Status:
COMPLETED
Indications for Gallbladder Surgery in Gallstone Disease
Lead Sponsor:
Haraldsplass Deaconess Hospital
Collaborating Sponsors:
University of Bergen
Conditions:
Gallstones
Eligibility:
All Genders
18-80 years
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. ...
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 cholecyste...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 1991
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01190280
Start Date
October 1 1991
End Date
August 1 2010
Last Update
August 27 2010
Active Locations (1)
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1
Haraldsplass Deaconal Hospital, Department of Surgery
Bergen, Norway, 5009