Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT01070693
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2010-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'georgios.pierides@hus.fi', 'phone': '+358 9 4711', 'title': 'Dr. Georgios Pierides', 'organization': 'Helsinki University Central Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Prolene Hernia System Device', 'description': 'Inguinal hernia repair either with a bilayer mesh (PHS)\n\nOpen mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique\n\nProlene Hernia System: Prolene Hernia System', 'otherNumAtRisk': 150, 'otherNumAffected': 0, 'seriousNumAtRisk': 150, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lichtenstein', 'description': 'Inguinal hernia repair with the Lichtenstein technique\n\nOpen mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique\n\nLichtenstein technique: Lichtenstein technique', 'otherNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Long-term Sequelae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prolene Hernia System Device', 'description': 'Inguinal hernia repair either with a bilayer mesh (PHS)\n\nOpen mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique\n\nProlene Hernia System: Prolene Hernia System'}, {'id': 'OG001', 'title': 'Lichtenstein', 'description': 'Inguinal hernia repair with the Lichtenstein technique\n\nOpen mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique\n\nLichtenstein technique: Lichtenstein technique'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Any pain at five years', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prolene Hernia System Device', 'description': 'Inguinal hernia repair either with a bilayer mesh (PHS)'}, {'id': 'FG001', 'title': 'Lichtenstein', 'description': 'Inguinal hernia repair with the Lichtenstein technique'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '39'}]}]}], 'recruitmentDetails': 'Included were 300 adult patients (282 men, 18 women) referred for elective repair having unilateral or bilateral inguinal hernias. Study period: September 2001 - January 2004, outpatient unit of Jorvi Hospital (Helsinki University Central Hospital, Espoo, Finland).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prolene Hernia System Device', 'description': 'Inguinal hernia repair either with a bilayer mesh (PHS)'}, {'id': 'BG001', 'title': 'Lichtenstein', 'description': 'Inguinal hernia repair with the Lichtenstein technique'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '72'}, {'value': '47', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '70'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '72'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-02', 'studyFirstSubmitDate': '2010-02-17', 'resultsFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2010-02-17', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-02', 'studyFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term Sequelae', 'timeFrame': '5 years', 'description': 'Any pain at five years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inguinal hernia', 'Open mesh repair', 'Long term outcome', 'Recurrence', 'Discomfort'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uni- or bilateral\n* Primary or recurrent\n\nExclusion Criteria:\n\n* body-mass index over 40kg/m2, severe co-morbidities'}, 'identificationModule': {'nctId': 'NCT01070693', 'briefTitle': 'Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'TYH1333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prolene Hernia System device', 'description': 'Inguinal hernia repair either with a bilayer mesh (PHS)', 'interventionNames': ['Procedure: Open mesh inguinal hernia repair', 'Device: Prolene Hernia System']}, {'type': 'EXPERIMENTAL', 'label': 'Lichtenstein', 'description': 'Inguinal hernia repair with the Lichtenstein technique', 'interventionNames': ['Procedure: Open mesh inguinal hernia repair', 'Procedure: Lichtenstein technique']}], 'interventions': [{'name': 'Open mesh inguinal hernia repair', 'type': 'PROCEDURE', 'description': 'Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique', 'armGroupLabels': ['Lichtenstein', 'Prolene Hernia System device']}, {'name': 'Prolene Hernia System', 'type': 'DEVICE', 'description': 'Prolene Hernia System', 'armGroupLabels': ['Prolene Hernia System device']}, {'name': 'Lichtenstein technique', 'type': 'PROCEDURE', 'description': 'Lichtenstein technique', 'armGroupLabels': ['Lichtenstein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07430', 'city': 'Espoo', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Jaana Vironen', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}