Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT06470360
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2024-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Safety of Absorbable and Hem-o-lok Clips in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2024-04-14', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications of patients using absorbable and haem-olok clips will be compared according to the Clavien-Dindo scoring system.', 'timeFrame': 'first 30 day', 'description': 'Is it safe to close the cystic stump with a single (haem-o-lok or absorbable) clip?'}], 'secondaryOutcomes': [{'measure': 'The costs of the clips used', 'timeFrame': 'one week', 'description': "The costs of the clips used will be determined in dollars using Student's t-test."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic cholecystectomy', 'cystic duct closure', 'safety'], 'conditions': ['Laparoscopic Cholecystectomy']}, 'descriptionModule': {'briefSummary': 'Safe closure of the cystic duct is the critical step in laparoscopic cholecystectomy. In the literature, the investigators did not observe any prospective study analysing the use of absorbable single clip and Hem-o-lok single clip. In this prospective study, the reliability of the two methods will be compared using a single clip.', 'detailedDescription': 'In this prospective randomised controlled clinical study; closure of the cystic duct in laparoscopic cholecystectomy will be performed by two different methods. Early clinical results and long-term effects on neighbouring anatomical structures will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective laparoscopic cholecystectomy ASA I-III Patients who accepted the study\n\nExclusion Criteria:\n\n* open surgery emergency cholecystectomy refuse to trial'}, 'identificationModule': {'nctId': 'NCT06470360', 'briefTitle': 'Comparison of the Safety of Absorbable and Hem-o-lok Clips in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}, 'officialTitle': 'Clinical Outcomes of Absorbable or Hem-o-lok Clip Closure of the Cystic Stump in Laparoscopic Cholecystectomy: a Prospective Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'Dicle University'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single absorbable', 'description': 'Cystic duct to be closed with absorbable single clip', 'interventionNames': ['Other: Surgycal procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single Hem-o-lok', 'description': 'Cystic duct to be closed with Hem-o-lok single clip', 'interventionNames': ['Other: Surgycal procedure']}], 'interventions': [{'name': 'Surgycal procedure', 'type': 'OTHER', 'description': 'surgical technique', 'armGroupLabels': ['Single Hem-o-lok', 'Single absorbable']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'Kartal', 'country': 'Turkey (Türkiye)', 'facility': 'Kartal Koşuyolu Higher Specialization Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Mustafa Duman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kartal Kosuyolu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulas Aday', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof.', 'investigatorFullName': 'Ulas Aday', 'investigatorAffiliation': 'Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital'}}}}