Indications for Gallbladder Surgery in Gallstone Disease

August 26, 2010 updated by: Haraldsplass Deaconess Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5009
        • Haraldsplass Deaconal Hospital, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AC - operation
Patients admitted with acute cholecystitis randomized to operation
Procedure: Cholecystectomy operation
Cholecystectomy after randomization
Other Names:
  • 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 Names:
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haraldsplass Deaconess Hospital

Collaborators

University of Bergen

Investigators

  • Study Chair: Karl Søndenaa, MD, PhD, Haraldsplass Deaconal Hospital, University of Bergen, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1991

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 26, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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