Clinical trial NCT04424095: Venous Disease in Pediatric Population
Official title: Investigation of Chronic Venous Disease in Pediatric Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Venous Insufficiency
Pediatric ALL
Keywords: Chronic venous disease
Pediatrics
vein reflux
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric subjects, of both sex, aged between 9 and 18 years old which are cooperative for visit and diagnostic testing.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Pediatric Patients

Exclusion Criteria:

* Patients with mental retardation
* Patients with Marfan syndrome
* Patients with an inability to stand or collaborate for the clinical tests.

Primary outcomes:
measure: Prevalence of Chronic Venous Disease
timeFrame: at 9 month
measure: Echo duplex evaluation
timeFrame: at 10 month
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: University Magna Graecia of Catanzaro
Study officials:
affiliation: University Magna Graecia of Catanzaro
name: Raffaele Serra, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.
citation: Beebe-Dimmer JL, Pfeifer JR, Engle JS, Schottenfeld D. The epidemiology of chronic venous insufficiency and varicose veins. Ann Epidemiol. 2005 Mar;15(3):175-84. doi: 10.1016/j.annepidem.2004.05.015.
citation: Griffiths L, Vasudevan V, Myers A, Morganstern BA, Palmer LS. The role of inheritance in the development of adolescent varicoceles. Transl Androl Urol. 2018 Dec;7(6):920-925. doi: 10.21037/tau.2018.09.02.