Randomized Single Center Comparative Study of the Treatment of Insufficient Greater Saphenous Vein: Surgery vs Ultrasound Guided Sclerotherapy With Foam and Endovenous Laser Therapy
试验速览
- 阶段
- 3 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- anatomical success rate (absence or obliteration of GSV on US examination)
研究概览
简要总结
For more than 100 years, surgery has been the standard of care of varicose veins of the legs. The down side of surgery is that it requires anesthesia, leaves scars, and has a relatively high recurrence rate in the long term (up to 40%). In the last decade, several new techniques have become available but they have not yet been compared to surgery. This trail will evaluate the effectiveness, patients' perspective and cost effectiveness of surgery and non-invasive techniques such as ultrasound guided sclerotherapy with foam and endovenous laser therapy.
详细描述
Inclusion criteria:
- Ultrasound confirmed GSV insufficiency (reflux time >0.5 second and vein diameter ≥0.5 cm)
- non-treated GSV varicosis
- CEAP -classification > C2 and As2
- >18 years old
- Informed consent.
Exclusion criteria:
- Acute venous thrombosis / phlebitis
- Absence of deep venous system
- Vascular syndromes
- Post-thrombotic syndrome of occlusive type
- Contra-indications for surgery
- use of anticoagulants
Primary outcomes:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary insufficient GSV confirmed by US: reflux>0.5 sec and diameter>0.5cm.
- •non-treated insufficient GSV
- •>18 years
- •informed consent
排除标准
- •acute thrombosis or phlebitis
- •absence of deep venous system
- •vascular syndromes
- •use of anticoagulants
- •contraindications surgery
研究组 & 干预措施
1
Surgery: crossectomy plus short stripping
干预措施: crossectomy and short stripping (Procedure)
2
ultrasound guided sclerotherapy with foam (3% polidocanol)
干预措施: ultrasound guided sclerotherapy with foam (Procedure)
3
Endovenous laser therapy (940 nm, about 70 J/cm)
干预措施: endovenous laser therapy (Procedure)
结局指标
主要结局
anatomical success rate (absence or obliteration of GSV on US examination)
时间窗: 3 months, 1 and 5 years
次要结局
- treatment related adverse events and complications(3 months, 1 and 5 years)
- patient reported outcomes (HRQOL and treatment satisfaction)(3 months, 1 and 5 years)
- cost effectiveness analysis(3 months, 1 and 5 years)