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Indications for Gallbladder Surgery in Gallstone Disease

Primary Purpose

Gallstones

Status

Completed

Phase

Locations

Norway

Study Type

Observational

Intervention

Cholecystectomy operation

About this trial

This is an observational trial for Gallstones

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Haraldsplass Deaconal Hospital, Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Arm Label

AC - operation

AC - observation

SGBS - operation

SGBS - observation

1983 - stones

1983 - operation

1983 - controls

Gallstone patients

Arm Description

Patients admitted with acute cholecystitis randomized to operation

Patients admitted with acute cholecystitis randomized to observation

Patients admitted with uncomplicated gallstone disease randomized to operation

Patients admitted with uncomplicated gallstone disease randomized to observation

Patients that in 1983 were diagnosed with gallstones in a population screening

Patients that were operated for gallstone disease at Haukeland University Hospital, Bergen, Norway, in 1983

Patients that were shown not to have gallstones in a 1983 population screening

Patients with symptoms from gallstone disease

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01190280

First Posted

August 26, 2010

Last Updated

August 26, 2010

Sponsor

Haraldsplass Deaconess Hospital

Collaborators

University of Bergen

1. Study Identification

Unique Protocol Identification Number

NCT01190280

Brief Title

Indications for Gallbladder Surgery in Gallstone Disease

Official Title

Indications for Gallbladder Surgery in Gallstone Disease

Study Type

Observational

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

October 1991 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Haraldsplass Deaconess Hospital

Collaborators

University of Bergen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gallstones

7. Study Design

Enrollment

500 (Actual)

Biospecimen Retention

Samples Without DNA

Biospecimen Description

Resected gallbladders for histological and bacteriological investigation

8. Arms, Groups, and Interventions

Arm Title

AC - operation

Arm Description

Patients admitted with acute cholecystitis randomized to operation

Arm Title

AC - observation

Arm Description

Patients admitted with acute cholecystitis randomized to observation

Arm Title

SGBS - operation

Arm Description

Patients admitted with uncomplicated gallstone disease randomized to operation

Arm Title

SGBS - observation

Arm Description

Patients admitted with uncomplicated gallstone disease randomized to observation

Arm Title

1983 - stones

Arm Description

Patients that in 1983 were diagnosed with gallstones in a population screening

Arm Title

1983 - operation

Arm Description

Patients that were operated for gallstone disease at Haukeland University Hospital, Bergen, Norway, in 1983

Arm Title

1983 - controls

Arm Description

Patients that were shown not to have gallstones in a 1983 population screening

Arm Title

Gallstone patients

Arm Description

Patients with symptoms from gallstone disease

Intervention Type

Procedure

Intervention Name(s)

Cholecystectomy operation

Other Intervention Name(s)

Removal of gallbladder

Intervention Description

Cholecystectomy after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Study Population Description

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.

Sampling Method

Non-Probability Sample

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl Søndenaa, MD, PhD

Organizational Affiliation

Haraldsplass Deaconal Hospital, University of Bergen, Norway

Official's Role

Study Chair

Facility Information:

Facility Name

Haraldsplass Deaconal Hospital, Department of Surgery

City

Bergen

ZIP/Postal Code

5009

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

9200296

Citation

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.

Results Reference

background

PubMed Identifier

3321395

Citation

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.

Results Reference

background

PubMed Identifier

12190099

Citation

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.

Results Reference

background

PubMed Identifier

14531537

Citation

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.

Results Reference

background

PubMed Identifier

15985239

Citation

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.

Results Reference

background

PubMed Identifier

22946484

Citation

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.

Results Reference

derived

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Indications for Gallbladder Surgery in Gallstone Disease

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