Delayed or Immediate Local Treatment of Veins

Helsinki University Central Hospital140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Varicose Veins Leg

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Need for sclerotherapy

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.

Time frame: 3 months

Secondary Outcomes

Patient satisfaction

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.

Time frame: 3 months

Occlusion rate of great saphenous vein

Long-term occlusion rate of main trunk after mechanochemical ablation, evaluated by duplex ultrasound.

Time frame: 36 months