Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT01719718
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2012-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2012-10-30', 'studyFirstSubmitQcDate': '2012-10-31', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroma formation after 4 weeks.', 'timeFrame': '4 weeks after surgery.', 'description': 'The seroma formation is checked by clinical evaluation.'}], 'secondaryOutcomes': [{'measure': 'Pain, discomfort and esthetic evaluation after 4 weeks.', 'timeFrame': '4 weeks after surgery.', 'description': 'Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.'}, {'measure': 'Pain, discomfort and esthetic evaluation after 1 year.', 'timeFrame': '1 year after surgery.', 'description': 'Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.'}, {'measure': 'Pain, discomfort and esthetic evaluation after 2 years.', 'timeFrame': '2 years after surgery.', 'description': 'Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ventral hernia'], 'conditions': ['Ventral Hernia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uzgent.be', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.'}, '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 or incisional hernia requiring elective surgical repair\n* Diameter between 2 and 5cm in width\n* Midline and flank hernias are eligible\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\n* Subxiphoidal hernia\n* Subcostal hernia\n* Suprapubic hernia\n* Clean-contaminated or contaminated field\n* Hernia diameter \\>5cm in width\n* Pregnancy\n* Non-compliance"}, 'identificationModule': {'nctId': 'NCT01719718', 'acronym': 'CLOSURE', 'briefTitle': 'The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.', 'orgStudyIdInfo': {'id': '2012/075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Closure', 'interventionNames': ['Procedure: Closure of hernia defect.']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non-Closure', 'interventionNames': ['Procedure: No closure of the hernia defect.']}], 'interventions': [{'name': 'Closure of hernia defect.', 'type': 'PROCEDURE', 'description': 'Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).', 'armGroupLabels': ['Closure']}, {'name': 'No closure of the hernia defect.', 'type': 'PROCEDURE', 'description': 'Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).', 'armGroupLabels': ['Non-Closure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'Algemeen Stedelijk Ziekenhuis', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda Hospital', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'city': 'Deinze', 'country': 'Belgium', 'facility': 'St Vincentius Hospital', 'geoPoint': {'lat': 50.98175, 'lon': 3.53096}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Namur', 'country': 'Belgium', 'facility': 'Hôpital Mont Godinne', 'geoPoint': {'lat': 50.4669, 'lon': 4.86746}}], 'overallOfficials': [{'name': 'Frederik Berrevoet, MD, PhD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Ghent'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}