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| Sponsor: | Cirujanos la Serena |
|---|---|
| Information provided by: | Cirujanos la Serena |
| ClinicalTrials.gov Identifier: | NCT00528632 |
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: | Case Control, Retrospective |
| Official Title: | Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides. |
| 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 |
A prospective database including the following variables was filled out:
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 |
Patients operated on elective basis for symtomatic gallbladder lithiasis
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Chile, IV REGION | |
| Hospital De La Serena | |
| La Serena, IV REGION, Chile, IV REGION | |
| Principal Investigator: | Marcelo A Beltran, MD | Hospital De La Serena |
| Study Director: | Carlos Barria, MD | Hospital De La Serena - HISTOMED |
More Information
| Responsible Party: | Hospital De La Serena ( MARCELO A. BELTRAN, MD ) |
| Study ID Numbers: | HLS-0012-09-07 |
| Study First Received: | September 10, 2007 |
| Last Updated: | July 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00528632 History of Changes |
| Health Authority: | Chile: Instituto de Salud Publica de Chile |
|
Gallstones Gallbladder Cholesterolosis |
Serum cholesterol triglycerides Body Mass Index |
|
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases |
Cholelithiasis Gallstones Biliary Tract Diseases Calculi |
