Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 12:20 PM
Study NCT ID:
NCT06209450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2024-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sutured vs Sutureless Mesh Fixation for Onlay Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'One year after surgery', 'description': 'Intraoperative and post operative complications occur due to technique used in study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ventral Hernia']}, 'descriptionModule': {'briefSummary': 'Comparison beta sutured and suturless mesh fixation for ventral hernia regarding recurrence rates and complications rate', 'detailedDescription': 'Ventral hernia repair is common procedure with over 250000 repairs each year in the unites states . Most ventral hernias are repaired using tension free type of repair using mesh that bridge the defect and reinforce the abdominal wall .\n\nThe mesh fixation technique has impact on recurrence rates,chronic pain and complications rates . Suturless ventral hernia repair with sealing agent fixation proved to be durable with comperable complication profile to other techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ventral hernia\n* both sexes\n\nExclusion Criteria:\n\n* obstructed or complicated ventral hernia\n* incisional hernia\n* recurrent hernia\n* multiple ventral hernia\n* large hernia more than 5 cm'}, 'identificationModule': {'nctId': 'NCT06209450', 'briefTitle': 'Sutured vs Sutureless Mesh Fixation for Onlay Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Sutured vs Suturless Mesh Fixation for Onlay Ventral Hernia Repair', 'orgStudyIdInfo': {'id': 'Hernia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ventral hernia repair', 'interventionNames': ['Procedure: Ventral hernia repair with mesh fixation']}], 'interventions': [{'name': 'Ventral hernia repair with mesh fixation', 'type': 'PROCEDURE', 'description': 'Sutured versus suturless mesh fixation', 'armGroupLabels': ['Ventral hernia repair']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Khaled Muhammad Mahmoud', 'role': 'CONTACT', 'email': 'Khaledgad19844@gmail.com', 'phone': '01069094017'}, {'name': 'Moray Muhammad Morsy, Prof', 'role': 'CONTACT', 'email': 'm.morsy@aun.edu.eg', 'phone': '01093688097'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assuit', 'investigatorFullName': 'Khaled Mohammed Mahmoud Gadelhak', 'investigatorAffiliation': 'Assiut University'}}}}