Comparison Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation and Microscopic Varicocelectomy

NCT06509321 | Completed

• 1 other identifier: M 652
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety of sub inguinal loupe-assisted varicocelectomy with nitroglycerin instillation as a vasodilator and compare it versus sub inguinal microscopic varicocelectomy

Conditions

Varicocele

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy and safety of Loupe varicocelectomy using nitroglycerine to induce vasodilatation during operation.

  by assessing number of ligated veins, visualization of artery (during operation), and to assess PSV \& EDV for testicular artery, \& semen parameter (After 3 months Post operation )

  3 months follow up

Secondary Outcomes (1)

• to assess the efficacy and safety of nitroglycerine instillation during Loupe varicocelectomy comparing to the standard Microscopic varicocelectomy.

  3 months follow up

Study Arms (2)

subinguinal loupe-assisted varicocelectomy (LV)

ACTIVE COMPARATOR

we are using nitroglycerine instillation during loupe assisted varicocelectomy to enhance its efficacy by the vasodilatation effect of Nitroglycerine

Procedure: subinguinal loupe-assisted varicocelectomy (LV)

subinguinal microscopic varicocelectomy (MV)

ACTIVE COMPARATOR

we are using surgical microscope to perform varicocelectomy as control group

Procedure: subinguinal microscopic varicocelectomy (MV)

Interventions

subinguinal loupe-assisted varicocelectomy (LV) PROCEDURE

to assess the efficacy and safety of sub inguinal loupe-assisted varicocelectomy with nitroglycerin instillation as a vasodilator and compare its results versus subinguinal microscopic varicocelectomy

subinguinal loupe-assisted varicocelectomy (LV)

subinguinal microscopic varicocelectomy (MV) PROCEDURE

we are using surgical microscope to perform varicocelectomy as control group

subinguinal microscopic varicocelectomy (MV)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 50 years old.
• Patient with clinically palpable varicocele with any of the following:
• ry or 2ry infertility.
• Intractable pain.
• Affected semen parameters.
• Reduced testicular volume.

You may not qualify if:

• Patients less than 18 years old.
• Patients older than 50 years old.
• Patients suffering from any systemic diseases that may have effect on the arterial flow like Diabetes, hypertension, liver disease and hypercholesterolemia.
• Patients who underwent previous varicocelectomy operations or inguinoscrotal operation on the same side.
• Sub-clinical varicocele.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, 63611, Egypt

Location

MeSH Terms

Conditions

Varicocele

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of urology

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: July 19, 2024
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

EG (1)