7.5F Versus 9.2F Flexible Ureteroscopy for the Treatment of 1-2cm Renal Calculi on Postoperative Infection:An International Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- postoperative fever
研究概览
简要总结
Ureteroscopic lithotripsy (RIRS) is the first-line treatment for 1-2 cm upper urinary tract stones, and the stone clearance rate can reach 81.4% - 92.5%. Fever after RIRS is the most common infection after RIRS, and its incidence is up to 20%. The incidence rate of systemic inflammatory response syndrome is 6.5% - 10.3%, sepsis 0.1% - 4.3%, with the infection progressed. If there is no timely and effective intervention in the early stage of urogenic sepsis, it can progress to septic shock, and the mortality can be as high as 30% - 40%. High intrarenal pressure is an important risk factor for postoperative infection. American Urological Association (AUA) guidelines point out that controlling intrarenal pressure at an appropriate level is particularly important to prevent postoperative infection.
The use of ureteroscopic sheath in ureteroscopic surgery can effectively reduce the intrarenal pressure, which is an important measure to reduce the incidence of postoperative infection. Theoretically, the larger the space, the better the reflux effect and the lower the incidence of postoperative infection. The study showed that the incidence of ureteral sheath infection was significantly lower than that of ureteral sheath infection after operation. When using the same caliber ureteroscopic sheath, use a smaller caliber ureteroscopy to increase the space between the ureteroscopy and the ureteral sheath, promote reflux, reduce intrarenal pressure and reduce the incidence of postoperative infection. However, there is still a lack of relevant research on the effect of different caliber ureteroscopy in the treatment of renal calculi on postoperative infection.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Agree to receive ureteroscopy
- •Aged 18-70 years. 3.1-2cm kidney stones
排除标准
- •Combined with middle and lower ureteral calculi, surgical operation other than RIRS is required;
- •Patients with abnormal anatomical structure, ureteral stenosis and urinary diversion, such as ectopic kidney, horseshoe kidney and duplicate kidney;
- •Patients who have undergone nephrostomy;
- •Severe cardiopulmonary insufficiency;
- •Pregnant women.
结局指标
主要结局
postoperative fever
时间窗: ≤ 1month postoperatively
Postoperative fever was defined as armpit temperature ≥38C
次要结局
- Stone free rate (SFR)(1 month after removing the pigtail stent)
研究者
Guohua Zeng
Vice president
The First Affiliated Hospital of Guangzhou Medical University
