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Onlay Mesh in Abdominal Aortic Aneurysm Repair.

No Clear Benefit With the Use of Onlay Mesh by Vascular Surgeons for Incisional Hernia Prevention in Patients With Abdominal Aortic Aneurysm Repair

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07416422
Enrollment
50
Registered
2026-02-18
Start date
2019-01-01
Completion date
2023-05-30
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia of Midline of Abdomen, Surgical Wound

Keywords

Aortic aneurysm, Open repair, Prophylactic reinforcement, Small-bites closure, Vascular surgery outcomes, Wound complication

Brief 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, 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).

Interventions

DIAGNOSTIC_TESTAbdominal Ultrasound or computed tomography

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

Sponsors

Hospital Universitario Ramon y Cajal
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who had open aortic surgery for AAA during the study period and gave their informed consent to participate in the study.

Exclusion criteria

* Urgent AAA repair * Patients treated for infective aortic aneurysms. * Different access to midline laparotomy.

Design outcomes

Primary

MeasureTime frameDescription
Presence of Incisional Hernia0-2 years.Presence of IH during follow-up in both groups and a comparison between both groups represented in a Kaplan meier curve

Secondary

MeasureTime frameDescription
Wound complications.0-2 yearsDifferences between both groups in surgical wound complications
Surgical Hospitalization times0-2 yearsdifferences between both groups in surgical hospitalization times
Reintervention due to IH0-2 yearsDifferences between both groups in need for reintervention due to IH

Countries

Spain

Contacts

PRINCIPAL_INVESTIGATORMarta Fernandez Reyes Doallo

Hospital Universitario Ramón y Cajal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026