Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-02-23 @ 5:15 AM
Study NCT ID:
NCT00528632
Status:
COMPLETED
Last Update Posted:
2011-08-10
First Post:
2007-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-09', 'studyFirstSubmitDate': '2007-09-10', 'studyFirstSubmitQcDate': '2007-09-10', 'lastUpdatePostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gallstones', 'Gallbladder', 'Cholesterolosis', 'Serum cholesterol', 'triglycerides', 'Body Mass Index'], 'conditions': ['Gallstones', 'Gallbladder Cholesterolosis']}, 'descriptionModule': {'briefSummary': 'Cholesterolosis is a common finding in biopsy specimens of gallbladders surgically removed for cholelithiasis.\n\nTo the best of the investigators knowledge no study has analyzed the relationships of Body Mass Index, serum Cholesterol and Triglycerides and gallbladder cholesterolosis.\n\nThe purpose of this study is to analyze and find relations between gallbladder cholesterolosis, Body Mass Index, serum cholesterol and triglycerides.', 'detailedDescription': 'A prospective database including the following variables was filled out:\n\n* Age\n* Gender\n* Diagnosis\n* Weight\n* Height\n* Body Mass Index\n* Histopathological results (Biopsy)\n* Serum cholesterol\n* Serum triglycerides\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients operated on elective basis for symtomatic gallbladder lithiasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients submitted to elective cholecystectomy\n* Histopathological report of gallbladder cholesterolosis\n* Histopathological report of chronic cholecystitis\n* Patients older than 15 years of age\n\nExclusion Criteria:\n\n* Patients younger than 15 years of age\n* Pathological report missing from the hospital records'}, 'identificationModule': {'nctId': 'NCT00528632', 'briefTitle': 'Gallbladder Cholesterolosis, Body Mass Index and Serum Cholesterol and Triglycerides', 'organization': {'class': 'OTHER', 'fullName': 'Cirujanos la Serena'}, 'officialTitle': 'Association of Gallbladder Cholesterolosis to Body Mass Index and Levels of Serum Cholesterol and Triglycerides.', 'orgStudyIdInfo': {'id': 'HLS-0012-09-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cholesterolosis', 'description': 'I. Patients with gallbladder cholesterolosis and symptomatic cholelithiasis', 'interventionNames': ['Other: Specimen biopsy and serum laboratory tests']}, {'label': 'Cholelithiasis', 'description': 'II. Patients without gallbladder cholesterolosis and with symptomatic cholelithiasis', 'interventionNames': ['Other: Specimen biopsy and serum laboratory tests']}], 'interventions': [{'name': 'Specimen biopsy and serum laboratory tests', 'type': 'OTHER', 'description': 'Biopsy of the surgical specimens (gallbladder) submitted after cholecystectomy\n\nLaboratory tests measuring levels of plasma total cholesterol and triglycerides', 'armGroupLabels': ['Cholelithiasis', 'Cholesterolosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'IV REGION', 'city': 'La Serena', 'state': 'Coquimbo Region', 'country': 'Chile', 'facility': 'Hospital De La Serena', 'geoPoint': {'lat': -29.90591, 'lon': -71.25014}}], 'overallOfficials': [{'name': 'Marcelo A Beltran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de La Serena'}, {'name': 'Carlos Barria, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital De La Serena - HISTOMED'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cirujanos la Serena', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'MARCELO A. BELTRAN, MD', 'oldOrganization': 'Hospital De La Serena'}}}}