Acute Cholecystitis: Delayed Surgery or Observation. A Randomized Clinical Trial

BACKGROUND: The aim of the present study was to compare the risk of observation versus that of cholecystectomy in acute cholecystitis in patients randomly allocated to delayed operation or conservative treatment. METHODS: One-hundred-and-eighty patients were considered for participation in the study; 71 were excluded according to predefined criteria and 45 did not join for other reasons. The remaining 64 patients were randomized to cholecystectomy (n = 31) or observation (n = 33). Randomized patients were contacted regularly and followed up for a median of 67 months. All gallstone-related hospital contacts were registered in both randomized and excluded patients. RESULTS: Gallstone-related complications or emergency admissions for pain occurred in six patients in the operation group (19%; 95% CI 5%-33%) and in 12 patients (36%; 9% CI 20%-53%) in the observation group. Twenty-seven of 31 patients randomized to cholecystectomy had a cholecystectomy at a median of 3.6 months after randomization, and, of these, 3 (11%; 95% CI 0%-23%) suffered a major and 7 (26%; 95% CI 9%-42%) a minor complication. Ten patients randomized to observation later had their gallbladders removed, 1 (10%; 95% CI 0%-29%) patient had a major and 1 (10%; 95% CI 0%-29%) a minor complication. We found no mortality after cholecystectomy. CONCLUSIONS: We found a certain risk of subsequent gallstone-related events following conservative treatment of acute cholecystitis, but the data also show that cholecystectomy should not necessarily be compulsory after acute cholecystitis.