Long-term follow-up of a randomized controlled trial of observation versus surgery for acute cholecystitis: non-operative management is an option in some patients.

BACKGROUND: Cholecystectomy is routinely recommended to prevent recurrent disease after an initial episode of acute cholecystitis. Therefore, randomized controlled trials have mainly focused on the timing of surgery, but many patients scheduled for cholecystectomy have deferred surgery with long periods of symptom-free intervals. Our present aim is to examine the long-term feasibility and safety of observation compared with surgery.
METHODS: Trial of 64 patients with acute cholecystitis previously randomized to observation or cholecystectomy, which examined outcome in terms of completed randomized treatment and appearance of further symptoms and the need for surgical treatment. Thirty-three patients were randomized to observation and 31 patients to cholecystectomy. Median follow-up was 14 years.
RESULTS: Of the 33 patients randomized to observation, 11 (33%) experienced a new event of gallstone-related disease (eight (24.2%) had acute cholecystitis) and 11 (33%) were operated. No significant difference (p = 0.565) was found between the two randomized groups with regard to recurrent disease or complications. Virtually no surgery took place after 5 years of follow-up. The difference in completed randomized treatment between the groups was not significant (p = 0.077). Long-term mortality was equal in those operated and in those observed.
CONCLUSIONS: Twenty-four percent of the patients experienced recurrent cholecystitis, but escalation of disease severity or increased mortality was not observed. Long-term observation after acute cholecystitis was feasible in two-thirds of the patients as the risk for recurrent disease was negligible after 5 years.

RCT Entities:   Population Interventions Outcomes