Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein

Shadid N, Ceulen R, Nelemans P, et al (Maastricht Univ Med Centre, The Netherlands; Albert Schweitzer Hosp, Dordrecht, The Netherlands; Maastricht Univ, The Netherlands; et al) Br J Surg 99:1062-1070, 2012^§

Abstract

Background

New minimally invasive treatment modalities, such as ultrasound-guided foam sclerotherapy (UGFS), are becoming more popular. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared.

Methods

Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life (EQ-5D™), adverse events and direct hospital costs.

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