Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- stone free rate
研究概览
简要总结
Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value
详细描述
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
- •radio-opaque stone
- •high attenuation value (≥ 1000 HU) stone
排除标准
- •Abnormal renal anatomy
- •renal insufficiency
- •solitary kidney
- •coagulopathies
- •uncontrolled hypertension
- •renal artery or aortic aneurysm
- •active urinary tract infection
- •pregnancy
- •severe skeletal malformations (spinal deformity) precluding proper stone localization
- •skin to stone distance (SSD) > 11 cm
- •BMI > 30 Kgm/m2
研究组 & 干预措施
Ultraslow shock wave lithotripsy (SWL)
SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes.
The rest of the session at 22kv (full power).
干预措施: SWL (Procedure)
Slow power-ramping SWL
SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.
干预措施: SWL (Procedure)
结局指标
主要结局
stone free rate
时间窗: 3 months following last session of SWL
Complete clearance of stones in addition to clinically insignificant residual fragments
次要结局
- Complications(1 year following last session of SWL)
研究者
Mohammed Said ElSheemy
Associate Professor of Urology
Cairo University