A Randomised Controlled Trial Investigating The Use Of Pelvic Vein Embolisation To Reduce Recurrent Varicose Veins Of The Legs In Women With Primary 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 venous 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 coil embolisaton) in females with leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic reflux, have a reduction in recurrence after varicose vein surgery.
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. Failure to treat varicose veins results in 10 to 20% of patients deteriorating to skin damage or leg ulceration. Recurrence rates following surgery vary that have been reported up to 70% at 10 years.
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 that contribute 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.
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
- •Female gender
- •Presenting with primary varicose veins in one or both legs with ultrasound --pelvic venous reflux in at least one trunk communicating with the leg varicose veins
- •Over 18 years old
- •Able to understand and give consent
- •Willing to attend for follow ups over five year period
排除标准
- •Pelvic 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 in the next five years
- •Under 18 years of age.
- •Unable to understand or give consent.
- •Any vascular malformation of the pelvis or 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 venous reflux
时间窗: 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
Recurrent varicose veins or venous reflux shown on duplex ultrasonography to be arising from pelvic venous reflux. Recurrent varicose veins will be divided into : Clinically insignificant (thread veins, reticular veins or varicose veins less than 3mm in diameter) Significant (varicose veins greater then 3mm in diameter, varicose veins associated with thrombophlebitis, or skin changes such as eczema, red skin or brown skin overlying the veins)
次要结局
- 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)
- 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)
- 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)