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临床试验/NCT02055430
NCT02055430已完成不适用

Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage in Children With Obstructive Anuria and Acute Renal Failure Due to Ureteral Calculi: a Prospective, Randomized Study

Cairo University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Period to Return to Normal Creatinine

研究概览

简要总结

To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children

详细描述

To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children with obstructive calcular anuria and acute renal failure due to ureteric calculi to identify selection criteria for initial urinary drainage method to improve drainage, to decrease complications and to facilitate subsequent definitive clearance of stones as this comparison is lacking in literature

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones

排除标准

  • Patients with grade 0-1 hydronephrosis
  • fever, pyonephrosis or sepsis.
  • any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy).

结局指标

主要结局

Period to Return to Normal Creatinine

时间窗: 1 week

period required for normalization of serum creatinine after initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with obstructive calcular anuria and Acute Renal Failure serum creatinine was compared to normal values in matched healthy children

Complications of Each Drainage Method

时间窗: 1 week

complications of initial urinary drainage using percutaneous nephrostomy or ureteric stent in children with Obstructive Anuria and Acute Renal Failure (mucosal complications, failure of insertion, slippage, fever and infection, hematuria, leakage) complications were calculated per 45 ureterorenal units in PCN group and 90 ureterorenal units in Double J group

次要结局

  • The Number of Subsequent Interventions Needed for Clearance of Stones .(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mohammed said elsheemy

Associte professor of urology

Cairo University

研究点 (2)

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