Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides

Gallstones Clinical Trial

Official title:

Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528632
• Other study ID #: HLS-0012-09-07
• Status: Completed
• Phase: N/A
• First received: September 10, 2007
• Last updated: August 9, 2011
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Cirujanos la Serena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Observational

Clinical Trial Summary

Cholesterolosis is a common finding in biopsy specimens of gallbladders surgically removed for cholelithiasis.

To the best of the investigators knowledge no study has analyzed the relationships of Body Mass Index, serum Cholesterol and Triglycerides and gallbladder cholesterolosis.

The purpose of this study is to analyze and find relations between gallbladder cholesterolosis, Body Mass Index, serum cholesterol and triglycerides.

Description:

A prospective database including the following variables was filled out:

• Age

• Gender

• Diagnosis

• Weight

• Height

• Body Mass Index

• Histopathological results (Biopsy)

• Serum cholesterol

• Serum triglycerides

All elective patients older than 15 years of age submitted to cholecystectomy for symptomatic gallstones were included. Plasma cholesterol and triglycerides levels were measured 5 to 7 days before surgery. Only patients with chronic cholecystitis and with cholesterolosis according to the histology of the surgical specimen were included, we did not include any patient with acute cholecystitis or gallbladder cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients submitted to elective cholecystectomy

• Histopathological report of gallbladder cholesterolosis

• Histopathological report of chronic cholecystitis

• Patients older than 15 years of age

Exclusion Criteria:

• Patients younger than 15 years of age

• Pathological report missing from the hospital records

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Gallbladder Cholesterolosis
• Gallstones

Intervention

Other:
• Specimen biopsy and serum laboratory tests
Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy Laboratory tests measuring levels of plasma total cholesterol and triglycerides

Locations

Country	Name	City	State
Chile	Hospital De La Serena	La Serena	Iv Region

Sponsors (1)

Lead Sponsor	Collaborator
Cirujanos la Serena

Country where clinical trial is conducted

Chile,