Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT04115150
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2019-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-term Outcome After Ventral Hernia Repair
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': 244}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2019-10-02', 'lastUpdatePostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '1 year', 'description': 'overall complication rate, seroma rate, SSI rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Short-term Outcome After Ventral Hernia Repair']}, 'descriptionModule': {'briefSummary': 'Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be advantageous in terms of complication and recurrence rates. Recently, self-gripping meshes are increasingly used for hernia repair with retromuscular mesh positioning. However, real-life data on the safe use in that specific indication are still lacking. Therefore, this study evaluated short-term postoperative outcome of self-gripping versus conventional non-self-gripping meshes in sublay hernia repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A retrospective single-centre cohort study was performed for the time period of January 2011 to July 2018. All patients, receiving a ventral hernia repair (including incisional, umbilical or epigastric hernias) in Rives-Stoppa retromuscular mesh placement technique (sublay), were included into the final analysis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ventral hernia repair in sublay technique\n\nExclusion Criteria:\n\n* ventral hernia repair in other technique'}, 'identificationModule': {'nctId': 'NCT04115150', 'briefTitle': 'Short-term Outcome After Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Short-term Outcome After Ventral Hernia Repair Using Self-gripping Mesh in Subway Technique - a Retrospective Cohort Analysis', 'orgStudyIdInfo': {'id': '1258/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'self-gripping mesh'}, {'label': 'non-self-gripping mesh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator, M.D.', 'investigatorFullName': 'Felix Harpain', 'investigatorAffiliation': 'Medical University of Vienna'}}}}