Trial of Radiofrequency Thermo-ablation Treatments of Great Saphenous Varicose Veins (3-RF Study)
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      A double blind randomised controlled trial of radiofrequency thermal ablation treatments of
      great saphenous varicose veins: Venefit (Closurefast), vs. Radiofrequency induced Thermal
      Therapy vs. Endovenous Radiofrequency.

      Assessments by visual pain scores, duplex ablation and quality of life questionaires
    

Detailed description: 
      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.

      Operation All treatments will be performed under local tumescent anaesthesia. Patients will
      receive thromboprophylaxis when indicated in line with the Hospital Trust's local
      thromboprophylaxis protocol. Procedures will be performed under duplex control (Sonosite
      M-Turbo, Bothell, Washington, USA) by an experienced vascular surgery Specialist Registrar or
      Consultant. The GSV will be catheterised percutaneously using a Seldinger technique at the
      level of the lowest point of reflux. The radiofrequency treatment catheter will be passed
      endoluminally to the level of the sapheno-femoral junction. Tumescent anaesthesia (50mg
      Prilocaine, 10mls 8.4% sodium bicarbonate in 1000mls 0.9% saline) will be injected in the
      peri-venous space in all patients (200 - 500ml). The position of the radiofrequency catheter
      will be confirmed just below the level of the sapheno-femoral junction prior to commencing
      the radiofrequency current and withdrawing the catheter to treat the vein in line with local
      practice. The Closurefast is withdrawn after a double treatment of the most proximal segment
      of the long saphenous vein and then segmentally thereafter, the RFiTT will be withdrawn
      continuously with retreatments, and the EVRF will be withdrawn in small stepwise movements
      (all as per the manufacturer's instructions for use). The volume of anaesthetic administered,
      length of vein treated and duration of the ablation will be recorded.

      In line with current NICE guidance (CG168), where necessary, patients will undergo avulsions
      of local varicosities at the same time. The number of avulsions will be recorded in both
      groups. Perforating veins will not be directly treated. Treated legs will be dressed with
      dressing pads a full length bandage (coban, 3M United Kingdom plc, Bracknell, Berkshire, UK)
      and compression hosiery. Patients will be discharged on the day of surgery (day-case) with
      oral analgesia as required and will be given contact information should any adverse events
      arise.

      Post-operative follow-up

      i) First week Patients will be asked to keep a pain score for the first post-operative week.
      This is a simple 10cm visual analogue score. All patients will be invited back to clinic at
      two weeks for a duplex scan (blind assessment). During this visit the vascular team will
      assess any complications in the area of ablation including bruising (digital photographic
      record), wound infection, neuralgia, deep vein thrombosis and pulmonary embolus.

      ii) Six months The primary endpoint of the study is an ablated GSV. Treatment failure will be
      defined as any segment of the treated trunk (> 2cm from the saphenofemoral junction) that is
      patent (compressible) and demonstrates reflux (>1 second) on duplex scanning.

      A number of secondary outcome measures will be evaluated in the study:

      Pain score/ analgesic requirements

      Time to return to normal activity

      Absence or recurrent varicose veins/return of symptoms

      Quality Of Life (QoL): Disease specific (AVVQ) and generic (EQ5D & SF36) quality of life
      assessments will be compared at 1 weeks post treatment, 6 months and 12 months. The 1-week
      questionnaire will be given to the patient at discharge, whereas other QoL questionnaires
      will be sent to the patient. AVVQ is the most widely utilised disease specific QoL tool in
      venous disease and has been extensively validated. A score out of 100 points is calculated,
      with a higher score indicating more severe QoL impairment.

      Other Markers Of Clinical Success: The Venous Clinical Severity Score (VCSS) will be assessed
      at 6 months. In addition, the incidence of complications related to the endovenous
      intervention as well as the presence of residual / recurrent varicose veins will also be
      assessed at 2 weeks.

      Medium and longer-term endpoints (follow-up) will be performed at 2 years and 5 years.
      However, this is likely to be limited by the high rates (>20%) of drop-out reported in other
      studies.
    

Intervention name(s): Venefit; Radiofrequency Induced Thermal Therapy; Endovenous Radiofrequency
Intervention type(s): Device; Device; Device
Intervention description(s): Endovenous radiofrequency device; Endovenous radiofrequency device; Endovenous radiofrequency device
Other intervention name(s): Closurefast; RFITT; EVRF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Radiofrequency ablation; varicose veins; endothermal ablation; RFITT; Venefit