Randomized controlled trial of endovenous N-butylcyanoacrylate endovenous nonthermal ablation and radiofrequency endovenous thermal ablation for incompetent great saphenous veins / 中华普通外科杂志

ABSTRACT

Objective:To evaluate the safety and efficacy of n-butyl cyanoacrylate (NBCA) in treating great saphenous vein(GSV) incompetence.Methods:60 patients (60 limbs) with GSV incompetence were randomly divided into NBCA glue group (30 cases) and radiofrequency ablation(RFA) group in 30 cases. The clinical outcomes, venous clinical severity score(VCSS), and quality of life using the Aberdeen varicose vein questionnaire(AVVQ) were evaluated. The primary endpoint is the occlusion rate of GSV at 3 months after surgery.Results:For the two groups, the occlusion rate of GSV was 100% immediately after surgery and at 3 months follow-up. AVVQ and VCSS were improved in the two groups( P<0.05). In terms of complications, the NBCA group had scleroma in 3 cases, pain and skin redness in 1 case respectively, but no ecchymosis and numbness. In the RFA group, numbness occurred in 1 case, skin redness in 2 cases, scleroma in 3 cases, ecchymosis and pain in 4 cases respectively. The incidence of ecchymosis and total complications in the NBCA group was significantly lower than that in the RFA group( P<0.05). No DVT or other adverse event occurred in both groups. Conclusion:NBCA and RFA have the same short-term closure rate. Furthermore, the NBCA treatment requires less equipment, no use of tumescent anesthetic, and has lower incidence in terms of complications than that of RFA.