Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT00568269
Status:
COMPLETED
Last Update Posted:
2007-12-06
First Post:
2007-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1513}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-05', 'studyFirstSubmitDate': '2007-12-05', 'studyFirstSubmitQcDate': '2007-12-05', 'lastUpdatePostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Operative complications, postoperative recovery and chronic pain at 5 years.', 'timeFrame': '5 years'}]}, 'conditionsModule': {'keywords': ['Recurrence rate after inguinal hernia repair on primary inguinal herina.'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '16862612', 'type': 'RESULT', 'citation': 'Eklund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Osterberg J, Montgomery A. Short-term results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg. 2006 Sep;93(9):1060-8. doi: 10.1002/bjs.5405.'}, {'pmid': '20186889', 'type': 'DERIVED', 'citation': 'Eklund A, Montgomery A, Bergkvist L, Rudberg C; Swedish Multicentre Trial of Inguinal Hernia Repair by Laparoscopy (SMIL) study group. Chronic pain 5 years after randomized comparison of laparoscopic and Lichtenstein inguinal hernia repair. Br J Surg. 2010 Apr;97(4):600-8. doi: 10.1002/bjs.6904.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age 30-70 years referred to hospital with a primary inguinal hernia.\n\nExclusion Criteria:\n\n* Recurrent hernia\n* Scrotal or bilateral hernia\n* Previous lower abdominal surgery\n* Unable to participate in follow up\n* ASA more than 3\n* Bleeding diathesis.'}, 'identificationModule': {'nctId': 'NCT00568269', 'briefTitle': 'Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University Hospital'}, 'officialTitle': 'Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia', 'orgStudyIdInfo': {'id': 'SMIL II'}, 'secondaryIdInfos': [{'id': 'Ups 144-96'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lichtenstein', 'interventionNames': ['Procedure: Open repair']}, {'type': 'EXPERIMENTAL', 'label': 'TEP', 'interventionNames': ['Procedure: Laparoscopic repair']}], 'interventions': [{'name': 'Open repair', 'type': 'PROCEDURE', 'description': 'Open repair is according to the Lichtenstein technique', 'armGroupLabels': ['Lichtenstein']}, {'name': 'Laparoscopic repair', 'type': 'PROCEDURE', 'description': 'The TEP (Totally ExtraPeritoneal patch) repair is used as the laparoscopic repair', 'armGroupLabels': ['TEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '721 89', 'city': 'Västerås', 'country': 'Sweden', 'facility': 'Centre for Clinical Research, Central hospital, entrance 29', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}], 'overallOfficials': [{'name': 'Arne S Eklund, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Clinical Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stig and Ragna Gorthon Foundation', 'class': 'UNKNOWN'}, {'name': 'Tyco Healthcare Group', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Arne Eklund, MD', 'oldOrganization': 'Centre for Clinical Research'}}}}