Efficacy of Pre-operative Silodosin on Facilitating Insertion of Ureteral Access SheathPrior to Retrograde Intra Renal Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Assess success of ureteric access sheath placement.
研究概览
简要总结
This study aims to provide robust evidence on whether a specific, potent pre-operative medication (silodosin) can make the critical step of ureteral access (UAS placement after dilation) easier and safer during f-URS for kidney stones in non-stented patients, potentially reducing complications and the need for pre-stenting.
详细描述
This study specifically evaluates the effect of administering pre-operative silodosin (8mg daily for one week) on facilitating ureteral dilation prior to ureteral access sheath (UAS) placement during flexible ureteroscopy (f-URS), aiming to leverage the drug's potent ureteral smooth muscle relaxation to ease mechanical dilation with Teflon dilators (6-14Fr) and subsequent UAS insertion. Its primary endpoint directly measures the ease of UAS placement (categorized as smooth, resistant, or failed) after sequential dilation. To objectively assess safety, post-operative diagnostic ureteroscopy by a second surgeon grades ureteral wall injuries using a specific 5-grade scale. Employing a rigorous randomized, placebo-controlled trial (RCT) design with strict criteria (non-stented patients, stone burden 1-2 cm, no prior interventions), the study also evaluates secondary outcomes including ureteral injury severity, stone-free rates (SFR), post-operative pain (VAS), complications, hospital stay length, and medication side effects.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult male or female
- •single renal or ureteric stone
- •1 to 2 cm in size.
排除标准
- •pregnant women
- •Untreated urinary tract infections
- •Uncorrected bleeding disorders or coagulopathies
- •Bilateral ureteric stones or multiple ipsilateral ureteric stones
- •ureteral stricture,
- •Patients who had previous ureteric stenting
研究组 & 干预措施
Receiving Placebo prior to intervention
干预措施: ureteric access sheath insertion in RIRS without silodosin (Placebo) (Procedure)
Receiving Sioldosin 8 mg prior to intervention
干预措施: Preoperative sioldosin to facilitate ureteric access sheath insertion in RIRS (Procedure)
结局指标
主要结局
Assess success of ureteric access sheath placement.
时间窗: during the operation in the OR
assess success of ureteric access sheath placement as follows: 1. spontaneous passage of UAS without dilatation or 2. passage of UAS after dilatation or 3. failure of the UAS insertion.
次要结局
- Operative time(from time of induction of anaesthesia in surgery till the end of procedure.)
- Cost of the procedure(from admission and through study completion)
- complications(Perioperative and up to 24 weeks)
研究者
Younan Ramsis
Lecturer of urology
Ain Shams University