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| Name | Class |
|---|---|
| University of Bergen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC - operation | Patients admitted with acute cholecystitis randomized to operation |
| |
| AC - observation | Patients admitted with acute cholecystitis randomized to observation | ||
| SGBS - operation | Patients admitted with uncomplicated gallstone disease randomized to 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecystectomy operation | Procedure | Cholecystectomy after randomization |
|
Inclusion criteria:
Episodes of pain in the right subcostal or midline epigastric area lasting more than 30 min, with ultrasonography signs of gallstones.
Exclusion Criteria SGBS:
Inclusion criteria, acute cholecystitis (AC):
Exclusion criteria, AC:
Inclusion criteria 1983 cohort of patients:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Karl Søndenaa, MD, PhD | Haraldsplass Deaconal Hospital, University of Bergen, Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haraldsplass Deaconal Hospital, Department of Surgery | Bergen | 5009 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9200296 | Background | 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. | |
| 3321395 | 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. |
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| ID | Term |
|---|---|
| D042882 | Gallstones |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
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| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Resected gallbladders for histological and bacteriological investigation
Patients that were shown not to have gallstones in a 1983 population screening
| Gallstone patients | Patients with symptoms from gallstone disease |
| 12190099 | 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. |
| 14531537 | 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. |
| 15985239 | 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. |
| 22946484 | Derived | 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. |
| D005705 |
| Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |