Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-26 @ 10:48 PM
Study NCT ID:
NCT06743932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Cohort Study of Combined Subinguinal Varicocele Ligation and Sclerotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014646', 'term': 'Varicocele'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'varicocele grade', 'timeFrame': '30 day', 'description': 'Assess the change in varicocele grade from baseline to post-treatment using clinical examination and/or ultrasound'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ligation', 'Sclerotherapy'], 'conditions': ['Varicocele']}, 'referencesModule': {'references': [{'pmid': '24917707', 'type': 'BACKGROUND', 'citation': 'Abd Ellatif ME, Asker W, Abbas A, Negm A, Al-Katary M, El-Kaffas H, Moatamed A. Varicocelectomy to treat pain, and predictors of success: a prospective study. Curr Urol. 2012 May;6(1):33-6. doi: 10.1159/000338867. Epub 2012 Mar 18.'}, {'pmid': '32271477', 'type': 'BACKGROUND', 'citation': 'Su JS, Farber NJ, Vij SC. Pathophysiology and treatment options of varicocele: An overview. Andrologia. 2021 Feb;53(1):e13576. doi: 10.1111/and.13576. Epub 2020 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Traditional surgical ligation of the spermatic cord veins is effective in reducing the size of the varicocele and improving fertility outcomes. However, this procedure can be associated with complications such as hydrocele formation and recurrence . Antegrade sclerotherapy offers a minimally invasive alternative, involving the injection of a sclerosing agent directly into the dilated veins to achieve occlusion and reduce reflux .\n\nThis study aims to optimize treatment outcomes for varicocele by combining the benefits of surgical ligation with the sclerosing effects of sclerotherapy .The primary goal is to evaluate the efficacy and safety of combining antegrade sclerotherapy and surgical ligation in the treatment of varicocele .', 'detailedDescription': 'Varicocele (VC) is a vascular condition characterized by the abnormal development or blockage of veins in the scrotum, resulting in dilation, elongation, and twisting of the veins in the spermatic cord. Clinically, VC can cause scrotal pain, discomfort, and progressive testicular dysfunction. The prevalence of clinically diagnosed varicocele is approximately 8-16% in adolescents and 15% in adults. VC is a common and correctable cause of male infertility, responsible for around 44% of primary infertility cases . Other reports suggest that the prevalence in childhood and adolescence is similar to that in adulthood. A recent European study of 7,000 young men (median age: 19 years) reported a 15.7% prevalence of varicocele .\n\nSevere and prolonged VC can lead to significant damage to the testes and accessory structures, causing 45-81% of secondary infertility cases. VC most commonly occurs on the left side (77-92% of cases) due to the anatomy of the left internal spermatic vein. Bilateral VC is observed in 10% of cases, while isolated right-sided VC is rare (1%). The diagnosis of VC is primarily based on physical examination, often supplemented by imaging . The American Society for Reproductive Medicine and the Society for Male Reproduction and Urology recommend treating VC favorably, even in the absence of severe symptoms, if it poses a risk for infertility or decreased semen quality. Treatment options for VC include general management (lifestyle modifications, physiotherapy), medication (for varicose symptoms, pain relief, and improvement in semen quality), and various surgical approaches (ligation of the internal spermatic vein via inguinal, retroperitoneal, or subinguinal routes) . Minimally invasive techniques, such as laparoscopy, surgical microscopy, and percutaneous embolization, have been developed to improve visualization and reduce surgical trauma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'varicocele patients withClinically and Doppler confirmed grades II or III varicocele.', 'genderDescription': 'male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1- Clinically and Doppler confirmed grades II or III varicocele. 2- All left, right or bilateral side varicocele. 3- Testicular pain or testicular atrophy. 4- Presence of at least one impaired semen parameter. 5- Age more than 18years\n\nExclusion Criteria:\n\n* 1- Pre-existing hydrocele. 2- Concomitant hernia 3- Previous inguinal surgery'}, 'identificationModule': {'nctId': 'NCT06743932', 'briefTitle': 'A Prospective Cohort Study of Combined Subinguinal Varicocele Ligation and Sclerotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'A Prospective Cohort Study of Combined Subinguinal Varicocele Ligation and Sclerotherapy', 'orgStudyIdInfo': {'id': 'VC Ligation + Sclerotherapy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'varicocel patients', 'description': 'varicocele patients will be follow up after Ligation and Sclerotherapy'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Mostafa Khedr, resident doctor', 'role': 'CONTACT', 'email': 'hamadakhedr1988@yahoo.com', 'phone': '01098726393'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at Assiut University hospital', 'investigatorFullName': 'Mohamed Mostafa Khedr', 'investigatorAffiliation': 'Assiut University'}}}}