Results of a Prospective Randomized Trial of Safety Guidewire Use in Ureteroscopic Stone Surgery: to Use or Not to Use
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Stone free rates
研究概览
简要总结
Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in ureteroscopy and recommended its routine use. However, the necessity of SGW placement in endourological procedures lack evidence and is being suggested as an expert opinion. Present study aimed to evaluate the use of SGW placement and its necessity in treatment of ureteral stones with semi-rigid ureteroscopy (s-URS).
For this purpose patients with ureteral stones are being stratified according to ureteral stone location and prospectively randomized into two groups' according to SGW usage or not in s-URS. Ureteroscopy and litotripsy is being done with a semi-rigid ureteroscope of 6.4/7.8 Fr (Olympus) and laser. Chi-square and student t-test were used for comparing data.
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
- •Ureteral stone disease patients who would undergo ureteroscopy procedure
排除标准
- •Patients who have a medical condition that makes randomisation not possible
- •Patients in whose operations safety guidewire is regarded as a necessity
- •Patients who refuse to participate
结局指标
主要结局
Stone free rates
时间窗: Post operative 3 months (12 weeks after surgery)
次要结局
- Early Complication rate(Post operative 3 days (up to 3 days after surgery))
- Operation duration of surgery(the duration of surgical procedure)
- Late Complication rate(Post operative 3 months (12 weeks after surgery))