Gallstones
Conditions
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
Interventions
PROCEDURECholecystectomy operation
Cholecystectomy after randomization
Sponsors
University of Bergen
Haraldsplass Deaconess Hospital
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Countries
Norway
Outcome results
None listed