NCT00180388终止4 期
Comparison of Clinical and Economical Parameters of Healing in Different Vein Harvesting Methods During Aortocoronary CABG
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Evaluation of the economic differences between methods of treatment
研究概览
简要总结
The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.
详细描述
The VENEK trial is a randomized, prospective trial to compare economic parameters, quality of life and wound healing after endoscopic vein harvesting versus open vein harvesting.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 60 years
- •Admission at Herzzentrum Dresden - Herzchirurgie for bypass-operation (OP) with planned veinectomy
- •Eligibility for different modes of planned intervention according to study protocol
- •Signed patient informed consent
排除标准
- •Varicose crural veins
- •Emergency patients
- •Combined operational procedures
- •Preoperative complete immobilization
研究组 & 干预措施
Endoscopic vein harvesting
Experimental
Harvesting of vein for coronary artery bypass grafting using endoscopy to visualize the vein
干预措施: endoscopic vein harvesting (Procedure)
Open Vein harvesting
Active Comparator
Harvesting of vein for coronary artery bypass grafting without endoscopy
干预措施: open vein harvesting (Procedure)
结局指标
主要结局
Evaluation of the economic differences between methods of treatment
时间窗: up to 2 months
Follow-up until wound healing
次要结局
- Evaluation of the outcome in quality of life (questions according to the protocol) and rate of disorders in wound healing(up to 2 months)
研究者
研究点 (2)
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