EVLA and Optimal Timing of Sclerotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endovenous laser ablation.
- Who it may be relevant to
- Registry conditions: Venous Reflux. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
FinnTrunk, EVLA and Optimal Timing of Sclerotherapy
Overview
The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.
Detailed 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.
Interventions
- Procedure Endovenous laser ablation
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
Primary outcome measures
- re-intervention [Time frame: 3 months]
- Pain after procedure [Time frame: up to 3 months after the treatment]
- Quality of life before after procedure [Time frame: up to 5 years]
- Recur [Time frame: up to 5 years]
Secondary outcome measures (1)
- Surgical complications [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Turku University Hospital — Turku
Publications
- Viljamaa J, Firoozi K, Venermo M, Pokela M, Pihlaja T, Halmesmaki K, Hakovirta H. A study protocol for comparing the treatment of varicose tributaries either concomitantly with or separately from endovenous laser ablation of the incompetent saphenous trunk (the FinnTrunk Study). A multicenter parallel-group randomized controlled study. PLoS One. 2023 May 23;18(5):e0285823. doi: 10.1371/journal.pon PMID 37220130
Identifiers
NCT: NCT04774939 · 93 /1801/2020