Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To determine which method of treatment causes the least pain to the patient.
研究概览
简要总结
The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.
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)
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
- •The patient has kidney stones that require treatment (tx) with percutaneous stone removal
- •18 years of age or over
排除标准
- •Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain
- •Patient taking coumadin
- •Pre-existing percutaneous nephrostomy
研究组 & 干预措施
1
Floseal
干预措施: Floseal (Procedure)
2
Cope-Loop/Nephrostomy Tube
干预措施: Cope Loop (Procedure)
3
Fascial Stitch
干预措施: Fascial Stitch (Procedure)
结局指标
主要结局
To determine which method of treatment causes the least pain to the patient.
时间窗: one month
次要结局
未报告次要终点
研究者
Jaime Landman
Professor and Chairman
University of California, Irvine
