Prospective Randomized Comparison of Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery for Pediatric Renal Stones (10-30 mm)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of complications
研究概览
简要总结
This work aimed to compare the safety and efficacy of retrograde intrarenal surgery using single-use flexible ureteroscopy (FURS) with mini-percutaneous nephrolithotomy (PCNL) in children with renal stones measuring 10-30 mm.
详细描述
Children have a smaller pelvicalyceal system, more delicate tissues, and a more curved ureter compared to adults.
While percutaneous nephrolithotomy (PCNL) offers excellent stone-free rates for large stones (>2 cm), its application in children presents challenges due to their smaller renal anatomy and increased kidney mobility.
Retrograde intrarenal surgery with flexible ureteroscopy (FURS) major advantage lies in utilizing natural orifices, eliminating the need for additional access routes with theoretically enhanced faster postoperative recovery.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children <18 years old.
- •Both sexes.
- •Single calyceal renal stone of 10-20 mm in maximum diameter, single renal pelvic stone of 10-20 in maximum diameter with history of failed, extracorporeal shock wave lithotripsy (ESWL) or refused ESWL, single renal stone 20-30 mm in maximum diameter and multiple renal stones with total stone size 10-30 mm (sum of maximum dimensions of each stone).
排除标准
- •Patients with uncorrected coagulopathy.
- •Renal or ureteral malformation.
- •Cases with significant anatomical obstruction requiring separate intervention or associated metabolic disorder.
研究组 & 干预措施
Mini PCNL
Patients underwent mini percutaneous nephrolithotomy (PCNL) technique.
干预措施: Mini percutaneous nephrolithotomy (Procedure)
FURS
Patients underwent single use flexible ureteroscopy (FURS).
干预措施: Flexible ureteroscopy (Procedure)
结局指标
主要结局
Incidence of complications
时间窗: 24 hours postoperatively
Incidence of complications will be recorded according to the Clavien-Dindo grading system. The Grades of the Clavien-Dindo Classification: * Grade I: Any deviation from the normal postoperative course. It does not need pharmacological treatment or surgical, endoscopic, and radiological interventions. * Grade II: Requires pharmacological treatment with drugs other than those allowed for Grade I. Blood transfusions and total parenteral nutrition. * Grade III: Requires surgical, endoscopic, or radiological intervention. Grade IIIa: Intervention done without general anesthesia. Grade IIIb: Intervention done under general anesthesia. * Grade IV: Life-threatening complication requiring intermediate or intensive care unit management. Grade IVa: Single-organ dysfunction. Grade IVb: Multi-organ failure. * Grade V: Death of the patient.
次要结局
- Operative time(Up to 3 hours)
- Fluoroscopy time(Intraoperatively)
- Postoperative stenting(Immediately after the procedure (Up to 2 hours))
- Lenght of hospital stay(Till the discharge from hospital (Up to 2 weeks))
研究者
Mohamed Ibrahim Ahmed Elmaadawy
Lecturer of Urology, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University