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Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00528632
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Cirujanos la Serena

Tracking Information
First Submitted Date September 10, 2007
First Posted Date September 12, 2007
Last Update Posted Date August 10, 2011
Study Start Date March 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides
Official Title Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides.
Brief 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.

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
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients operated on elective basis for symtomatic gallbladder lithiasis
Condition
  • Gallstones
  • Gallbladder Cholesterolosis
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

Study Groups/Cohorts
  • Cholesterolosis
    I. Patients with gallbladder cholesterolosis and symptomatic cholelithiasis
    Intervention: Other: Specimen biopsy and serum laboratory tests
  • Cholelithiasis
    II. Patients without gallbladder cholesterolosis and with symptomatic cholelithiasis
    Intervention: Other: Specimen biopsy and serum laboratory tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July¬†13,¬†2009)
406
Original Enrollment Not Provided
Actual Study Completion Date July 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Chile
Removed Location Countries  
 
Administrative Information
NCT Number NCT00528632
Other Study ID Numbers HLS-0012-09-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party MARCELO A. BELTRAN, MD, Hospital De La Serena
Study Sponsor Cirujanos la Serena
Collaborators Not Provided
Investigators
Principal Investigator: Marcelo A Beltran, MD Hospital de La Serena
Study Director: Carlos Barria, MD Hospital De La Serena - HISTOMED
PRS Account Cirujanos la Serena
Verification Date July 2009