NCT04428138

Brief Summary

Inguinal hernias are associated with problems related to the venous system by the linking to extracellular matrix alterations (ECM). On the other hand, arterial diseases (arterial aneurysms, carotid, stenosis, peripheral artery disease) are widespread in the general population and may share others pathological pathways related to ECM impairment. Aim to this study is to evaluate the prevalence of arterial diseases in patients with inguinal hernia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

June 9, 2020

Last Update Submit

June 10, 2020

Conditions

Inguinal HerniaArterial Disease

Keywords

Inguinal HerniaArterial DiseasePeripheral artery diseaseCarotid stenosisArterial aneurysm

Outcome Measures

Primary Outcomes (1)

  • Prevalence of arterial disease in patients with inguinal hernia

    Patients with inguinal hernia will be assessed for the presence of arterial aneurysm, carotid stenosis, and peripheral artery disease in order to find any correlation between these pathological conditions.

    at 1 year

Study Arms (1)

Patients with Inguinal hernia

Patients presenting with inguinal hernia will undergo vascular in-office visit and echo duplex of aorta, carotid arteries and lower limb arteries in order to detect any abnormalities related to arterial disease (aneurysm, stenosis, flow alteration).

Diagnostic Test: In-office vascular visitDiagnostic Test: Echo duplex scan of arterial system

Interventions

In-office vascular visitDIAGNOSTIC_TEST

Every patient will undergo a complete physical examination in order to detect any clinical or sub clinical vascular disease.

Patients with Inguinal hernia
Echo duplex scan of arterial systemDIAGNOSTIC_TEST

Every patient will undergo a complete echo duplex scan in order to detect any morphological or hemodynamic alteration of aorta, carotid arteries and lower limb arteries.

Patients with Inguinal hernia

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the general population presenting with inguinale hernia.

You may qualify if:

  • patients with inguinal hernia

You may not qualify if:

  • patients with malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CIFL- Interuniversity Center of Phlebolymphology

Catanzaro, 88100, Italy

RECRUITING

University Magna Graecia of Catanzaro

Catanzaro, 88100, Italy

RECRUITING

Related Publications (3)

  • Serra R, Buffone G, Costanzo G, Montemurro R, Scarcello E, Stillitano DM, Damiano R, de Franciscis S. Altered metalloproteinase-9 expression as least common denominator between varicocele, inguinal hernia, and chronic venous disorders. Ann Vasc Surg. 2014 Apr;28(3):705-9. doi: 10.1016/j.avsg.2013.07.026. Epub 2013 Oct 31.

    PMID: 24184457BACKGROUND

  • Serra R, Buffone G, Costanzo G, Montemurro R, Perri P, Damiano R, de Franciscis S. Varicocele in younger as risk factor for inguinal hernia and for chronic venous disease in older: preliminary results of a prospective cohort study. Ann Vasc Surg. 2013 Apr;27(3):329-31. doi: 10.1016/j.avsg.2012.03.016. Epub 2012 Sep 19.

    PMID: 22998788BACKGROUND

  • Rowse PG, Crestanello JA. Commentary: Abdominal wall hernia: An important risk association in aortic aneurysmal disease or just a dull ache? J Thorac Cardiovasc Surg. 2021 Dec;162(6):1678-1679. doi: 10.1016/j.jtcvs.2020.03.105. Epub 2020 Apr 6. No abstract available.

    PMID: 32448686BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalPeripheral Arterial DiseaseCarotid Stenosis

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesCarotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Raffaele Serra, M.D., Ph.D.

    University Magna Graecia of Catanzaro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+3909613647380rserra@unicz.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Vascular Surgery

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 11, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)