Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 2:42 AM
Study NCT ID:
NCT07386067
Status:
COMPLETED
Last Update Posted:
2026-02-04
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesh Design for Open Inguinal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hernia recurrence', 'timeFrame': '6 months following the operation', 'description': 'The rate of return of the hernia in the same location.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mesh', 'Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'Inguinal hernia repair is the most common operation performed by general surgeons worldwide, surgical repair is the only established definitive treatment for inguinal hernia with multiple variable described approaches, Since Lichtenstein and his colleagues pronounced the use of mesh in tension-free inguinal hernia repair, the open Lichtenstein mesh repair of inguinal hernia became a standard of care for inguinal hernia repair due to easiness of performance with low recurrence rates (1, 2, 3).\n\nIn the past many different factors have been identified to reduce chronic postoperative inguinal pain CPIP, Sophisticated studies suggested that mechanical mesh fixation should be avoided, and proper knowledge of inguinal nerves is essential (4-9).\n\nSurgeons must consider patient characteristics and mesh properties when selecting a mesh for hernia treatment. Mechanical compatibility between meshes and abdominal wall layers is crucial for avoiding complications. Lightweight, monofilament meshes with large pores and minimal surface area are ideal; however, the surgeon should never forget that the way the mesh is positioned as important as the type of mesh used. Despite the new materials available, surgical skill still has a major role in preventing hernia post-operative complications and recurrence. Future research will continue to focus on the surgical techniques and biomaterials to achieve the best outcomes (10).\n\nOur method uses a smaller single mesh that covers all weaknesses in the inguinal canal and is covered with a fibro-cremasteric sheath to prevent the prosthesis from coming into touch with neural processes. This method is applicable to all cases of primary inguinal hernia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • males older than 18 years old with primary inguinal hernia.\n\nExclusion Criteria:\n\n* females patients with bleeding tendency.\n\n * Complicated inguinal hernia.\n * Huge inguinoscrotal hernia'}, 'identificationModule': {'nctId': 'NCT07386067', 'briefTitle': 'Mesh Design for Open Inguinal Hernia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Mesh Design for Open Inguinal Hernia Repair: Superior Outcomes and Fewer Complications', 'orgStudyIdInfo': {'id': 'Mesh Design'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hernia arm represent patients with inguinal hernia', 'description': 'the new mesh desined to fit the posterior wall of inguinal canal', 'interventionNames': ['Procedure: new mesh design for inguinal hernia']}], 'interventions': [{'name': 'new mesh design for inguinal hernia', 'type': 'PROCEDURE', 'description': 'the new mesh design is cut to fit the posterior wall of the inguinal canal', 'armGroupLabels': ['hernia arm represent patients with inguinal hernia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig Univeesity Hospitals', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant professor', 'investigatorFullName': 'Yasser Ali Orban', 'investigatorAffiliation': 'Zagazig University'}}}}