Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides

August 9, 2011 updated by: Cirujanos la Serena

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

406

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Iv Region
      • La Serena, Iv Region, Chile, IV REGION
        • Hospital de La Serena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients operated on elective basis for symtomatic gallbladder lithiasis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cholesterolosis
I. Patients with gallbladder cholesterolosis and symptomatic cholelithiasis
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
Cholelithiasis
II. Patients without gallbladder cholesterolosis and with symptomatic cholelithiasis
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cirujanos la Serena

Investigators

  • Principal Investigator: Marcelo A Beltran, MD, Hospital de La Serena
  • Study Director: Carlos Barria, MD, Hospital De La Serena - HISTOMED

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 10, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

August 10, 2011

Last Update Submitted That Met QC Criteria

August 9, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLS-0012-09-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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