Indications for Gallbladder Surgery in Gallstone Disease
NCT ID: NCT01190280
Last Updated: 2010-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
1991-10-31
2010-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Groups
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AC - operation
Patients admitted with acute cholecystitis randomized to operation
Cholecystectomy operation
Cholecystectomy after randomization
AC - observation
Patients admitted with acute cholecystitis randomized to observation
No interventions assigned to this group
SGBS - operation
Patients admitted with uncomplicated gallstone disease randomized to operation
Cholecystectomy operation
Cholecystectomy after randomization
SGBS - observation
Patients admitted with uncomplicated gallstone disease randomized to observation
No interventions assigned to this group
1983 - stones
Patients that in 1983 were diagnosed with gallstones in a population screening
No interventions assigned to this group
1983 - operation
Patients that were operated for gallstone disease at Haukeland University Hospital, Bergen, Norway, in 1983
No interventions assigned to this group
1983 - controls
Patients that were shown not to have gallstones in a 1983 population screening
No interventions assigned to this group
Gallstone patients
Patients with symptoms from gallstone disease
No interventions assigned to this group
Interventions
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Cholecystectomy operation
Cholecystectomy after randomization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
* Participation in a screening study for gallstones in 1983
* Operated for symptomatic gallstone disease in Bergen, Norway in 1983
Exclusion Criteria
* Age below 18 or above 80
* Not willing to participate
* Severe concomitant disease
* Suspected Common Bile Duct stone
* Acalculous cholecystitis
* Localized peritonitis suggesting gallbladder perforation or gangrenous cholecystitis
18 Years
80 Years
ALL
No
Sponsors
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University of Bergen
OTHER
Haraldsplass Deaconess Hospital
OTHER
Responsible Party
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Haraldsplass Deaconal Hospital, Department of Surgery, University of Bergen, Bergen, Norway
Principal Investigators
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Karl Søndenaa, MD, PhD
Role: STUDY_CHAIR
Haraldsplass Deaconal Hospital, University of Bergen, Norway
Locations
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Haraldsplass Deaconal Hospital, Department of Surgery
Bergen, , Norway
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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GS06
Identifier Type: -
Identifier Source: org_study_id
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