Robotic-assisted cholecystectomy linked to higher rates of bile duct injury, complications
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Key takeaways:
- Robotic-assisted cholecystectomy correlated with a higher risk for bile duct injury and other serious complications.
- Findings suggest the use of robotic-assisted cholecystectomy should be reconsidered.
Although the use of robotic-assisted cholecystectomy increased 37-fold from 2010 to 2019, the procedure was associated with significantly higher rates of bile duct injury compared with laparoscopic cholecystectomy, according to research.
“While cholecystectomy remains one of the most routine operations performed by general surgeons, a recent several-fold increase in the use of robotic-assisted surgical procedures has driven the ongoing debate over the potential safety implications of this change in practice,” Stanley Kalata, MD, MS, of the department of surgery at the University of Michigan, and colleagues wrote in JAMA Surgery. “Whether robotic-assisted cholecystectomy leads to even safer outcomes than minimally invasive laparoscopic cholecystectomy remains unclear.”
Using Medicare administrative claims data, researchers retrospectively analyzed 1,026,088 individuals (mean age, 72 years; 53.3% women) who underwent cholecystectomy from 2010 to 2019 to investigate the comparative safety of robotic-assisted (n = 1,001,004) vs. laparoscopic (n = 25,084) surgery.
The primary studied outcome was the rate of bile duct injury that required surgical reconstruction within 1 year of cholecystectomy, while secondary outcomes included bile duct injury requiring less invasive postoperative interventions and overall incidence of 30-day complications.
Results showed the use of robotic-assisted cholecystectomy increased 37-fold from 0.1% in 2010 to 5.2% in 2019. Laparoscopic surgery also increased during this time from 75.4% to 77.8%, while open cholecystectomy decreased from 24.4% to 17%.
Compared with laparoscopic surgery, robotic-assisted cholecystectomy correlated with a higher risk for bile duct injury requiring repair within 1 year (0.7% vs. 0.2%; RR = 3.16; 95% CI, 2.57-3.75), as well as biliary interventions (7.4% vs. 6%; RR = 1.25; 95% CI, 1.16-1.33) and serious complications (9.3% vs. 8.6%; RR = 1.08; 95% CI, 1.03-1.13).
Researchers reported no significant differences between the procedures for overall 30-day complication rates (20.5% vs. 20.6%; RR = 1; 95% CI, 0.97-1.03).
Moreover, an instrumental variable analysis, which addressed potential confounders among patients, showed robotic-assisted surgery “was still associated” with an increased risk for bile duct injury (0.4% vs. 0.2%; RR = 1.88; 95% CI, 1.14-2.63).
Several sensitivity analyses demonstrated similarly higher rates of injury during both elective (1.3% vs. 0.5%; RR = 2.64; 95% CI, 2.04-3.25) and urgent or emergent (0.3% vs. 0.2%; RR = 1.87; 95% CI, 1.36-2.38) surgical procedures, as well as among patients who underwent cholecystectomy for acute or chronic cholecystitis (0.5% vs. 0.2%; RR = 2.29; 95% CI, 1.79-2.79).
“Among Medicare beneficiaries, the use of robotic-assisted cholecystectomy increased from 2010 through 2019 and was associated with higher rates of bile duct injury compared with laparoscopic cholecystectomy,” Kalata and colleagues concluded. “In the absence of other advantages over an already minimally invasive procedure, these data call into question the practice of robotic-assisted cholecystectomy.”
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