NCT01190280

Indications for Gallbladder Surgery in Gallstone Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Haraldsplass Deaconess Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gallstones

Interventions

Type	Name	Description
PROCEDURE	Cholecystectomy operation	Cholecystectomy after randomization

Timeline

• Start date: 1991-10-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-08-27
• Last updated: 2010-08-27

Locations

1 site across 1 country: Norway