Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-29 @ 1:28 AM
Study NCT ID:
NCT01219166
Status:
COMPLETED
Last Update Posted:
2010-12-10
First Post:
2010-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Routine Cholecystectomy Reasonable in All Patients Receiving a Bypass Procedure: a Comparative Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-09', 'studyFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2010-10-12', 'lastUpdatePostDateStruct': {'date': '2010-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biliary complications resulting from omitted prophylactic cholecystectomy', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'safety of concurrent cholecystectomy', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Given Indication for Gastric Bypass Procedure']}, 'descriptionModule': {'briefSummary': 'Gallbladder management in bariatric surgery is controversially discussed. While some surgeons advocate routine prophylactic cholecystectomy (CCE) during Roux-en-Y gastric bypass (RYGB) others advocate CCE only in patients with pathological gallbladder findings. The aim of this study was to evaluate the necessity of prophylactic CCE in patients receiving a laparoscopic RYGB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Given indication for laparoscopic Roux-en-Y-gastric bypass', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who received a laparoscopic Roux-en-Y-gastric bypass\n\nExclusion Criteria:\n\n* previous CCE\n* open gastric bypass procedure\n* previous bariatric procedure other than gastric banding\n* patients lost to follow up'}, 'identificationModule': {'nctId': 'NCT01219166', 'briefTitle': 'Is Routine Cholecystectomy Reasonable in All Patients Receiving a Bypass Procedure: a Comparative Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'orgStudyIdInfo': {'id': 'EKSG10/140/U'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'laparoscopic Roux-en-Y-gastric-bypass without cholecystectomy'}, {'label': 'laparoscopic Roux-en-Y-gastric baypass with cholecystectomy', 'interventionNames': ['Procedure: Laparoscopic Cholecystectomy']}], 'interventions': [{'name': 'Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic Cholecystectomy', 'armGroupLabels': ['laparoscopic Roux-en-Y-gastric baypass with cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Department of surgery', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Martin Thurnheer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital St. Gallen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Andreas Zerz, MD', 'oldOrganization': 'Kantonal Hospital St. Gallen, Department of Visceral Surgery'}}}}