Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Stone Free Rate
研究概览
简要总结
The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser.
The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.
The outcomes of the URS procedures are compared for the two treatment arms.
详细描述
The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total.
Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting.
The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.
The outcomes of the URS procedures are compared for the two treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The patient is in narcosis when the designated treatment is decided by randomisation, and the treatment is about to start.
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
- •Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway
排除标准
- •Known pathology of the upper urinary tract
- •Untreated infection
结局指标
主要结局
Stone Free Rate
时间窗: 3 months after the URS
Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.
次要结局
- Operating Time(Decided immediately after the surgery)
- Intraoperative Complications(Decided immediately after the surgery)
- Postoperative Complications(Within 3 months post endoscopically)
- Postoperative JJ-stenting(Decided immediately after the surgery)