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临床试验/NCT04317443
NCT04317443Unknown不适用

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

The International Alliance of Urolithiasis0 个研究点目标入组 250 人开始时间: 2020年5月1日最近更新:
适应症

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

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)

研究者

发起方
The International Alliance of Urolithiasis
申办方类型
Network
责任方
Sponsor

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