跳至主要内容
临床试验/NCT04526626
NCT04526626Unknown不适用

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

The University of Hong Kong-Shenzhen Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Technical success

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of long saphenous varicose veins

排除标准

  • Contraindicated to operation due to severe comorbidities

结局指标

主要结局

Technical success

时间窗: up to 24 months

Occlusion of the long saphenous vein

Complications

时间窗: 2 weeks after operation

Deep vein thrombosis, skin burn

Recurrence of varicose vein

时间窗: up to 24 months

Recurrence of varicose vein

次要结局

未报告次要终点

研究者

发起方
The University of Hong Kong-Shenzhen Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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