FinnTrunk, EVLA and Optimal Timing of Sclerotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- re-intervention
研究概览
简要总结
The aim of the study is to investigate the optimal timing of sclerotherapy for treatment of varicose tributaries on EVLA (endogenous laser ablation) patients.
详细描述
The study inclusion criteria is patients with main trunk (VSM, SSV, AASV) reflux to be treated with EVLA, suffering C2-C3 varicose disease, age 18-years and no severe co-morbidities.
Patients with written consent will be randomized to two primary treatments groups; EVLA only and EVLA combined with sclerotherapy of varicose tributaries. The primary outcome is the requirement additional sclerotherapy on 3 month control visit. Other study outcomes are pain, quality of life (veins questionnaire), severity score and also recurring of varicose disease at 1, 3 and 5 years.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Varicose disease of lower extremity caused by reflux of VSM, SSV or AASV to be treated with EVLA. Age over 18 years. Clinical symptoms C2-3.
排除标准
- •No severe comorbidities. Previous DVT.
结局指标
主要结局
re-intervention
时间窗: 3 months
Requirement of re-intervention
Pain after procedure
时间窗: up to 3 months after the treatment
Post procedural pain measured with VAS scale
Quality of life before after procedure
时间窗: up to 5 years
Quality of life will be measured with Veins questionnaire
Recur
时间窗: up to 5 years
The recurring varicose veins
次要结局
- Surgical complications(3 months)
研究者
Khalil Firoozi
MD
Turku University Hospital