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临床试验/NCT00360477
NCT00360477已完成不适用

Prospective Randomized Trial of Floseal Tubeless Exit vs. Cope Loop Nephrostomy vs. Fascial Stitch Following Percutaneous Nephrolithotripsy

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2004年6月1日最近更新:
适应症
干预措施

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

Active Comparator

Floseal

干预措施: Floseal (Procedure)

2

Active Comparator

Cope-Loop/Nephrostomy Tube

干预措施: Cope Loop (Procedure)

3

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Landman

Professor and Chairman

University of California, Irvine

研究点 (1)

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