A Randomized Controlled Trial Comparing Robotic Flexible Ureteroscopy With Standard Flexible Ureteroscopy for Treatment of Renal Stones - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Stone-free rate at 1 month
研究概览
简要总结
This is a prospective randomized clinical trial which aims to compare the clinical outcomes of robotic flexible ureteroscopy and standard flexible ureteroscopy for the treatment of renal stones.
详细描述
This is a prospective randomized controlled trial comparing robotic flexible ureteroscopy and standard flexible ureteroscopy for patients with treatment of renal stones. All consecutive patients who are scheduled for flexible ureteroscopy for treatment of renal stones would be screened for study eligibility. Patients are randomised to receive either robotic or standard flexible ureteroscopy with an allocation ratio of 1:1. by computer generated random block. The urologist performing the surgery could not be blinded due to the nature of the intervention. Patients receiving the treatment and investigators assessing for any disease recurrence are blinded from the allocated treatment arm.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Age ≥ 18 years old with informed consent
- •Being willing and able to provide written informed consent
排除标准
- •Patients with abnormal urinary tract (e.g. ileal conduit, neobladder, ureteric stricture)
- •American Society of Anesthesiologists (ASA) physical status classification system >3
- •Untreated urinary tract infection
- •Renal stones > 3cm in diameter
结局指标
主要结局
Stone-free rate at 1 month
时间窗: Month 1
Stone-free rate at 1 month is defined by non contrast computer tomography (NCCT) performed within 24 hours of surgery without residual stone fragments or residual stone fragments \<2mm
次要结局
- Stone-free rate at 3 month(Month 3)
- Operative time(During operation)
- Lasing Time(During operation)
- Total laser energy used(During operation)
- Total radiation dose(During operation)
- Total radiation time(during operation)
- Length of hospital stay(On Discharge)
- Postoperative pain(Baseline, Week 1 and Week 12)
- Surgeon radiation exposure(During operation)
研究者
NG Chi Fai
Professor
Chinese University of Hong Kong