Three-year Outcomes of a RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency (FOVELASS Study, by the French Society of Phlebology)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 主要终点
- Absence of reflux in the treated SSV segment
研究概览
简要总结
FOVELASS is a multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating SSV insufficiency, conducted by the French Society of Phlebology.
详细描述
Saphenous vein insufficiency is a common finding in varicose veins cases. International guidelines currently recommend endovenous thermal ablation using laser (EVLA) or radiofrequency as first line treatment for truncal Great Saphenous Vein (GSV) incompetence in preference to Ultrasound Guided Foam Sclerotherapy (UGFS) (1,2). This GSV-based recommendation has tended to be used for treating Small Saphenous Vein (SSV) incompetence.
To date, no RCTs have directly compared UGFS and EVLA for SSV treatment. The French Society of Phlebology (SFP) decided to compare these two most utilised endovenous treatments in France in a controlled study called the FOam VErsus LAser in the SSv (FOVELASS) study, involving 13 investigators in 11 vascular medical centres.
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
盲法说明
Blinding of participants and investigators is not possible because of the obvious differences between the two treatments (a single mid-calf injection versus multiple injections for tumescent anaesthesia/laser precautions etc...).
A blind third-party check was carried out, only at 3 years, and those assessors were completely independent of the study and blinded.
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
- •symptomatic varicose veins (CEAP C2s-C6)
- •underlying isolated SSV incompetence (SSV reflux time>0.5sec on duplex ultrasound (DUS))
- •reflux involving at least 15 cm of proximal SSV
- •minimal SSV diameter of 4 mm at mid-calf (luminal diameter in standing position)
排除标准
- •SSV treatment in the preceding 3 months
- •post-thrombotic disease
- •deep or superficial vein thrombosis of less than 3 months duration
- •coexistent ipsilateral GSV insufficiency
- •morbid obesity (BMI>40)
- •presence of significant arterial disease (ABPI<0.5)
研究组 & 干预措施
Ultrasound-guided-foam sclerotherapy (UGFS)
Injection of Polidocanol foam into SSV
干预措施: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant (Drug)
Endovenous Laser Ablation (EVLA)
Ablation of SSV using laser energy
干预措施: Endovenous Laser Ablation (EVLA) (Device)
结局指标
主要结局
Absence of reflux in the treated SSV segment
时间窗: 3Assessed at years
closed veins or patent veins with no reflux (\>0.5sec)
次要结局
- Treatment time(Assessed on day of treatment)
- Periprocedural pain score(up to four weeks)
- Quality of Life questionnaire (CIVIQ)(Through study completion, average of 3 years)
- Procedure related complications(Assessed through study completion, an average of 3 years)
- Venous symptoms questionnaire(Through study completion, average of 3 years)
- Revised Venous Clinical Severity Score -rVCSS(Through study completion, average of 3 years)
- Presence of visible varices(Through study completion, average of 3 years)