A Dual Centre, Randomised Controlled Trial of the Clinical and Cost Effectiveness of Endovenous Laser Therapy (EVLT) in the Treatment of Varicose Veins and Venous Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Generic Quality of life - Short Form-36
研究概览
简要总结
Varicose veins are a common problem, affecting up to a third of the western adult population. Most suffer with aching, discomfort, pruritis, and muscle cramps, whilst complications include oedema, eczema, lipodermatosclerosis, ulceration, phlebitis, and bleeding. This is known to have a significant negative effect on patient's quality of life (QoL).
Surgery has been used for many years, but it is known that there is a temporary decline in QoL post-op. This was demonstrated in our pilot study. Surgery leads to painful and prolonged recovery in some patients and has the risks of infection, haematoma and nerve injury.
Recurrence rates are known to be significant. Duplex of veins post surgery has demonstrated persistent reflux in 9-29% of cases at 1 year, 13-40% at 2 years, 40% at 5 years and 60% at 34 years.
26% of NHS patients were 'very dissatisfied' with their varicose vein surgery.
Newer, less invasive treatments are being developed. It would be advantageous to find a treatment that avoided the morbidity of surgery, one that could be performed as a day-case procedure under a local anaesthetic, a treatment that could offer lower recurrence rates and allow an early return to work. These should be the aims of any new treatment for varicose veins.
Endovenous Laser Treatment (EVLT) is performed under a local anaesthetic and uses laser energy delivered into the vein to obliterate it. The vein therefore need not be tied off surgically and stripped out.
The aim of this study is to compare the clinical, cost effectiveness and safety of Surgery and EVLT.
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
- None
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
- •Primary, symptomatic, varicose veins.
- •Isolated Saphenofemoral junction (SFJ) incompetence leading to long saphenous (LSV) reflux on duplex ultrasound.
- •LSV of 4mm diameter at the knee.
- •Ability to give informed written consent.
排除标准
- •Inability to give informed written consent.
- •Symptomatic or complicated varicose veins not attributable to SFJ/LSV reflux.
- •Evidence of deep venous reflux on duplex scan.
结局指标
主要结局
Generic Quality of life - Short Form-36
时间窗: 1 week, 6 weeks, 3 months, 1 year, 2 years
次要结局
- Disease Specific quality of life - Aberdeen Varicose Vein Questionnaire(1 week, 6 weeks, 3 months, 1 year, 2 years)
- Venous Clinical Severity Score(3 months, 1 year, 2 years)
- Would undergo EVLT again if necessary(1 week, 6 weeks, 3 months, 1 year, 2 years)
- Complication rates(1 week, 6 weeks, 3 months, 1 year, 2 years)
- Generic quality of life - EuroQol(1 week, 6 weeks, 3 months, 1 year, 2 years)
- Return to work and normal functioning(1 week, 6 weeks)
- Cost Effectiveness(2 years)
- Visual analogue pain scores(1 week)
- Duplex and clinical assessment(1 week, 6 weeks, 3 months, 1 year, 2 years)