Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Truncal vein occlusion rate
研究概览
简要总结
Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)
详细描述
In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group.
Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage.
Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
- •Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
- •Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation
排除标准
- •History of pulmonary embolism or deep venous thrombosis
- •Large (>12mm) truncal vein diameter
- •CEAP C5-C6
- •Patient unwilling to participate
研究组 & 干预措施
No Compression
Patients in this group will not receive any compression after treatment.
Compression
Patients in this group will use compression stockings for seven days after treatment (2 days continuously and 5 days during daytime).
干预措施: Class II Compression Stockings (Device)
结局指标
主要结局
Truncal vein occlusion rate
时间窗: 6 months
次要结局
- Time required returning to normal work and activity level(14 days)
- Painkillers usage after treatment(10 days)
- Post-operative pain assessed with visual analogue scale (VAS)(10 days)
- Aberdeen Varicose Veins Questionnaire (AVVQ)(6 months)
- Compliance with compression stockings(7 days)
- Signs of deep venous thrombosis, pigmentation, blisters, skin irritation, thrombophlebitis, hematoma, wound infection or paraesthesia post operatively(30days)
研究者
Toni Pihlaja
M.D.
Oulu University Hospital