Foam sclerotherapy of the saphenous veins: randomised controlled trial with or without compression.

OBJECTIVES This study aims to compare the efficacy and side effects of foam sclerotherapy of the saphenous veins with or without post-treatment compression using graduated elastic stockings. DESIGN This is a prospective open randomised controlled trial conducted in two centres. PATIENTS AND METHODS Sixty patients with incompetent great (GSV) or small saphenous veins (SSV) underwent ultrasound-guided foam sclerotherapy. Randomisation was conducted immediately after sclerotherapy to two parallel groups, one (CG) with compression stockings (15-20 mmHg worn during the day, for 3 weeks) and the other (WCG) without compression. Efficacy of sclerotherapy and all of the side effects were assessed, including side effects in the treated region. On days 14 and 28, clinical and duplex ultrasound (DUS) assessments were performed by independent experts. Patients also completed quality of life (QOL), symptom questionnaires and provided satisfaction scores. RESULTS Five men and 55 women ranging in age from 32 to 78 (mean 57 years) years were included: 29 in the WCG and 31 in the CG group. On day 28, abolition of venous reflux and occlusion of the vein was obtained in 100% of the cases in both groups. The length of the occluded vein was the same in both groups (mean 36 cm for the GSV and 30 cm for the SSV) as was the mean diameter of the occluded vein (5 mm). Symptoms and QOL questionnaires showed equivalent improvement in both groups on day 28 compared to pre-treatment assessments. Side effects were few with no statistical difference between the two groups. Patient satisfaction scores were high in both groups for the outcome of sclerotherapy results, and good or very good for compression in 50% of the CG cases. CONCLUSION We found no difference between compression and control groups when comparing efficacy, side effects, satisfaction scores, symptoms and QOL. Further studies are required to establish the role of compression in sclerotherapy and to evaluate other compression strategies.