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临床试验/NCT07306572
NCT07306572已完成不适用

Comparative Study Between Loupe-Assisted Varicocelectomy With Nitroglycerin Instillation Versus Microscopic Varicocelectomy

Fayoum University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
percent of sperm motility in semen analysis

研究概览

简要总结

Goal: To evaluate the safety and effectiveness of subinguinal microscopic varicocelectomy versus subinguinal loupe-assisted varicocelectomy with nitroglycerin instillation as a vasodilator.

Materials and Procedures: 60 patients were enrolled in our prospective randomized trial between May 2023 and April 2024. They were split into two groups, Group A undergoing Loupe varicocelectomy (LV) with nitroglycerin instillation, and Group B undergoing Microscopic varicocelectomy (MV). Nitroglycerin was administered to the LV group following delivery and cord incision to help visualize cord veins and arterial pulse and avoid confusion with other cord structures that were to be preserved. Three months after the procedure, both groups had scrotal Doppler and semen analysis.

详细描述

Introduction:

The dilation and anomaly of the testicular veins within the spermatic cord is known as varicocele. It is the most frequent treatable cause of male infertility and a significant contributor to poor spermatogenesis. Only 20% of males with verified varicocele, according to reports, have infertility issues . Disrupting the venous return from the pampiniform plexus's enlarged veins is the main objective of varicocele repair. The internal spermatic artery, vas deferens, and spermatic cord lymphatics are among the vital spermatic cord structures that must be preserved during surgery .

Urologists now use a variety of techniques for varicocele repair, such as inguinal, subinguinal, retroperitoneal, laparoscopic, angioembolization, and both loupe-assisted (LV) and microscopic varicocelectomy (MV) .

The results of varicocelectomy have been greatly improved by the use of surgical microscopes and loupes, and MV is now regarded as the gold standard procedure. Recurrence rates and the frequency of problems such hydrocele formation are remarkably low when done with the right expertise and experience, ranging from 1-2% and 0-1%, respectively.Vasodilators have been used in certain cases to increase vein recognition and visualize the pulse of the testicular artery during surgery, which may further improve surgical outcomes and lower complications .Compared to surgical microscopes, surgical loupes are more widely available, less expensive, and have a simpler learning curve .

Patient and methods:

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

入选标准

  • Patients with clinically evident varicocele who presented with primary or secondary infertility
  • intractable pain
  • aberrant semen values
  • and diminished testicular volume were included in the study.

排除标准

  • Those with systemic conditions that impact arterial flow, such as diabetes, hypertension, liver disease, and hypercholesterolemia
  • Younger than 18 or older than
  • Patients with subclinical varicocele
  • patients had previously had a varicocelectomy or inguinoscrotal surgery on the same side were not included.

结局指标

主要结局

percent of sperm motility in semen analysis

时间窗: 3 months

percent of improvement of sperm motility

次要结局

  • testicular Doppler parameters, mainly percentages of resistive index changes(From enrollment to the end of treatment at 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Mahmoud Dogha

assistant professor of urology

Fayoum University Hospital

研究点 (2)

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