FOAM-study. Cost minimization study comparing surgery versus duplex guided foam sclerotherapy of varicose veins: a randomized controlled study

OBJECTIVE(S) / RESEARCH QUESTION(S): Varicose vein disease is a common health problem, which causes much discomfort to patients. Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population. Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins. STUDY DESIGN: a randomized controlled study STUDY POPULATION(S)/ DATASETS: patients referred to the outpatient department of either the dermatological or the surgical department of the university hospital Maastricht, the Laurentiushospital Roermond and the Atrium hospital Heerlen. INTERVENTION: surgery (stripping) versus duplex guided foam sclerotherapy OUTCOME MEASURES: The primary outcome measure is the cumulative probability of recurrent varicose vein within 24 months after treatment. Secondary outcome measures are quality of life (as measured by EuroQol-5D), patient preferences (as measured by conjoint analysis) and costs. POWER/DATA ANALYSIS: The number of patients needed per group (surgery vs duplex guided foam sclerotherapy) is estimated to be n=200. ECONOMIC EVALUATION: cost-minimization analysis with potentially cost savings of €339.328 per year for the adherence (=target) population of the University Hospital Maastricht. TIME SCHEDULE: 36 months: preparation (2 months), inclusion of patients (12 months), follow-up (18-24 months), analysis and reporting (4 months).