Pain and quality of life in patients with symptomatic, non-complicated gallbladder stones: results of a randomized controlled trial.

BACKGROUND: Cholecystectomy is intended to relieve symptoms of gallstones, but unfortunately some patients will experience postcholecystectomy symptoms, including pain. There is limited information in the literature on gallstone-related pain and its influence on quality of life. The aim of this study was to examine how pain and quality of life in patients with symptomatic, uncomplicated gallbladder stones were affected by observation of their condition compared with removal of the gallbladder.
METHODS: One-hundred and thirty-seven patients were randomized to observation (watchful waiting; n = 69) or cholecystectomy (n = 68) and answered questionnaires on pain, quality of life (PGWB index and NHP Part II) at randomization and fixed intervals (6, 12 and 60 months). All gallstone-related events (hospital admission for pain, complications of gallstone disease and cholecystectomy) and crossover between treatment groups were recorded.
RESULTS: Of patients randomized to observation, 35 of 69 patients (51%) eventually underwent a cholecystectomy. Significant improvements in quality of life and pain scores were detected regardless of surgical treatment. Patients that subsequently experienced gallstone-related events had significantly higher pain scores at randomization than patients that did not experience any subsequent events, and this difference was maintained throughout follow-up.
CONCLUSIONS: Unexpectedly, in the majority of patients symptoms did abate without any significant differences between groups in pain and quality of life. Patients that had high intensity and frequency of pain at randomization had a higher risk of experiencing subsequent events.

RCT Entities:   Population Interventions Outcomes