Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 7:39 PM
Study NCT ID:
NCT06257459
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'semen parameters improvement', 'timeFrame': '3 and 6 months after surgery', 'description': 'semen analysis'}, {'measure': 'symptoms improvement (pain and swelling)', 'timeFrame': '3 and 6 months after surgery', 'description': 'improvement of preoperative scrotal pain and swelling was assessed'}], 'secondaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': 'early after surgery and late', 'description': 'post-operative scrotal edema, hematoma and wound infection were assessed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Male Infertility']}, 'descriptionModule': {'briefSummary': 'In the current study, the adult infertile patients with clinical varicoceles will be included. the patients will undergo subinguinal varicocelectomy. The patients with spermatic cord lipoma detected at the time of surgery will be enrolled and divided into 2 groups( excision group, group A and preservation group (B). semen parameters will be compared in both group at 3 and 6 months after surgery', 'detailedDescription': 'This will be a prospective randomized study, in which adult infertile patients with clinical varicocele and oligo-athenospermia admitted to Urology department Tanta university hospital will be included and then the patients with detected spermatic cord lipoma at the time surgery will be enrolled and divided into 2 groups:\n\nGROUP A : will undergo subinguinal varicocelectomy with excision of spermatic cord lipoma GROUP B : will undergo subinguinal varicocelectomy with preservation of spermatic cord lipoma\n\nInclusion criteria:\n\n* Adult infertile males\n* Clinical varicocele\n* oligo-asthenospermia\n\nExclusion criteria:\n\n* Adolescent varicocele\n* Recurrent varicocele\n* Presence of inguinal hernia\n* Azospermic patients'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult infertile males\n* Clinical varicocele\n* Semen analysis show oligo-athenospermia\n\nExclusion Criteria:\n\n* Adolescent varicocele\n* Recurrent varicocele\n* Presence of inguinal hernia\n* Azospermic patients'}, 'identificationModule': {'nctId': 'NCT06257459', 'briefTitle': 'Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Excision Versus Preservation of Spermatic Cord Lipoma Detected During Subinguinal Varicocelectomy in Infertile Men With Oligo-asthenzoospermia: A Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': '36137/12/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lipoma Excision (group A)', 'description': 'excison of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males', 'interventionNames': ['Procedure: subinguinal varicocelectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lipoma Preservation (group B)', 'description': 'preservation of spermatic cord lipoma detected during subinguinal varicocelectomy in infertile males', 'interventionNames': ['Procedure: subinguinal varicocelectomy']}], 'interventions': [{'name': 'subinguinal varicocelectomy', 'type': 'PROCEDURE', 'description': 'exision or preservation of spermatic cord lipoma during subinguinal varicocelectomy', 'armGroupLabels': ['Lipoma Excision (group A)', 'Lipoma Preservation (group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11511', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Zoeir', 'role': 'CONTACT', 'email': 'drahmedzoeir27@gmail.com', 'phone': '+201008634198'}], 'facility': 'Ahmed Zoeir', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'faculty of medicine, Tanta, ElGeish street, Egypt', 'investigatorFullName': 'Ahmed Zoeir', 'investigatorAffiliation': 'Tanta University'}}}}