High Versus Low Power Settings During Ureteroscopic Laser Lithotripsy - a Prospective, Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
The primary aim of the study is to compare the operative times following ureteroscopic lithotripsy for renal stones with Thulium Fiber Laser using low and high power settings.
Secondary aims are to compare the results of low and high power settings in terms of stone free rates, laser time, laser activation patterns, intraoperative and postoperative complications.
Patients ≥ 18 years with renal stones (8-25 mm) scheduled for ureteroscopic lithotripsy at the Day Surgery Clinic at Haukeland University Hospital in Bergen, Norway, are eligible for inclusion in the study. After written consent and inclusion, patients are randomised to laser lithotripsy using either low power settings (Group 1: 4-6 Watt, short pulse mode) or high power settings (Group 2: 16-18 Watt, short pulse mode). The ureteroscopic procedures are performed in general anaesthesia using a standardised technique. All patients are followed up with a low dose CT scan 3 months post endoscopically to assess stone free status as well as a consultation at the outpatient clinic.
Results and data for the two randomisation groups are compared according to the aims of the study.
详细描述
BACKGROUND: The Holmium:Yttrium-Aluminium-Garnet (Ho:YAG) has been considered the gold-standard laser for ureteroscopy (URS) because of its versatility, with the ability to break all kinds of stones in the urinary tract as well as tumor- and soft tissue ablation. Recently, a new Thulium fiber laser (TFL) has been introduced, with more favourable basic physical characteristics. Previous pre-clinical studies have predicted TFL lithotripsy to be up to four times faster than Ho:YAG lithotripsy using the same power settings. Earlier this year the present investigators published the first clinical randomised trial comparing the outcomes after ureteroscopic lithotripsy using TFL and Ho:YAG. The study demonstrated that the TFL gained superior stone free rate (SFR) compared to Ho:YAG, in addition to lower complication rate and shorter operative times. Due to the study, the investigators believe the TFL is emerging as the laser of choice. In the study very low laser settings were shown to be highly efficient using TFL during URS lithotripsy. However, no consensus exists on the preferred laser settings for the TFL during this procedure, and a variety of different settings have been suggested included high power settings as high as 45 Watts (W).
To date, there are no clinical randomised trials comparing different laser settings for TFL to determine what is optimal regarding the clinical outcomes.
AIMS OF THE STUDY: The primary aim of the study is to compare the operative times following URS lithotripsy for renal stones with TFL using low and high power settings. Secondary aims are to compare the results of low and high power settings in terms of SFR, laser time, laser activation patterns, intraoperative and postoperative complications.
STUDY DESIGN: The study is planned as a prospective randomized trial. All patients ≥ 18 years scheduled to URS lithotripsy for renal stones, 8-25 mm, at the day surgery unit at Haukeland University Hospital (HUH) are invited to be enrolled in the study. After written informed consent, patients are randomized to URS TFL lithotripsy with either low or high power laser settings.
LASER SETTINGS: The laser settings in the two study groups are standardized and need to be maintained throughout the procedure.
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 (Outcomes Assessor)
盲法说明
Stone free status is assessed on low dose CT 3 months post endoscopically by an outcome assessor blinded to the randomisation.
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 ≥ 18 years scheduled for URS lithotripsy for renal stones, 8-25 mm, at the day surgery unit at Haukeland University Hospital
排除标准
- •Concomitant ureteral stone
- •Urinary diversion
- •Active infection
- •Untreated cancer in the upper urinary tract
研究组 & 干预措施
Group 1 - low power laser settings
4-6 Watts, short pulse mode. 0.4 - 0.6 J at 10 Hz.
干预措施: Laser power settings (Thulium Fiber Laser) (Other)
Group 2 - high power laser settings
16-18 Watts, short pulse mode. 0.4 J / 40 Hz, 0.6 J / 30 Hz or 0.8 J / 20 Hz.
干预措施: Laser power settings (Thulium Fiber Laser) (Other)
结局指标
主要结局
Operative time
时间窗: During surgery (approximately 1 hour), registered immediately after surgery
Surgical time in minutes, counted from start of the procedure with insertion of the cystoscope until emptying the bladder in the end.
次要结局
- Stone free rate(3 months post endoscopically)
- Laser activation patterns - duration(During surgery (approximately 1 hour), registered immediately after surgery)
- Intraoperative complications(During surgery (approximately 1 hour), registered immediately after surgery)
- Post operative complications(After surgery until 3 months post endoscopically.)
- Laser activation patterns - number(During surgery (approximately 1 hour), registered immediately after surgery)