Video Telescopic Operating Microscope (VITOM) Versus Loupe- Assisted Varicocelectomy
Comparative Study Between Video Telescopic Operating Microscope (VITOM) and Loupe- Assisted Varicocelectomy (Randomized Controlled Trial)
This study aims to compare the efficacy, outcome and surgeon satisfaction in Video Telescopic Operating Microscope (VITOM) microsurgical subinguinal varicocelectomy with Loupe- assisted subinguinal varicocelectomy.
研究概览
地位
详细说明
Varicocele is a common medical condition characterized by abnormal dilation and enlargement of the scrotal venous pampiniform plexus, which drains blood from the testicles resulting in complex network of swollen regurging veins.
There are different approaches in varicocelectomy; open surgical inguinal , subinguinal or intrascrotal ,which can be conventional open surgery or by using surgical microscope or Video Telescopic Operating Microscope (VITOM) or Loupeassisted. Also varicocelectomy can be done by laparoscopic retroperitoneal abdominal ligation of gonadal veins or endovascular approach using antegrade sclerotherapy. Improved semen parameters and fewer complications are noticed, when magnification has been used. Magnification can be done using surgical microscope or VITOM or Loupe-assisted.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mohamed A Mahmoud, MSc
- 电话号码：00201559589004
- 邮箱：galal241019888@gmail.com
学习地点
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-
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Cairo、埃及、12613
- 招聘中
- Cairo University
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接触：
- Mohamed A Mahmoud, MSc
- 电话号码：00201559589004
- 邮箱：galal241019888@gmail.com
-
副研究员：
- Ahmed M ElFeel, MD
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副研究员：
- Amr M Sayed, MD
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副研究员：
- Mohamed A Ateya, MD
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副研究员：
- Ahmed S Elsayed, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age: male patients from 18 - 60 years.
- Males with grade II or III varicocele (unilateral or bilateral).
- Males complaining of scrotal swelling or pain not responding to medical treatment.
- Infertile males with impaired semen parameters.
Exclusion Criteria:
- Patients with subclinical varicocele or grade 1 varicocele.
- Acute urogenital infection.
- Patients with hypogonadism (hypogonadotrophic or hypergonadotrophic)
- Patients with hyperprolactenemia.
- Patient with small testicular volume.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group A
Patients will be managed using video telescopic operating microscope (VITOM). |
Patients will be managed using video telescopic operating microscope (VITOM). |
|
实验性的：Group B
Patients will be managed using Loupe with magnification 4x. |
Patients will be managed using Loupe with magnification 4x. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Motile Sperm Count
大体时间：3 months after surgery
|
Total motile sperm count (TMSC), expressed as millions of motile sperm per ejaculate, will be assessed by semen analysis. TMSC will be calculated by multiplying semen volume (mL) by sperm concentration (million/mL) and the proportion of motile sperm. |
3 months after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Scrotal Pain Intensity
大体时间：3 months after surgery
|
Scrotal pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. |
3 months after surgery
|
|
Scrotal Swelling
大体时间：3 months after surgery
|
Number of participants with scrotal swelling will be assessed by clinical examination. |
3 months after surgery
|
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Surgeon Satisfaction With the Visualization Device
大体时间：Immediately after surgery (with in one hour)
|
Surgeon-reported assessment using the protocol's 13-item questionnaire covering image quality, equipment handling, ergonomics, and educational usefulness. Each item is rated on a five-point scale. |
Immediately after surgery (with in one hour)
|
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Erectile Function
大体时间：3 months after surgery
|
Erectile function will be assessed using the five-item International Index of Erectile Function (IIEF-5). As presented in the protocol, total scores range from 5 to 25, with higher scores indicating better erectile function. |
3 months after surgery
|
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Serum Total Testosterone
大体时间：3 months after surgery
|
Serum total testosterone concentration will be measured by laboratory testing and compared between treatment groups. |
3 months after surgery
|
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Varicocele Recurrence
大体时间：3 months after surgery
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Number of participants with recurrent varicocele will be assessed clinically at follow-up, with scrotal duplex ultrasonography performed at 3 months. |
3 months after surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- MD-372-2025 (11-3-2026)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD 共享时间框架
After the end of study for one year.
IPD 共享访问标准
The data will be available upon a reasonable request from the corresponding author.
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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