Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-26 @ 4:55 PM
Study NCT ID:
NCT01026935
Status:
COMPLETED
Last Update Posted:
2011-07-20
First Post:
2009-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2009-12-04', 'studyFirstSubmitQcDate': '2009-12-04', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative complaints', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['open mesh repair', 'sutured', 'non-sutured', 'pro-grip', 'postoperative pain'], 'conditions': ['Inguinal Hernia', 'Primary', 'Unilateral']}, 'referencesModule': {'references': [{'pmid': '22362035', 'type': 'DERIVED', 'citation': 'Pierides G, Scheinin T, Remes V, Hermunen K, Vironen J. Randomized comparison of self-fixating and sutured mesh in open inguinal hernia repair. Br J Surg. 2012 May;99(5):630-6. doi: 10.1002/bjs.8705. Epub 2012 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary unilateral inguinal hernia\n\nExclusion Criteria:\n\n* not willing to participate\n* not capable to understand or fill in the questionnaires'}, 'identificationModule': {'nctId': 'NCT01026935', 'briefTitle': 'The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'The Effect of Mesh Type on Pain After Surgery for Inguinal Hernia. Randomized Clinical Trial of Lichtenstein Operation With Sutured Polypropylene Patch or Self-adhesive ProGrip Patch.', 'orgStudyIdInfo': {'id': '231268'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sutured mesh', 'description': '200 patients are randomized to inguinal hernia repair with sutured light weight (38g/m2) polypropylene mesh (Lichtenstein repair)', 'interventionNames': ['Device: Open inguinal hernia repair']}, {'type': 'EXPERIMENTAL', 'label': 'non-sutured mesh', 'description': '200 patients are randomized to receive a light weight mesh that adheres to tissues with polylactic micro hooks without sutures', 'interventionNames': ['Device: Open inguinal hernia repair']}], 'interventions': [{'name': 'Open inguinal hernia repair', 'type': 'DEVICE', 'otherNames': ['Parietene Light', 'Parietene ProGrip'], 'description': 'Altogether 400 patients are randomized to receive an open mesh repair with either sutured light weight mesh (38g/m2) or with a non-sutured light weight polypropylene mesh that adheres to tissues with polylactic micro hooks', 'armGroupLabels': ['non-sutured mesh', 'sutured mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02480', 'city': 'Espoo', 'country': 'Finland', 'facility': 'HUCH Jorvi Hospital, department of Surgery', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'HUCH Surgical Hospital, Dept of Surgery', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Jaana Vironen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUCH Jorvi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jaana Vironen, MD PhD', 'oldOrganization': 'Helsinki University Central Hospital'}}}}