Comparison of LAser, Surgery and foam Sclerotherapy

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Trial purpose

Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins.

Background

The treatment of patients with varicose veins results in a considerable workload and financial burden to the NHS. Visible varicose veins occur in up to 40% of men and 32% of women, resulting in approximately 95,000 operations being performed each year in England alone, approximately 20% of these operations are for recurrent varicose veins.

Throughout the United Kingdom there are considerable variations in access to treatment for uncomplicated varicose veins as it may be believed to be a cosmetic procedure. The evidence to support this belief is mixed and a recent randomised controlled trial of surgery versus conservative management of patients with uncomplicated varicose veins estimated that the incremental cost per QALY gained was £4682, with a 70 percent probability that the cost per QALY would be less than NICE’s threshold of £20,000.

Objectives

Primary objective: To compare the clinical and cost-effectiveness of conventional surgery with two minimally invasive treatment modalities (a) foam sclerotherapy alone of main long or short saphenous trunk and non-trunk varicosities and (b) Endovenous laser ablation (EVLA) of main trunk including foam sclerotherapy of non-trunk varicosities performed under local anaesthetic in respect of quality of life for each intervention at 6 months (and ultimately through to 5 years) and cost-effectiveness as cost per quality adjusted life year (QALY) gained.

Secondary objectives are to compare the two novel interventions against conventional surgery in respect of: 

  • Clinical success as determined by residual varicose veins, Venous Clinical Severity Score, complication rates and return to normal activities. 
  • Technical success (duplex scan verified partial or complete ablation of the main long or short saphenous trunk veins) at 6 months (and ultimately through to 5 years). In addition, any development of deep venous incompetence and neovascularisation up to 5 years. 
  • Cost to the health service and patients of each intervention and any subsequent care.