Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-04 @ 1:20 PM
Study NCT ID:
NCT00496418
Status:
COMPLETED
Last Update Posted:
2015-01-14
First Post:
2007-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peristomal Mesh for Prophylaxis of Parastomal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-12', 'studyFirstSubmitDate': '2007-07-03', 'studyFirstSubmitQcDate': '2007-07-03', 'lastUpdatePostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parastomal hernia', 'timeFrame': 'at 3, 12, 24, 36 and 48 months'}], 'secondaryOutcomes': [{'measure': 'Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy', 'timeFrame': '4 years'}]}, 'conditionsModule': {'keywords': ['colostomy', 'parastomal', 'peristomal', 'hernia', 'mesh', 'surgery', 'Indication for permanent end colostomy'], 'conditions': ['Hernia']}, 'referencesModule': {'references': [{'pmid': '32222841', 'type': 'DERIVED', 'citation': 'Lambrecht JR. Diagnostic methods in parastomal hernia; research and clinical relevance. Hernia. 2021 Jun;25(3):817-820. doi: 10.1007/s10029-020-02177-8. Epub 2020 Mar 28. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.', 'detailedDescription': 'Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation.\n\nPrimary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Condition with indication for establishing a permanent end-colostomy.\n\nExclusion Criteria:\n\n* Age under 18\n* ASA score above 3'}, 'identificationModule': {'nctId': 'NCT00496418', 'briefTitle': 'Peristomal Mesh for Prophylaxis of Parastomal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Randomized Controlled Open Interventional Study for Evaluation of Use of Peristomal Mesh for Prophylaxis of Parastomal Hernia', 'orgStudyIdInfo': {'id': 'S-07203a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prophylactic stoma mesh', 'description': 'Mesh', 'interventionNames': ['Device: Mesh in permanent colostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No mesh prophylaxis', 'description': 'No mesh', 'interventionNames': ['Device: Mesh in permanent colostomy']}], 'interventions': [{'name': 'Mesh in permanent colostomy', 'type': 'DEVICE', 'armGroupLabels': ['No mesh prophylaxis', 'Prophylactic stoma mesh']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NO-0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Rikshospitalet-Radiumhospitalet HF', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Jan Lambrecht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rikshospitalet-Radiumhospitalet HF, Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jan Lambrecht', 'investigatorAffiliation': 'Oslo University Hospital'}}}}