EVLA and Optimal Timing of Sclerotherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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FinnTrunk, EVLA and Optimal Timing of Sclerotherapy

Conditions
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Venous Reflux

Intervention / Treatment
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* Procedure: Endovenous laser ablation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EVLA only<br>Only main trunk/trunks with venous reflux will be treated | Procedure: Endovenous laser ablation<br>* The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment<br>* Other names: Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries;|
| Active Comparator: EVLA and sclerotherapy of tributaries<br>Main trunk/trunks with venous reflux will be treated combined with foam sclerotherapy | Procedure: Endovenous laser ablation<br>* The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment<br>* Other names: Endovenous laser ablation combined with foam sclerotherapy of varicose tributaries;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| re-intervention | Requirement of re-intervention | 3 months | 
| Pain after procedure | Post procedural pain measured with VAS scale | up to 3 months after the treatment | 
| Quality of life before after procedure | Quality of life will be measured with Veins questionnaire | up to 5 years | 
| Recur | The recurring varicose veins | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Infections, DVT, Pulmonary embolus will be reported | 3 months |