Randomised Controlled Study to Determine Whether Treating Incompetent Perforating Veins at the Time of Endothermal Varicose Vein Surgery for Truncal Reflux Reduces Recurrence After Varicose Vein Treatments.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Differences in the level of significant recurrence between the two treatment pathways
研究概览
简要总结
The aim of this randomised case-controlled trial is to investigate whether ablation of incompetent perforating vein in addition to ablation of truncal vein reduces the rate of recurrent varicose veins post-treatment compared with patients who only have ablation of the truncal vein, who are left with untreated incompetent perforating veins.
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 varicose veins caused by great saphenous vein reflux
- •At least one incompetent perforating vein refluxing into the varicosities
- •Over 18 years of age
排除标准
- •Reflux from pelvic vein origin or small saphenous vein
- •Previous varicose vein surgery,
- •Incompetent perforators remote from the varicosities treated,
- •Deep vein incompetence
- •Deep vein obstruction or occlusion
结局指标
主要结局
Differences in the level of significant recurrence between the two treatment pathways
时间窗: Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery
Differences in the level of significant recurrence between the two treatment pathways at each follow up. Significant recurrence would be indicated if the participant demonstrates varicose veins greater than 3mm in diameter, varicose veins associated with thrombophlebitis or skin changes such as venous eczema, red skin or brown skin overlying the veins which require further treatment.
次要结局
- Differences in insignificant recurrence between the two treatment pathways(Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery)
- Patient reported symptom severity(Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery)
- Patient reported quality of life(Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery)
- Patient satisfaction with treatment.(Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery)
- Clinician reported severity of symptoms(Four weeks, three months, six months, one year, two years, three years, four years and five years post-surgery)