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临床试验/NCT03726502
NCT03726502已完成不适用

Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
stone free rate

研究概览

简要总结

The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

详细描述

While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ureteral stone who underwent ureteroscopy

排除标准

  • transplant kidney
  • coagulopathy disorders
  • history of ureteral stenosis
  • skeletal disorders

研究组 & 干预措施

ureteroscopy with safety guide-wire

Active Comparator

ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy

干预措施: ureteroscopy with safety guide-wire (Procedure)

ureteroscopy with safety guide-wire

Active Comparator

ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy

干预措施: with safety guide-wire (Procedure)

ureteroscopy alone

Placebo Comparator

ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy

干预措施: ureteroscopy alone (Procedure)

with safety guide-wire

Active Comparator

ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy

干预措施: with safety guide-wire (Procedure)

ureteroscopy alone

Placebo Comparator

ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy

干预措施: without safety guide-wire (Procedure)

with safety guide-wire

Active Comparator

ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy

干预措施: ureteroscopy with safety guide-wire (Procedure)

without safety guide-wire

Placebo Comparator

ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy

干预措施: ureteroscopy alone (Procedure)

without safety guide-wire

Placebo Comparator

ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy

干预措施: without safety guide-wire (Procedure)

结局指标

主要结局

stone free rate

时间窗: 3 months after surgery

rate of patients without any residue of stone

次要结局

  • grade of kidney hydronephrosis(3 months after surgery)
  • ureteral injury(at time of surgery)
  • operation time(at time of surgery)

研究者

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

Hamidreza Shemshaki

Director

Isfahan University of Medical Sciences

研究点 (1)

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