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.

RCT Entities:   Population Interventions Outcomes