Endovenous laser ablation of the great saphenous vein using a bare fibre versus a tulip fibre: a randomised clinical trial.

ABSTRACT

OBJECTIVE: This clinical trial aimed to evaluate the clinical results of the use of a tulip fibre versus the use of a bare fibre for endovenous laser ablation. METHODS: In a multicentre prospective randomised trial 174 patients were randomised for the treatment of great saphenous vein reflux. A duplex scan was scheduled 1 month, 6 months and 1 year postoperatively. Ecchymosis was measured on the 5th postoperative day. In addition, pain, analgesics requirement, postoperative quality of life (CIVIQ 2) and patient satisfaction rate were noted. RESULTS: Patients treated with a tulip fibre had significantly less postoperative ecchymosis (0.04 vs. 0.21; p < 0.001) and pain (5th day) (1.00 vs. 2.00; p < 0.001) and had a better postoperative quality of life (27 vs. 32; p = 0.023). There was no difference in analgesic intake (p = 0.11) and patient satisfaction rate (p = 0.564). The total occlusion rate at 1 year was 97.02% and there was no significant difference between the two groups (p = 0.309). CONCLUSION: Using a tulip fibre for EVLA of the great saphenous vein results, when compared with the use of a bare fibre, in equal occlusion rates at 1 year but causes less postoperative ecchymosis and pain and in a better postoperative quality of life.