Investigation of Chronic Venous Disease in Pediatric Population
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of Chronic Venous Disease
研究概览
简要总结
Chronic venous disease (CVD) is widespread in adult subjects of western countries and is responsible of important morbidity and healthcare costs. CVD has never been extensively studied in pediatric population where the early pathophysiological alterations may occur undetected. The aim of this study is to assess the prevalence of CVD searching also for the early clinical and instrumental signs of this disease.
详细描述
Chronic venous disease (CVD) of lower limbs for its high prevalence in adult population represents one of the main causes of morbidity in western countries, and it has also an important effect on healthcare cost absorbing 1-2% of the total health budget in western countries. Clinical manifestations related to CVD are well documented in adults, with clinical guidelines that standardize both diagnosis and treatment. Nevertheless, there is a scarcity of published data regarding CVD in children, and in addition, venous duplex ultrasound test of the lower limbs is performed much less commonly in children than in adults.
Therefore, the natural history of pediatric venous reflux remains unclear, although it is possible that it precedes the onset of CVD in adulthood. In this context, this observational study aims to identify the presence of venous reflux, as well as clinical and morphological data in pediatric subjects, aged between 9 and 18 years old, by performing an office vascular visit and an echo duplex scan of lower limbs. The endpoints of this study are to prospectively assess the prevalence of CVD in children, as well as to evaluate a possible correlation between vein diameter and pathological vein reflux.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric Patients
排除标准
- •Patients with mental retardation
- •Patients with Marfan syndrome
- •Patients with an inability to stand or collaborate for the clinical tests.
结局指标
主要结局
Prevalence of Chronic Venous Disease
时间窗: at 9 month
The Prevalence of Chronic Venous Disease in the population study will be assessed.
Echo duplex evaluation
时间窗: at 10 month
The correlation between veins diameter and the presence of reflux will be evaluated in pediatric population
次要结局
未报告次要终点
研究者
Prof. Raffaele Serra, MD, Ph.D.
Associate Professor of Vascular Surgery
University of Catanzaro
