Comparison Between Supine Mini Percutaneous Nephrolithotomy (PCNL) and Flexible Ureteroscopy (FURS) in Management of Lower Calyceal Stones 1-2 Centimeters With More Than 1000 Hounsfield Unit in School-Age Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Stone-Free Rate
研究概览
简要总结
This randomized controlled clinical study compared supine mini percutaneous nephrolithotomy versus flexible ureteroscopy for the management of dense lower calyceal renal stones measuring 1-2 centimeters (≤20 millimeters) with stone density greater than 1000 Hounsfield units in school-age pediatric patients aged 6-12 years. Participants were randomized to undergo either supine mini percutaneous nephrolithotomy with laser lithotripsy or flexible ureteroscopy with laser lithotripsy. The study assessed stone-free rate on non-contrast computed tomography of the urinary tract at 1 month postoperatively, along with operative time, fluoroscopy time, intraoperative and postoperative complications, and length of hospital stay. The trial has ended.
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
盲法说明
This was an open-label study; participants and treating clinicians were aware of the assigned procedure. Outcome assessment was based on postoperative imaging and clinical follow-up.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 12 years
- •Single lower calyceal renal stone measuring 1-2 centimeters (≤20 millimeters) with stone density greater than 1000 Hounsfield units
- •No previous urological surgery that could distort the pelvicalyceal system
排除标准
- •Additional ureteral stones and/or congenital renal anomalies (for example, horseshoe kidney or pelviureteric junction obstruction)
- •Multiple renal stones
- •Untreated urinary tract infection (temporarily excluded until treated)
结局指标
主要结局
Stone-Free Rate
时间窗: 1 month postoperatively
Proportion of participants who were stone-free on non-contrast computed tomography of the urinary tract at 1 month after the procedure. Clinically insignificant residual fragments were defined as asymptomatic residual stones smaller than 2 millimeters.
次要结局
- Operative Time(Intraoperative)
- Fluoroscopy Time(Intraoperative)
- Length of Hospital Stay(From end of procedure (day of surgery) until hospital discharge, assessed up to 30 days.)
- Intraoperative and Postoperative Complications(Up to 3 months postoperatively)
研究者
Shereef almegabar
Resident of Urology
Ain Shams University