Prospective Randomized Comparison of SP TFL and Ho:YAG for RIRS Using 145 µm and 200 µm Fibers for the Management of Lower Pole Kidney Stones: Single-center Study
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Laser-on time
研究概览
简要总结
The authors hypothesize that the RIRS using 150-microm Tm-fiber laser is superior than fiber with larger diameters, as 200-microm Tm-fiber laser or 200-microm holmium fiber laser, in such points as follows:
- decreasing surgery time and laser-on time due to possibility of 4.3 fold ablation efficacy increase, which has been shown by Andreeva et al.;
- increasing the flexible ureteroscope tip deflection lower pole stones availability;
- decreased risk of complications and a better irrigation and visualization due to better irrigation with smaller fiber;
- increasing of lithotripsy efficacy and laser beam density by lowering of beam focal spot due to using of lesser fiber diameter
详细描述
RIRS will be performed with SP TFL or Ho:YAG (100 W). The procedure is performed under general anesthesia with the patient in the dorsal lithotomy position. The bladder is entered either with a cystoscope or a semi-rigid ureterorenoscope. Guidewires (0.035") will be used to facilitate access (under fluoroscopic guidance). After access sheath (12/14) will be placed up to the kidney pelvis. Through the access sheath ureteroscope will be introduced. For nephrolithotripsy 145 mcm and 200 mcm fibers will be used. Large fragments could be extracted with nitinol basket. After the surgery ureteral stent (7 Fr.) will be placed inside the ureter for 10 to 14 days.
A 10 Fr urethral catheter can be placed in the bladder for the drainage of the bladder during the operation.
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
- 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
- •Males and Females > 18 y.o.;
- •Radiologically confirmed (CT) kidney stone;
- •Stone size from 10 to 20 mm.
排除标准
- •Multiple (more than 3) kidney stones > 5 mm
结局指标
主要结局
Laser-on time
时间窗: during surgery
Time of laser emission during surgery, seconds
次要结局
- adverse events(during surgery and 6 months after surgery)
- Stone-free rate(3 month)
- Catheter stay(1 week)
- Operative time(during surgery)
- Hemoglobin drop(1 day after surgery)
- hospitalization length(1 week)
- Radiation exposure(during surgery)
研究者
Dmitry Enikeev, MD, PhD
Deputy director for research
I.M. Sechenov First Moscow State Medical University