Delayed or Immediate Local Treatment of Varicose Veins
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Need for sclerotherapy
研究概览
简要总结
Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism.
This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ultrasound verified insufficiency of great saphenous vein (GSV)
- •GSV diameter 5-10 mm
- •C2-C4 varicosities
- •Most proximal insufficient branch in the distal thigh
- •Written and signed informed consent
排除标准
- •Peripheral arterial disease
- •Body mass index >40
- •Lymphoedema
- •Known allergy to sclerosant
- •Any known coagulopathy or history of deep vein thrombosis
- •Severe illness
- •Pregnancy
结局指标
主要结局
Need for sclerotherapy
时间窗: 3 months
Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. \>C2 will be eligible for treatment.
次要结局
- Occlusion rate of great saphenous vein(36 months)
- Patient satisfaction(3 months)
研究者
Maarit Venermo
Professor of Vascular Surgery
Helsinki University Central Hospital