BACKGROUND: Acute cholecystitis carries a higher risk of subsequent gallstone related events than symptomatic, non-complicated disease. However, it is largely unknown to what extent non-operative treatment will affect the patient's well-being as no trial has studied the possible consequences on pain and quality of life. Our aim was to study in a randomized trial how observational treatment (watchful waiting) compared to cholecystectomy. METHODS:Sixty-four patients with acute cholecystitis were randomized to observation or cholecystectomy. All gallstone related events were registered and patients answered questionnaires on quality of life (PGWB and NHP) and pain (Pain score and VAPS) at randomization and at 6, 12 and 60 months later. RESULTS: Patients were followed-up for a median of 67 months. Ten of 33 patients (30%, 95% CI 15%-46%) patients randomized to observation and 27 of 31 (87%, 95% CI 75 %- 99%) of patients randomized to operation had a cholecystectomy. Twelve of 33 (36%, 95% CI 20%-53%) patients in the observation group had a gallstone related event compared to 6 of 31 (19%, 95% CI 5%-33%) patients in the operation group, but the difference was not significant. When patients were grouped according to randomization or actual operative outcome (+/- cholecystectomy), we did not find any significant differences in pain or quality of life measurements. CONCLUSION: Although conservative treatment of AC carried a certain but not significantly increased risk of subsequent gallstone related events, this did not influence the symptomatic outcome as assessed by quality of life and pain measurements. Thus, we argue that conservative (non-operative) treatment and observation of AC is an acceptable option and should at least be considered in elderly and frail patients.
RCT Entities:
BACKGROUND:Acute cholecystitis carries a higher risk of subsequent gallstone related events than symptomatic, non-complicated disease. However, it is largely unknown to what extent non-operative treatment will affect the patient's well-being as no trial has studied the possible consequences on pain and quality of life. Our aim was to study in a randomized trial how observational treatment (watchful waiting) compared to cholecystectomy. METHODS: Sixty-four patients with acute cholecystitis were randomized to observation or cholecystectomy. All gallstone related events were registered and patients answered questionnaires on quality of life (PGWB and NHP) and pain (Pain score and VAPS) at randomization and at 6, 12 and 60 months later. RESULTS:Patients were followed-up for a median of 67 months. Ten of 33 patients (30%, 95% CI 15%-46%) patients randomized to observation and 27 of 31 (87%, 95% CI 75 %- 99%) of patients randomized to operation had a cholecystectomy. Twelve of 33 (36%, 95% CI 20%-53%) patients in the observation group had a gallstone related event compared to 6 of 31 (19%, 95% CI 5%-33%) patients in the operation group, but the difference was not significant. When patients were grouped according to randomization or actual operative outcome (+/- cholecystectomy), we did not find any significant differences in pain or quality of life measurements. CONCLUSION: Although conservative treatment of AC carried a certain but not significantly increased risk of subsequent gallstone related events, this did not influence the symptomatic outcome as assessed by quality of life and pain measurements. Thus, we argue that conservative (non-operative) treatment and observation of AC is an acceptable option and should at least be considered in elderly and frail patients.