Endovenous RFA Versus Ligation and Striping for Varicose Veins

Study Overview
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Brief Summary
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Varicose vein is a common chronic disease affecting patient's quality of life. High ligation and stripping of the long saphenous vein is the traditional operation for varicose vein. The radiofrequency ablation (RFA) device used for treatment of varicose vein has been available in China since 2014. There are few studies comparing RFA and stripping in the treatment of varicose vein. This study was to investigate the outcomes of RFA and stripping for varicose vein. Patients with varicose veins will be prospectively allocated to RFA group and stripping group. Ultrasound follow-up will be performed to assess recanalization of long saphenous vein at 1 month, 3, 6 and 12 months. Recurrence of varicose vein and improvement of symptoms will also be evaluated. The primary endpoints are technical success, complications and recurrence of varicose vein. Secondary endpoints are duration of operation, blood loss, recovery time, venous clinical severity score, and medical cost. The treatment outcomes will be compared between the RFA group and stripping group. RFA is comparable to traditional stripping in the treatment of varicose vein, however, it is associated quick recovery, lower incidence of complications and higher medical cost.

Official Title
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Endovenous Radiofrequency Ablation Versus High Ligation and Striping for Treatment of Varicose Veins: a Prospective Controlled Trial

Conditions
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Varicose Veins of Lower Limb

Intervention / Treatment
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* Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of long saphenous varicose veins Exclusion Criteria: Contraindicated to operation due to severe comorbidities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High ligation and stripping<br>High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins | Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)<br>* Thermal injury to long saphenous vein<br>* Other names: ClosureFast, Medtronic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Occlusion of the long saphenous vein | up to 24 months | 
| Complications | Deep vein thrombosis, skin burn | 2 weeks after operation | 
| Recurrence of varicose vein | Recurrence of varicose vein | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency ablation, High ligation and striping