NCT06987760招募中不适用
Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trials
Ningbo No. 1 Hospital1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2025年3月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Success rate of ureteral access sheath insertion
研究概览
简要总结
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
详细描述
Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients with kidney stones or upper ureteral stones with a cumulative diameter of less than 3 cm are selected for ureteral soft lens holmium laser lithotripsy.
- •2.Age 18 to 80 years old, gender unlimited. 3.The subjects have no mental illness or language dysfunction, can understand the situation of the study and can sign informed consent.
排除标准
- •1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.
- •2.Patients with fever one week before surgery 3.Pregnant women and menstruating patients. 4.Patients with combined systemic disease or inability to tolerate anesthesia. 5.Patients undergoing simultaneous surgery for bilateral upper urinary tract stones.
- •6.Patients with ureteral stent indwelling before surgery. 7.In patients with severe hydronephrosis, the separation of the renal collecting system is greater than 4 cm.
- •8.Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.
结局指标
主要结局
Success rate of ureteral access sheath insertion
时间窗: From enrollment to completion of surgery
Proportion of successful ureteral implantation, success rate = number of successful cases/total number of cases
次要结局
- The condition of ureter injury(24 hours)
- Stone clearance rate(up to 8 weeks.)
- Operation time(24 hours)
- The incidence of surgical complications(7 days)
研究者
研究点 (1)
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