NCT00621062已完成不适用
Randomized Prospective Trial of Varicose Vein Surgery
Uppsala University2 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.
研究概览
简要总结
Through a prospective RCT evaluate and compare the three new endovenous methods for great saphenous vein ablation (Radiofrequency, endovenous laser and foam sclerotherapy) versus high ligation and stripping. Procedure (proof-of-concept) and patient related (clinical outcome) factors will be studied.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical examinations by an experienced surgeon as well as duplex evaluation. Duplex evaluation of both the deep and the superficial system is required but not of the perforating vessels. It is performed by experienced BMA or surgeon with profound knowledge in vein diagnosis with duplex.
- •Patients with primary varicose vein disease between age 18 to
- •Signature of informed consent.
- •Varicose veins and duplex verified GSV incompetence defined as >0,5 seconds reflux time after manual compression in upright position 60 degrees.
- •Vein size <20 mm in upright position 60 degrees, 2 cm below the SFJ.
- •Minimum distance between skin and the GSV in the first 20 cm from the SFJ > 5mm.
- •CEAP classification C2-C5
排除标准
- •Non-consent for randomisation.
- •Age <18 years.
- •Age >75 years.
- •Deep vein insufficiency in the same extremity (duplex verified).
- •Vein size >20mm in upright position 60 degrees below the SFJ.
- •Meander and superficial veins with a distance of <5mm to the skin surface ( RF or Laser cannot be applied).
- •Patients with double GSV's and/or lateral accessory insufficient branch.
- •Patients with cognitive disturbances, dementia or unable to understand for any reason the importance of follow up.
- •Earlier operation with HL/S (recurrency).
- •Operated for small saphenous vein (SSV) incompetence the last 3 months.
- •Known ABI <0,9 or history of intermittent claudication or peripheral pulselessness (clinical examination)in either extremity.
- •Patients with recent cancer diagnosis or undergoing cancer treatment.
- •Patients with other known medical condition that contradict any of the treatments in the study.
- •Minimum distance between skin and the GSV in the first 20 cm from the SFJ >5mm.
结局指标
主要结局
Recurrence rate and complications after venous surgery. Duplex ultrasound and clinical evaluation.
时间窗: 3 years
次要结局
- Quality of Life with SF36, Aberdeen Vein Score, VCSS and Visual Analogue Scale Scoring.(3 years)
研究者
研究点 (2)
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