NCT07279389已完成不适用
Comparative Study Between One-Shot Dilatation Versus Serial Dilatation Techniques for Access in Percutaneous Nephrolithotomy in Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Fluoroscopy time
研究概览
简要总结
This comparative study aims to compare and assess the safety, efficacy, outcome, feasibility, intraoperative and postoperative complications of one-shot dilatation versus serial dilatation techniques for access during percutaneous nephrolithotomy for management of renal stone disease in adult patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 70 years.
- •Patients with renal stones which their size in maximum diameter is more than 2cm and indicated for percutaneous nephrolithotomy.
- •Patients clinically fit for surgery.
- •Patients with normal anatomy of urinary tract.
- •Patients able to understand the procedure and accept to sign the informed consent.
排除标准
- •Patients aged below 18 or above 70 years.
- •Patients with renal stones which their size in maximum diameter is less than 2cm or contraindicated for endoscopic management.
- •Patients with urinary tract infection, abnormal coagulopathy state or clinically unfit for surgery.
- •Patients with nephrostomy tube in situ.
- •Patients with more than single access tract.
- •Patients undergoing simultaneous bilateral stone procedures.
- •Patients with urinary tract abnormalities or history of renal transplantation.
- •Renal insufficiency with serum creatinine above 3.0mg/dL
- •Patients unable to understand the procedure or refuse to sign the informed consent.
结局指标
主要结局
Mean Fluoroscopy time
时间窗: From enrollment to the end of treatment at 8 weeks
Mean access time
时间窗: From enrollment to the end of treatment at 8 weeks
Stone free rate
时间窗: From enrollment to the end of treatment at 8 weeks
Hospitalization Period
时间窗: From enrollment to the end of treatment at 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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