Efficacy and Safety of Ureteroscopic Lithotripsy (Including Flexible Ureteroscopy) Without Indwelling Urinary Catheter: a Multicenter, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
A prospective, multicenter, randomized, controlled clinical trial was conducted to compare the efficacy and safety of non-indwelling catheter and indwelling catheter in relieving postoperative catheter-related complications after ureteroscopic lithotripsy. By comparing the pain score and urination urgency score (PPIUS) of patients after ureteroscopic lithotripsy (including flexible ureteroscopy) lithotripsy to provide a reliable scientific basis for indwelling catheter after ureteroscopic lithotripsy.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with upper urinary tract calculi undergoing rigid ureteroscopic and soft ureteroscopic lithotripsy;
- •Normal renal function;
- •Aged between 18 and 70 years old
- •Complete the operation under general anesthesia
排除标准
- •Solitary kidney;
- •Previous history of renal transplantation or urinary diversion;
- •Congenital malformation of urinary system;
- •Abnormal coagulation mechanism due to blood system diseases, liver diseases, etc.
- •Severe heart or lung disease, Malignant tumor and immunodeficiency state
- •Urethral stricture
- •Neurogenic bladder
- •Operation under epidural anesthesia or spinal anesthesia
- •Large amount of bleeding during operation should be observed by indwelling catheter to observe urine color
- •High risk factors such as large amount of pus fur should be observed during operation.
- •Urethral injury during operation leads to false passage
- •Operation time is more than 90 minutes. Higher risk of bleeding or infection
结局指标
主要结局
Pain score
时间窗: 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
pain scoring will be measured by VAS scale. There are 10 scales, with "0" and "10" at both ends. 0 indicates no pain and 10 represents the most severe pain that is unbearable.
Urinary urgency score
时间窗: 4 hours after surgery and 2 hours after catheter removal (same time points for non-indwelling catheters)
urinary urgency score will be measured by PPIUS scale. 0 No urgency 1. Mild urgency 2. Moderate urgency 3. Severe urgency 4. Urge incontinence
次要结局
- Painful Memory(1 month after surgery)
- Operation time(The end of operation)
- blood routine(Before surgery and 4 hours after surgery)
研究者
Yi Shao
Director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine