Inguinal Hernia and Arterial Disease

NCT ID: NCT04428138

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Inguinal Hernia Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

In-office vascular visit

Intervention Type DIAGNOSTIC_TEST

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

Echo duplex scan of arterial system

Intervention Type DIAGNOSTIC_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.

Interventions

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In-office vascular visit

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with inguinal hernia

Exclusion Criteria

* patients with malignancies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Catanzaro

OTHER

Sponsor Role lead

Responsible Party

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Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University Magna Graecia of Catanzaro

Locations

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CIFL- Interuniversity Center of Phlebolymphology

Catanzaro, , Italy

Site Status RECRUITING

University Magna Graecia of Catanzaro

Catanzaro, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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

Role: CONTACT

+3909613647380

Facility Contacts

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Raffaele Serra, MD

Role: primary

+393387078043

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

Role: primary

+3909613647380

References

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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.

Reference Type BACKGROUND
PMID: 24184457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22998788 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32448686 (View on PubMed)

Other Identifiers

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ER.ALL.2018.30

Identifier Type: -

Identifier Source: org_study_id

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