• Eur J Vasc Endovasc Surg · Nov 2015

    Randomized Controlled Trial Multicenter Study Comparative Study

    Same Site Recurrence is More Frequent After Endovenous Laser Ablation Compared with High Ligation and Stripping of the Great Saphenous Vein: 5 year Results of a Randomized Clinical Trial (RELACS Study).

    • K Rass, N Frings, P Glowacki, S Gräber, W Tilgen, and T Vogt.
    • Department of Dermatology, Venerology and Allergology, Saarland University Hospital, Homburg, Germany; Eifelklinik St. Brigida, Vein and Skin Centre, Simmerath, Germany. Electronic address: knuth.rass@st-brigida.de.
    • Eur J Vasc Endovasc Surg. 2015 Nov 1;50(5):648-56.

    ObjectiveTo compare the long-term clinical efficacy of endovenous laser ablation (EVLA) with high ligation and stripping (HLS) as standard treatment for great saphenous vein (GSV) incompetence.DesignInvestigator initiated two centre randomized controlled trial with 5 year follow up.Materials And MethodsInterventions were performed on ambulatory and hospitalized patients at two vein centres, a university dermatology department (EVLA) and a specialized vein clinic (HLS). Four hundred patients suffering from GSV incompetence were assigned to EVLA or HLS of the GSV. One hundred and eighty five and 161 patients (=limbs), respectively, were treated per protocol. Main outcome measures were clinically recurrent varicose veins after surgery (REVAS classification, primary study objective), Duplex detected saphenofemoral recurrence, clinical venous severity scoring (Homburg Varicose Vein Severity Score), quality of life (Chronic Venous Insufficiency Questionnaire 2), side effects, and patient satisfaction 5 years after treatment.ResultsTwo hundred and eighty one legs (81% of the study population) were evaluated with a median follow up of 60.4 (EVLA) and 60.7 months (HLS). Overall, REVAS was similarly observed in both groups: 45% (EVLA) and 54% (HLS), p = .152. Patients of the EVLA group showed significantly more clinical recurrences in the operated region (REVAS: same site): 18% vs. 5%, p = .002. In contrast, more different site recurrences were observed in the HLS group: 50% vs. 31%, p = .002. Duplex detected saphenofemoral refluxes occurred more frequently after EVLA: 28% vs. 5%, p < .001. Both treatments improved disease severity and quality of life without any difference.ConclusionsEVLA and HLS are comparably effective concerning overall REVAS, improvement of disease severity, and quality of life. In terms of same site clinical recurrence and saphenofemoral refluxes, HLS is superior to EVLA 5 years after treatment.Clinical Trial RegistrationISRCTN18322872.Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

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