CTRI/2021/05/033627尚未招募4 期
A Comparative study of Thulium laser fibre Vs Holmium laser for kidney stone in RIRS(Retrograde intrarenal surgery): A Randomised controlled single centre trial
muljibhai urology hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年5月17日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of Fragmentation rate
研究概览
简要总结
—Holmium:YAG laser has been the Gold standard in the treatment of upper and lower urinary tract stones.
—The SuperPulse Thulium fiber laser is an alternative laser source being studied world over as it is proposed to have lower retropulsion and higher efficiency.
— There are quite a few prior experimental studies comparing Holmium:YAG laser and Thulium fiber laser for lithotripsy. Multiple studies reported about a 1.5–4 times faster stone ablation rate in favour of the Thulium laser fiber [1,2,3].
This needs to be tested in the patients. Safety of both lasers has been proven in literature but there are no studies comparing the two lasers
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All stones less than 2 cm who will undergo RIRS will be randomised except two mentioned in the exclusion criteria.
排除标准
- •Age less than 18 years Stone larger than 2 cm Active infection Anomalous anatomy.
结局指标
主要结局
Comparison of Fragmentation rate
时间窗: day 0, 30 day follow up
次要结局
- 1. Operative time(2.Vision during lasing)
研究者
研究点 (1)
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