Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-01 @ 3:31 PM
Study NCT ID:
NCT03355950
Status:
UNKNOWN
Last Update Posted:
2017-11-29
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ASA Levels in TEP and Lichtenstein Repair Patients
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': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-22', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline Anti-sperm antibody levels after inguinal hernia surgery', 'timeFrame': 'Three months for each patient', 'description': 'Samples will be collected before hernia surgery and three months after surgery'}], 'secondaryOutcomes': [{'measure': 'Comparison of Anti-sperm antibody levels between inguinal hernia patients who have undergone laparoscopic totally extraperitoneal repair and Lichtenstein repair techniques', 'timeFrame': '2 years anticipated'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hernia, Inguinal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels.', 'detailedDescription': "Antisperm antibody levels are thought to be indirect indicators of spermatic duct injuries. The investigators' ultimate goal is to draw a conclusion about the effect of the type of surgery on spermatic duct integrity. The investigators are going to collect serum samples from inguinal hernia patients before and after surgery. The investigators aim to assess the effect of surgery on antisperm antibody levels of patients who undergo Licthenstein and TEP repair. Preoperative antisperm antibody levels will serve as control levels for each patient group."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* to accept the terms of the randomization and all study\n* to have unilateral inguinal hernia and set for an inguinal hernia repair\n* to be a father\n\nExclusion Criteria:\n\n* to have any kind of autoimmune disorders\n* any kind of infertility history\n* to have a history of inguinal and/or genital surgery and/or trauma'}, 'identificationModule': {'nctId': 'NCT03355950', 'briefTitle': 'ASA Levels in TEP and Lichtenstein Repair Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of Anti-sperm Antibody Levels in Inguinal Hernia Patients Who Undergo Totally Extra-peritoneal and Lichtenstein Repair', 'orgStudyIdInfo': {'id': 'E-16-1019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TEP group', 'description': 'Patients who undergo totally extraperitoneal hernia repair, TEP Repair.', 'interventionNames': ['Procedure: TEP Repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lichtenstein group', 'description': 'Patients who undergo Lichtenstein repair.', 'interventionNames': ['Procedure: Lichtenstein Repair']}], 'interventions': [{'name': 'Lichtenstein Repair', 'type': 'PROCEDURE', 'description': 'Well defined Lichtenstein Repair for inguinal hernias', 'armGroupLabels': ['Lichtenstein group']}, {'name': 'TEP Repair', 'type': 'PROCEDURE', 'description': 'Laparoscopic totally extraperitoneal repair for inguianal hernias', 'armGroupLabels': ['TEP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Selami Ilgaz Kayılıoğlu, MD', 'role': 'CONTACT', 'email': 'kayilioglu@yahoo.com', 'phone': '+905332036595'}], 'facility': 'Ankara Numune Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Selami Ilgaz Kayılıoğlu, MD', 'role': 'CONTACT', 'email': 'kayilioglu@yahoo.com', 'phone': '+90 533 203 6595'}, {'name': 'Ömer Özduman, MD', 'role': 'CONTACT', 'email': 'omer_ozduman@yahoo.com', 'phone': '+90 544 253 9683'}], 'overallOfficials': [{'name': 'Faruk Coskun, MD, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Numune Research and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}