Venous Disease in Pediatric Population

NCT ID: NCT04424095

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-10-01

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.

Conditions

Chronic Venous Insufficiency; Pediatric ALL

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric patients

Recruited pediatric patients will undergo an in-office vascular visit and an echo duplex scan of lower limbs, in order to detect any symptoms or signs related to chronic venous disease.

In-office vascular visit

Intervention Type: DIAGNOSTIC_TEST

The patient will be examined to search for signs or symptoms of chronic venous disease (teleangiectasia, reticular veins, varicose veins, skin changes, pain, itching, heavy legs, ankle edema)

Echo Duplex of lower limbs

Intervention Type: DIAGNOSTIC_TEST

The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.

Interventions

In-office vascular visit

The patient will be examined to search for signs or symptoms of chronic venous disease (teleangiectasia, reticular veins, varicose veins, skin changes, pain, itching, heavy legs, ankle edema)

Intervention Type: DIAGNOSTIC_TEST

Echo Duplex of lower limbs

The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catanzaro

OTHER

Sponsor Role: lead

Responsible Party

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raffaele Serra, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Magna Graecia of Catanzaro

Locations

University Magna Graecia of Catanzaro

Catanzaro, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Raffaele Serra, M.D., Ph.D.

Role: CONTACT

rserra@unicz.it

+3909613647380

Facility Contacts

Raffaele Serra, M.D., Ph.D.

Role: primary

rserra@unicz.it

+3909613647380

References

Robertson L, Evans C, Fowkes FG. Epidemiology of chronic venous disease. Phlebology. 2008;23(3):103-11. doi: 10.1258/phleb.2007.007061.

Reference Type: BACKGROUND

PMID: 18467617 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15723761 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30505728 (View on PubMed)

Other Identifiers

ER.ALL.2018.21

Identifier Type: -

Identifier Source: org_study_id