Effect of Perioperative Silodosin on Ureteric Dilatation in Retrograde Intrarenal Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ureteric access sheath placement
研究概览
简要总结
Selective alpha-blockers have been used for the treatment of ureteric stones as medical expulsive therapy (MET). Recently they have been successfully used in passive ureteric dilatation before semirigid ureteroscopy. This study enables us to know the role of silodosin in ureteric dilatation to facilitate ureteral access sheath placement in Retrograde Intrarenal Surgery with flexible ureteroscopy.
详细描述
The ureteral access sheaths (UAS) used during Retrograde Intrarenal Surgery (RIRS) were produced for easy access to the upper urinary tract. The main advantages of UAS are providing repetitive access to the ureteral and collecting duct system, decreasing intrarenal pressure, preventing bleeding-related distortion of vision by the acceleration of liquid flow, and eventually contributing toward the protection of the flexible device.
Nevertheless, there might be certain challenges during UAS placement. There are also risks, such as ureteral injury and the occurrence of ureteral stricture in the long term. However, considering the benefit/risk balance, RIRS is routinely performed in many clinics because of the ease provided by UAS.
Some problems might occur during the placement of UAS whose diameters vary between 9.5 and 14 Fr. In cases where UAS cannot be placed, manipulations can be used, such as ureteral balloon dilatation, providing access through a rigid ureteroscope with a guide wire, or dilatation with the inner sheath of the UAS, which may vary depending on the amount of personal experience. Despite such manipulations, if UAS placement is still unsuccessful, it is always more logical to place a double-J stent, enables passive dilatation, and postpone RIRS until the second operation.
This study will examine whether intramural ureteral resistance can be reduced or not and whether UAS placement can be facilitated using silodosin or not.
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
- •Both sex.
- •Age >18 yrs old.
- •Upper ureteric stones or renal stones < 2 cm.
- •Patients with normal renal anatomy.
- •No history of infectious or inflammatory renal condition.
排除标准
- •• < 18 years old.
- •Multiple or bilateral stones.
- •Pregnant women.
- •Ureteric strictures.
- •Urinary tract infection.
- •Coagulopathy and uncorrected bleeding disorders.
- •Refusal of the surgery and requiring stent.
研究组 & 干预措施
Silodosin group (the intervention group)
Patients will receive silodosin 8 mg one tablet per day for 7 days before their scheduled retrograde intrarenal surgery.
干预措施: Silodosin 8 mg (Drug)
Placebo group (the control group)
Patients will receive Placebo for 7 days before their scheduled retrograde intrarenal surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
ureteric access sheath placement
时间窗: intraoperative immediate diagnosis, at the beginning of surgery.
to assess the success of ureteric access sheath placement as follows: 1. Direct assessment: A. Success of ureteric access sheath insertion without ureteric dilatation. B. Success of ureteric access sheath insertion with ureteric dilatation. C. Failed ureteric access sheath insertion.
次要结局
- operative time(intraoperative diagnosis during the surgery from beginning of the surgery till the end of the procedure)
- Perioperative complication(till 7 days postoperative)
- Cost analysis(1 day post operative)
研究者
Ahmed Maher Gamil Ahmed Higazy
principle investigator
Ain Shams University