Indications for Gallbladder Surgery in Gallstone Disease

NCT01190280 | Completed

• 1 other identifier: GS06
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gallstones

Study Arms (8)

AC - operation

Patients admitted with acute cholecystitis randomized to operation

Procedure: Cholecystectomy operation

AC - observation

Patients admitted with acute cholecystitis randomized to observation

SGBS - operation

Patients admitted with uncomplicated gallstone disease randomized to operation

Procedure: Cholecystectomy operation

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

Interventions

Cholecystectomy operation PROCEDURE

Cholecystectomy after randomization

Also known as: Removal of gallbladder

AC - operation; SGBS - operation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Infrequent and/or minimal pain that need only very occasional medication
• Age below 18 or above 80
• Not willing to participate
• 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
• Severe concomitant disease
• Suspected Common Bile Duct stone
• Acalculous cholecystitis
• Localized peritonitis suggesting gallbladder perforation or gangrenous cholecystitis
• Participation in a screening study for gallstones in 1983
• Operated for symptomatic gallstone disease in Bergen, Norway in 1983

Sponsors & Collaborators

• Haraldsplass Deaconess Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haraldsplass Deaconal Hospital, Department of Surgery

Bergen, 5009, Norway

Location

Related Publications (6)

• Sondenaa K, Nesvik I, Solhaug JH, Soreide 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. doi: 10.3109/00365529709025108.

  PMID: 9200296 BACKGROUND

• Glambek I, Kvaale G, Arnesjo B, Soreide O. Prevalence of gallstones in a Norwegian population. Scand J Gastroenterol. 1987 Nov;22(9):1089-94. doi: 10.3109/00365528708991963.

  PMID: 3321395 BACKGROUND

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

  PMID: 12190099 BACKGROUND

• Vetrhus M, Soreide O, Nesvik I, Sondenaa K. Acute cholecystitis: delayed surgery or observation. A randomized clinical trial. Scand J Gastroenterol. 2003 Sep;38(9):985-90. doi: 10.1080/00365520310004056.

  PMID: 14531537 BACKGROUND

• Vetrhus M, Berhane T, Soreide O, Sondenaa 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. doi: 10.1016/j.gassur.2005.01.291.

  PMID: 15985239 BACKGROUND

• Schmidt M, Smastuen MC, Sondenaa 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.

  PMID: 22946484 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Resected gallbladders for histological and bacteriological investigation

MeSH Terms

Conditions

Gallstones

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Karl Søndenaa, MD, PhD

  Haraldsplass Deaconal Hospital, University of Bergen, Norway

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2010
• First Posted: August 27, 2010
• Study Start: October 1, 1991
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 27, 2010

Record last verified: 2010-08

Locations

NO (1)