Retrograde Intrarenal Surgery With Tip Flexible Pressure-controlling Ureteral Access Sheath Versus Mini Percutaneous Nephrolithotomy for the Treatment of 2-3-cm Kidney Stones
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Operation time
研究概览
简要总结
The goal of this observational study is to compare the safety and efficacy between RIRS with tip flexible pressure-controlling ureteral access sheath and mini percutaneous nephrolithotripsy（PCNL） for the treatment of 2-3-cm kidney stones.
详细描述
Retrograde Intrarenal Stone Surgery (RIRS) has become one of the most common treatments for renal stones. The development of ureteral access sheath (UAS) is a significant advance in RIRS. In recent years, various improvements have been made to UAS, especially the emergence of a suction UAS and a tip flexible UAS. Using the advantages of suction and tip flexible technology, our team developed a tip flexible pressure-controlling UAS, which significantly improves the safety and effectiveness of RIRS. However, the current guidelines can recommend the indication of RIRS in kidney stones less than 2cm, and percutaneous nephrolithotomy(PCNL) is still preferred for kidney stones larger than 2 cm. Therefore, this study is the first to compare the safety and efficacy between RIRS with tip flexible pressure-controlling UAS and mini PCNL in the treatment of 2 to 3 cm kidney stones.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adults aged ≥ 18 years
- •American Society of Anesthesiology score 1-2
- •Kidney stone diameter of 2-3 cm confirmed by CT
- •Capable of giving written informed consent, which includes adherence with the requirements of the trial
排除标准
- •Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit)
- •Patients with uncontrolled UTI
- •Patients with health or other factors that are absolute contraindications to RIRS or PCNL .Patients unable to understand or complete trial documentation.
结局指标
主要结局
Operation time
时间窗: the time from the insertion of the suction sheath and renal puncture to the end of the operation,assessed up to 90 minutes.
The operation time of RIRS and mini PCNL was defined as the time from the insertion of the suction sheath and renal puncture to the end of the operation
Immediate stone-free rate
时间窗: Postoperative day 1-7
No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1-7 are defined as stone free.
Complications up to 3 months post
时间窗: Postoperative 3 month
Stone-free rate at 1 months
时间窗: Postoperative 1 month
No residual stone or stone fragments less than 2 mm on kidney, ureter, and bladder at 1 months are defined as stone free.
次要结局
未报告次要终点
研究者
Huang Xin
Associate Senior Doctor
The Affiliated Ganzhou Hospital of Nanchang University