A Randomised Controlled Trial Investigating The Use Of Pelvic Vein Embolisation To Reduce Recurrent Varicose Veins Of The Legs In Women With Recurrent Varicose Veins And Associated Pelvic Venous Reflux.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 270
- 试验地点
- 3
- 主要终点
- Change in recurrent varicose veins or venus reflux
研究概览
简要总结
The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic embolisation) in females with recurrent leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic venous reflux, have a reduction in future recurrence after endovenous laser treatment for recurrent varicose veins in the legs.
详细描述
Varicose veins of the legs effect between 20 and 40% of the adult population in the UK. Approximately 100,000 operations performed per year for varicose veins, although it is unknown how many of these are for recurrent varicose veins. Failure to treat varicose veins results in 10 to 20% of patients deteriorating to skin damage or leg ulceration. Recurrence rates following surgery vary and have been reported up to 70% at 10 years. Recurrence causes an increased cost as well as an increase in the patient's healthcare requirements.
The commonest causes of recurrence are reported to be:
- neovascularisation (new vessel growth after treatment)
- missing veins at the initial operation
- perforator vein incompetence
- de novo reflux due to normal deterioration with age
Recent studies have shown that leg varicose veins can be caused by pelvic venous reflux and that pelvic venous reflux is a cause of recurrent varicose veins. Previous published work from our own unit has shown that approximately 20% of women who present with varicose veins of the legs and who have had children previously have pelvic venous reflux on duplex ultrasound. Such pelvic venous reflux contributes to the venous reflux in the legs, causing the varicose veins. Furthermore, a recent retrospective study from our own unit has suggested that failure to treat pelvic venous reflux before treating leg varicose veins is a major cause of recurrent varicose veins in up to a quarter of women.
However, despite this circumstantial evidence, there is no evidence to prove whether the treatment of pelvic venous reflux confers any advantage on these patients in terms of reduction in future recurrence of their varicose veins, following treatment.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Females presenting with recurrent varicose veins in one or both legs with ultrasound proven pelvic venous reflux in at least one pelvic venous trunk communicating with the leg varicose veins
- •Duplex proven reflux in the superficial venous system of the leg
- •Over 18 years old
- •Able to understand and give consent
- •Willing to attend for follow-up over the five years
排除标准
- •Pelvic venous reflux does not communicate with the varicose veins to be treated in the legs
- •If pelvic venous reflux communicates and contributes to varicose veins in one leg but not the other, only the leg with a pelvic venous contribution will be entered into the study
- •Currently pregnant or plans for pregnancy within the next five years
- •Under 18 years of age
- •Unable to understand all give consent
- •Any vascular malformation of the pelvis all the legs apart from that diagnosed as venous reflux disease
- •Any medical condition likely to cause death or serious ill-health within the next five years Any deep venous obstruction or reflux
结局指标
主要结局
Change in recurrent varicose veins or venus reflux
时间窗: 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post surgery
Does the patient have recurrence? Recurrent varicose veins will be divided into: * Clinically insignificant (thread veins, reticular veins or varicose veins less than 3 mm in diameter) * Significant (varicose veins greater than 3 mm in diameter, varicose veins associated with thrombophlebitis, or skin changes such as venous eczema, red skin or Brown skin overlying the veins)
次要结局
- Quality of life(6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery)
- Source of recurrence(6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery)
- Patient satisfaction(6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery)
- Symptom severity(6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery)