Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-02-22 @ 1:45 PM
Study NCT ID:
NCT01622712
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], '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': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2014-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-28', 'studyFirstSubmitDate': '2012-06-15', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calculation and measurement of shrinkage (%) of mesh surface after surgical mesh implantation.', 'timeFrame': '12 months post-surgery', 'description': 'A CT scan is performed.'}], 'secondaryOutcomes': [{'measure': 'Pain assessment.', 'timeFrame': 'after 1 year'}, {'measure': 'Discomfort assessment.', 'timeFrame': 'after 1 year'}, {'measure': 'Use of oral analgetics.', 'timeFrame': 'after 1 year'}, {'measure': 'Wound morbidity.', 'timeFrame': 'after 4 weeks'}, {'measure': 'Recurrence of hernia.', 'timeFrame': 'after 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inguinal hernia'], 'conditions': ['Unilateral Inguinal Hernia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate whether preperitoneal mesh placement using a nitinol containing large pore polypropylene mesh (REBOUND HRD™) offers a satisfying patient recovery, quick reconvalescence and adequate tissue integration with acceptable mesh contraction in a multicenter (Belgian) prospective trial.\n\nPatients treated by open preperitoneal mesh repair for an unilateral inguinal hernia according the current surgical practice in the participating centers will be observed during one year post-surgery, after which they will have a CT scan of the surgical area in the groin to evaluate the mesh changes regarding shrinkage and migration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective repair for a primary unilateral inguinal hernia OR\n* elective repair for a recurrent unilateral inguinal hernia after non-mesh repair\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01622712', 'acronym': 'REBOUND', 'briefTitle': 'Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Evaluation of Mesh Integration and Mesh Contraction After Open Preperitoneal Inguinal Hernia Repair Using a Memory Ring Containing Device.', 'orgStudyIdInfo': {'id': '2011/823'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Unilateral inguinal hernia', 'description': 'A Nitinol containing large pore polypropylene mesh will be placed in patients with unilateral inguinal hernia.', 'interventionNames': ['Device: Rebound HRD Mesh']}], 'interventions': [{'name': 'Rebound HRD Mesh', 'type': 'DEVICE', 'description': 'Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.', 'armGroupLabels': ['Unilateral inguinal hernia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'ASZ Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Frederik Berrevoet, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medri', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}