Long Term Study of 3 Radiofrequency Devices

Study Overview
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Brief Summary
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To establish which of the radiofrequency venous ablation modalities studied in the original 3RF study (Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency) is most effective in relieving patients' symptoms and signs from varicose veins disease, and in maintaining absence of reflux in the treated vein segment (of the great saphenous vein (GSV)) 5 years following surgery.

Detailed Description
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Results of randomised trials and meta-analyses have shown that endovenous thermal ablation of the GSV using radiofrequency ablation or laser is associated with improved recovery compared with conventional surgery. Furthermore, radiofrequency ablation (using the Closurefast device) has been shown to cause less pain and require less analgesic intake than laser treatment. At the time the 3 RF study was conceived there were two other radiofrequency devices that were marketed to have theoretical advantages over the Closurefast technique. All three devices were in use in clinical practice (including at Worcestershire Royal Hospital) in 2013. The initial study focused on clinical results (up to 12 months) and anatomical results (up to 6 months) and remains the only clinical trial to date that has directly compared the outcomes of radiofrequency thermal ablation devices. This second (long term) phase of the study aims to assess which of the radiofrequency venous ablation modalities studied in the original 3RF study (Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency) is most effective in relieving patients' symptoms and signs from varicose veins disease, and in maintaining absence of reflux in the treated vein segment (of the great saphenous vein (GSV)) 5 years following surgery.

Official Title
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Long Term Outcomes of the Double Blind Randomised Controlled Trial of Radiofrequency Thermal Ablation Treatments of Great Saphenous Varicose Veins: Closurefast vs. RFITT vs. EVRF

Conditions
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Varicose Veins of Lower Limb

Intervention / Treatment
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* Diagnostic Test: Duplex imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881) who give informed consent to take part in this long term study Exclusion Criteria: Patients originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881) who do not give informed consent to take part in this long term study

Ages Eligible for Study
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Minimum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Closurefast<br>Patients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study | Diagnostic Test: Duplex imaging<br>* Completion of AVVQ and EQ5D questionnairs<br>* Other names: Completion of Quality Of Life Questionnaires;|
| Radiofrequency Induced Thermal Therapy (RFITT)<br>Patients who were randomised to and underwent radiofrequency ablation using the RFITT device in the original 3RF Study | Diagnostic Test: Duplex imaging<br>* Completion of AVVQ and EQ5D questionnairs<br>* Other names: Completion of Quality Of Life Questionnaires;|
| EndoVenous Radiofrequency (EVRF)<br>Patients who were randomised to and underwent radiofrequency ablation using the EVRF device in the original 3RF Study | Diagnostic Test: Duplex imaging<br>* Completion of AVVQ and EQ5D questionnairs<br>* Other names: Completion of Quality Of Life Questionnaires;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical assessment of ablation of treated GSV segment | Aanatomical assessment of total ablation of treated segment will be assessed: 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. | 5 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of recurrent varicose veins and or return of symptoms | Assessments using disease specific (AVVQ) and generic (EQ5D) quality of life scores by means of self-completed questionnaires completed at a single consultation. | 5 years after treatment |