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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided-foam sclerotherapy (UGFS) | Active Comparator | Injection of Polidocanol foam into SSV |
|
| Endovenous Laser Ablation (EVLA) | Active Comparator | Ablation of SSV using laser energy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant | Drug | Direct injection Foam sclerotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of reflux in the treated SSV segment | closed veins or patent veins with no reflux (>0.5sec) | 3Assessed at years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment time | Time (in minutes) spent in undertaking each treatment | Assessed on day of treatment |
| Procedure related complications | Any related complications arising from the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudine Hamel-Desnos | Institut des Varices- GHPJS Groupe Hospitalier | Study Director |
| Matthieu Josnin | Société Française de Phlébologie | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 9) Hamel-Desnos C., Josnin M., Allaert F.-A. Etude contrôlée randomisée de l'efficacité du laser endoveineux (1470 nm) versus échosclérothérapie à la mousse dans le traitement de l'insuffisance de la petite veine saphène. Phlébologie 2019 (72): 8-18 | ||
| 36470312 | Derived | Hamel-Desnos C, Nyamekye I, Chauzat B, Gracia S, Josnin M, Abbadie F. FOVELASS: A Randomised Trial of Endovenous Laser Ablation Versus Polidocanol Foam for Small Saphenous Vein Incompetence. Eur J Vasc Endovasc Surg. 2023 Mar;65(3):415-423. doi: 10.1016/j.ejvs.2022.11.021. Epub 2022 Dec 5. |
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Randomised is provided by the independent statistics centre (Cenbiotech; Dijon-France), who also analysed IPD. Investigators cannot access other centres' data.
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating small saphenous veins (SSV) insufficiency
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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.
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| Endovenous Laser Ablation (EVLA) | Device | EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA) |
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| Assessed through study completion, an average of 3 years |
| Periprocedural pain score | assessed on a visual analogue score (zero = no pain, 100 = maximum pain) | up to four weeks |
| Presence of visible varices | Reported recurrence of varicose veins | Through study completion, average of 3 years |
| Venous symptoms questionnaire | Validated questionnaire scores | Through study completion, average of 3 years |
| Revised Venous Clinical Severity Score -rVCSS | Validated questionnaire scores | Through study completion, average of 3 years |
| Quality of Life questionnaire (CIVIQ) | Validated questionnaire scores | Through study completion, average of 3 years |