Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT00925067
Status:
COMPLETED
Last Update Posted:
2009-06-19
First Post:
2009-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'C072829', 'term': 'tetraethylpyrazine'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-18', 'studyFirstSubmitDate': '2009-06-18', 'studyFirstSubmitQcDate': '2009-06-18', 'lastUpdatePostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Male fertility aspects', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Quality of life, pain development, recurrence', 'timeFrame': '1, 3, 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inguinal hernia', 'Laparoscopic repair', 'Prostheses', 'Male fertility'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '20622657', 'type': 'DERIVED', 'citation': 'Peeters E, Spiessens C, Oyen R, De Wever L, Vanderschueren D, Penninckx F, Miserez M. Laparoscopic inguinal hernia repair in men with lightweight meshes may significantly impair sperm motility: a randomized controlled trial. Ann Surg. 2010 Aug;252(2):240-6. doi: 10.1097/SLA.0b013e3181e8fac5.'}]}, 'descriptionModule': {'briefSummary': 'A randomized, prospective clinical trial analyzing whether the use of lightweight prostheses during laparoscopic inguinal hernia repair of male patients could have a beneficial effect on postoperative discomfort, chronic pain development, recurrence and male fertility aspects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary, unilateral or bilateral, inguinal hernia patients\n* Informed consent\n\nExclusion Criteria:\n\n* Sterilized patients'}, 'identificationModule': {'nctId': 'NCT00925067', 'briefTitle': 'Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Effects of Lightweight Meshes in Laparoscopic Inguinal Hernia Repair on Quality of Life and Male Fertility Aspects', 'orgStudyIdInfo': {'id': 'G.0457.04N'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lightweight TiMesh', 'interventionNames': ['Procedure: laparoscopic (TEP) inguinal hernia repair', 'Device: lightweight TiMesh']}, {'type': 'EXPERIMENTAL', 'label': 'lightweight VyproII', 'interventionNames': ['Procedure: laparoscopic (TEP) inguinal hernia repair', 'Device: lightweight VyproII']}, {'type': 'EXPERIMENTAL', 'label': 'Heavyweight Marlex', 'interventionNames': ['Procedure: laparoscopic (TEP) inguinal hernia repair', 'Device: Heavyweight Marlex']}], 'interventions': [{'name': 'laparoscopic (TEP) inguinal hernia repair', 'type': 'PROCEDURE', 'description': 'laparoscopic inguinal hernia repair with a standard heavyweight Marlex (control group) prosthesis or new generation lightweight VyproII and TiMesh prostheses (study group)', 'armGroupLabels': ['Heavyweight Marlex', 'lightweight TiMesh', 'lightweight VyproII']}, {'name': 'lightweight TiMesh', 'type': 'DEVICE', 'armGroupLabels': ['lightweight TiMesh']}, {'name': 'lightweight VyproII', 'type': 'DEVICE', 'armGroupLabels': ['lightweight VyproII']}, {'name': 'Heavyweight Marlex', 'type': 'DEVICE', 'armGroupLabels': ['Heavyweight Marlex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Marc Miserez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fund for Scientific Research, Flanders, Belgium', 'class': 'OTHER'}, {'name': 'Agentschap voor Innovatie door Wetenschap en Technologie', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Marc Miserez', 'oldOrganization': 'University Hospitals Leuven'}}}}