Comparative Randomized Clinical Study to Evaluate the Efficacy of Radiofrequency vs Surgical Technique of Internal Saphenous Vein Stripping and CHIVA Technique in the Treatment of Chronic Venous Insufficiency.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Absence of venous reflux
研究概览
简要总结
Randomized controlled clinical trial aimed to compare the effectiveness and safety of radiofrequency, saphenous vein stripping and conservative hemodynamic treatment of venous insufficiency (CHIVA) in the treatment of saphenous varicose veins, in terms of absence of saphenous vein reflux, patient quality of life and post-surgical complications.
详细描述
A randomized controlled trial will compare three surgical techniques (stripping, CHIVA and radiofrequency) for the treatment of varicose veins which are currently considered interchangeable standards of care.
The trial will include symptomatic patients with chronic venous insufficiency and saphenous vein insufficiency confirmed by Doppler with diameter greater than 4 mm.
Clinical assessments will be made on first and seventh day after surgery, and then at months 1, 6, 12 and 24. The primary endpoint of the study is the absence of venous reflux in the great saphenous vein segment above-knee. Secondary variables will include VAS for pain and quality of life as assessed by the SF 36 and CIVIQ questionnaires validated in Spanish language. Ultrasound scans will be done the first week and after 1, 6, 12 and 24 months. Intra- and postoperative complications will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insufficiency of internal major saphenous vein, confirmed by diameter greater than or equal to 4 mm, assessed by Eco- Dupplex.
- •Age > 18 years
- •Informed consent
排除标准
- •Recurrent varicose veins
- •Post-thrombotic syndrome.
- •Patients with active malignancies or severe ischemic heart disease.
- •Serious liver disease
- •Thrombophilia.
- •Serious psychiatric diseases
研究组 & 干预措施
Saphenous vein stripping
Saphenous venous stripping surgical technique
干预措施: Saphenous vein stripping (Procedure)
CHIVA
conservative hemodynamic treatment venous insufficiency (CHIVA)
干预措施: CHIVA (Procedure)
Radiofrequency
Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
干预措施: Radiofrequency (Procedure)
结局指标
主要结局
Absence of venous reflux
时间窗: 2 years
Absence of venous reflux by duplex ultrasound
次要结局
- CIVIQ(2 years)
- SF-36(2 years)
- VCSS(2 years)
- Surgical complications(1 month)
研究者
Elena González Cañas
MD, PhD
Corporacion Parc Tauli