Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 20
- 主要终点
- Stone Clearance Time in mm2/Min
研究概览
简要总结
The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.
详细描述
Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages.
In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges.
We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater
- •Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively
- •Age 18 years or older
- •Able to give informed consent
排除标准
- •Size of single largest stone less than 2 cm
- •Pregnancy
- •Active urinary tract infection
- •Extracorporeal shockwave lithotripsy within the last three months
- •Complex stone anticipating multiple access sites
- •Stones that are not clearly able to be measured on KUB or CT scan
- •Inability to give informed consent
- •Age less than 18 years
研究组 & 干预措施
Stonebreaker
Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.
干预措施: Stonebreaker (Device)
Lithoclast Select
Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented.
干预措施: Lithoclast Select (Device)
Cyberwand
The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented.
干预措施: Cyberwand (Device)
结局指标
主要结局
Stone Clearance Time in mm2/Min
时间窗: collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket
Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min)
次要结局
- Stone-free After First Procedure(Post-operative Day 1)
- Secondary Procedure Required(Within three days of initial procedure)
- Ureteral Stent Placed(Intra-operatively)
- Length of Stay(Post-operatively)
- Post-operative Complications(Post-operative Days 2 and 3)
- EBL>400mL(Intra-operatively)
- Nephrostomy Tube Placed(Intra-operatively)
- Use of Other Device(Intra-operatively)
- RBC Transfusion(Post-operatively <24 hours)
研究者
James Lingeman
James Lingeman, MD
Indiana Kidney Stone Institute