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.

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.

Only one third of patients with FGID experienced postoperative relief, indicating that FGID was a dominant cause of post-cholecystectomy symptoms.

Unexpectedly, only a minority of persons examined with ultrasonography had present day gallstones without any obvious explanation for this low figure. The rate of cholecystectomy was low in a conservative setting and no adverse events could be ascertained from such a policy.