Incisional Hernia of Midline of AbdomenNCT07416422
Onlay Mesh in Abdominal Aortic Aneurysm Repair.
An observational study of Incisional Hernia of Midline of Abdomen and Surgical Wound, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The aim of the study was to compare the incidence of IH after abdominal aortic aneurysm (AAA) open repair according to the abdominal wall closure technique used. The main question it aims to answer is: Does prophylactic mesh reinforcement prevents from IH after AAA open repair? Patients were divided in 2 groups… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia of Midline of Abdomen, Surgical Wound
- What is being tested?
- Abdominal Ultrasound or computed tomography
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 30 May 2023
- How long will I take part?
- 2 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AAA open repair between January 2019 and December 2021 in our institution.
Who may be able to join
- Patients who had open aortic surgery for AAA during the study period and gave their informed consent to participate in the study.
Who cannot join
- Urgent AAA repair
- Patients treated for infective aortic aneurysms.
- Different access to midline laparotomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: No Clear Benefit With the Use of Onlay Mesh by Vascular Surgeons for Incisional Hernia Prevention in Patients With Abdominal Aortic Aneurysm Repair
The aim of the study was to compare the incidence of IH after abdominal aortic aneurysm (AAA) open repair according to the abdominal wall closure technique used. The main question it aims to answer is: Does prophylactic mesh reinforcement prevents from IH after AAA open repair?
Patients were divided in 2 groups, fascial closure with small bites and prophylactic mesh reinforcement (Group A); and primary fascial closure with small bites alone (Group B) and were performed a clinical examination at least once within the first 24 post-operative months, where the clinical diagnosis of IH could be evaluated.
Read the detailed description
This study included patients treated for AAA between January 2019 and December 2021 in our institution.
Two groups were evaluated, group A where patients were treated by small-bites closure plus PMR (onlay mesh) and group B where patients received primary closure with small-bites alone.
The surgeries were performed as per standard of care in our department, and the decision to use the onlay mesh was per surgeon discretion.
The main variable of study was the presence of incisional hernia evaluated by both clinical and image examination (at least once within the first 24 post-operative months). Patients included in the study that had any post-operative CT scan for any reason were evaluated and diagnosed with that imaging technique.For remaining patients, one radiologist with experience in ultrasound imaging performed diagnosis.
A descriptive analysis of the population and variables collected was carried out using the statistical analysis package IBM SPSS statistics v22 (IBM Co).
- Being tested
- Abdominal Ultrasound or computed tomography
- Keywords
- Aortic aneurysm, Open repair, Prophylactic reinforcement, Small-bites closure, Vascular surgery outcomes, Wound complication
- Medical subject headings
- Surgical Wound, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Ultrasound or computed tomographyDiagnostic test
One radiologist with experience in ultrasound imaging performed diagnosis. This exploration was performed using a single-blind technique. Patients included in the study that had any post-operative CT scan for any reason were evaluated and diagnosed with that imaging technique
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic mesh reinforcement | Patients were treated by small-bites closure plus prophylactic mesh reinforcement (onlay mesh). The mesh used was monofibrilar, non-absorbable and made of polypropylene and was fixed by simple stiches in an onlay position. Receives: Diagnostic Test: Abdominal Ultrasound or computed tomography | |
| Primary closure | Patients received primary fascial closure with small-bites alone. Receives: Diagnostic Test: Abdominal Ultrasound or computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Incisional Hernia
Presence of IH during follow-up in both groups and a comparison between both groups represented in a Kaplan meier curve
Measured: 0-2 years.
Secondary outcomes (3)
Wound complications.
