NCT04871984Unknown不适用
Ureteroscopy for Upper Tract Lithiasis : Comparison of Costs and Effectiveness of Both Holmium and Thulium Lasers, in a Prospective Monocentric Study.
University Hospital, Angers0 个研究点目标入组 200 人开始时间: 2021年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Stone free rate
研究概览
简要总结
Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published.
The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers.
The costs and complications will also be studied.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography
- •treatment with rigid or flexible ureteroscopy
- •laser lithotripsy during the procedure
- •bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics)
排除标准
- •non-use of laser for stone lithotripsy
- •pregnant women
- •under 18 years old
- •refusal to give informed consent
- •urinary malformation
结局指标
主要结局
Stone free rate
时间窗: Three months after surgery
Urinary tract echography or renal computer tomography imaging. Patients with residual fragments under 4 mm are stone free.
次要结局
- Operating time(Immediately after the intervention)
- Postoperative complications(Up to three months after surgery)
- Perioperative complications(During the intervention)
研究者
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