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临床试验/NCT02037906
NCT02037906已完成不适用

Comparison of Escalating, Constant and Reduction Energy Output in SWL for Renal Stones: Multi-arm Prospective Randomized Study.

Princess Al-Johara Al-Ibrahim Cancer Research Center1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Stone clearance after escalating shockwave lithotripsy

研究概览

简要总结

Research Problem: Shock wave lithotripsy (SWL) dramatically changed the management of renal and ureteral calculus disease. In vitro studies suggest that progressive increase in lithotripter energy output voltage could produce the best overall stone comminution in comparison with constant or deescalating energy output. However, it is possible that the beneficial impact of slow rate SWL on comminution of stones and stone free rates has masked any marginal benefits for energy output escalation. The Escalating SW method adds the benefit of less renal tissue injury.

Research Significance:The present study will signifies and evaluates the stone free rates of three groups of patients with renal stones treated with different SWL energy outputs (Escalating, Constant and Reduction energy output).

Research Objectives: The aim of this research project is to study the effect of dose adjustment strategies on success rate of Shock Wave Lithotripsy in the clinical setting and to optimize the conditions for successful Shock Wave Lithotripsy.

Research Methodology: This clinical trial will be conducted at a tertiary care university hospital. 150 patients referred to the Shock wave lithotripsy unit will be evaluated for eligibility to be randomized into three groups (Dose Escalation, Dose reduction and constant dose). Parameter of the three groups will be compared to detect the treatment difference.

详细描述

Escalating SW amplitude treatment protocols have been shown to be safe on long-term with less harm to kidney tissue. This clinical trial will be conducted at a tertiary care university hospital. All patients referred to the SWL unit will be evaluated for eligibility to be randomized. Randomization process "complete" or "unrestricted" randomization was used to allocate patients to the three arms of the clinical trial where one patient was randomly assigned to one of the three arms blindly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Single stone
  • Radio opaque
  • Less than 2cm in size
  • Renal stone

排除标准

  • bleeding disorder,
  • urinary tract infection (UTI)
  • distal ureteric obstruction

结局指标

主要结局

Stone clearance after escalating shockwave lithotripsy

时间窗: 14 days after escalating shockwave lithotripsy

All patients undergo for imaging investigation of the kidneys, ureters, or bladder (KUB) plain x-ray film at day 14 to assess stone free rate. Stone free was defined as no stones or painless fragments less than 4mm. In additions all patients received pre and post shockwave lithotripsy renal ultrasound on day 1 prior and day 1 shockwave lithotripsy to evaluate for shockwave lithotripsy related hematoma formation.

次要结局

  • Stone clearance after constant shockwave lithotripsy(14 days after constant shockwave lithotripsy)

研究者

发起方
Princess Al-Johara Al-Ibrahim Cancer Research Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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