Randomized clinical trial of radiofrequency-induced thermotherapy combined with transilluminated powered phlebectomy versus high ligation and stripping for the treatment of lower limb varicose veins.

OBJECTIVE

The objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP.

METHODS

The patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications.

RESULTS

The total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ2 = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other.

CONCLUSIONS

RFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.