Clinical trial NCT01190280: Indications for Gallbladder Surgery in Gallstone Disease
Official title: Indications for Gallbladder Surgery in Gallstone Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gallstones
Lead sponsor: Haraldsplass Deaconess Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2010-08-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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: 1. Randomized clinical trial (RCT) of observation versus surgery for uncomplicated gallstone disease
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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Deaconal Hospital, Department of Surgery
Study officials:
affiliation: Haraldsplass Deaconal Hospital, University of Bergen, Norway
name: Karl Søndenaa, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.