Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-03-08 @ 3:40 AM
Study NCT ID:
NCT06514859
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repair of Inguinal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-07', 'releaseDate': '2025-07-24'}], 'estimatedResultsFirstSubmitDate': '2025-07-24'}}, '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': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence in management of inguinal hernia', 'timeFrame': '6 months after operation', 'description': 'Rate of recurrence in both open and laparoscopic repair of inguinal hernia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '21187993', 'type': 'BACKGROUND', 'citation': 'Bhandarkar DS, Shankar M, Udwadia TE. Laparoscopic surgery for inguinal hernia: Current status and controversies. J Minim Access Surg. 2006 Sep;2(3):178-86. doi: 10.4103/0972-9941.27735.'}, {'pmid': '15333356', 'type': 'BACKGROUND', 'citation': 'Aguirre DA, Casola G, Sirlin C. Abdominal wall hernias: MDCT findings. AJR Am J Roentgenol. 2004 Sep;183(3):681-90. doi: 10.2214/ajr.183.3.1830681. No abstract available.'}, {'pmid': '15842951', 'type': 'BACKGROUND', 'citation': 'McCormack K, Wake B, Perez J, Fraser C, Cook J, McIntosh E, Vale L, Grant A. Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation. Health Technol Assess. 2005 Apr;9(14):1-203, iii-iv. doi: 10.3310/hta9140.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the outcomes of open versus laparoscopic approaches for inguinal hernia surgery and provide evidence-based guidance to the selection of the most appropriate operative technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale patient \\> 18 years of age\n\n• Primary groin hernias requiring surgical intervention that are eligible for both open and laparoscopic repair.\n\nExclusion Criteria:\n\n* Emergency procedures .\n\n * ASA score \\> 2.\n * Irreducible inguinoscrotal hernia .\n * Local or systemic infection .\n * Other abdominal hernias being operated at the same time or planned operated during Follow up.\n\nPrevious surgery which has impaired the sensation in the groin area .\n\n* BMI \\> 40 kg/m2.\n* Known disease which Impairs central or peripheral nerve function .\n* Concurrent malignant Disease .\n* Chronic pain which requires daily medication . • Mental disorder which requires daily medication .'}, 'identificationModule': {'nctId': 'NCT06514859', 'briefTitle': 'Repair of Inguinal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Outcomes of Laparoscopic Versus Open Repair of Inguinal Hernia', 'orgStudyIdInfo': {'id': 'Soh-Med-24-06-07MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic repair of inguinal hernia', 'interventionNames': ['Procedure: Laparoscopic repair of inguinal hernia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open repair of inguinal hernia', 'interventionNames': ['Procedure: Open repair of inguinal hernia']}], 'interventions': [{'name': 'Laparoscopic repair of inguinal hernia', 'type': 'PROCEDURE', 'description': 'Laparoscopic repair of inguinal hernia', 'armGroupLabels': ['Laparoscopic repair of inguinal hernia']}, {'name': 'Open repair of inguinal hernia', 'type': 'PROCEDURE', 'description': 'Repair of inguinal hernia by open technique-mesh hernioplasty -', 'armGroupLabels': ['Open repair of inguinal hernia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Magdy M Amin', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Abdul-aziz M Abdul-aziz', 'role': 'CONTACT', 'email': 'adam1212asad@gmail.com', 'phone': '01026055970'}, {'name': 'Alaa A Redwan, Prof', 'role': 'CONTACT', 'phone': '01001988455'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at General, Oncology, Laparoscopic Surgery Department , Faculty of Medicine, Sohag University', 'investigatorFullName': 'Abdelaziz Mohamed Abdelaziz', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-24', 'type': 'RELEASE'}, {'date': '2025-08-07', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Abdelaziz Mohamed Abdelaziz, Resident at General, Oncology, Laparoscopic Surgery Department , Faculty of Medicine, Sohag University, Sohag University'}}}}