Differences between both groups in surgical wound complications
Measured: 0-2 years
Surgical Hospitalization times
differences between both groups in surgical hospitalization times
Measured: 0-2 years
Reintervention due to IH
Differences between both groups in need for reintervention due to IH
Measured: 0-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional Hernia of Midline of AbdomenStudies 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
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Fernández Reyes, Hospital Universitario Ramon y Cajal
- Investigators
- Marta Fernandez Reyes Doallo, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416422
- Sponsor's protocol ID
- 043-22
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available. The datasets generated and analyzed during the current study will remain under the custody of the Investigators of Hospital Universitario Ramón y Cajal to ensure patient confidentiality and comply with institutional privacy policies
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Clear Benefit With the Use of Onlay Mesh by Vascular Surgeons for Incisional Hernia Prevention in Patients With Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT07416422
- Acronym / sponsor ID
- 043-22
- Keywords
- Aortic aneurysm, Open repair, Prophylactic reinforcement, Small-bites closure, Vascular surgery outcomes, Wound complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 18 Feb 2026 (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.
The aim of the study was to compare the incidence of IH after abdominal aortic aneurysm (AAA) open repair according to the abdominal wall closure technique used. The main question it aims to answer is: Does prophylactic mesh reinforcement prevents from IH after AAA open repair?
Patients were divided in 2 groups, fascial closure with small bites and prophylactic mesh reinforcement (Group A); and primary fascial closure with small bites alone (Group B) and were performed a clinical examination at least once within the first 24 post-operative months, where the clinical diagnosis of IH could be evaluated.
Detailed description
This study included patients treated for AAA between January 2019 and December 2021 in our institution.
Two groups were evaluated, group A where patients were treated by small-bites closure plus PMR (onlay mesh) and group B where patients received primary closure with small-bites alone.
The surgeries were performed as per standard of care in our department, and the decision to use the onlay mesh was per surgeon discretion.
The main variable of study was the presence of incisional hernia evaluated by both clinical and image examination (at least once within the first 24 post-operative months). Patients included in the study that had any post-operative CT scan for any reason were evaluated and diagnosed with that imaging technique.For remaining patients, one radiologist with experience in ultrasound imaging performed diagnosis.
A descriptive analysis of the population and variables collected was carried out using the statistical analysis package IBM SPSS statistics v22 (IBM Co).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic mesh reinforcement | – | Diagnostic Test: Abdominal Ultrasound or computed tomographyPatients were treated by small-bites closure plus prophylactic mesh reinforcement (onlay mesh). The mesh used was monofibrilar, non-absorbable and made of polypropylene and was fixed by simple stiches in an onlay position. |
| Primary closure | – | Diagnostic Test: Abdominal Ultrasound or computed tomographyPatients received primary fascial closure with small-bites alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AAA open repair between January 2019 and December 2021 in our institution.
Key inclusion criteria (1 listed)
- Patients who had open aortic surgery for AAA during the study period and gave their informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Urgent AAA repair
- Patients treated for infective aortic aneurysms.
- Different access to midline laparotomy.
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 |
|---|---|---|
| Abdominal Ultrasound or computed tomographyOne radiologist with experience in ultrasound imaging performed diagnosis. This exploration was performed using a single-blind technique. Patients included in the study that had any post-operative CT scan for any reason were evaluated and diagnosed with that imaging technique | Diagnostic test | Primary closure, Prophylactic mesh reinforcement |
Primary outcome
Presence of Incisional Hernia
Time frame: 0-2 years.
Presence of IH during follow-up in both groups and a comparison between both groups represented in a Kaplan meier curve
3 secondary outcomes
Wound complications.
Time frame: 0-2 years
Surgical Hospitalization times
Time frame: 0-2 years
Reintervention due to IH
Time frame: 0-2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available. The datasets generated and analyzed during the current study will remain under the custody of the Investigators of Hospital Universitario Ramón y Cajal to ensure patient confidentiality and comply with institutional privacy policies
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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.
Marta Fernandez Reyes Doallo principal investigator
Hospital Universitario Ramon y Cajal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia of Midline of Abdomen and Surgical Wound, run by Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Incisional Hernia (time frame: 0-2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.