Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fayoum University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To assess the efficacy and safety of Loupe varicocelectomy using nitroglycerine to induce vasodilatation during operation.
Study Overview
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
Detailed Description
This study will include 60 patients with clinical varicocele indicated for varicocelectomy admitted to the Urology Department, at Fayoum University Hospital. The patients will be prospectively randomized into two groups (with ratio 1:1, 30 patients for each group).
- Group A will be treated with subinguinal loupe-assisted varicocelectomy (LV) technique with nitroglycerin instillation as a vasodilator.
- Group B will be treated with subinguinal microscopic varicocelectomy (MV) technique.
Informed consent will be obtained from all patients according to the regulation of the ethical committee of Faculty of medicine Fayoum University.
Inclusion criteria:
- Patients aged 18 to 50 years old.
- Patient with clinically palpable varicocele with any of the following:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 to 50 years old.
- •Patient with clinically palpable varicocele with any of the following:
- •1ry or 2ry infertility.
- •Intractable pain.
- •Affected semen parameters.
- •Reduced testicular volume.
Exclusion Criteria
- •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.
Arms & Interventions
subinguinal loupe-assisted varicocelectomy (LV)
we are using nitroglycerine instillation during loupe assisted varicocelectomy to enhance its efficacy by the vasodilatation effect of Nitroglycerine
Intervention: subinguinal loupe-assisted varicocelectomy (LV) (Procedure)
subinguinal microscopic varicocelectomy (MV)
we are using surgical microscope to perform varicocelectomy as control group
Intervention: subinguinal microscopic varicocelectomy (MV) (Procedure)
Outcomes
Primary Outcomes
To assess the efficacy and safety of Loupe varicocelectomy using nitroglycerine to induce vasodilatation during operation.
Time Frame: 3 months follow up
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 )
Secondary Outcomes
- to assess the efficacy and safety of nitroglycerine instillation during Loupe varicocelectomy comparing to the standard Microscopic varicocelectomy.(3 months follow up)
Investigators
Khaled Mohyelden
Professor of urology
Fayoum University Hospital