Indications for Gallbladder Surgery in Gallstone Disease

This study has been completed.
Sponsor:
Collaborator:
University of Bergen
Information provided by:
Haraldsplass Deaconess Hospital
ClinicalTrials.gov Identifier:
NCT01190280
First received: August 26, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Gallstones
Procedure: Cholecystectomy operation
Phase 3

Study Type: Observational
Official Title: Indications for Gallbladder Surgery in Gallstone Disease

Resource links provided by NLM:


Further study details as provided by Haraldsplass Deaconess Hospital:

Biospecimen Retention:   Samples Without DNA

Resected gallbladders for histological and bacteriological investigation


Enrollment: 500
Study Start Date: October 1991
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AC - operation
Patients admitted with acute cholecystitis randomized to operation
Procedure: Cholecystectomy operation
Cholecystectomy after randomization
Other Name: Removal of gallbladder
AC - observation
Patients admitted with acute cholecystitis randomized to observation
SGBS - operation
Patients admitted with uncomplicated gallstone disease randomized to operation
Procedure: Cholecystectomy operation
Cholecystectomy after randomization
Other Name: Removal of gallbladder
SGBS - observation
Patients admitted with uncomplicated gallstone disease randomized to observation
1983 - stones
Patients that in 1983 were diagnosed with gallstones in a population screening
1983 - operation
Patients that were operated for gallstone disease at Haukeland University Hospital, Bergen, Norway, in 1983
1983 - controls
Patients that were shown not to have gallstones in a 1983 population screening
Gallstone patients
Patients with symptoms from gallstone disease

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to a hospital for either acute cholecystitis or uncomplicated symptomatic gallstone disease randomized to observation or operation. Patients from a population screening study for gallstones performed in 1983. Patients operated for gallstone disease in 1983.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190280

Locations
Norway
Haraldsplass Deaconal Hospital, Department of Surgery
Bergen, Norway, 5009
Sponsors and Collaborators
Haraldsplass Deaconess Hospital
University of Bergen
Investigators
Study Chair: Karl Søndenaa, MD, PhD Haraldsplass Deaconal Hospital, University of Bergen, Norway
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karl Søndenaa, Haraldsplass Deaconal Hospital, Department of Surgery, University of Bergen, Bergen, Norway
ClinicalTrials.gov Identifier: NCT01190280     History of Changes
Other Study ID Numbers: GS06
Study First Received: August 26, 2010
Last Updated: August 26, 2010
Health Authority: Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Ethics Committee
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 28, 2014