Randomised Controlled Trial Comparing Sapheno-Femoral Ligation and Stripping of the Great Saphenous Vein with Endovenous Laser Ablation (980 nm) Using Local Tumescent Anaesthesia: One Year Results

Objectives: Comparison of sapheno-femoral ligation and stripping (SFL/S) versus endovenous laser ablation (EVLA, 980-nm) in the treatment of great saphenous vein (GSV) insufficiency, using local tumescent anaesthesia. Design: Randomised, single centre trial. Materials and methods: Patients with GSV incompetence and varicose veins were randomised to either SFL/S or EVLA. At days 1, 2, 3, 7, 10, and 14 post-treatment, patients completed questionnaires on pain and quality of life. Recurrent varicose veins were evaluated by Duplex ultrasound (DUS) performed at 1 and 6 weeks, and 6 and 12 months. Results: 130 legs in 121 patients were treated by SFL/S (n = 68) or EVLA (n = 62). Significantly more post-treatment pain was noted after EVLA at days 7, 10 and 14 (p < 0.01; p < 0.01; p = 0.01), more hindrance in mobility at days 7 (p < 0.01) and 10 (p = 0.01), and in self care (p = 0.03) and daily activities (p = 0.01) at day 7 compared to SFL/S. DUS at 1-year follow-up showed 9% recurrences (5/56) after EVLA and 10% (5/49) after SFL/S. Conclusion: Both SFL/S and EVLA, using local tumescent anaesthesia, were well tolerated, with no difference in short-term recurrence rate. In the second week after EVLA, patients experienced significantly more pain resulting in restricted mobility, self care and daily activity compared to SFL/S. (C) 2010 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.