CTRI/2025/09/094269尚未招募2/3 期
A Study to Compare the Outcome between Laparoscopic and Open Varicocelectomy
Dr Mohammad Aadil1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in Semen Parameters
研究概览
简要总结
To compare between laparoscopic varicocelectomy and open varicocelectomy in terms of
- Duration of surgery
- Post operative pain
- Post operative complications
- Duration of hospital stay
- Time to resume normal activity
- Patient satisfaction
- Residual disease/Recurrence
- Pre and Post operative semen parameters
Patients are divided in two groups in OPD by Simple randomisation method
Group A - Laparoscopic Varicocelectomy
Group B - Open Varicocelectomy
Patients are admitted one day prior to surgery, after surgery patient is assessed at 6th post op hour, at discharge, 7th day and after 3 months for the objectives of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 14.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patient giving informed consent.
- •Patients with uncomplicated symptomatic unilateral/bilateral varicele.
排除标准
- •Coagulation disorder.
- •H/O Recurrence H/O multiple abdominal surgery Patients who do not give consent Subclinical and Grade 1 varicocele Patients requiring additional concomitant procedures.
结局指标
主要结局
Improvement in Semen Parameters
时间窗: Before Surgery and 1 month after Surgery
次要结局
- Post operative pain(6th hour)
- Time to resume normal activity(Time after which patient can walk by himself)
- Post operative complications(6th hour)
- Duration of surgery(Time from incision to closure of skin)
- Hospital stay duration(Time duration from Surgery to discharge)
- Recurrence(After 7 days)
研究者
Dr Shahbaz Habib Faridi
Jawaharlal Nehru Medical College, AMU
研究点 (1)
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