External Physical Vibration Lithecbole(EPVL) Contrast With the Traditional Row of Stone Effect After Retrograde Intrarenal Surgery(RIRS): A Multi-center Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change from stone free rate(SFR) with different follow-up periods
研究概览
简要总结
The treatment of renal calculus by retrograde intrarenal surgery(RIRS) isn't able to eliminate stone completely, hastening fragments clearance just only rely on traditional expulsive methods such as high fluid intake ,increasing physical activity, medical expulsive therapy and changing body position. Therefore, researchers purpose to evaluate the effectiveness of external physical vibration lithecbole(EPVL) in treatment of residual fragments after RIRS by prospective study of clinical trial, which will improve stone-free rate of residual fragments and benefit more patients.
详细描述
To evaluate the efficacy and safety of external physical vibration lithecbole for the treatment of residual stone after the operation of RIRS，thereby improving stone clearance rate. Investigators will do a multi-centers randomized controlled trial(RCT)，and investigators plan to perform this study in 10 hospitals，which are the First Affiliated Hospital of Guangzhou Medical University of China, Department of Urology, The Second Affiliated Hospital of Zhengzhou University of China, Jiangsu Province Hospital, Hubei Province Hospital, Zhongshan Hospital, Tongji Hospital,Hubei provincial people's Hospital,Guilin 181 Hospital，the People' Hospital of Huzhou，The People' Hospital of Shaoyang.
Investigators plan to beginning their study August 2015 and end July 2016. One hundred and eighty patients with postoperative residual stone after RIRS will be enrolled in this study. By simple random sampling technique, all the patients will be assigned to the segment of natural stone row group or physical row of stone group, compared two groups of patients with stone clearance rate and complications, Investigators hope that through this test, improve stone clearance rate after RIRS.
The principle of extracorporeal physical vibration:
A Simple harmonic motion technology in multi-direction was applied. The Lateral acceleration was provided by the physical vibration device in the base through the harmonic vibration wave in the horizontal direction, which induces the urinary stone separate with the kidney or ureter, and expands a moving space for the stone. Meanwhile, an axial effect was produced to push the stone by the physical vibration device in the handle through the harmonic vibration wave in the multi- direction. Finally, with the help of changing the position and direction of the extracorporeally physical vibration machine, the urinary stone was discharged from the urinary collecting system.
Number:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-65 years;
- •The imaging demonstrate the presence of residual fragments in 1 week after RIRS;
- •Renal or upper ureteral calculus;
- •There's no urinary tract obstruction below stones, and stones didn't cause complete urinary tract obstruction;
- •Stones are fragmented successfully on single session of RIRS, and the diameter of any of fragments is less than 4mm;
- •Normal renal function.
排除标准
- •Couldn't tolerate EPVL;
- •Urinary tract anomalies, stricture or obstruction;
- •Calculus in diverticulum;
- •Severe hydronephrosis;
- •Combined with acute urinary tract infection;
- •Coagulation abnormalities;
结局指标
主要结局
Change from stone free rate(SFR) with different follow-up periods
时间窗: return hospital respectively in 2,3 and 5 week after RIRS
Primary SFR is assessed by abdominal plain film （KUB）at2,3,5 week after operation. Stone-free status are defined as either the absence of any residual stone fragments.
次要结局
- extracorporeal physical vibration complications(return hospital respectively in 2 ,3 and 5 weeks after RIRS)
研究者
Guohua Zeng
Vice President of the Hospital
The First Affiliated Hospital of Guangzhou Medical University