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OpenTrials
Completed

NCT Number: NCT01190280

Indications for Gallbladder Surgery in Gallstone Disease

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haraldsplass Deaconal Hospital, Department of Surgery

Bergen, 5009, Norway

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecystectomy operation

Procedure

Cholecystectomy after randomization

Other names: Removal of gallbladder

Sponsors and collaborators

Lead sponsor

Haraldsplass Deaconess Hospital

Other

Collaborators

  • University of Bergen

Registry information

Important dates

Study start
1991
Primary completion
2010
Study completion
2010
First posted
Aug 27, 2010
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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