Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Stone free rate
研究概览
简要总结
Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with 5 to 20 mm renal stone
- •Age ≥ 18 years old
- •Patient agreement signed
- •BMI < 35
- •Contraception
排除标准
- •Pregnancy
- •Severe musculoskeletal deformities
- •Renal artery or aorta aneurysm
- •Pacemaker
- •Anesthesia contra indication
- •Psychiatric trouble or law protection
研究组 & 干预措施
Extracorporeal shockwave lithotripsy
stone treatment using electroconductive technology
干预措施: extracorporeal shockwave lithotripsy (Procedure)
Flexible ureteroscopy
intra renal retrograde surgery with or without laser and stone extraction
干预措施: flexible ureteroscopy (Procedure)
结局指标
主要结局
Stone free rate
时间窗: Three months
Rate of stone free patient or patient with residual fragment ≤ 3 mm, 3 months after the treatment evaluated, will be compare. This outcome is measured with a tomodensitometry and compares with pre treatment exams.
次要结局
- Stone free rate in weight's sub group(3 months)
- Stone free rate in sub group depending on stone diameters(3 months)
- Serious and non serious adverse events(3 months)
- Secondary procedure rate(3 months)