Indications for Gallbladder Surgery in Gallstone Disease

Study Overview
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Brief Summary
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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
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Randomized clinical trial (RCT) of observation versus surgery for uncomplicated gallstone disease RCT of observation versus operation for acute cholecystitis Study of outcome after cholecystectomy in patients from 1. and 2. Study of symptoms in gallstone disease and symptom relief after cholecystectomy Long-term morbidity and mortality, including cancer, after cholecystectomy Long-term follow-up of patients with silent gallstones

Official Title
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Indications for Gallbladder Surgery in Gallstone Disease

Conditions
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Gallstones

Intervention / Treatment
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* Procedure: Cholecystectomy operation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Symptomatic gallstone disease (SGBS): Episodes of pain in the right subcostal or midline epigastric area lasting more than 30 min, with ultrasonography signs of gallstones. Ultrasonographic: echo with an acoustic shadow in a visible gallbladder, or an echo with positional change and size <3 mm or, alternatively no demonstrable gallbladder but a strong echo with an acoustic shadow in the position of the gallbladder Exclusion Criteria SGBS: Infrequent and/or minimal pain that need only very occasional medication Age below 18 or above 80 Not willing to participate Inclusion criteria, acute cholecystitis (AC): Acute abdominal pain Duration of more than 8-12 h Tenderness on clinical examination in the upper right quadrant Presence of gallbladder stones and signs of inflammation on ultrasonography and in clinical biochemistry data, including an elevated temperature Exclusion criteria, AC: Severe concomitant disease Suspected Common Bile Duct stone Acalculous cholecystitis Localized peritonitis suggesting gallbladder perforation or gangrenous cholecystitis Inclusion criteria 1983 cohort of patients: Participation in a screening study for gallstones in 1983 Operated for symptomatic gallstone disease in Bergen, Norway in 1983

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AC - operation<br>Patients admitted with acute cholecystitis randomized to operation | Procedure: Cholecystectomy operation<br>* Cholecystectomy after randomization<br>* Other names: Removal of gallbladder;|
| AC - observation<br>Patients admitted with acute cholecystitis randomized to observation | |
| SGBS - operation<br>Patients admitted with uncomplicated gallstone disease randomized to operation | Procedure: Cholecystectomy operation<br>* Cholecystectomy after randomization<br>* Other names: Removal of gallbladder;|
| SGBS - observation<br>Patients admitted with uncomplicated gallstone disease randomized to observation | |
| 1983 - stones<br>Patients that in 1983 were diagnosed with gallstones in a population screening | |
| 1983 - operation<br>Patients that were operated for gallstone disease at Haukeland University Hospital, Bergen, Norway, in 1983 | |
| 1983 - controls<br>Patients that were shown not to have gallstones in a 1983 population screening | |
| Gallstone patients<br>Patients with symptoms from gallstone disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |