Second opinion on da Vinci surgery

 

Last year the SAGES TAVAC Safety and Effectiveness subcommittee published a review: Analysis – DaVinci Surgical System. It was published in Surgical Endoscopy.  

The group analyzed many available studies and reports on the clinical efficacy of da Vinci surgery, and came to the following main 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 do 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 singleport platforms for robotic cholecystectomy.
• Current data are limited to the da Vinci Surgical System. Further analyses will be needed as other devices are introduced."

As expected, Intuitive Surgical took the opportunity to defend its system in the most recent issue of Surgical Endoscopy:

"As the scientific representatives of Intuitive Surgical Inc., we have three main concerns with the methodology presented by the TAVAC.
First, throughout the assessment, laparoscopic surgery is used as the sole comparator for robotic-assisted surgery. However, robotic-assisted surgery provides a minimally invasive surgery (MIS) option to patients who otherwise would have undergone an open procedure. By limiting the comparator to laparoscopic surgery, the analysis does not account for the substantial number of patients still receiving open procedures in general surgery in the USA (over 50 % of colectomies, over 80 % of rectal surgeries and over 70 % of ventral hernia repairs, for example).

Our second concern is with the methodology for selecting studies included by the TAVAC. These types of assessments typically use a rigorous methodology for identifying and reviewing qualified peer-reviewed literature. The selection criteria used by the Committee are not described, and a broader review shows that the authors omit a significant portion of relevant literature. The assessment primarily uses data that are more than 5 years old—while disregarding more current data that are often at a higher quality and evidence level. 

Furthermore, the lack of randomized controlled trials (RCTs) is mentioned numerous times in the assessment. RCTs are not typically, nor frequently, used as a sole data source when making clinical decisions in the field of surgery. 

Our final point regarding the TAVAC analysis relates to cost comparison methods. When evaluating costs, it is essential to look at total cost of care for a patient episode encompassing direct costs, direct non-healthcare costs, indirect costs and downstream costs, which the authors have not done.

Very few issues in the healthcare arena remain static, and this is true of the ongoing discussion about the value and effectiveness of robotic-assisted surgery. As surgeons become more proficient with complex robotic-assisted surgery procedures and as the body of clinical literature builds, we encourage the SAGES community to continue to assess this technology and the value it brings to hospitals, surgeons and patients."  

Read the full article here.