Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-18 @ 10:45 PM
Study NCT ID:
NCT02500056
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2015-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D059350', 'term': 'Chronic Pain'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ceith.nikkolo@kliinikum.ee', 'phone': '+37253319082', 'title': 'Ceith Nikkolo', 'organization': 'Tartu University Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3-year', 'eventGroups': [{'id': 'EG000', 'title': 'OM Group', 'description': 'Optilene LP mesh\n\nOptilene LP mesh: Lichtenstein hernioplasty', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 10, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'UM Group', 'description': 'Ultrapro mesh\n\nUltrapro mesh: Lichtenstein hernioplasty', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 10, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Chronic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM Group', 'description': 'Optilene LP mesh\n\nOptilene LP mesh: Lichtenstein hernioplasty'}, {'id': 'OG001', 'title': 'UM Group', 'description': 'Ultrapro mesh\n\nUltrapro mesh: Lichtenstein hernioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '46.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-month follow-up', 'description': 'On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise', 'unitOfMeasure': 'percentage of patients with pain', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Chronic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM Group', 'description': 'Optilene LP mesh\n\nOptilene LP mesh: Lichtenstein hernioplasty'}, {'id': 'OG001', 'title': 'UM Group', 'description': 'Ultrapro mesh\n\nUltrapro mesh: Lichtenstein hernioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}, {'value': '33.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-year follow-up', 'description': 'On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise', 'unitOfMeasure': 'percentage of patients with pain', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Foreign Body Feeling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OM Group', 'description': 'Optilene LP mesh\n\nOptilene LP mesh: Lichtenstein hernioplasty'}, {'id': 'OG001', 'title': 'UM Group', 'description': 'Ultrapro mesh\n\nUltrapro mesh: Lichtenstein hernioplasty'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6-month follow-up', 'description': 'The question about foreign body feeling was a yes-or-no question', 'unitOfMeasure': 'percentage of patients with foreign body', 'reportingStatus': 'POSTED', 'populationDescription': 'Drop-outs at 6-month follow-up (3+6) not included'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OM Group', 'description': 'Optilene LP mesh\n\nOptilene LP mesh: Lichtenstein hernioplasty'}, {'id': 'FG001', 'title': 'UM Group', 'description': 'Ultrapro mesh\n\nUltrapro mesh: Lichtenstein hernioplasty'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Recurrence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OM Group', 'description': 'Optilene LP mesh\n\nOptilene LP mesh: Lichtenstein hernioplasty'}, {'id': 'BG001', 'title': 'UM Group', 'description': 'Ultrapro mesh\n\nUltrapro mesh: Lichtenstein hernioplasty'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>=18 years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': '\\>=18 years', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender (male + female)', 'unitOfMeasure': 'participants'}, {'title': 'Unilateral inguinal hernia', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary inguinal hernia', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Reducible inguinal hernia', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Elective operation', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-08', 'studyFirstSubmitDate': '2015-07-10', 'resultsFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-25', 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic Pain', 'timeFrame': '6-month follow-up', 'description': 'On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise'}], 'secondaryOutcomes': [{'measure': 'Chronic Pain', 'timeFrame': '3-year follow-up', 'description': 'On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise'}, {'measure': 'Foreign Body Feeling', 'timeFrame': '6-month follow-up', 'description': 'The question about foreign body feeling was a yes-or-no question'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inguinal hernia', 'Chronic pain', 'Mesh', 'Lichtenstein hernioplasty'], 'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.', 'detailedDescription': 'The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* unilateral primary reducible inguinal hernia\n* elective operation\n* consent to participate in the study.\n\nExclusion Criteria:\n\n* age \\<18 years\n* irreducible\n* strangulated\n* recurrent hernia\n* inability to understand the questionnaire\n* unwillingness to participate in the study'}, 'identificationModule': {'nctId': 'NCT02500056', 'briefTitle': 'Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty', 'organization': {'class': 'OTHER', 'fullName': 'Tartu University Hospital'}, 'officialTitle': 'Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty', 'orgStudyIdInfo': {'id': '10100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OM group', 'description': 'Optilene LP mesh', 'interventionNames': ['Device: Optilene LP mesh']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'UM group', 'description': 'Ultrapro mesh', 'interventionNames': ['Device: Ultrapro mesh']}], 'interventions': [{'name': 'Optilene LP mesh', 'type': 'DEVICE', 'description': 'Lichtenstein hernioplasty', 'armGroupLabels': ['OM group']}, {'name': 'Ultrapro mesh', 'type': 'DEVICE', 'description': 'Lichtenstein hernioplasty', 'armGroupLabels': ['UM group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tartu University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Ceith Nikkolo', 'investigatorAffiliation': 'Tartu University Hospital'}}}}