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临床试验/NCT02139059
NCT02139059Unknown不适用

Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
stone free status

研究概览

简要总结

To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children.

详细描述

To compare staged ureteroscopy following initial urinary drainage and stabilization of renal functions using percutaneous nephrostomy or double J stent versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure due to ureteric calculi in children.

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
否

入选标准

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

排除标准

  • •Fever, pyonephrosis or sepsis.
  • •unstable patients are stabilized first by dialysis.

研究组 & 干预措施

initial urinary drainage

Active Comparator

initial urinary drainage to stabilize renal functions before ureteroscopy

干预措施: initial urinary drainage (Procedure)

direct ureteroscopy

Active Comparator

direct ureteroscopy without initial urinary drainage

干预措施: direct ureteroscopy (Procedure)

结局指标

主要结局

stone free status

时间窗: 1 week

success in removal of ureteric stones using ureteroscopy

Return to normal creatinine

时间窗: 1 week

period for return to normal creatinine in both groups

operative and early post operative complications

时间窗: 1 week

Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever

次要结局

  • ureteric stricture(6 months)
  • period to reach stone free status bilaterally(6 months)
  • number of times of exposure to general anesthesia(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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