NCT01584193撤回不适用
Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial
University of Lausanne Hospitals2 个研究点 分布在 1 个国家开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- surgical procedure time
研究概览
简要总结
The purpose of this study is to compare two different surgical techniques for implementation of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture is compared to cephalic vein dissection.
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
- •Age > 18
- •Informed consent
- •Need for central venous access port implementation under local anesthesia
排除标准
- •Impaired blood clotting
- •Ongoing antiplatelet drugs therapy, except acetylsalicylic acid
- •Trauma or surgical past history on both shoulder girdles
- •Known central venous thrombosis (subclavian vein, upper vena cava)
- •Known pneumothorax
- •Septic state
- •Agranulocytosis
结局指标
主要结局
surgical procedure time
时间窗: during surgical procedure
次要结局
- technique conversion rate and causes(during surgical procedure)
- primary implementation success rate(during surgical procedure)
- Pain at 30 days(30 days post-procedure)
- Complications rate at 30 days(30 days post-procedure)
- pain during surgical procedure(during surgical procedure)
- pain at 5 days(5 days post-procedure)
- overall implementation success rate(during surgical procedure)
- Complications rate during surgical procedure(during surgical procedure)
- Complications rate at 5 days(5 days post-procedure)
研究者
Nicolas DEMARTINES
Professor
University of Lausanne Hospitals
研究点 (2)
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