Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the efficacy and safety of Loupe varicocelectomy using nitroglycerine to induce vasodilatation during operation.
研究概览
简要总结
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
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
subinguinal loupe-assisted varicocelectomy (LV)
we are using nitroglycerine instillation during loupe assisted varicocelectomy to enhance its efficacy by the vasodilatation effect of Nitroglycerine
干预措施: subinguinal loupe-assisted varicocelectomy (LV) (Procedure)
subinguinal microscopic varicocelectomy (MV)
we are using surgical microscope to perform varicocelectomy as control group
干预措施: subinguinal microscopic varicocelectomy (MV) (Procedure)
结局指标
主要结局
To assess the efficacy and safety of Loupe varicocelectomy using nitroglycerine to induce vasodilatation during operation.
时间窗: 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 )
次要结局
- to assess the efficacy and safety of nitroglycerine instillation during Loupe varicocelectomy comparing to the standard Microscopic varicocelectomy.(3 months follow up)
研究者
Khaled Mohyelden
Professor of urology
Fayoum University Hospital