Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT00492804
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2007-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elective Neurectomy During Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D006987', 'term': 'Hypesthesia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003714', 'term': 'Denervation'}], 'ancestors': [{'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-25', 'studyFirstSubmitDate': '2007-06-26', 'studyFirstSubmitQcDate': '2007-06-26', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative pain', 'timeFrame': 'up to three years'}], 'secondaryOutcomes': [{'measure': 'Incidence of hypesthesia or paraesthesia', 'timeFrame': 'one and three years'}, {'measure': 'Recurrence rate', 'timeFrame': 'one and three years'}, {'measure': 'Rate of intra- and postoperative complications', 'timeFrame': 'one and three years'}, {'measure': 'Quality of life', 'timeFrame': 'one and three years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inguinal hernia', 'chronic pain', 'neurectomy', 'hypesthesia'], 'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair.\n\nIt may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain.\n\nThis study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uni- or bilateral inguinal hernia\n* Karnofsky-index ≥70\n* Informed consent\n\nExclusion Criteria:\n\n* Recurrent inguinal hernia\n* Previous inguinal operation\n* Emergent operation\n* Severe comorbidities'}, 'identificationModule': {'nctId': 'NCT00492804', 'briefTitle': 'Elective Neurectomy During Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '05/015/2B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Neurectomy', 'interventionNames': ['Procedure: Lichtenstein hernia repair', 'Procedure: Neurectomy']}, {'type': 'OTHER', 'label': 'Nerve preservation', 'interventionNames': ['Procedure: Lichtenstein hernia repair']}], 'interventions': [{'name': 'Lichtenstein hernia repair', 'type': 'PROCEDURE', 'description': 'Lichtenstein hernia repair with tension free mesh', 'armGroupLabels': ['Nerve preservation', 'Neurectomy']}, {'name': 'Neurectomy', 'type': 'PROCEDURE', 'description': 'Neurectomy', 'armGroupLabels': ['Neurectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'state': 'Canton of St. Gallen', 'country': 'Switzerland', 'facility': 'Department of Surgery, Cantonal Hospital of St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Martin Thurnheer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Cantonal Hospital St. Gallen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Martin Turnheer', 'oldOrganization': 'Cantonal Hospital of St. Gallen'}}}}