A prospective randomised controlled trial of VNUS closure versus surgery for the treatment of recurrent long saphenous varicose veins

Abstract

Objective: This study aimed to assess the outcome of endoluminal thermal ablation (VNUS) and traditional redo groin surgery (RGS) and long saphenous vein (LSV) stripping in patients with bilateral recurrent long saphenous varicose veins.

Methods: This was a randomised patient controlled double blind study. Sample size calculations required 16 patients. Their median age was 54 and 11 were women. The median CEAP class was 3. At operation one leg, chosen at random, was treated with VNUS and avulsions using intra-operative duplex control. The other leg was treated with traditional RGS, exposure of the femoral vein, stripping of the LSV and multiple avulsions. Post-operatively patients completed 10 cm visual analogue scales for pain and bruising. Digital Image analysis was used to objectively assess bruising. Statistical analysis was done using Wilcoxon signed rank test for paired data. Results are expressed as median values (inter-quartile ranges).

Results: Time to perform VNUS was 25.5 (20.5-31.3) min compared with 40 (34.5-45.5) min it took for RGS (p=0.02). Pain score for VNUS was 1.7 (0.2-4), significantly lower than that for RGS 3.8 (0.6-6.3) (p=0.02). Bruise score for VNUS was 1.7 (0.4-4.4), and that for RGS was 5.2 (2.6-7) (p=0.03). All LSVs were sealed by VNUS at duplex follow up. Three legs in the RGS group and two in the VNUS group had a minor complication.

Conclusions: VNUS caused less pain and bruising and was performed more quickly than RGS. VNUS should be considered the treatment of choice for recurrent long saphenous varicose veins.