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临床试验/NCT02304146
NCT02304146Unknown不适用

Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study

Maastricht University Medical Center3 个研究点 分布在 1 个国家目标入组 460 人开始时间: 2014年11月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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