A Prospective Randomized Study Comparing Single-use Digital Flexible Ureteroscope, Nondisposable Fiber Optic and Digital Ureteroscope in Treatment of Upper Urinary Stone Less Than 2 cm
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 主要终点
- cost of surgery
研究概览
简要总结
The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.
详细描述
With the advancement of technology, flexible ureteroscopy (f-URS) has become an attractive option for surgical management of kidney stones. However, the durability of flexible ureteroscope still remains a major concern. Due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining fURS programs worldwide, especially in the developing countries. Nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years
- •American society of Anesthesiology (ASA) score 1 and 2
- •Renal or upper ureteral stone of diameter ≤ 2.0 cm
排除标准
- •Ureteral stricture, renal or ureteral deformity
- •Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L)
结局指标
主要结局
cost of surgery
时间窗: intraoperative
the total cost of the procedure
次要结局
- stone free rate(3months after surgery)
- Stone free rate(1month after surgery)
- operator's satisfaction with the scope(intraoperative)
- complication rates(upto 3months)
- operative time(intraoperative)
研究者
Guohua Zeng
Doctor and Proffesor
The First Affiliated Hospital of Guangzhou Medical University