Varicose veins Circulatory System Varicose veins
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with primary symptomatic varicose veins 2. Clinical, aetiological, anatomical, pathological elements (CEAP) clinical class C2 venous disease 3. Informed written consent 4. Age 19 - 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 ultrasound imaging
Exclusion criteria
Exclusion criteria: 1. Previous venous surgery 2. History of deep vein thrombosis (DVT) 3. C3-6 CEAP 4. Deep vein reflux 5. Anatomical duplication 6. Reflux in below-knee perforator veins
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at 6, 12 and 24 months: 1. Operative time 2. Complications 3. Activity impairment 4. Quality-adjusted life years (QALY) 4. Patient satisfaction | — |
Primary
| Measure | Time frame |
|---|---|
| The following were assessed at 6, 12 and 24 months: 1. Freedom from recurrence 2. Improvement in Venous Clinical Severity Score (VCSS) 3. Improvement in Aberdeen Varicose Vein Severity Score (AVVSS) 4. Improvement in the short form 6D (SF-6D), a single preference based measure of health, representing overall quality of life derived from the 36-item short form 36 (SF-36) questionnaires | — |
Countries
Netherlands