NCT03416413招募中4 期
Randomised Controlled Trial of Foam Sclerotherapy Versus Ambulatory Phlebectomy for the Treatment of Varicose Vein Tributaries
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Re-intervention rate
研究概览
简要总结
This study will be comparing the treatment of varicose vein tributaries using either foam sclerotherapy or ambulatory phlebectomies. Patients will be randomised to having either ambulatory phlebectomy (group A) or foam sclerotherapy (group B) following treatment of their saphenous vein.
The re-intervention rates, safety, patient experience as well as the cost effectiveness of each intervention will be assessed.
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
- •Adults over 18 years of age
- •Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
- •Varicose vein tributary requiring treatment
排除标准
- •Current DVT
- •Recurrent varicose veins
- •Arterial disease (ABPI<0.8)
- •Vein diameter < 3mm
- •Preference for one of the treatment options
- •Patient who are unwilling to participate
- •Inability or unwillingness to complete questionnaires
- •Inability to attend follow-up appointments
- •Patient currently included in a study of varicose vein treatment
研究组 & 干预措施
Ambulatory Phlebectomy
Active Comparator
Ambulatory phlebectomy of varicose vein tributaries
干预措施: Ambulatory phlebectomy (Procedure)
Foam Sclerotherapy
Active Comparator
Injection of foam sclerosant into varicose vein tributaries
干预措施: Foam sclerotherapy (Drug)
结局指标
主要结局
Re-intervention rate
时间窗: 12 months
Re-intervention on varicose vein tributaries during study period
次要结局
- Generic quality of life score(12 months)
- Disease specific quality of life score(12 months)
- Disease-specific quality of life score(12 months)
- Degree of bruising at 2 weeks(2 weeks)
- Time to return to normal activities(2 weeks)
- Pain score over the first 10 days(2 weeks)
- Clinical score(12 months)
研究者
研究点 (1)
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