Indications for Gallbladder Surgery in Gallstone Disease

Gallstones Clinical Trial

Official title:

Indications for Gallbladder Surgery in Gallstone Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190280
• Other study ID #: GS06
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2010
• Last updated: August 26, 2010
• Start date: October 1991
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: Haraldsplass Deaconess Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Directorate of HealthNorway: Ethics CommitteeNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Cholecystectomy operation
Cholecystectomy after randomization

Locations

Country	Name	City	State
Norway	Haraldsplass Deaconal Hospital, Department of Surgery	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haraldsplass Deaconess Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (5)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation