Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery. A 5-year Follow-up Using Duplex Ultrasound, Plethysmography, VCSS, AVVQ and EQ-5D
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 198
- 试验地点
- 4
- 主要终点
- Number of treated veins with recanalization using duplex.
研究概览
简要总结
200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insufficient great saphenous vein
- •Possible to treat with both radiofrequency ablation and high ligation/stripping
- •Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6
排除标准
- •Previous intervention in the affected leg
- •Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
- •Small saphenous vein insufficiency with diameter >6 mm and/or flow >100ml/min
- •Patient that is not able to perform plethysmography
结局指标
主要结局
Number of treated veins with recanalization using duplex.
时间窗: 5 years
Flow detected by duplex at the site of the treated vein.
Number of treated limbs with neovascularization using duplex and/or plethysmography.
时间窗: 5 years
Prediction of treatment outcome using plethysmography with superficial shut-down.
时间窗: 1 month postoperatively
If plethysmography with superficial shut-down of the superficial venous system is able to predict the effect of treatment.
次要结局
- VCSS score(5 years)
- AVVQ score(5 years)
- EQ-5D score(5 years)
研究者
Oskar Nelzén
MD, PhD
University Hospital, Linkoeping