Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides

NCT ID: NCT00528632

Last Updated: 2011-08-10

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

406 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gallstones Gallbladder Cholesterolosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cholesterolosis

I. Patients with gallbladder cholesterolosis and symptomatic cholelithiasis

Specimen biopsy and serum laboratory tests

Intervention Type OTHER

Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy

Laboratory tests measuring levels of plasma total cholesterol and triglycerides

Cholelithiasis

II. Patients without gallbladder cholesterolosis and with symptomatic cholelithiasis

Specimen biopsy and serum laboratory tests

Intervention Type OTHER

Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy

Laboratory tests measuring levels of plasma total cholesterol and triglycerides

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cirujanos la Serena

OTHER

Sponsor Role lead

Responsible Party

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Hospital De La Serena

Principal Investigators

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Marcelo A Beltran, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de La Serena

Carlos Barria, MD

Role: STUDY_DIRECTOR

Hospital De La Serena - HISTOMED

Locations

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Hospital De La Serena

La Serena, Coquimbo Region, Chile

Site Status

Countries

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Chile

Other Identifiers

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HLS-0012-09-07

Identifier Type: -

Identifier Source: org_study_id

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