A randomized trial of class II compression sleeves for full legs versus stockings after thermal ablation with phlebectomy

Abstract

Objective: Compression stockings and bandages are widely used after invasive treatment of varicose veins. The goals of compression after venous interventions are to reduce pain, bruising, and ecchymosis. Nevertheless, patients often report discomfort with the compression. To make postprocedural compression more tolerable, foot-sparing bandages were tested in a randomized clinical trial of noninferiority.

Methods: A total of 187 patients were randomized to use class II foot-sparing compression sleeves for the full leg or class II stockings after radiofrequency ablation with concomitant phlebectomy. The primary endpoint was the quality of life, measured using the Chronic Venous Disease Quality of Life Questionnaire 20-item scale 30 days after intervention. The secondary endpoints were pain in the leg and discomfort related to the compression garment, which were assessed using the visual analog scale (VAS) at 2, 7, 14, and 30 days.

Results: The global index score of the questionnaire was 66.1 and 70.6 and 83.8 and 87.7 for the sleeve and stocking groups before and 30 days after intervention, respectively (P = .542 and P = .150, respectively). The VAS for pain score in the operated leg was slightly higher in the sleeve group the day after the intervention (score, 2.1 vs 1.6; P = .03). At 7, 14, and 30 days, the VAS for pain scores did not differ significantly (score, 0.7 vs 0.5; 0.5 vs 0.3; and 0.1 vs 0.1, respectively; P = NS for all). The VAS for discomfort score was not significantly different statistically in the study group at 2 days (sleeve, 1.9; vs stocking, 1.4; P = .08) but was higher after 7 days (sleeve, 0.9; vs stocking, 0.6; P = .008). No difference in discomfort was found between the study and control groups at 14 or 30 days (sleeve, 0.6; vs stocking, 0.4; and sleeve, 0.4; vs stocking, 0.4, respectively; P = NS for both).

Conclusions: Quality of life after thermal ablation with phlebectomy improved equivalently in patients who had used class II compression sleeves for full legs and those who had used class II compression stockings. Pain and discomfort were slightly higher in the sleeve group.

Trial registration: ClinicalTrials.gov NCT03477227.

Keywords: Chronic venous disease; Compression; Sleeves for full legs; Stockings; Varicose veins.