Viljamaa J, Firoozi K, Venermo M, Pokela M, Pihlaja T, Halmesmäki K, et al. (2023) 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 18(5): e0285823. https://doi.org/10.1371/journal.pone.0285823
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
|Author:||Viljamaa, Jaakko1; Firoozi, Khalil1; Venermo, Maarit2;|
1University of Turku, Turku, Finland, Department of Vascular Surgery, Turku University Hospital, Turku, Finland
2Department of Vascular Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland
3Department of Vascular Surgery, Oulu University Hospital, Oulu, Finland, University of Oulu, Oulu, Finland
4University of Turku, Turku, Finland, Department of Vascular Surgery, Turku University Hospital, Turku, Finland, Satasairaala, Pori, Finland
|Online Access:||PDF Full Text (PDF, 0.7 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe20230926137410
Public Library of Science,
|Publish Date:|| 2023-09-26
Background: Opinions on the treatment of varicose tributaries in relation to saphenous ablation in varicose disease vary. Moreover, the possible role of the tributaries regarding the recurrence of varicose disease remains unclear. The aim of the FinnTrunk study is to compare two different treatment strategies for varicose disease in a randomized setting. In group one, the initial treatment will entail endovenous laser ablation (EVLA) of the incompetent saphenous trunk without tributary treatment. In group two, the varicose tributaries will be treated with ultrasound-guided foam sclerotherapy (UGFS) concomitantly with truncal ablation. The primary outcome measure is the need for additional procedures during the follow-up. The secondary outcome measures are the cost of treatment and recurrence of varicose disease.
Methods: Consecutive patients with symptomatic varicose disease (CEAP clinical class C₂–C₃) will be screened for the study. Patients who fulfil the study criteria and give their informed consent will be scheduled for the procedure and randomized to either study group. Patients will be followed-up at 3 months, 1 year, 3 years, and 5 years. The post-procedure pain score based on a numeric rating scale (NRS) and also the use of analgesics, as well as possible procedure-related complications will be recorded at 3 months. Patient-reported outcome measures (PROMs) will be recorded at 1 year. Data pertaining to the additional treatment of varicose tributaries, the Aberdeen Varicose Vein Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and the health-related quality of life (EQ-5D-5L) will be collected at each follow-up visit. A duplex ultrasound (DUS) examination will be performed at each visit, and data on varicose tributaries and the need for additional treatment will be recorded.
Trial registration: Registered on ClinicalTrials.gov, ID NCT04774939.
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3121 General medicine, internal medicine and other clinical medicine
The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. H.H. Varsinais-Suomen Rahasto, Award number: 85211811 H.H. Satasairaala, Pori (federal fund), Award number: (None).
© 2023 Viljamaa et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.