A Prospective Cohort Study of Combined Subinguinal Varicocele Ligation and Sclerotherapy

Not yet recruiting

• Conditions: Varicocele

• Registration Number: NCT06743932
• Lead Sponsor: Assiut University

Brief Summary

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 .

This 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 .

Detailed Description

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 .

Severe 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• 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

Exclusion Criteria

• 1- Pre-existing hydrocele. 2- Concomitant hernia 3- Previous inguinal surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
varicocele grade	30 day	Assess the change in varicocele grade from baseline to post-treatment using clinical examination and/or ultrasound