Varicose Veins of Lower Limb
Conditions
Keywords
small saphenous veins, varicose veins, ultrasound guided foam sclerotherapy, endovenous laser ablation
Brief summary
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.
Detailed description
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.
Interventions
DRUGUltrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant
Direct injection Foam sclerotherapy
EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)
Sponsors
Societe Francaise de Phlebologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating small saphenous veins (SSV) insufficiency
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of reflux in the treated SSV segment | 3Assessed at years | closed veins or patent veins with no reflux (\>0.5sec) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure related complications | Assessed through study completion, an average of 3 years | Any related complications arising from the procedure |
| Periprocedural pain score | up to four weeks | assessed on a visual analogue score (zero = no pain, 100 = maximum pain) |
| Presence of visible varices | Through study completion, average of 3 years | Reported recurrence of varicose veins |
| Treatment time | Assessed on day of treatment | Time (in minutes) spent in undertaking each treatment |
| Revised Venous Clinical Severity Score -rVCSS | Through study completion, average of 3 years | Validated questionnaire scores |
| Quality of Life questionnaire (CIVIQ) | Through study completion, average of 3 years | Validated questionnaire scores |
| Venous symptoms questionnaire | Through study completion, average of 3 years | Validated questionnaire scores |
Outcome results
None listed