Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Stone-free rate (SFR)
研究概览
简要总结
The efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared.
详细描述
The target population of this study is patients with proximal ureteral stones who are scheduled to undergo semirigid ureteroscopic laser lithotripsy. After enrollment, the subjects will be randomly assigned to the semirigid ureteroscopic holmium laser (Ho: YAG) lithotripsy group and the semirigid ureteroscopic thulium fiber laser (TFL) lithotripsy group for surgical treatment. The subjects will be followed up after surgery, and the collected data will be summarized and analyzed after the study.
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 (Participant)
盲法说明
Patients and data analysts were blinded to the allocation measures.
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
- •≥18 years old;
- •patients diagnosed with unilateral proximal ureteral stones ≤2cm by computed tomography (CT)/Kidney and upper bladder (KUB) radiography who required surgery;
- •patients who volunteered to participate in this study.
排除标准
- •Unable to give informed consent;
- •Untreated urinary tract infection;
- •Pregnant women;
- •Known anatomical abnormalities (such as urinary diversion or ureteral stenosis);
- •Urothelial tumors, transplanted kidney stones, irreversible coagulopathy;
- •The semi-rigid ureteroscope cannot reach the stone site, ureteroscopy-negative stones, and stones can be removed directly without laser lithotripsy;
- •The researchers believe that they are not suitable for participation in this study.
结局指标
主要结局
Stone-free rate (SFR)
时间窗: 2-4 weeks after surgery
Stone-free rate (SFR) after single-session laser lithotripsy using a semirigid ureteroscope without an auxiliary procedure assessed by CT/X-ray at 2-4 weeks follow-up after laser lithotripsy.
次要结局
- Intraoperative complications(Immediately during surgery)
- Operative time(Immediately during surgery)
- Postoperative complications(2-4 weeks after surgery)
- Additional procedures(Intraoperatively and before removal of the Ureteral stents)