Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-01 @ 12:13 PM
Study NCT ID:
NCT01056250
Status:
COMPLETED
Last Update Posted:
2011-05-10
First Post:
2010-01-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SILS Cholecystectomy: Cholangiography of the Biliary Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D002769', 'term': 'Cholelithiasis'}], '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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-08', 'studyFirstSubmitDate': '2010-01-24', 'studyFirstSubmitQcDate': '2010-01-25', 'lastUpdatePostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of cholangiography during SILS cholecystectomy', 'timeFrame': 'at operation'}], 'secondaryOutcomes': [{'measure': 'biliary tract injury', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cholelithiasis'], 'conditions': ['Cholecystolithiasis']}, 'descriptionModule': {'briefSummary': 'Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cholecystolithiasis\n\nExclusion Criteria:\n\n* acute cholecystitis'}, 'identificationModule': {'nctId': 'NCT01056250', 'briefTitle': 'SILS Cholecystectomy: Cholangiography of the Biliary Tract', 'organization': {'class': 'OTHER', 'fullName': 'St John of God Hospital, Vienna'}, 'officialTitle': 'Performing Cholangiography During SILS Cholecystectomy: is it Feasible?', 'orgStudyIdInfo': {'id': 'CT3'}, 'secondaryIdInfos': [{'id': 'SJOG 3', 'type': 'OTHER', 'domain': 'Ethikkommission'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SILS cholangiography', 'description': 'Performing cholangiography in all patients undergoing SILS cholecystectomy.', 'interventionNames': ['Procedure: SILS cholangiography']}], 'interventions': [{'name': 'SILS cholangiography', 'type': 'PROCEDURE', 'otherNames': ['LESS', 'E-NOTES'], 'description': 'intraoperative', 'armGroupLabels': ['SILS cholangiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1180', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'St John of God Hospital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Bernhard Dauser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St John of God Hospital, Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St John of God Hospital, Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Bernhard Dauser, MD', 'oldOrganization': 'St John of God Hospital, Vienna'}}}}