EVLA and Optimal Timing of Sclerotherapy (FinnTrunk)

Turku University Hospital (TYKS)

Status: Not yet enrolling

Conditions: Venous Reflux

Treatments: Procedure: Endovenous laser ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04774939

93 /1801/2020

Details and patient eligibility

About

The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.

Full description

The study inclusion criteria is patients with main trunk (VSM, SSV, AASV) reflux to be treated with EVLA, suffering C2-C3 varicose disease, age 18-years and no severe co-morbidities.

Patients with written consent will be randomized to two primary treatments groups; EVLA only and EVLA combined with sclerotherapy of varicose tributaries. The primary outcome is the requirement additional sclerotherapy on 3 month control visit. Other study outcomes are pain, quality of life (veins questionnaire), severity score and also recurring of varicose disease at 1, 3 and 5 years.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Varicose disease of lower extremity caused by reflux of VSM, SSV or AASV to be treated with EVLA. Age over 18 years. Clinical symptoms C2-3.

Exclusion criteria

• No severe comorbidities. Previous DVT.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

EVLA only

Active Comparator group

Description:

Only main trunk/trunks with venous reflux will be treated

Treatment:

Procedure: Endovenous laser ablation

EVLA and sclerotherapy of tributaries

Active Comparator group

Description:

Main trunk/trunks with venous reflux will be treated combined with foam sclerotherapy

Treatment:

Procedure: Endovenous laser ablation