Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins

Abstract

Background: Endovenous laser ablation (EVLA) is a minimally invasive technique for treating varicose veins due to truncal vein incompetence. This randomized trial compared EVLA with conventional surgery in patients with primary saphenofemoral and great saphenous vein (GSV) reflux. Methods: Consecutive consenting patients with symptomatic varicose veins were randomized to EVLA 1 (stepwise laser withdrawal), EVLA 2 (continuous laser withdrawal) or surgery (saphenofemoral ligation, GSV stripping, multiple phlebectomies). Principal outcome measures were abolition of GSV reflux and improvement in Aberdeen Varicose Vein Symptom Score (AWSS) 3 months after treatment. Results: GSV reflux was abolished in 41 of 42 legs treated with EVLA 1, 26 of 29 following EVLA 2 and 28 of 32 after surgery (P = 0.227). The median (interquartile range, i.q.r.) AWSS improvement was similar: 9.38 (4.54-14.93) with EVLA 1, 10.26 (5.03-15.03) after EVLA 2 and 8.36 (4.54-13.21) following surgery (P = 0.694). Return to normal activity (median (i.q.r.) 2 (0-7) versus 1 (2-26) days; P = 0-001) and work (4 (2-7) versus 17 (7.25-33.25) days; P = 0.005) was quicker after EVLA by either method. Conclusion: Abolition of reflux and improvement in disease-specific quality of life was comparable following both EVLA and surgery. The earlier return to normal activity following EVLA may confer important socioeconomic advantages. Registration number: ISRCTN99270116 (http://www.controlled-trials.com). Copyright © 2008 British Journal of Surgery Society Ltd.