NCT01514032Unknown不适用
TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- stonefree-rates 3month after therapy
研究概览
简要总结
The purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.
- Trial with surgical intervention
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
- •kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)
- •male and female patients between 18 and 99 years
- •informed consent signed by patient after explanation of the both treatment-modalities
排除标准
- •age < 18 or > 99
- •pregnancy
- •breastfeeding mother
- •disorders of blood clotting
- •kidneystones > 15mm
- •aneurysms of the aorta or renal artery
- •severe skeletal deformations which hamper one of the treatment modalities
- •synchronous stones of the ipsilateral ureter
- •stones which can not visualized which X-ray or sonography
研究组 & 干预措施
Extracorporal shockwave lithotripsy
Active Comparator
干预措施: Extracorporal shockwave lithotripsy (Procedure)
Retrograde intrarenal surgery
Active Comparator
干预措施: Retrograde intrarenal surgery (Procedure)
结局指标
主要结局
stonefree-rates 3month after therapy
时间窗: 3 month
次要结局
未报告次要终点
研究者
研究点 (1)
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