NCT01103258已完成不适用
FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- cumulative probability of recurrent varicose vein within 24 months after treatment
研究概览
简要总结
Varicose vein disease is a common health problem, which causes much discomfort to patients.
Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population.
Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.
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
- •incompetence of great saphenous vein for minimal 20 cm
- •life expectancy at least 3 years
- •open and competent deep venous system
- •willing to undergo both treatments
排除标准
- •active ulcer
- •signs of deep venous thrombosis with duplex
- •incompetence of the deep venous system
结局指标
主要结局
cumulative probability of recurrent varicose vein within 24 months after treatment
时间窗: 24 months
次要结局
- quality of life (as measured by EuroQol-5D)(24 months)
- patient preferences (as measured by conjoint analysis)(24 months)
- direct Health care costs(24 months)
研究者
研究点 (1)
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