A Prospective Observational Comparison of Super-mini Percutaneous Nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the Treatment of Renal Stones ≥20 mm in Children: An IAU Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- Stone free rate
研究概览
简要总结
ESWL and PNL are the two treatment modalities for kidney stones greater than 20 mm in the pediatric population. ESWL is non-invasive, does not require anesthesia and inexpensive, but its success rate may be lower, and require multiple treatment sessions. On the contrary, PNL has a higher success rate, does not require multiple sessions but is an invasive method. Compared to standard PNL, miniaturized PNL systems have been shown to decrease complications with comparable success rates. SMP is a unique miniaturized PNL system with integrated active irrigation and suction systems. The current literature lacks studies comparing SMP and ESWL prospectively in the pediatric population. In this study, the effectiveness, reliability, and reusability of ESWL and SMP will be compared.
详细描述
To compare the success and complication rates of super-mini-percutaneous nephrolithotomy (SMP) and Extracorporeal Shock Wave Lithotripsy (ESWL) for the treatment of renal stones ≥20 mm in children.An international multicentre, prospective, observational study. Pediatric cases with renal Stones ≥20 mm who undergo ESWL or SMP will be evaluated and compared proespectively. The total number of departments planned to be included in the study is 10 and the number of cases is 180.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ≤14 years old with renal Stones ≥20 mm
- •Willing and able to sign informed consent
- •Normal renal function
- •No stone-related surgical history
- •American Society of Anesthesiology (ASA) score 1-2
排除标准
- •Congenital renal anomalies (horseshoe kidney, ureteropelvic junction obstruction)
- •Uncorrected UTI
- •Abnormal coagulation function
- •Morbid obese children (BMI≥35)
结局指标
主要结局
Stone free rate
时间窗: 3-months
Stone clearance on the computed tomography (2mm thickness)
次要结局
- auxiliary procedures(Postoperative month 3)
- blood loss(Postoperative day 1)
- complications(Postoperative month 3)
- hospital stay(Postoperative month 3)
