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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04428138
Other study ID # ER.ALL.2018.30
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date July 1, 2021

Study information

Verified date June 2020
Source University of Catanzaro
Contact Raffaele Serra, M.D., Ph.D.
Phone +3909613647380
Email rserra@unicz.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with inguinal hernia

Exclusion Criteria:

- patients with malignancies

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Italy CIFL- Interuniversity Center of Phlebolymphology Catanzaro
Italy University Magna Graecia of Catanzaro Catanzaro

Sponsors (1)

Lead Sponsor Collaborator
University of Catanzaro

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. 2020 Apr 6. pii: S0022-5223(20)30804-7. doi: 10.1016/j.jtcvs.2020.03.105. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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