NCT01922414已完成不适用
Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Stone Free rate
研究概览
简要总结
This study will be conducted to compare the results of Laser and ultrasonic lithotripsy in disintegration of staghorn stones during percutaneous nephrolithotomy.
详细描述
Patients with complete staghorn stones who are eligible to percutaneous nephrolithotomy (PNL) will be randomized between two groups.
Group 1: will undergo Laser lithotripsy during PNL Group 2: will undergo ultrasonic lithotripsy during PNL
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete staghorn stones (filling the renal pelvis and branching to 3 major calyces
- •Age: 18-70 years
排除标准
- •Congenital renal anomalies such as horse shoe kidney.
- •Contraindications to PNL such as bleeding tendency and uncontrolled hypertension.
- •Associated pathological features requiring open intervention such as UPJO
- •Partial staghorn stones (filling the renal pelvis and branching to 2 major calyces)
- •Giant staghorn stone (very large staghorn stone that branch and re-branch in hugely dilated calyceal system)
研究组 & 干预措施
Laser
Active Comparator
Patients will undergo Laser lithotripsy
干预措施: Laser (Device)
Ultrasonic
Active Comparator
Patients will undergo ultrasonic lithotripsy
干预措施: Ultrasonic (Device)
结局指标
主要结局
Stone Free rate
时间窗: Patients will be followed for 3 months after the procedure
Assessment of stone free rate after 3 months from treatment using NCCT
次要结局
- Operative time(An expected average of 3 hours)
- Assessment of the safety of each technique(From the start of the operation till 3 months after discharge from the hospital)
- Hospital stay(up to 7 days)
研究者
Ahmed R. EL-Nahas
Assistant Professor of Urology
Mansoura University
研究点 (1)
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