Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-04 @ 6:09 PM
Study NCT ID:
NCT03930667
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2019-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closure of the Appendix Stump in Laparoscopic Appendectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013525', 'term': 'Surgical Instruments'}], 'ancestors': [{'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-27', 'studyFirstSubmitDate': '2019-04-21', 'studyFirstSubmitQcDate': '2019-04-25', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cost effectiveness', 'timeFrame': '4 years', 'description': 'cost of treatment from surgery to discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Appendicitis; Laparoscopic Surgery; Cost Effectiveness'], 'conditions': ['Appendicitis, Surgery']}, 'descriptionModule': {'briefSummary': 'Aimed to the study evaluate the superiority of intracorporal sutures and Hem-o-lok clips in terms of efficiency.', 'detailedDescription': 'Performed laparoscopic surgery for acute appendicitis. Appendiceal stump was closed by Hem-o-lok clips (Group I) and intracorporal knotting (Group II) in a randomize manner. Groups were compared for cost effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of acute appendicitis\n\nExclusion Criteria:\n\n* under 18 years of age\n* other patology in addition to appendiceal pathology'}, 'identificationModule': {'nctId': 'NCT03930667', 'briefTitle': 'Closure of the Appendix Stump in Laparoscopic Appendectomy', 'organization': {'class': 'OTHER', 'fullName': 'Bozyaka Training and Research Hospital'}, 'officialTitle': 'Hem-o-lok Clips Versus ıntracorporeal Knotting for Closure of the Appendix Stump in Laparoscopic Appendectomy: Prospective Randomized Study', 'orgStudyIdInfo': {'id': '24.03.2015-no:3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'clips', 'description': 'Closure of the appendix stump with hem-o-lok clips', 'interventionNames': ['Procedure: clips']}, {'type': 'EXPERIMENTAL', 'label': 'knotting', 'description': 'Closure of the appendix stump with intracorporal knotting.', 'interventionNames': ['Procedure: knotting']}], 'interventions': [{'name': 'clips', 'type': 'PROCEDURE', 'armGroupLabels': ['clips']}, {'name': 'knotting', 'type': 'PROCEDURE', 'armGroupLabels': ['knotting']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Orhan Ureyen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Health Sciences University, İzmir Bozyaka Training and Research Hospital, General Surgery Department, Izmir'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': '2015-2019', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orhan Üreyen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical expert in General Surgery,Principal Investigator', 'investigatorFullName': 'Orhan Üreyen', 'investigatorAffiliation': 'Bozyaka Training and Research Hospital'}}}}