Comparison of Surgery Versus Foam Sclerotherapy for Isolated Accessory Great Saphenous Vein Varicosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- duplex-sonographic recurrence after 3 years
研究概览
简要总结
The purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reflux in anterior accessory great saphenous vein (AAGSV) > 0,5 sek
排除标准
- •concomitant reflux in great saphenous vein (GSV)
- •reflux in the deep venous system (postthrombotic syndrome)
- •acute thrombosis
- •hypercoagulability
- •allergy to aethoxysclerol or local anesthetics
- •immobility
- •open foramen ovale
- •bacterial infection of the skin
- •pregnancy and breast feeding
- •peripheral arterial occlusive disease III, IV (PAOD)
研究组 & 干预措施
surgery
crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
干预措施: surgery (Procedure)
sclerotherapy
foam sclerotherapy with aethoxysclerol foam
干预措施: sclerotherapy with aethoxysclerol foam (Drug)
结局指标
主要结局
duplex-sonographic recurrence after 3 years
时间窗: 3 years
duplex-sonographic recurrence is defined as reverse blood flow of \> 0.5 sec along the anterior accessory great saphenous vein (AAGSV) in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group.
次要结局
- neovascularisation in the saphenofemoral junction(1 year and 3 years)
- duplex-sonographic recurrence after 1 year(1 year)
- clinical recurrence(1 year and 3 years)
研究者
Kornelia Boehler
MD
Medical University of Vienna