Inguinal Hernia and Arterial Disease (HEARD)

Observational Cross-sectional Study on the Association Between Inguinal Hernias and Arterial Diseases

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.

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia; Arterial Disease
• Intervention / Treatment: Diagnostic test: In-office vascular visit; Diagnostic test: Echo duplex scan of arterial system

Detailed Description

Previous studies showed the correlation between inguinal hernias and venous disease. The common pathophysiological pathway between these clinical conditions is linked to extracellular matrix (ECM) alterations. Arterial diseases, mainly represented by carotid stenosis, peripheral artery disease and arterial aneurysms, are widespread in western population and are responsible of high rates of morbidity and mortality. These diseases are also related to some ECM alterations.

Aim of this cross-sectional study is to evaluate the prevalence of arterial disease among patients with inguinal hernias. The primary endpoint of this study is to provide new epidemiological evidences on this association that may help physicians in novel preventive strategies. The study will consider the inclusion of consecutive patients assessed for inguinal hernia over 1 year period in order to study the prevalence of concomitant arterial disease, by means of office visit, echo duplex scan of the aorta and its main branches, carotid arteries and lower limb arteries.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • CIFL- Interuniversity Center of Phlebolymphology
  • Catanzaro, Italy, 88100
    • Recruiting
    • University Magna Graecia of Catanzaro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of the general population presenting with inguinale hernia.

Description

Inclusion Criteria:

• patients with inguinal hernia

Exclusion Criteria:

• patients with malignancies

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 visit; Every patient will undergo a complete physical examination in order to detect any clinical or sub clinical vascular disease.; Diagnostic test: Echo duplex scan of arterial system; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Catanzaro

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Carotid stenosis; Peripheral artery disease; Inguinal Hernia; Arterial Disease; Arterial aneurysm
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: ER.ALL.2018.30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No