Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-28 @ 5:32 AM
Study NCT ID:
NCT00573105
Status:
TERMINATED
Last Update Posted:
2011-01-26
First Post:
2007-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'whyStopped': 'slow inclusion rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-25', 'studyFirstSubmitDate': '2007-12-11', 'studyFirstSubmitQcDate': '2007-12-11', 'lastUpdatePostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence rate', 'timeFrame': 'after 1 year'}], 'secondaryOutcomes': [{'measure': 'morbidity rate', 'timeFrame': 'perioperative'}, {'measure': 'quality of life', 'timeFrame': 'after 1 year'}, {'measure': 'postoperative pain', 'timeFrame': 'within 1 week'}, {'measure': 'long term complication rate', 'timeFrame': 'after 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ventral Hernia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Website University Hospital Ghent'}]}, 'descriptionModule': {'briefSummary': '1. General\n\n \\- antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery\n2. Laparoscopic surgery\n\n * at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm)\n * with or without anchoring transparietal sutures or double crown technique'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* written informed consent from the patient or his/her legal representative\n* ventral hernia requiring elective surgical repair\n\nExclusion Criteria:\n\n* no written informed consent\n* 'hostile' abdomen; open abdomen treatment\n* contraindication to pneumoperitoneum\n* emergency surgery (incarcerated hernia)\n* parastomal hernia"}, 'identificationModule': {'nctId': 'NCT00573105', 'briefTitle': 'Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Laparoscopic Ventral Hernia Repair by Heavy Weight or Lighter Weight Mesh (COMPOSIX-trial)', 'orgStudyIdInfo': {'id': '2007/421'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Laparoscopic Ventral hernia repair by heavy weight mesh', 'interventionNames': ['Procedure: Laparoscopic Ventral hernia repair by heavy weight mesh']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Laparoscopic Ventral hernia repair by lighter weight mesh', 'interventionNames': ['Procedure: Laparoscopic Ventral hernia repair by lighter weight mesh']}], 'interventions': [{'name': 'Laparoscopic Ventral hernia repair by heavy weight mesh', 'type': 'PROCEDURE', 'description': 'Laparoscopic Ventral hernia repair by heavy weight mesh', 'armGroupLabels': ['1']}, {'name': 'Laparoscopic Ventral hernia repair by lighter weight mesh', 'type': 'PROCEDURE', 'description': 'Laparoscopic Ventral hernia repair by lighter weight mesh', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Frederik Berrevoet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'C. R. Bard', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Frederik Berrevoet', 'oldOrganization': 'University Hospital Ghent'}}}}