A randomized controlled study of uncomplicated gallstone disease with a 14-year follow-up showed that operation was the preferred treatment

Dig Surg. 2011;28(4):270-6. doi: 10.1159/000329464. Epub 2011 Jul 9.


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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Cholecystectomy*
  • Cholecystitis / etiology
  • Choledocholithiasis / etiology
  • Cholelithiasis / complications
  • Cholelithiasis / therapy*
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Pancreatitis / etiology
  • Severity of Illness Index
  • Treatment Outcome
  • Watchful Waiting*
  • Young Adult