Is Preoperative Sildosine Adminstration Faciltate Ureteral Diltation During Flexible Ureterorenoscopy?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Entrance to bladder time (ETBT)
研究概览
简要总结
We proposed that silodosin administration preoperatively may facilitate ureteral access sheath (UAS) placement prior to flexible ureteroscopy (F-URS) and decrease the incidence of ureteric injury in some difficult cases.
详细描述
Urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. The goal of treatment is to achieve the highest stone-free rate (SFR) with the least invasive. Per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (F-URS) are the two main minimally invasive procedures for the treatment of upper urinary tract stones.
The challenging step in flexible ureterorenoscopy (F-URS) is ureteroscopic access sheath (UAS) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. However, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (UAS) placement.
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
- •Upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm).
- •Non stented.
- •Age (Above 18 years old).
排除标准
- •Acute or chronic renal insufficiency.
- •Uncorrected coagulopathy.
- •Previous open (lumber or ureteric) surgery.
- •Active urinary tract infection unless treated.
研究组 & 干预措施
Sildosin group
included 70 patients for whom flexible ureteroscopy (F-URS) was done with the daily preoperative intake of 8 mg silodosin for one week.
干预措施: Sildosin group (Drug)
Placebo/control group
included 70 patients for whom flexible ureteroscopy (F-URS) was done with daily preoperative intake of placebo tablets.
干预措施: Placebo/control group (Procedure)
结局指标
主要结局
Entrance to bladder time (ETBT)
时间窗: Intraoperatively
Entrance to bladder time (ETBT) will be recorded
次要结局
- Entrance to ureteric orifice time (ETUOT)(Intraoperatively)
- Application of access sheath time (AAST)(Intraoperatively)
研究者
Tamer Abd El-Wahab Diab
Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt
Benha University