Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT01637818
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2012-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair
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': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 594}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-11', 'studyFirstSubmitDate': '2012-07-06', 'studyFirstSubmitQcDate': '2012-07-10', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence', 'timeFrame': '6 years', 'description': "Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)"}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': '6 years', 'description': "Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)"}, {'measure': 'Reoperation', 'timeFrame': '6 years', 'description': "Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)"}, {'measure': 'Sensitivity', 'timeFrame': '6 years', 'description': "Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inguinal hernia repair', 'long-term follow-up', 'Surgical technique'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '17094166', 'type': 'RESULT', 'citation': "Frey DM, Wildisen A, Hamel CT, Zuber M, Oertli D, Metzger J. Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41. doi: 10.1002/bjs.5580."}, {'pmid': '24169195', 'type': 'DERIVED', 'citation': "Droeser RA, Dell-Kuster S, Kurmann A, Rosenthal R, Zuber M, Metzger J, Oertli D, Hamel CT, Frey DM. Long-term follow-up of a randomized controlled trial of Lichtenstein's operation versus mesh plug repair for inguinal hernia. Ann Surg. 2014 May;259(5):966-72. doi: 10.1097/SLA.0000000000000297."}]}, 'descriptionModule': {'briefSummary': 'Long-term follow-up of a randomized clinical trial of Lichtenstein\'s operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein\'s operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41."\n\nPrimary endpoints is recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '39 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish).\n* provision of written informed consent,\n* symptomatic unilateral or bilateral inguinal hernia.\n\nExclusion Criteria:\n\n* presence of a femoral hernia,\n* history of hernia repair with mesh,\n* type I diabetes,\n* presence of local or diffuse infection (urine, skin, lung, sepsis),\n* immune deficiency,\n* severe medical problems contraindicating safe induction of general anaesthesia or elective surgery,\n* pregnancy,\n* malignant tumours and\n* life expectancy of less than 2 years"}, 'identificationModule': {'nctId': 'NCT01637818', 'briefTitle': "Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': "Long-term Follow-up of a Randomized Clinical Trial of Lichtenstein's Operation Versus Mesh Plug for Inguinal Hernia Repair", 'orgStudyIdInfo': {'id': 'R59'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "Lichtenstein's Operation", 'interventionNames': ["Procedure: Lichtenstein's operation", 'Drug: Opiate', 'Drug: Paracetamol', 'Drug: non-steroidal anti-inflammatory drug']}, {'type': 'OTHER', 'label': 'Mesh Plug Repair', 'interventionNames': ['Procedure: Mesh Plug Repair', 'Drug: Opiate', 'Drug: Paracetamol', 'Drug: non-steroidal anti-inflammatory drug']}], 'interventions': [{'name': "Lichtenstein's operation", 'type': 'PROCEDURE', 'armGroupLabels': ["Lichtenstein's Operation"]}, {'name': 'Mesh Plug Repair', 'type': 'PROCEDURE', 'armGroupLabels': ['Mesh Plug Repair']}, {'name': 'Opiate', 'type': 'DRUG', 'description': 'Postoperative pain therapy', 'armGroupLabels': ["Lichtenstein's Operation", 'Mesh Plug Repair']}, {'name': 'Paracetamol', 'type': 'DRUG', 'description': 'Postoperative pain therapy', 'armGroupLabels': ["Lichtenstein's Operation", 'Mesh Plug Repair']}, {'name': 'non-steroidal anti-inflammatory drug', 'type': 'DRUG', 'description': 'Postoperative pain therapy', 'armGroupLabels': ["Lichtenstein's Operation", 'Mesh Plug Repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Daniel M Frey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GZO Wetzikon'}, {'name': 'Markus Zuber, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kantonsspital Olten'}, {'name': 'Jürg Metzger, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luzerner Kantonsspital'}, {'name': 'Rachel Rosenthal, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}, {'name': 'Raoul Droeser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'PD Dr. D. Frey, GZO Wetzikon, Wetzikon, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Kantonsspital Olten', 'class': 'OTHER'}, {'name': 'Prof. J. Metzger, Kantonsspital Luzern, Luzern, Switzerland', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Raoul Droeser', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}