Indications for Gallbladder Surgery in Gallstone Disease

Completed

• Conditions: Gallstones
• Interventions: Procedure: Cholecystectomy operation

• Registration Number: NCT01190280
• Lead Sponsor: Haraldsplass Deaconess Hospital

Brief Summary

The aim of the study is to identify patients with gallstone disease that should be operated and those that may potentially be observed. This selection was based on symptoms and clinical presentation. The consequences that may arise for the patient if observation is chosen compared with outcome after cholecystectomy has been markers of outcome.

Detailed Description

1. Randomized clinical trial (RCT) of observation versus surgery for uncomplicated gallstone disease

2. RCT of observation versus operation for acute cholecystitis

3. Study of outcome after cholecystectomy in patients from 1. and 2.

4. Study of symptoms in gallstone disease and symptom relief after cholecystectomy

5. Long-term morbidity and mortality, including cancer, after cholecystectomy

6. Long-term follow-up of patients with silent gallstones

Study Timeline

• Study Start: 1991-10
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2010-08-26
• Study First Submitted QC: 2010-08-26
• Last Update Submitted: 2010-08-26
• Study First Posted: 2010-08-27
• Last Update Posted: 2010-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AC - operation	Cholecystectomy operation	Patients admitted with acute cholecystitis randomized to operation
SGBS - operation	Cholecystectomy operation	Patients admitted with uncomplicated gallstone disease randomized to operation

Trial Locations

Locations (1)

Haraldsplass Deaconal Hospital, Department of Surgery; 🇳🇴 Bergen, Norway