Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT01000116
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2009-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006550', 'term': 'Hernia, Femoral'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D049291', 'term': 'Seroma'}, {'id': 'D006406', 'term': 'Hematoma'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D006470', 'term': 'Hemorrhage'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2009-10-16', 'studyFirstSubmitQcDate': '2009-10-21', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early pain after operation', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'haematoma in groin region', 'timeFrame': 'day 10'}, {'measure': 'seroma in groin region', 'timeFrame': 'day 10'}, {'measure': 'fatigue', 'timeFrame': '10 days'}, {'measure': 'discomfort', 'timeFrame': '6 month'}, {'measure': 'Postoperative nausea and vomiting (PONV)', 'timeFrame': '10 days'}, {'measure': 'Use of Analgesics at PACU', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tapp', 'Early pain', 'well-being', 'Seroma', 'Haematoma', 'Fibrin glue', 'tacks'], 'conditions': ['Inguinal Hernia', 'Femoral Hernia']}, 'referencesModule': {'references': [{'pmid': '23355162', 'type': 'DERIVED', 'citation': 'Tolver MA, Rosenberg J, Juul P, Bisgaard T. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair. Surg Endosc. 2013 Aug;27(8):2727-33. doi: 10.1007/s00464-012-2766-6. Epub 2013 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'In this study the researchers want to compare fibrin glue versus tacked fixation in fixation of the mesh in laparoscopic groin hernia repair. The primary endpoints are early pain in the first 3 days postoperative days. Moreover, the researchers investigate general well-being, fatigue, seroma, haematoma, postoperative nausea and vomiting. Thirdly, they are investigating chronic pain and clinical recurrence.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral groin hernia\n* planned laparoscopic inguinal or femoral herniorrhaphy\n* ASA I-III\n* fluent Danish\n\nExclusion Criteria:\n\n* converting to open operation\n* low compliance\n* daily use of morphine or similar drugs daily in the last month\n* complications to the operation'}, 'identificationModule': {'nctId': 'NCT01000116', 'briefTitle': 'Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP)', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Fibrin Glue Versus Tacked Fixation in Laparoscopic Groin Hernia Repair. A Randomized Double-blind Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': 'SJ-138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fibrin glue', 'interventionNames': ['Procedure: Tacks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tacks', 'interventionNames': ['Procedure: Fibrin glue']}], 'interventions': [{'name': 'Fibrin glue', 'type': 'PROCEDURE', 'description': 'Tissucol 2 ml', 'armGroupLabels': ['Tacks']}, {'name': 'Tacks', 'type': 'PROCEDURE', 'description': 'Protacks', 'armGroupLabels': ['Fibrin glue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2160', 'city': 'Søborg', 'country': 'Denmark', 'facility': 'Private Hospital Hamlet', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}], 'overallOfficials': [{'name': 'Mette A Tolver, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Koege'}, {'name': 'Thue Bisgaard, M.D. DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Koege'}, {'name': 'Poul Juul, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Private Hospital Hamlet'}, {'name': 'Jacob Rosenberg, M.D. DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Mette Astrup Madsen', 'investigatorAffiliation': 'Zealand University Hospital'}}}}