Varicose Veins Leg
Conditions
Keywords
Varicose veins, phlebectomy
Brief summary
Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism. This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.
Interventions
PROCEDUREDelayed sclerotherapy
See arm descriptions
PROCEDUREImmediate phlebectomy
See arm description
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Ultrasound verified insufficiency of great saphenous vein (GSV) * GSV diameter 5-10 mm * C2-C4 varicosities * Most proximal insufficient branch in the distal thigh * Written and signed informed consent
Exclusion criteria
* Peripheral arterial disease * Body mass index \>40 * Lymphoedema * Known allergy to sclerosant * Any known coagulopathy or history of deep vein thrombosis * Severe illness * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for sclerotherapy | 3 months | Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. \>C2 will be eligible for treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 3 months | Overall patient satisfaction and symptoms regarding varicosities and procedure at three months. Evaluated by the Aberdeen Varicose Veins Questionnaire (AVVQ). The AVVQ is a validated test, in which patients are asked to check boxes with regard to symptoms and quality of life (QoL). Scale 0-100, with 100 indicating worst possible QoL. |
| Occlusion rate of great saphenous vein | 36 months | Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound. |
Countries
Finland
Outcome results
None listed