medwireNews: Robotic-assisted cholecystectomy is associated with a higher risk for bile duct injury than the laparoscopic approach, regardless of the patient’s baseline risk, a study concludes.
“As use of robotic-assisted surgery continues to expand, it must be done with caution and intentional balance of adequately training surgeons on the platform while ensuring patient safety,” write Cody Lendon Mullens (University of Michigan, Ann Arbor, USA) and colleagues in JAMA Network Open.
The advantage of robotic-assisted cholecystectomy over laparoscopic cholecystectomy has been unclear until now, with this study casting doubt on previous suggestions that the greater risks associated with robotic-assisted cholecystectomy may be due to surgeons using it for more high-risk and complex patients, they say.
Mullens et al used deidentified Medicare data from 737,908 patients aged 66–99 years who underwent cholecystectomy between 2010 and 2021 to compare the safety of robotic-assisted versus laparoscopic approaches when stratified for a range of risk factors including age, sex, race, ethnicity, and comorbidities. They assigned 60% of the participants to a training cohort to identify the most influential risk factors, and the remaining 40% to an experimental cohort to test their statistical models.
The primary outcome of the study was bile duct injury requiring operative repair with hepaticojejunostomy or choledochojejunostomy within 1 year of the index operation.
As a secondary outcome, Mullens and colleagues calculated a 90-day composite outcome score encompassing the incidence of any complications, serious complications (complications with a hospital length of stay greater than the 75th percentile), reoperations, and rehospitalization for any cause after index cholecystectomy. This ranged from 0 (for none of the outcomes) to 4 (for all outcomes). This was used to risk stratify the patients based on score terciles into those at low, medium, or high risk.
The participants were a mean of 74.7 years old, 57.4% were women, 84.8% were White, and 73.2% were seen in a nonprofit hospital. The majority (96.6%) of the patients underwent laparoscopic cholecystectomy.
The most common indication for cholecystectomy was cholecystitis, accounting for 87.7% of the patients. Just 6.2% of the participants had no Elixhauser comorbidities, 16.1% had one, and 21.6% had two, while 21.0% had five or more, with a greater number indicating a greater burden of illness and a risk for poorer outcomes.
The investigators found that mean bile duct injury rates in the experimental cohort were significantly higher among patients undergoing robotic-assisted cholecystectomy than laparoscopic cholecystectomy, with mean rates of 0.72% versus 0.23% and a relative risk (RR) of 3.12. The training cohort showed a similar trend, they note.
The trend was also present across different risk stratification groups, with RRs of 3.14, 3.13, and 3.11 in low-, medium-, and high-risk patients, respectively. The researchers highlight that the average bile duct injury rate for robotic-assisted cholecystectomy in the low-risk group was significantly higher than that of laparoscopic cholecystectomy in the high-risk group, with corresponding rates of 0.47% and 0.33%.
Overall, 26.0%, 10.7%, 3.6%, and 19.8% of participants experienced any complications, serious complications, reoperations, and rehospitalization, respectively.
Mullens and colleagues observed that the robotic-assisted and laparoscopic cholecystectomy groups had similar mean rates for the composite secondary outcome in the experimental cohort, at 40.67% and 37.26%, respectively, and a RR of 1.09.
The researchers found that there was a similar risk of overall complications and readmissions among patients treated with robotic-assisted and laparoscopic cholecystectomy, but the higher rate of bile duct injury led to significantly greater risk of reoperation with the robotic-assisted approach (RR=1.47).
Given that an estimated 300–450 procedures are required to achieve comparable rates of bile duct injuries in robotic-assisted and laparoscopic cholecystectomy, the data “suggest that surgeons should consider leveraging other familiar operations as training cases for becoming comfortable with the robotic-assisted platform,” the authors write.
In a related editorial, David Urbach, from Women’s College Hospital in Toronto, Ontario, Canada, says that “[r]obotic-assisted cholecystectomy is more costly and lacks any meaningful short-term benefit compared with the gold standard procedure of laparoscopic cholecystectomy.”
Recognizing that patients may express a preference for robotic surgery and other “aggressively marketed health interventions that are not aligned with their treatment goals and values,” he cautions: “Patient perceptions are highly influenced by concepts such as novelty and innovation, and we must be mindful of the extraordinary power we exert in framing these perceptions, potentially swaying patients toward riskier treatments.”
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JAMA Network Open 2025; 8: e251705
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