跳至主要内容
临床试验/CTRI/2023/03/050827
CTRI/2023/03/050827尚未招募不适用

Prospective RandomisedControlled Trial to comparedusting versus fragmentationusing Thulium Fibre Laser inRIRS

Muljibhai Patel Urological hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Stone free rate

研究概览

简要总结

Thulium laser lithotripters allow the urologist to control laser settings

(energy and frequency) to adjust the power that is delivered at the tip of

the laser fibre.

Low energy, high frequency lithotripsy results in tiny fragment sizes that

can pass spontaneously, and this technique has been termed ‘dusting’.

On the other hand, higher energy levels with lower frequencies results

in fragments that require active retrieval with baskets and this

technique has been termed ‘fragmentation’.

The widespread use of thulium laser lithotripsy has created debates

about the best laser lithotripter settings.

A few studies have compared fragmentation and active retrieval with

dusting and spontaneous passage for renal stones, and the laser settings

were not mentioned in one of them.

The present study was conducted to compare two techniques of thulium

laser lithotripsy (dusting and spontaneous passage with fragmentation)

during fURS for renal stones.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Renal stone 1-1.5 cm in size.
  • Upper ureteral stone less than 1.5 cm in size.

排除标准

  • Active UTI.
  • Incomplete procedure due to technical error/malfunction.
  • Previous endoscopic intervention.
  • Ineligible patient for RIRS.
  • Patient not consenting.

结局指标

主要结局

Stone free rate

时间窗: at Post op day 1 and at 1 month

次要结局

  • Mean operating time.(Hospital stay duration.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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