Doctors perform laparoscopic surgery using robotic arms while looking at a three-dimensional image from cameras inserted into the patient's abdomen. Photo: Mike Derer / AP
Two separate studies published Tuesday in the Journal of the American Medical Association suggest outcomes for robotic-assisted surgeries when compared with other minimally invasive surgeries were not significant enough to balance the higher costs and longer treatment times involved.
Why it matters: Expensive robotic-assisted minimally invasive surgery has become the trend in hospitals over the past two decades, as it allows for 3-D visualization and an enhanced range of instrument motion. However, there is limited rigorous evaluation of the effectiveness of this technology in clinical practice, according to Columbia University's Jason Wright, who wrote a JAMA editorial about the two studies.
Study on removing rectal cancer
- The details: The research team compared the results of robotic-assisted (236) and conventional (230) laparoscopies at various sites around the world to remove cancerous tissues. They wanted to see if using robot technologies would lessen the chance that a surgeon would need to revert to a more invasive type of surgery (called an open laparotomy).
- The findings: They found no significant difference in the numbers of surgeons needing to use the more invasive surgical procedures, but found, on average, the length of an operation was 37.5 minutes longer for robotic-assisted surgery and cost $1,132 more.
Study on removing a kidney
- The details: The researchers looked at 23,753 patients who needed a kidney removed via minimally invasive surgeries by compared the outcomes and costs between robotic-assisted (5,180) and conventional (18,573) procedures.
- The findings: They found the results on safety and efficacy were similar, but the chance of an operation lasting more than four hours was higher in robotic-assisted surgeries (46.3%) versus conventional ones (25.8%). Plus, the average 90-day direct hospital costs were $2,678 more for the robotic-assisted procedures.
Clayton Lau, chair of urology and urologic oncology at City of Hope National Medical Center, points out that one of the reasons the robotic-assisted surgeries were longer was because some of the surgeons were in a "learning phase." However, he suggests patients go to "centers of excellence" for these types of complex surgeries because the technology is still being developed.
U.S. standards: "The regulatory standards for new procedures and devices are much less stringent than for new drugs and often only require demonstration that a device is equivalent to some previously approved device," Wright said in his editorial. "There are numerous examples of how these challenges have resulted in widespread adaptation and use of new devices and procedures in routine clinical practice without rigorous evaluation."
Wright pointed to a new program called NEST that is being built by the FDA in order to help determine the efficacy of devices. Lau, who was not part of either study, agreed: "NEST will be important in evidence-based evaluation of all medical devices. This will help provide oversight and safety...[and] hopefully foster future innovation."
Stanford University's Benjamin Chung, one of the authors of the kidney study, told Axios: "There may be advantages to the robotic platform in the performance of this procedure that will be borne out with future endeavors that are driving the rapid adoption [of technology] and if so, these need to be identified."