A Prospective Cohort Study of Combined Subinguinal Varicocele Ligation and Sclerotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Varicocele

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Ligation Sclerotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

varicocel patients

varicocele patients will be follow up after Ligation and Sclerotherapy

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohamed Mostafa Khedr

resident doctor at Assiut University hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed Mostafa Khedr, resident doctor

Role: CONTACT

Phone: 01098726393

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 24917707 (View on PubMed)

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.