Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00451893
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2007-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Significance of the Mesh Thickness in the Operation of Inguinal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-31', 'studyFirstSubmitDate': '2007-03-23', 'studyFirstSubmitQcDate': '2007-03-23', 'lastUpdatePostDateStruct': {'date': '2016-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related Quality of Life', 'timeFrame': 'Two, seven and eleven postoperative days. Four months and one year after the operation.'}, {'measure': 'Pain', 'timeFrame': 'Two, seven and eleven postoperative days. Four months and one year after the operation.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'Four months and one year after the operation.'}, {'measure': 'Recurrences', 'timeFrame': 'Four months and one year after the operation.'}, {'measure': 'Health-care costs', 'timeFrame': 'Four months and one year after the operation.'}, {'measure': 'Sick leave', 'timeFrame': 'Four months and one year after the operation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inguinal hernia', 'polypropylene mesh', 'heavy-weight mesh', 'light-weight mesh'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '33711123', 'type': 'DERIVED', 'citation': 'Rutegard M, Lindqvist M, Svensson J, Nordin P, Haapamaki MM. Chronic pain after open inguinal hernia repair: expertise-based randomized clinical trial of heavyweight or lightweight mesh. Br J Surg. 2021 Mar 12;108(2):138-144. doi: 10.1093/bjs/znaa049.'}, {'pmid': '29353339', 'type': 'DERIVED', 'citation': 'Rutegard M, Gumuscu R, Stylianidis G, Nordin P, Nilsson E, Haapamaki MM. Chronic pain, discomfort, quality of life and impact on sex life after open inguinal hernia mesh repair: an expertise-based randomized clinical trial comparing lightweight and heavyweight mesh. Hernia. 2018 Jun;22(3):411-418. doi: 10.1007/s10029-018-1734-z. Epub 2018 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes.\n\nHypothesis: There is less postoperative pain after the implantation of a light-weight mesh.', 'detailedDescription': 'The implantation of mesh in the operation of inguinal hernia has resulted in a continuously diminishing frequency of reoperations. Randomized controlled trials indicate that hernia repair with an open mesh technique has a shorter learning curve, is cheaper and may give less recurrences than laparoscopic hernia repair in general surgical practice. Furthermore, local anesthesia has significant advantages for both the patient and the health related economy compared to general anesthesia and regional anesthesia. The experience of the last decade within the field of groin hernia surgery has focused interest on quality of life and postoperative pain (especially chronic pain). Chronic pain is defined as pain that remains 3 months after the operation. Recent studies indicate that one third of all patients operated on for inguinal hernia have some degree of chronic pain and that 4-6 % of patients have pain interfering with daily activities one year after surgery.\n\nIn the present study a heavy-weight polypropylene mesh will be compared with a light-weight partly absorbable mesh. In an expertise-based randomized control trial patients will be randomly allocated to two groups of surgeons, each group well trained to use one of the two meshes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, age 25 years or older\n* Reducible, unilateral, inguinal hernia (not femoral hernia) that has not been operated on before\n\nExclusion Criteria:\n\n* The patient is not able or do not want to give written informed consent\n* The patient is not suitable for an operation in local anesthesia\n* Anticoagulant medication or a known coagulation disorder'}, 'identificationModule': {'nctId': 'NCT00451893', 'acronym': 'LJUNO', 'briefTitle': 'The Significance of the Mesh Thickness in the Operation of Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'An Expertise-based Multicentre Randomized Controlled Trial Comparing a Heavy-weight and a Light-weight Mesh in the Operation of Inguinal Hernia', 'orgStudyIdInfo': {'id': 'LJUNO 05-109M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Heavy-weight', 'description': 'Lichtenstein operation performed with a heavy-weight mesh.', 'interventionNames': ['Procedure: Lichtenstein operation with a heavy-weight mesh']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Light-weight', 'description': 'Lichtenstein operation performed with a light-weight mesh.', 'interventionNames': ['Procedure: Lichtenstein operation with a light-weight mesh']}], 'interventions': [{'name': 'Lichtenstein operation with a heavy-weight mesh', 'type': 'PROCEDURE', 'description': 'Bard flat mesh, polypropylene, 7,5 x 15 cm, 90 g/m2', 'armGroupLabels': ['Heavy-weight']}, {'name': 'Lichtenstein operation with a light-weight mesh', 'type': 'PROCEDURE', 'description': 'Johnson\\&Johnson Ultrapro, polypropylene/poliglecaprone, 10 x 15 cm, 28 g/m2', 'armGroupLabels': ['Light-weight']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE 83183', 'city': 'Östersund', 'country': 'Sweden', 'facility': 'Östersund Hospital', 'geoPoint': {'lat': 63.1792, 'lon': 14.63566}}, {'zip': 'SE 90185', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Department of Surgical and Perioperativ Sciences, Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Markku M Haapamaki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University, Department of Surgical and Perioperative Sciences'}, {'name': 'Erik Nilsson, MD, Ph D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Umeå University, Department of Surgical and Perioperative Sciences'}, {'name': 'Pär Nordin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University, Department of Surgical and Perioperative Sciences'}, {'name': 'Rojda Gumuscu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University, Department of Surgical and Perioperative Sciences'}, {'name': 'Martin Rutegård, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University, Department of Surgical and Perioperative Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norrlandstingens Regionförbund', 'class': 'OTHER'}, {'name': 'Jämtland County Council, Sweden', 'class': 'OTHER_GOV'}, {'name': 'Västerbotten County Council, Sweden', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, MD, PhD', 'investigatorFullName': 'Markku Haapamaki', 'investigatorAffiliation': 'Umeå University'}}}}