Varicose Veins
Conditions
Brief summary
The goal of this registry is to evaluate the indication for EndoVenous Laser Ablation (EVLA) therapy. Can this be enhanced? What are the reasons for not using the laser? Therefore, this study aims to define clear indications for EVLA by registering the incentives of the participating investigators to use the laser instead of conventional corrective surgery for the treatment of varicose veins, at baseline and post-operative. Additionally, the efficacy and safety of the different varicose vein treatments will be evaluated by registering procedural characteristics, anatomic outcome (duplex ultrasound), quality of life (AVVQ) and postoperative pain (VAS).
Interventions
DEVICEELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation
Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
Sponsors
Duomed
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is at least 18 years old. 2. Patient must sign and date the informed consent form prior to treatment. 3. Presence of unilateral or bilateral primary or recurrent symptomatic varicose veins (CEAP grade ≥ C2). 4. Patient has an insufficient Great Saphenous Vein (GSV), Anterior Accessory Saphenous Vein (AASV) and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence).
Exclusion criteria
1. Current deep vein thrombosis. 2. Acute superficial thrombosis. 3. Pregnancy. 4. Coagulopathy or bleeding disorders. 5. Contraindications to the use of general or regional anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins. | At baseline | The participating investigators will register the incentives (based on clinical examination and/or anatomic outcome by duplex ultrasound, as well as secondary considerations) to use laser ablation or conventional treatment for varicose veins in the study database in order to define clear indications for EndoVenous Laser Ablation (EVLA) treatment of varicose veins and to investigate whether the use of EVLA can be enlarged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scoring using the Visual Analog Scale (VAS) | At discharge, up to 1 week | The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0. |
| Anatomic success of EndoVenous Laser Ablation (EVLA) | At 6 weeks follow-up | Defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography. |
| Procedural characteristics | At index-procedure | Type of anesthesia |
| Post-operative adverse events | At discharge, up to 1 week | Number of participants with numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc. |
| Re-interventions | At discharge, up to 1 week | Number of participants with re-interventions |
| Quality of life by scoring Aberdeen Varicose Vein Questionnaire (AVVQ) | At baseline | Aberdeen Varicose Vein Questionnaire (AVVQ) is a validated tool for assessing the perceived health of patients with varicose veins. The AVVQ comprises 13 quality of life questions, including a set of manikin legs, on which participants are asked to draw their veins. |
Countries
Belgium
Outcome results
None listed