Restrictive selection may avoid unnecessary cholecystectomy for abdominal pain, gallstones
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Key takeaways:
- At 5 years, 62.8% of patients in the usual care group were pain free vs. 61.2% in the restrictive care group.
- Restrictive care resulted in 8.3% fewer cholecystectomies, with no increase in complications.
Although a restrictive strategy for cholecystectomy reduced the operation rate by 8.3% at 5 years vs. usual care for patients with symptomatic cholelithiasis, the proportion of patients who were pain free did not differ between groups.
“While complicated cholelithiasis is an indication for cholecystectomy, there is lack of consensus about patients with uncomplicated symptomatic cholelithiasis for who will benefit from surgery,” Daan J. Comes, MD, of the department of surgery at Radboud University Medical Center in the Netherlands, and colleagues wrote in JAMA Surgery. “To investigate the appropriateness and the benefit from a stepwise selection for cholecystectomy in patients with uncomplicated cholelithiasis, the Scrutinizing (In)efficient Use of Cholecystectomy, A Randomized Trial Concerning Variation in Practice (SECURE trial), was initiated.”
The multicenter, noninferiority, prospective trial included 1,067 patients (median age, 49 years; 73.7% women) with symptomatic, uncomplicated cholelithiasis, who were randomly assigned 1:1 to receive usual care (n = 537) or a restrictive strategy with stepwise selection for cholecystectomy (n = 530).
Initial results reported at 1 year showed a significantly lower cholecystectomy rate with the restrictive strategy, but no significant difference in pain-free patients between groups. To better evaluate long-term outcomes, the researchers extended the assessment of pain-free patients, as evaluated by Izbicki pain score, to 5 years. Secondary outcomes were cholecystectomy rate, biliary and surgery complications and patient satisfaction, based on phone interviews and an email questionnaire.
According to 5-year results, 62.8% (95% CI, 57.8-67.8) of patients in the usual care group were pain free vs. 61.2% (95% CI, 56.1-66.3) in the restrictive care group. Following cholecystectomy, approximately two-thirds of patients were pain free in each group (usual care, n = 63.6%; restrictive care, n = 63%). Compared with usual care, restrictive care resulted in 8.3% fewer cholecystectomies.
Researchers reported no significant differences between groups in surgery- or cholelithiasis-related complications, patient-reported outcomes of biliary or functional gastrointestinal symptoms and patient-reported satisfaction.
“Although noninferiority could not be demonstrated over time, the restrictive strategy was not associated with an increase in biliary or surgical complications while resulting in fewer operations,” Comes and colleagues wrote. “The results of this long-term analysis may suggest that, in the future, a more restrictive approach could be adopted to avoid unnecessary cholecystectomies, and improving the selection of patients who actually benefit from cholecystectomy needs to be the focus of care.”
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