Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
研究概览
简要总结
This is a prospective, randomized controlled trial evaluating the effect of a hemostatic agent on tract-related bleeding during percutaneous nephrolithotomy (PCNL). Patients undergoing standardized PCNL will be randomized to receive either application of a hemostatic agent or no agent during tract closure, following uniform balloon occlusion, complete aspiration, and irrigation-free endoscopic assessment. The researchers hypothesize that adjunctive hemostatic agent use reduces perioperative hemoglobin decline compared with balloon tamponade alone and improves tract-related hemostasis outcomes.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one stone ≥ 1.2cm
- •Scheduled to undergo planned PCNL
- •Age ≥ 18 years
排除标准
- •Unable to provide informed consent
- •Pre-existing nephrostomy tube
- •Multi access cases
- •Stone in calyceal diverticulum/hydrocalyx
- •Preoperatively planned overnight admission for any reason
- •Infundibular stenosis
- •Coagulation disorders
- •Other significant anatomic abnormalities
研究组 & 干预措施
Balloon Tamponade with Surgicel
Balloon Tamponade with Surgicel as hemostatic agent.
干预措施: Surgicel (Device)
Balloon Tamponade with Floseal
Balloon tamponade with Floseal as hemostatic agent.
干预措施: Balloon Tamponade (Procedure)
Balloon Tamponade with no hemostatic agent
Balloon tamponade alone with no hemostatic agent acts as a control.
干预措施: Balloon Tamponade (Procedure)
Balloon Tamponade with Floseal
Balloon tamponade with Floseal as hemostatic agent.
干预措施: Floseal (Device)
Balloon Tamponade with Surgicel
Balloon Tamponade with Surgicel as hemostatic agent.
干预措施: Balloon Tamponade (Procedure)
Balloon Tamponade with Surgiflo
Balloon tamponade with Surgilfo as hemostatic agent.
干预措施: Surgiflo (Device)
Balloon Tamponade with Surgiflo
Balloon tamponade with Surgilfo as hemostatic agent.
干预措施: Balloon Tamponade (Procedure)
研究者
Mantu Gupta
Professor of Urology
Icahn School of Medicine at Mount Sinai