Standard Versus Flexible and Navigable Suction Ureteral Access Sheath in Pediatric Flexible Ureterorenoscopy for Renal Stones < 2 cm : A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stone-free rate (SFR)
研究概览
简要总结
This randomized controlled trial aims to compare the efficacy and safety of a Flexible and Navigable Suction Ureteral Access Sheath (FANS) versus a standard ureteral access sheath during flexible ureterorenoscopy (FURS) in pediatric patients with renal stones less than 2 cm. The study will evaluate stone-free rates. operative time. intraoperative parameters. operative and postoperative complication and the need for any auxiliary procedures. Sixty pediatric patients will be randomly allocated into two equal groups and treated at the Urology Department, Tanta University.
详细描述
Pediatric urolithiasis is an increasingly recognized condition associated with substantial morbidity and recurrence risk. Flexible ureterorenoscopy has become an established minimally invasive treatment option for renal stones smaller than 2 cm. The use of ureteral access sheaths facilitates repeated upper urinary tract access and may improve operative efficiency; however, concerns regarding ureteral trauma remain.
Recently developed suction-assisted ureteral access sheaths have been introduced to improve visibility, facilitate fragment evacuation, and reduce intrarenal pressure. Although promising results have been reported in adults, evidence in pediatric patients remains limited.
This prospective randomized controlled trial will compare a standard ureteral access sheath with a Flexible and Navigable Suction Ureteral Access Sheath (FANS) in pediatric patients undergoing flexible ureterorenoscopy for renal stones less than 2 cm.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (age ≤ 18 years)
- •Patients with renal stones less than 2 cm
- •Indicated for flexible ureterorenoscopy
- •Fit for general anesthesia
- •Informed consent obtained from parents or guardians
排除标准
- •Stones larger than 2 cm
- •Active urinary tract infection
- •Congenital urinary tract anomalies affecting access
- •Previous ureteral surgery affecting the ureter
- •Coagulopathy or unfit for surgery
结局指标
主要结局
Stone-free rate (SFR)
时间窗: 1 month postoperatively
Absence of residual fragments or presence of clinically insignificant residual fragments measuring \< 3 mm, assessed by postoperative CT scan.
次要结局
- Operative time(Intraoperatively . from insertion of sheath)
- Intraoperative visibility and ease of access(intraoperatively)
- Intraoperative complications(intraoperatively)
- Postoperative complications(up to 30 days postoperatively)
- Need for auxiliary procedures.(up to 30 days postoperatively)
- Length of hospital stay.(From the day of surgery up to hospital discharge (estimated average of 3 days))
研究者
Khaled Mostafa Saed Elmaradny
Resident of Urology, Damanhour Teaching Hospital, Egypt
Tanta University