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Background/Aims: Cholecystectomy is considered the treatment of choice for symptomatic gallstone disease. Some patients abstain from surgery and provide the opportunity to study the natural history of cholelithiasis. The aim of the present study was to examine the feasibility and safety of observation after extended long-term follow-up in a randomized controlled trial. Methods: A total of 137 patients (40.5% of those assessed) were randomized to observation or cholecystectomy and followed up for 14 years. The prevalence of symptomatic events or major complications after treatment was the primary end point. A secondary end point was completion of randomized treatment. Results: There were no differences in outcome between the observation group and the surgical group (p = 0.298). Virtually no cholecystectomy was performed after 5 years of follow-up, and no clear escalation in the severity of the disease was observed. A total of 50.7% of patients from the observation group and 88.2% from the surgical group underwent surgery. The group randomized to surgery completed their designated treatment significantly more often (p < 0.001), especially among patients younger than 70 years of age (p = 0.005). Conclusion: Cholecystectomy was the preferred treatment after extended long-term follow-up, but conservative management for symptomatic gallstone disease is an alternative to surgery in the elderly. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]