FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins

• quality of life (as measured by EuroQol-5D) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• patient preferences (as measured by conjoint analysis) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• direct Health care costs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  materials, operation costs, personnel costs

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.

• Procedure: high ligation and stripping (surgery)
  surgery consisting of high ligation in combination with long saphenous stripping
• Procedure: FOAM
  duplex guided foam sclerotherapy

• Active Comparator: high ligation and stripping
  surgery consisting of high ligation in combination with long saphenous stripping
  Intervention: Procedure: high ligation and stripping (surgery)
• Active Comparator: duplex guided foam sclerotherapy
  duplex guided foam sclerotherapy
  Intervention: Procedure: FOAM

Inclusion Criteria:

• incompetence of great saphenous vein for minimal 20 cm
• life expectancy at least 3 years
• open and competent deep venous system
• willing to undergo both treatments

Exclusion Criteria:

• active ulcer
• signs of deep venous thrombosis with duplex
• incompetence of the deep venous system