Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT07229703
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Burst Abdomen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 252}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound infection', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'incisional hernia', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tension suture', 'burst abdomen'], 'conditions': ['Burst Abdomen']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://tameralnaimy@hotmail.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the long-term effects of repair of burst abdomen by both primary repair and component separation. The main question it aims to answer is:\n\nDoes component separation lower postoperative complications ?', 'detailedDescription': 'to compare between 2 common techniques for management of burst abdomen'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '\\> 18 years with BA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients (≥18 years) underwent PCS+TAR+MA or primary suture with tension sutures for complete burst abdomen\n\nExclusion Criteria:\n\n* 1\\. BA grade 1B, 2, 3, and 4 (n=17),\n* \\< 18 years (n=2)\n* Primary laparotomy performed through a non-midline incision (n=4)\n* Open abdomen (n=5)'}, 'identificationModule': {'nctId': 'NCT07229703', 'briefTitle': 'Management of Burst Abdomen', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Burst Abdomen Surgery', 'orgStudyIdInfo': {'id': 'burst abdomen management'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'component separation', 'description': 'management of burst abdomen by component separation', 'interventionNames': ['Procedure: component separation']}, {'label': 'primary repair', 'description': 'primary repair of burst abdomen', 'interventionNames': ['Procedure: primary repair for burst abdomen']}], 'interventions': [{'name': 'component separation', 'type': 'PROCEDURE', 'description': 'component separation for management of burst abdomen', 'armGroupLabels': ['component separation']}, {'name': 'primary repair for burst abdomen', 'type': 'PROCEDURE', 'description': 'management of burst abdomen by primary repair', 'armGroupLabels': ['primary repair']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof', 'investigatorFullName': 'Tamer.A.A.M.Habeeb', 'investigatorAffiliation': 'Zagazig University'}}}}