Varicose veins Circulatory System Varicose veins
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with primary symptomatic bilateral varicose veins 2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease 3. Informed written consent 4. Aged 20 - 75 years 5. Great saphenous vein (GSV) incompetence from the groin to below the knee, defined as retrograde flow lasting longer than 0.5 seconds on duplex scanning
Exclusion criteria
Exclusion criteria: 1. Previous venous surgery 2. History of deep vein thrombosis (DVT) 3. C3-6 CEAP venous disease 4. Deep vein relux 5. Reflux in below knee perforator veins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from recurrent varicose veins in the groin, as confirmed by duplex ultrasound, two years after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at 6, 12 and 24 months: 1. Abolition of reflux in the GSV 2. Venous Clinical Severity Score (VCSS) 3. Freedom from overall recurrent varicose veins 4. Procedural complications, including pain, bruising, saphenous nerve paraesthesia, tightness, superficial thrombophlebitis, skin burns, thrombotic events, and wounds | — |
Countries
Netherlands