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临床试验/NCT06761378
NCT06761378已完成不适用

Ideal Time of Stenting Prior to Ureteral Access Sheath for Stone Disease , Two vs Four Weeks Prospective Study

Menoufia University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1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
60
试验地点
1
主要终点
passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks

研究概览

简要总结

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished : fiberoptic and digital flexible URS. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

详细描述

The miniaturization of endourological instruments and improvements in laser lithotripsy have revolutionized the approach to renal stones . - Flexible URS has become popular with urologists, as it is easy to learn, is associated with high stone-free rates, and is acceptable to patients. Firstly described in 1964 by Marshall, the uretroscope was only passively deflectable and did not include working channel. - Although the first successful procedure in humans with a ureteroscope integrating active deflection has been reported by Takayasu, it was not until 1987 that Demetrius Bagley introduced flexible ureteroscopy as we know it today ).] - two types of flexible uretroscopy can be distinguished. The difference between them is the image relay and light transmission. - Now either to use ureteral access sheath (AS) or not , but usage of AS decrease intrarenal pressure and clear vision by drainage of dust , so , for access of AS stent better to be inserted prior to the procedure ) So, there are little publications regarding the optimal timing of the stent In this study we will assess the feasibility of passage AS after two versus four weeks from stent insertion

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

性别
All
接受健康志愿者
否

入选标准

  • •All patients with stone kidney up to 2 cm
  • •failed ESWL (extracorporeal shock wave lithotripsy)
  • •difficult PCNL (percutaneous nephrolithotomy)

排除标准

  • •Size more than 2 cm

研究组 & 干预措施

2 weeks Dj insertion

Active Comparator

Renal stent for 2 weeks prior flexible uretroscopy

干预措施: Renal stent (Procedure)

2 weeks Dj insertion

Active Comparator

Renal stent for 2 weeks prior flexible uretroscopy

干预措施: Flexible uretroscopy (Device)

4weeks Dj insertion

Active Comparator

Renal stent for 4 weeks prior flexible uretroscopy

干预措施: Renal stent (Procedure)

4weeks Dj insertion

Active Comparator

Renal stent for 4 weeks prior flexible uretroscopy

干预措施: Flexible uretroscopy (Device)

结局指标

主要结局

passage of access sheath after dilation of the ureter by DJ 2 vs 4 weeks

时间窗: 6 months

Patients will classified in two groups, one will insert DJ for two weeks and the other insert DJ for four weeks then remove it and trial to insert access sheath for flexible uretroscopy duriing passage of the sheath the ureteric dilitation will be assessed if the sheath pass or not measure so , the ability of the ureteric dilitation to obtain the sheath is it dilated enough after 2 or 4 weeks

次要结局

未报告次要终点

研究者

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

Hossam Kandeel

Assistant lecturer of urology

Menoufia University

研究点 (1)

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