Inguinal HerniaHEARDNCT04428138
Inguinal Hernia and Arterial Disease
An observational study of Inguinal Hernia and Arterial Disease, run by University of Catanzaro at 2 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Arterial Disease
- What is being tested?
- In-office vascular visit and Echo duplex scan of arterial system
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jun 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients of the general population presenting with inguinale hernia.
Who may be able to join
- patients with inguinal hernia
Who cannot join
- patients with malignancies
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
CIFL- Interuniversity Center of Phlebolymphology
Catanzaro, 88100
Raffaele Serra, MD, +393387078043, rserra@unicz.it
- Recruiting
University Magna Graecia of Catanzaro
Catanzaro, 88100
Raffaele Serra, M.D.; Ph.D., +3909613647380, rserra@unicz.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia, Arterial Disease
- Being tested
- In-office vascular visit, Echo duplex scan of arterial system
- Keywords
- Inguinal Hernia, Arterial Disease, Peripheral artery disease, Carotid stenosis, Arterial aneurysm
- Medical subject headings
- Hernia, Inguinal, Peripheral Arterial Disease, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-office vascular visitDiagnostic 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 systemDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: In-office vascular visit; Diagnostic Test: Echo duplex scan of arterial system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Raffaele Serra, M.D., Ph.D., Principal investigator, University Magna Graecia of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428138
- Sponsor's protocol ID
- ER.ALL.2018.30
- Acronym
- HEARD
- Status last verified
- Jun 2020
- First submitted
- 9 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24184457Serra 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.
PubMed 22998788Rowse 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.
PubMed 32448686
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cross-sectional Study on the Association Between Inguinal Hernias and Arterial Diseases
- ClinicalTrials.gov ID
- NCT04428138
- Acronym / sponsor ID
- HEARD / ER.ALL.2018.30
- Conditions
- Inguinal Hernia, Arterial Disease
- Keywords
- Inguinal Hernia, Arterial Disease, Peripheral artery disease, Carotid stenosis, Arterial aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Inguinal hernia | – | Diagnostic Test: In-office vascular visit, Diagnostic Test: Echo duplex scan of arterial systemPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of the general population presenting with inguinale hernia.
Key inclusion criteria (1 listed)
- patients with inguinal hernia
Key exclusion criteria (1 listed)
- patients with malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-office vascular visitEvery patient will undergo a complete physical examination in order to detect any clinical or sub clinical vascular disease. | Diagnostic test | Patients with Inguinal hernia |
| Echo duplex scan of arterial systemEvery 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. | Diagnostic test | Patients with Inguinal hernia |
Primary outcome
Prevalence of arterial disease in patients with inguinal hernia
Time frame: at 1 year
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Background: PubMed 24184457Serra 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.
- Background: PubMed 22998788Serra 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.
- Background: PubMed 32448686Rowse 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Serra, M.D., Ph.D. principal investigator
University Magna Graecia of Catanzaro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Arterial Disease, run by University of Catanzaro at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Serra, M.D., Ph.D. (+3909613647380, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of arterial disease in patients with inguinal hernia (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04428138, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.