The Utility of Novel Ambulatory Treatment Techniques in Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 4
- 主要终点
- Recanalization or reflux of the treated venous trunk
研究概览
简要总结
Randomized controlled trial, a method used to implement the random allocation sequence is numbered containers.
The aim of the study is to compare operative treatment, ultrasound guided laser ablation and ultrasound guided foam sclerotherapy in occluding/ablating of insufficiency in great saphenous trunks. On the grounds of the available data, the study hypothesis is that using laser or operative treatment more than 20 percent better outcome can be achieved compared to foam sclerotherapy.
详细描述
In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk. In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein. Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control. In each group patients will use supportive treatment stockings 2 weeks after treatment. The patients in all groups are followed up one year by ultrasound scanning.
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
- •patients with chronic superficial vein insufficiency
- •patient must be 20-70 years old
- •degree of difficulty of vein insufficiency C2-C4
- •average diameter of refluxing great saphenous vein 4 -10 mm
- •patient is agreeable to the study
排除标准
- •peripheral atherosclerotic occlusive disease
- •lymphoedema
- •severe concomitant disease
- •venous ulcers or unclassified skin changes
- •BMI more than 40
- •pregnancy
- •allergy to the foam used in sclerotherapy or to local anaesthetics
- •coagulation disorder
- •bilateral vein insufficiency (equal symptoms)
结局指标
主要结局
Recanalization or reflux of the treated venous trunk
时间窗: at 1 and 12 months
Results will be verified by Duplex scanning
次要结局
- Symptom relief(at 1 and 12 months)
- Complications related to procedure(at 1 and 12 months)
- Quality of life(at 1 and 12 months)
研究者
Maarit Venermo
MD, PhD
Helsinki University Central Hospital