Retrograde Intrarenal Surgery (RIRS) With Suction Using Direct in Scope Suction (DISS) Versus Flexible and Navigable Access Sheath (FANS): Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stone free rate
研究概览
简要总结
Suction has been initially used in endoscopic stone management for more than 25 years during PCNL, but the emergence of new devices applying suction through patented ureteroscopes, ureteral access sheaths (UAS) and ureteral catheters led to application of suction in URS/RIRS. The application of ureteral access sheath (UAS) in RIRS can improve surgical vision , reduce intrarenal pressure (IRP) ,and decrease postoperative infectious complications .
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)
盲法说明
research randomizer
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
- •Single stone
- •Medium sized stone ≤ 3 cm
- •Renal stone
- •age group > 18
排除标准
- •multiple renal stones
- •stone size > 3 cm
- •age group < 18
- •solitary kidney
- •Obstruction distal to the stone.
- •urinary tract infection
研究组 & 干预措施
Retrograde intrarenal surgery using DISS
Retrograde intrarenal surgery using DISS
干预措施: Retrograde intrarenal surgery using DISS (Device)
Retrograde intrarenal surgery using FANS
Retrograde intrarenal surgery using FANS
干预措施: Retrograde intrarenal surgery using FANS (Device)
结局指标
主要结局
Stone free rate
时间窗: One month
No residual or non siginficant residual less than 4 mm
次要结局
- Operatove data(2 hours)
- Post operative complication(2 days)
研究者
Elsayed Abdelhalim Elsayed
assistant lecturer of urology
Kafrelsheikh University