Catheter-directed foam sclerotherapy with tumescence of the great saphenous vein versus ultrasound-guided foam sclerotherapy: A randomized controlled trial

Objectives To compare the effectiveness of two foam sclerotherapy techniques of the great saphenous vein. Methods Fifty subjects with varicose veins, edema, and great saphenous vein incompetence (diameter 6-10 mm) were randomly categorized into two equal groups and were treated with different foam sclerotherapy techniques: A (usual ultrasound-guided) and B (catheter-directed with tumescence). Concomitant phlebectomy was performed in all patients. Patients were seen on days 7 and 28, and at six and 12 months. The primary outcomes were the full success rate of the treated great saphenous vein and the number of patients who required retreatment sessions performed at 28-day follow-up. The secondary-assisted outcomes were the full success rates of the treated great saphenous vein after the retreatment sessions at six- and 12-month follow-up. Secondary outcomes were changes in quality of life and side effects and complications of the intervention. In case of reflux, retreatment sessions were performed at 28 days and six months in both groups. Results Full success rate of the treated great saphenous vein was 36% in group A vs. 80% in group B (p = 0.012) and the number of patients who required retreatment sessions were n = 14 in group A vs. n = 3 in group B at 28-day follow-up (p = 0.002). Both were statistically significant. At six and 12 months, the success rates were not statistically significant between the groups. Complication rates were similar between the groups. Quality of life improved in both groups with statistical difference (p < 0.001). Conclusions Catheter-directed foam sclerotherapy with tumescence was better than usual ultrasound-guided foam sclerotherapy as it reached higher full success rate of the treated great saphenous vein and as a lower number of patients required retreatment sessions in the short-term. Both methods proved to be safe and improved the quality of life.