vs robotic bariatric surgery

Robotic surgery has demonstrated some benefit when compared to laparoscopy in reduction of GJ leak rates, reduced strictures rates, or reduced length of stay

A review of the DaVinci Surgical System (Intuitive Surgical) by the SAGES daVinci Safety and Effectiveness Subcommittee has found that a robotic approach to bariatric surgery can facilitate hand-sewn gastro-jejunal (GJ) creation that offers several advantages to the bariatric surgeon compared to laparoscopy and, since the standard is a stapled anastomosis there appears to be “no difference in either safety or outcomes between laparoscopic and robotic approaches.” The review, ‘SAGES TAVAC safety and effectiveness analysis: da Vinci(®) Surgical System (Intuitive Surgical, Sunnyvale, CA).’, published in the journal Surgical Endoscopy, reviewed multiple general and gastrointestinal surgeries with robotic surgery, including cholecystectomy, oesophagectomy, fundoplication, Heller myotomy, gastrectomy, splenectomy, pancreatectomy, liver resection, colectomy, sleeve gastrectomy, and Roux-en-Y gastric bypass.

The da Vinci Surgical System is a computer-assisted (robotic) surgical system designed to enable and enhance minimally invasive surgery. The system has been cleared  for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general, cardiac, colorectal, gynaecologic, head and neck, thoracic and urologic surgical procedures.

The system, the review states, is not technically a robot but is a computer-assisted tele-manipulator. 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 manoeuvres that would be difficult with standard laparoscopic instruments. High-definition, 3D visualisation 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).

Bariatric  surgery

With regards to bariatric surgery, the review states that the use of robotic technology has been increasingly reported in bariatric surgery, including five systematic reviews. The only procedure studied in any volume is the Roux-en-Y gastric bypass, with robotic laparoscopic RYGBP procedure using the da Vinci surgical system has previously 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, the review does acknowledge that it fail to demonstrate superiority, pointing to the lack of high quality data. A single randomised trial exists showing equivalent outcomes  and other large trials include case control studies with up to 400 patients per group or case series (one including over 1000 robotic RYGB)  - all of which confirmed non-inferiority of the robotic approach, and most demonstrated some benefit when compared to laparoscopy in reduction of 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.

The review states that 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. 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,” the review states.

The SAGES Technology and Value Assessment Committee concluded that:

  • 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.
  • 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.
  • 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.
  • 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.
  • On the basis of available evidence, the panel concluded 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, para-oesophageal 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 and further analyses will be needed as other devices are introduced.

To access the review, please click here

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