Randomized Clinical Trial of Routine Preoperative Duplex Imaging Before Varicose Vein Surgery; Long-term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 2
- 主要终点
- Rate of Re-do Surgery
研究概览
简要总结
Duplex imaging is costly and time-consuming, but is used increasingly for preoperative evaluation of varicose veins. Its value in terms of the long-term results of surgery is not clear. 293 patients (343 limbs) with primary varicose veins were randomized to operation with or without preoperative duplex imaging. Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery. Routine preoperative duplex examination led to an improvement in results. However two years is a short time, and with a longer follow-up other mechanisms for recurrence may become more important, e.g. neovascularization (new vessel formation) or progression of disease, hence the value of a detailed preoperative diagnosis may be diminished. The aim of this phase of the investigation is to study the results after 8 years, in particular what mechanisms for recurrences were most important.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with primary varicose veins
排除标准
- •pure cosmetic complaints
- •previous venous surgery or sclerotherapy
- •history of suspect or manifest deep venous thrombosis
- •active or healed venous ulceration
- •peripheral arterial disease
- •previous significant trauma to the leg
- •general illness
- •alcohol or drug abuse
- •unable to understand information
结局指标
主要结局
Rate of Re-do Surgery
时间窗: 7 years mean
number of reoperations (legs) in the two treatment arms
次要结局
- Recurrence Rate(7 years)
研究者
Lena Blomgren
MD, PhD
Uppsala University Hospital
