Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-02 @ 12:19 AM
Study NCT ID:
NCT00732550
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2008-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D002764', 'term': 'Cholecystitis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2008-08-03', 'studyFirstSubmitQcDate': '2008-08-11', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques.', 'timeFrame': 'Continuous'}], 'secondaryOutcomes': [{'measure': 'To assess pain associated with the single trocar approach', 'timeFrame': 'Continuous'}, {'measure': 'To assess scar formation associated with single trocar approach', 'timeFrame': 'Continuous'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cholelithiasis', 'cholecystitis'], 'conditions': ['Cholelithiasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60\n* symptomatic cholelithiasis\n* ASA 1-2\n\nExclusion Criteria:\n\n* pregnancy\n* morbid obesity with BMI\\>35\n* other gallbladder pathology like polyps or tumor\n* history of upper abdomen laparotomy\n* suspected choledocholithiasis'}, 'identificationModule': {'nctId': 'NCT00732550', 'briefTitle': 'Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'Single trocar HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single trocar', 'description': 'Patients will undergo cholecystectomy by the single trocar approach', 'interventionNames': ['Procedure: Single trocar cholecystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard lap cholecystectomy', 'description': 'Standard lap choly', 'interventionNames': ['Procedure: Standard laparoscopic cholecystectomy']}], 'interventions': [{'name': 'Single trocar cholecystectomy', 'type': 'PROCEDURE', 'description': 'Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach', 'armGroupLabels': ['Single trocar']}, {'name': 'Standard laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy', 'armGroupLabels': ['Standard lap cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization Ein-Kerem campus', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Yoav Mintz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}, {'name': 'Avraham Rivkind, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}