Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Symptom relief
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 compression therapy with compression stockings and surgery eliminating superficial venous reflux in patients with duplex ultrasound verified superficial venous reflux without skin changes or ulceration.
详细描述
Superficial venous reflux is common in adult population. Uncomplicated disease, where there is no skin changes but varicose veins with or without leg swelling, can be totally asymptomatic but also cause various symptoms as pain, aching and discomfort of leg usually caused by increased venous pressure. Varicose veins may also cause cosmetic problem. Compression stockings relief the symptoms as they normalize venous pressure. In surgical treatment, axial reflux is treated usually by removing incompetent superficial veins. The aim of the study is to compare conservative treatment with compression stockings with surgical treatment of superficial venous reflux. In operative treatment the great saphenous vein or lesser saphenous vein are removed after flush ligation by femoral vein and stripping of the trunk. If the main trunk has been removes previously, axial refluating veins are removed or ligated according to the DUS finding. The patients in both groups are examined at the baseline and followed up to two years by ultrasound scanning. Patients clinical classification, venous disability score, venous disease severity score, anatomical path of reflux as well as quality of life are studied at the baseline, at one year follow-up and two years follow-up.
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-C3
- •venous disability score 1-2
- •patient is agreeable to the study
排除标准
- •peripheral atherosclerotic occlusive disease
- •lymphoedema
- •severe concomitant disease (ASA 3-5)
- •venous ulcers or unclassified skin changes
- •BMI more than 35
研究组 & 干预措施
conservative treatment
Compression stockings class II
干预措施: conservative treatment (Other)
Operative treatment
stripping of main trunk or if previously removed, removal or ligating the refloating trunk
干预措施: Operative treatment (Procedure)
结局指标
主要结局
Symptom relief
时间窗: two years
Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination.
次要结局
- Quality of life(two years)
研究者
Maarit Venermo
MD,PhD
Helsinki University Central Hospital
