by Zung Vu Tran, PhD
Having read the article published in JAMA Surgery on Oct 21, 2020: Patient-Reported Outcomes of Robotic vs Laparoscopic Ventral Hernia Repair With Intraperitoneal Mesh – The PROVE-IT Randomized Clinical Trial, the need for far more comprehensive data on robotic-assisted surgery has become even more obvious.
The conclusion of this the study from the Cleveland Clinic stated: “Laparoscopic and robotic ventral hernia repair with intraperitoneal mesh have comparable outcomes. [However] the increased operative time and proportional cost of the robotic approach are not offset by a measurable clinical benefit.”
Scientifically, results of a single clinical trial (or even several) are not adequate to determine reliable evidence of outcomes. This can only be achieved by obtaining results of many trials and meta-analyzing all available evidence.
As an example, MedAware Systems’ SOHInfo (www.sohinfo.com) recently completed two large, comprehensive meta-analyses for a major device manufacturer to assess all available evidence from the published literature pertaining to robotic-assisted surgeries. Both projects were to determine whether outcomes differ related to three surgical approaches: open, laparoscopic, and robotic-assisted.
The meta-analyses focused on various urological procedures. For the two studies, we identified over 1,000 published studies and analyzed data from over 500 of those that met inclusion criteria. This was accomplished in approximately 12 weeks per project.
In the larger of the two studies (578 published studies reviewed with data extracted and analyzed from 258 of those that met inclusion criteria) a pooled statistical comparison showed that for robotic-assisted vs. laparoscopic, across all the different procedures we investigated, there were statistically significant differences for 5-year survival, overall survival, and length of hospital stay, all favoring robotic-assisted surgery. Additionally, both intraoperative blood loss and length of hospital stay were significantly lower for robotic-assisted vs. open surgery for these same procedures.
In a related article in MedTech Dive, published October 22, 2020, the author points out that the Cleveland Clinic study may have underrepresented the benefits of robotics as the surgeons were not primarily experts in the technology. (And hence the longer operative time for robotic surgery.) Further, in this article, he cites Emory University surgeons as saying: “The onus is on robotic protagonists to demonstrate the benefits with higher-level evidence to support widespread adoption.”
We could not agree more. Only through the collection and analysis of all available data will reliable evidence on robotic-assisted surgery outcomes be ascertained.