Prospective, Randomized Study on the Efficiency of Alpha-Blockers Prior to Ureteral Sheath Placement in Flexible Ureterolithotripsy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Reduction in the failure rate of ureteral access sheath insertion with preoperative tamsulosin use
研究概览
简要总结
This study aims to evaluate whether the use of alpha-blockers before flexible ureterorenolithotripsy facilitates the passage of the ureteral access sheath. The trial will enroll adult patients diagnosed with kidney stones who are scheduled for flexible ureteroscopy. Participants will be randomly assigned to receive or not receive alpha-blockers for seven days before surgery. The primary outcome is the rate of successful sheath placement without the need for a second procedure. Secondary outcomes include the incidence of ureteral injuries and the need for additional surgical interventions. The goal is to improve surgical efficiency and patient outcomes in the treatment of kidney stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Age ≥ 18 years
- •Diagnosis of nephrolithiasis with surgical indication for flexible ureterorenolithotripsy
- •Ability to provide written informed consent
排除标准
- •Age < 18 years
- •Pregnancy
- •History of ureteral stricture, prior ureteral reconstructive surgery, and/or abdominal or pelvic radiotherapy
- •Prior ureteroscopy or ipsilateral double-J stent placement within the past 3 months
- •Chronic use of alpha-blockers for benign prostatic hyperplasia or medical expulsive therapy for ureteral stones
研究组 & 干预措施
No Intervention: Control group
Participants will undergo flexible ureterorenolithotripsy without the use of alpha-blockers prior to surgery. All other aspects of perioperative care and surgical technique will be identical to those of the experimental group.
干预措施: No intervention (observational study) (Drug)
结局指标
主要结局
Reduction in the failure rate of ureteral access sheath insertion with preoperative tamsulosin use
时间窗: During the surgical procedure
次要结局
未报告次要终点
研究者
Pedro de Figueiredo Buchalla
Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study
Centro Universitário FMABC