Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-31 @ 10:08 PM
Study NCT ID:
NCT06862167
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2025-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Desarda's Technique Versus Lichtenstein's Technique Hernia Repair in Management of Elective Non-Complicated 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-01', 'studyFirstSubmitDate': '2025-03-01', 'studyFirstSubmitQcDate': '2025-03-01', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of postoperative complications', 'timeFrame': '1 year postoperatively', 'description': 'Incidence of postoperative complications such as groin pain, hemorrhage, orchitis, testicular atrophy, and seroma will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Time till stop of postoperative analgesic', 'timeFrame': '30 days postoperatively', 'description': 'Stop of postoperative analgesic (Within 3 days, 3 to 6 days, More than 6 days)'}, {'measure': 'Return to normal activity', 'timeFrame': '30 days postoperatively', 'description': 'Return to normal activity will be recorded from 1 to 7 days, 8 to 15 days, and 16 to 30 days postoperatively.'}, {'measure': 'Incidence of recurrence', 'timeFrame': '1 year postoperatively', 'description': 'Incidence of recurrence will be recorded within 1 year postoperatively'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Desarda's Technique", "Lichtenstein's Technique", 'Hernia Repair', 'Inguinal Hernia']}, 'descriptionModule': {'briefSummary': "This study aims to compare Desarda's technique and Lichtenstein's technique of hernia repair in managing elective, non-complicated inguinal hernia.", 'detailedDescription': 'Mesh prosthesis was introduced to hernial surgery as a magic solution for any inguinal hernia, and it has significant advantages (Simplicity of the procedure, Mesh is cheap, and has a low recurrence rate). Still, mesh induces fibrosis that can lead to stiffness and foreign body sensation, which become a source of agony for the patient. Mesh infection is one of the serious complications that can lead to the removal of the mesh and long-term terms morbidity from Lichtenstein hernia repairs, such as Vas entrapment and Chronic groin pain.\n\nDesarda technique requires no extensive dissection or only suturing; no mesh is needed, and it is easy to learn. It is still ferrated and determined the optimum procedure to treat an inguinal hernia. It is a straightforward operation that avoids the risks of mesh implantation, has a low recurrence rate, and can be done by non-consultant staff.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 14 years of age.\n* With reducible non-complicated inguinal or inguinoscrotal hernia; unilateral or bilateral\n\nExclusion Criteria:\n\n* Obstructive uropathy or chronic obstructive pulmonary disease because they are contraindications to elective hernia surgery. They are associated with definite poor outcomes, such as high recurrence rates.\n* Unfit patients for surgery\n* Patients with strangulated hernia.\n* Recurrent Hernias.\n* Per operative finding of separated, thin, and/or weak external oblique aponeurosis'}, 'identificationModule': {'nctId': 'NCT06862167', 'briefTitle': "Desarda's Technique Versus Lichtenstein's Technique Hernia Repair in Management of Elective Non-Complicated Inguinal Hernia", 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': "Comparative Study Between Desarda's Technique Versus Lichtenstein's Technique Hernia Repair in Management of Elective Non-complicated Inguinal Hernia (Randomized Controlled Trial)", 'orgStudyIdInfo': {'id': '1240/08/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Desarda's technique group", 'description': "Patients will undergo Desarda's technique.", 'interventionNames': ["Procedure: Desarda's technique"]}, {'type': 'ACTIVE_COMPARATOR', 'label': "Lichtenstein's technique group", 'description': "Patients will undergo Lichtenstein's technique.", 'interventionNames': ["Procedure: Lichtenstein's technique"]}], 'interventions': [{'name': "Desarda's technique", 'type': 'PROCEDURE', 'description': "Patients will undergo Desarda's technique.", 'armGroupLabels': ["Desarda's technique group"]}, {'name': "Lichtenstein's technique", 'type': 'PROCEDURE', 'description': "Patients will undergo Lichtenstein's technique.", 'armGroupLabels': ["Lichtenstein's technique group"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '61611', 'city': 'Minya', 'state': 'Minya Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelrahman M Salah, MD', 'role': 'CONTACT', 'email': 'Abdelrahman.salah@mu.edu.eg', 'phone': '01064746493'}], 'facility': 'Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'centralContacts': [{'name': 'Abdelrahman M Salah, MD', 'role': 'CONTACT', 'email': 'Abdelrahman.salah@mu.edu.eg', 'phone': '00201064746493'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in General Surgery Department, Minia University, Minia, Egypt', 'investigatorFullName': 'Abdelrahman Mohamed Salah', 'investigatorAffiliation': 'Minia University'}}}}