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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 10, 2007 | ||||||||
| Last Updated Date | July 30, 2009 | ||||||||
| Start Date ICMJE | March 2008 | ||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00528632 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides | ||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case Control, Retrospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Other: Specimen biopsy and serum laboratory tests | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 406 | ||||||||
| Completion Date | July 2009 | ||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 15 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Chile | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00528632 | ||||||||
| Responsible Party | MARCELO A. BELTRAN, MD, Hospital De La Serena | ||||||||
| Study ID Numbers ICMJE | HLS-0012-09-07 | ||||||||
| Study Sponsor ICMJE | Cirujanos la Serena | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Cirujanos la Serena | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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