Clinical trial NCT04428138: Inguinal Hernia and Arterial Disease
Official title: Observational Cross-sectional Study on the Association Between Inguinal Hernias and Arterial Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Arterial Disease
Keywords: Inguinal Hernia
Arterial Disease
Peripheral artery disease
Carotid stenosis
Arterial aneurysm
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the general population presenting with inguinale hernia.

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.

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.

Eligibility criteria: Inclusion Criteria:

* patients with inguinal hernia

Exclusion Criteria:

* patients with malignancies

Primary outcomes:
measure: Prevalence of arterial disease in patients with inguinal hernia
timeFrame: at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: CIFL- Interuniversity Center of Phlebolymphology
city: Catanzaro
country: Italy
facility: University Magna Graecia of Catanzaro
Study officials:
affiliation: University Magna Graecia of Catanzaro
name: Raffaele Serra, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.