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临床试验/NCT07328659
NCT07328659已完成不适用

Our Stone Fixation Technique to Improve the Efficacy of Peumatic Lithotripsy With Suction Sheath in Mini-pcnl.

Yasser Gamil Elnagar1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年1月15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
发起方
入组人数
45
试验地点
1
主要终点
Stone disintegration time

研究概览

简要总结

Prospective study to assist safty and efficieny of our technique of using peumatic lithotripsy with suction mini-pcnl.

详细描述

anew techniqe was designed to improve the results of pneumatic lithotripsy in suction mini-PCNL by:

  1. Customize our instrument to be suitable for a short 12 Fr nephroscope.
  2. using certain measures to avoid stone migration during pneumatic disintegration.

By fixing stones during disintegration and suction.

  • Our puncture strategy was planned to prevent stone migration.
  • Use a suction sheath to gently fix the stone between the tip of the sheath and the inner wall of the kidney and disintegrate it from inside the sheath.
  • The dormai basket was used to fix the stone in front of the sheath in difficult situations.

The investigators will assess disintegration time as the primary endpoint and stone-free rate and complications as secondary endpoints.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 85 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any patient with kidney stones less than 4 cm .

排除标准

  • children less than 3 yrs.
  • single kidney patient.
  • patient with ectopic kidney and spinal deformities.
  • unfit patient for surgry.

研究组 & 干预措施

Patient with kidney stones treated by our technique

Experimental

Prospective assesment of results.

干预措施: Peumatic lithotripsy in mini-pcnl (Procedure)

结局指标

主要结局

Stone disintegration time

时间窗: Day 1

Assesment of peumatic lithotripsy time during the operation.

次要结局

  • Stone free rate(-after the operation immediately and then after 1 month of the operation.)
  • Rate of complications(Intraoperative and immediately post operative till one week.)

研究者

发起方
Yasser Gamil Elnagar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasser Gamil Elnagar

Principal Investigator

Aswan University

研究点 (1)

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