Indications for Gallbladder Surgery in Gallstone Disease - Full Text View

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:

MedlinePlus related topics: Gallstones

U.S. FDA Resources

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:

Randomized clinical trial (RCT) of observation versus surgery for uncomplicated gallstone disease
RCT of observation versus operation for acute cholecystitis
Study of outcome after cholecystectomy in patients from 1. and 2.
Study of symptoms in gallstone disease and symptom relief after cholecystectomy
Long-term morbidity and mortality, including cancer, after cholecystectomy
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

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:

Søndenaa K, Nesvik I, Solhaug JH, Søreide O. Randomization to surgery or observation in patients with symptomatic gallbladder stone disease. The problem of evidence-based medicine in clinical practice. Scand J Gastroenterol. 1997 Jun;32(6):611-6.

Glambek I, Kvaale G, Arnesjö B, Søreide O. Prevalence of gallstones in a Norwegian population. Scand J Gastroenterol. 1987 Nov;22(9):1089-94.

Vetrhus M, Søreide O, Solhaug JH, Nesvik I, Søndenaa K. Symptomatic, non-complicated gallbladder stone disease. Operation or observation? A randomized clinical study. Scand J Gastroenterol. 2002 Jul;37(7):834-9.

Vetrhus M, Søreide O, Nesvik I, Søndenaa K. Acute cholecystitis: delayed surgery or observation. A randomized clinical trial. Scand J Gastroenterol. 2003 Sep;38(9):985-90.

Vetrhus M, Berhane T, Søreide O, Søndenaa K. Pain persists in many patients five years after removal of the gallbladder: observations from two randomized controlled trials of symptomatic, noncomplicated gallstone disease and acute cholecystitis. J Gastrointest Surg. 2005 Jul-Aug;9(6):826-31.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Schmidt M, Småstuen MC, Søndenaa K. Increased cancer incidence in some gallstone diseases, and equivocal effect of cholecystectomy: a long-term analysis of cancer and mortality. Scand J Gastroenterol. 2012 Dec;47(12):1467-74. doi: 10.3109/00365521.2012.719928. Epub 2012 Sep 5.

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 June 18, 2013