COmpressioN Following Endovenous TreatmenT of Incompetent Varicose Veins (CONFETTI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Patient's pain score post-procedure using a visual analogue scale (VAS)
研究概览
简要总结
This study will be looking at the effect of compression therapy in patients having endovenous treatment for varicose veins using foam sclerotherapy. Patients will be randomised to either the compression group (group A) or the no compression group (group B).
The pain scores, compliance, quality of life scores, occlusion rate at 6 months as well as the cost effectiveness of each intervention will be assessed.
详细描述
This will be a randomised clinical trial looking at the impact of wearing or not wearing compression stocking following endovenous ablation using foam sclerotherapy.
Patients will be randomised to group A (compression) and group B (no compression).
Target Population Patients referred to the Imperial College NHS Trust for treatment of symptomatic varicose veins will be recruited if they are found to have varicose veins suitable for foam sclerotherapy on colour duplex scan.
Intervention
Patients will be randomised to have compression (group A) or no compression (group B). This will be done by using an online randomisation software (Sealed Envelope Ltd).
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
- •Varicose veins suitable for foam sclerotherapy
排除标准
- •Allergic to sclerosant
- •Current DVT
- •Arterial disease (ABPI<0.8)
- •Patients unable to wear compression stockings
- •Patients who are unwilling to participate
- •Inability or unwillingness to complete questionnaires
- •Inability to attend follow-up appointments
结局指标
主要结局
Patient's pain score post-procedure using a visual analogue scale (VAS)
时间窗: 10 days
Pain score
次要结局
- Venous clinical severity score (VCSS)(6 months)
- Chronic venous insufficiency (CIVIQ) score(6 months)
- Occlusion rate(6 months)
- Degree of phlebitis(6 months)
- Aberdeen Varicose Vein Questionnaire (AVVQ) score(6 months)
- EuroQol's EQ-5D(6 months)