Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides

This study has been completed.
Sponsor:
Information provided by:
Cirujanos la Serena
ClinicalTrials.gov Identifier:
NCT00528632
First received: September 10, 2007
Last updated: August 9, 2011
Last verified: July 2009
  Purpose

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.


Condition Intervention
Gallstones
Gallbladder Cholesterolosis
Other: Specimen biopsy and serum laboratory tests

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides.

Resource links provided by NLM:


Further study details as provided by Cirujanos la Serena:

Enrollment: 406
Study Start Date: March 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients operated on elective basis for symtomatic gallbladder lithiasis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528632

Locations
Chile
Hospital De La Serena
La Serena, Iv Region, Chile, IV REGION
Sponsors and Collaborators
Cirujanos la Serena
Investigators
Principal Investigator: Marcelo A Beltran, MD Hospital De La Serena
Study Director: Carlos Barria, MD Hospital De La Serena - HISTOMED
  More Information

No publications provided

Responsible Party: MARCELO A. BELTRAN, MD, Hospital De La Serena
ClinicalTrials.gov Identifier: NCT00528632     History of Changes
Other Study ID Numbers: HLS-0012-09-07
Study First Received: September 10, 2007
Last Updated: August 9, 2011
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by Cirujanos la Serena:
Gallstones
Gallbladder
Cholesterolosis
Serum cholesterol
triglycerides
Body Mass Index

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 21, 2014