Chronic venous insufficiency varicose veins
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -Patients with primary varicosity of the GSV, between age 18-80 year. -CEAP 2-4(Appendix B/VI), without deep vein insufficiency. -Minimum distance between skin and the GSV in the first 20 cm from the SFJ >5mm. -Minimum length of to be treated GSV 10cm. -GSV on one side will be treated in the case of bilateral insufficiency. -GSV will be treated only in the case of solitary GSV insufficiency. -Patients treated by experienced surgeon/center.
Exclusion criteria
Exclusion criteria: -Age 80 years. -Deep vein insufficiency in the same extremity (duplex verified). -Previous thrombosis of the affected limb (secondary thrombosis) -Tortuosity of the GSV, double GSV system. -Superficial veins with a distance of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary studyparameter will be a clinical recurrence measured by duplex echography at 3,12 and 24 months after intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters will be quality of life as measured by different questionnaires. This study will use the SF-36, EuroQol-5, Aberdeen varicose Vein Questionnaire (AVVQ) and the Pain Disability Index for measuring quality of life. Questionnaires will be completed before and 1, 3, 12, 24 months after intervention. Another secondary parameter which will be evaluated is the cost of the intervention. | — |
Countries
Netherlands