Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
试验速览
- 阶段
- 不适用
- 入组人数
- 460
- 试验地点
- 3
- 主要终点
- long-term QoL follow-up of patients after UGFS and surgical stripping
研究概览
简要总结
The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.
详细描述
It describes the long-term quality of life (QoL) after ultrasound guided foam sclerotherapy (UGFS) and surgical stripping, outcomes with regard to clinical, and ultrasound recurrence, progression of venous disease, predictive value of the presence of central / deep venous obstruction for recurrence of varicose veins and the long term cost analysis.
Recurrence of varicose veins was defined as the presence of one or more venous symptoms such as pain, cramps, restless legs and a tired/heavy feeling in the treated leg, in combination with the presence of reflux longer than 0·5 s.
The initial definition of recurrent reflux, which is defined as reflux for more than 2 cm in length in the treated vein segment (proximal great saphenous vein (GSV) ) as measured by colour flow duplex ultrasound (DUS). DUS findings of the treated proximal GSV were categorized as: 1, absence of reflux; 2, reflux; 3, occlusion; 4, partial occlusion with reflux; 5, absence of vein, is being used. Patients in categories 2 and 4 are considered to have reflux.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all patients included in previous FOAM study
排除标准
- •no received informed consent
结局指标
主要结局
long-term QoL follow-up of patients after UGFS and surgical stripping
时间窗: 6-10 years follow-up
次要结局
- Clinical recurrence(6-10 years follow-up)
- Technical recurrence(6-10 years follow-up)
- Number of retreatments(6-10 years follow-up)
- Venous Clinical Severity Score change(6-10 years follow-up)
