A Double Blind Randomised Controlled Trial of Radiofrequency Thermo-ablation Treatments of Great Saphenous Varicose Veins: Venefit (Closurefast) vs. Radiofrequency Induced Thermal Therapy (RFITT) vs. Endovenous Radiofrequency (EVRF).

Purpose To establish which of the radiofrequency venous ablation modalities is most effective in preventing reflux in the treated segment of GSV six months following surgery.

Design Results of randomised trials and meta-analyses have shown that endovenous thermal ablation using radiofrequency ablation and laser are associated with improved recovery compared with conventional surgery on the GSV. Further, radiofrequency (Closurefast) has been showed to cause less pain and require less analgesic intake than laser. There are two other radiofrequency devices that have theoretical advantages over the Closurefast technique. All three procedures have been used in clinical practice (including at Worcestershire Royal Hospital). There has been no trial to date which has directly compared the outcomes of the three radiofrequency thermal ablation devices.

Recruitment Patients will be recruited from Worcestershire Acute Hospitals NHS Trust vascular surgical out-patient clinics. All patients will receive a duplex scan (Toshiba Viamo Ultrasound, Tokyo, Japan or Sonosite M-Turbo Bothell, Washington, USA) prior to entry into the trial to confirm their suitability for endovenous thermal ablation treatment. During this assessment patients will also have their CEAP (Clinical, Etiological, Anatomical, and Pathophysiological) classification of severity and aetiology of venous disease score recorded. If the patient consents to the trial they will be asked to fill in the disease specific Aberdeen Varicose Vein Questionnaire (AVVQ)and generic quality of life SF-36 and Euroquol (EQ-5D) questionnaires and have their Venous Clinical Severity Score (VCSS) calculated.

Patients will be recruited to the trial following an appropriate explanation of the study (see patient information / consent sheet). Randomisation will be performed by a random number generator (www.random.org).

Patients will be randomised to radiofrequency ablation either by Closurefast (Venefit, VNUS Medical Technologies, Inc., Sunnyvale, CA), the Radiofrequency induced Thermal Therapy (RFiTT, Olympus Surgical Technologies Europe, Hamburg, Germany) or EndoVenous Radiofrequency (EVRF, Medical Innovations, Bolton, United Kingdom). All treatments are already in use in Worcestershire.