Symptomatic, non-complicated gallbladder stone disease. Operation or observation? A randomized clinical study.

BACKGROUND Cholecystectomy has been recognized as the treatment of choice for symptomatic gallbladder stone disease. Not all patients are cured by an operation and the reason for having the gallbladder removed may rest on common practice rather than evidence-based medicine. The aim was to compare cholecystectomy with observation (watchful waiting) in patients with uncomplicated symptomatic GBS disease. Three-hundred-and-thirty-eight patients were considered for participation in the study; 45 patients were excluded according to predefined criteria and 156 did not join for other reasons. The remaining 137 were randomized to cholecystectomy (n = 68) or non-operative, expectant treatment (n = 69). METHODS Randomized patients were contacted regularly and followed for a median of 67 months. All gallstone-related hospital contacts were registered in both randomized and excluded patients. RESULTS Eight of the patients randomized to cholecystectomy did not undergo operation, while 35 of the patients randomized to observation later had their gallbladders removed. The cumulative risk of having a cholecystectomy seemed to level off after 4 years. Gallstone-related complications occurred in 3 patients in the observation group, 1 in the operation group and 5 of 201 excluded patients. After cholecystectomy, 16 of 222 patients had a major complication and 10 a minor. CONCLUSIONS We found that non-operative expectant treatment carries a low risk of complications. Patients should be informed that watchful waiting is a safe option.