Indications for Gallbladder Surgery in Gallstone Disease

Haraldsplass Deaconess Hospital

Status: Completed

Conditions: Gallstones

Treatments: Procedure: Cholecystectomy operation

Study type: Observational

Funder types: Other

Identifiers

NCT01190280

GS06

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

500 participants in 8 patient groups

AC - operation

Description:

Patients admitted with acute cholecystitis randomized to operation

Treatment:

Procedure: Cholecystectomy operation

AC - observation

Description:

Patients admitted with acute cholecystitis randomized to observation

SGBS - operation

Description:

Patients admitted with uncomplicated gallstone disease randomized to operation

Treatment:

Procedure: Cholecystectomy operation

SGBS - observation

Description:

Patients admitted with uncomplicated gallstone disease randomized to observation

1983 - stones

Description:

Patients that in 1983 were diagnosed with gallstones in a population screening

1983 - operation

Description:

Patients that were operated for gallstone disease at Haukeland University Hospital, Bergen, Norway, in 1983

1983 - controls

Description:

Patients that were shown not to have gallstones in a 1983 population screening

Gallstone patients

Description:

Patients with symptoms from gallstone disease