Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
350 participants
INTERVENTIONAL
2021-03-15
2030-03-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EVLA only
Only main trunk/trunks with venous reflux will be treated
Endovenous laser ablation
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
EVLA and sclerotherapy of tributaries
Main trunk/trunks with venous reflux will be treated combined with foam sclerotherapy
Endovenous laser ablation
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
Interventions
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Endovenous laser ablation
The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Oulu University Hospital
OTHER
Tampere University Hospital
OTHER
Päijänne Tavastia Central Hospital
OTHER
Satasairaala
OTHER
Vaasa Central Hospital, Vaasa, Finland
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Khalil Firoozi
MD
Principal Investigators
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Harri Hakovirta, Professor
Role: STUDY_CHAIR
University of Turku
Locations
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Turku University Hospital
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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93 /1801/2020
Identifier Type: -
Identifier Source: org_study_id
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