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临床试验/NCT03939325
NCT03939325Unknown不适用

Impact of Different Shock Wave Release Frequencies on Disintegration of Renal Stones in Assuit Urology & Nephrology University Hospital

Assiut University0 个研究点目标入组 90 人开始时间: 2019年5月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
主要终点
stone free rate

研究概览

简要总结

The impact of different frequencies on pattern of disintegration of renal stones

详细描述

  • Prior to the introduction of extracorporeal shockwave lithotripsy (ESWL) in 1980, the only treatment available for calculi that could not pass through the urinary tract was open surgery. Since then, ESWL has become the preferred tool in the urologist's armamentarium for the treatment of renal stones, , ESWL is minimally invasive, exposes patients to less anaesthesia, and yields equivalent stone-free rates in appropriately selected patients.
  • The efficacy of ESWL lies in its ability to pulverize calculi in vivo into smaller fragments, which the body can then expulse spontaneously. Shockwaves are generated and then focused onto a point within the body. The shockwaves propagate through the body with negligible dissipation of energy (and therefore damage) owing to the minimal difference in density of the soft tissues. At the stone-fluid interface, the relatively large difference in density, coupled with the concentration of multiple shockwaves in a small area, produces a large dissipation of energy. Via various mechanisms, this energy is then able to overcome the tensile strength of the calculi, leading to fragmentation. Repetition of this process eventually leads to pulverization of the calculi into small fragments that the body can pass spontaneously and painlessly.
  • It is well recognized that the popularity of extracorporeal shock wave lithotripsy (SWL), despite its non-invasive character, has decreased during recent years. This is partly explained by the technological achievements in endoscopy and urologists' enthusiasm for such procedures. Another explanation is that many urologists have been insufficiently successful with SWL. The latter effect might to some extent be a result of the performance of the lithotripter used, but in too many cases, it is evident that the principles of how shock wave lithotripsy should be carried out are poorly appliedical aspect

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pelvic and upper ureteric stones
  • Stone size less than 2 cm
  • Stone density up to 1000 HU

排除标准

  • Lower calycle stone
  • Stone size 2 cm or more
  • Stone denstiy more than 1000
  • age group less than 18 y
  • uncontrolled hypertension patient and bleeding disorder
  • Pregnancy
  • Patients with UPJ obstruction, ureteral strictures,
  • Congenital anomalies
  • Previous stented ureter
  • Narrow neck of the calycx less than 30 %

结局指标

主要结局

stone free rate

时间窗: 2 weeks

complete disintegration of renal stones or having clinically insignificant gravel smaller than 2 mm

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

Mohamed Ahmed Mohamed El Taher

M.B.B.CH

Assiut University

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