Endovenous RFA Versus Ligation and Striping for Varicose Veins

The University of Hong Kong-Shenzhen Hospital

Status: Unknown

Conditions: Varicose Veins of Lower Limb

Treatments: Device: Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)

Study type: Interventional

Funder types: Other

Identifiers

NCT04526626

HKUSZH201901013

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of long saphenous varicose veins

Exclusion criteria

• Contraindicated to operation due to severe comorbidities

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

High ligation and stripping

Experimental group

Description:

High ligation and stripping of long saphenous vein is the traditional standard procedure for the treatment of varicose veins

Treatment:

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