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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Oulu University Hospital | OTHER |
| Tampere University Hospital | OTHER |
| Päijänne Tavastia Central Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVLA only | Active Comparator | Only main trunk/trunks with venous reflux will be treated |
|
| EVLA and sclerotherapy of tributaries | Active Comparator | Main trunk/trunks with venous reflux will be treated combined with foam sclerotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovenous laser ablation | Procedure | The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications | Infections, DVT, Pulmonary embolus will be reported | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Harri Hakovirta, Professor | Contact | +358405918811 | haheha@utu.fi | |
| Khalil Firoozi, MD | Contact | +35823130000 | khalil.firoozi@tyks.fi |
| Name | Affiliation | Role |
|---|---|---|
| Harri Hakovirta, Professor | University of Turku | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | 20520 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37220130 | Derived | 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.pone.0285823. eCollection 2023. |
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| OTHER |
| Satasairaala | OTHER |
| Vaasa Central Hospital, Vaasa, Finland | OTHER |
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