Comparison of foam sclerotherapy versus radiofrequency ablation in the treatment of primary varicose veins due to incompetent great saphenous vein: Randomized clinical trial

( )Background and Objective: Minimally invasive procedures such as foam sclerotherapy and radiofrequency ablation (RFA) have gained attention for treatment of incompetent great saphenous vein (GSV). The objective of this study was to compare recurrence rate and quality of life between foam sclerotherapy and RFA in patients with incompetent GSV varicose veins. Methods: In this parallel single-blinded randomized clinical trial, 60 adult patients with primary varicose veins due to incompetent GSV (CEAP classes C2-4EPAsPr) were included and randomly divided to receive RFA or foam sclerotherapy. Health-related quality of life (HRQOL) was assessed by the Short Form 36, and the Aberdeen Varicose Vein Questionnaire (AVVQ) was applied to assess the impact of varicose veins on quality of life of the patients. In addition, pain severity after the procedures was investigated by a visual analog scale (VAS) (range, 0 to 10). The patients were followed at 1 week, 1 month, 3 months, and 6 months postoperation. GSV reflux and recurrence was assessed by color Doppler ultrasound examination after 6 months. Results: Twenty-eight patients in RFA and 27 patients in foam sclerotherapy remained for the final analyses. The time interval from the procedure and recovery to daily normal activities was 1 day in both groups. Mean (+/- SD)pain VAS score in RFA group decreased from preintervention score of 7.35 (+/- 3.28) to 1.21 (+/- 0.68); P < .0001. Likewise, this score decreased from 6.64 (+/- 2.04) to 1.29 (+/- 0.91) in foam sclerotherapy group. HRQOL scores increased gradually at 1, 3, and 6 months after the intervention. AVVQ scores decreased significantly 1 week postintervention in both groups. After 6 months, 17.9% ( 5 patients) in RFA group and 14.8% (4 patients) in foam sclerotherapy group had recurrence of GSV reflux (P = .52). Conclusion: Both foam sclerotherapy and RFA were effective in treatment of GSV reflux. Comparable findings were observed between the 2 groups regarding postoperative pain, recovery time, HRQOL, and AVVQ scores.