Inguinal Hernia and Arterial Disease

Inguinal Hernia Clinical Trial

— HEARD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428138
• Other study ID #: ER.ALL.2018.30
• Status: Recruiting
• 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
• 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
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with inguinal hernia

Exclusion Criteria:

• patients with malignancies

Related Conditions & MeSH terms

• Arterial Disease
• Hernia
• Hernia, Inguinal
• Inguinal Hernia

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