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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound; Incisional Hernia of Midline of Abdomen
• Intervention / Treatment: Diagnostic test: Abdominal Ultrasound or computed tomography

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with AAA open repair between January 2019 and December 2021 in our institution.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Abdominal 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
Primary closure; Patients received primary fascial closure with small-bites alone.	Diagnostic test: Abdominal 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	0-2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound complications.	Differences between both groups in surgical wound complications	0-2 years
Surgical Hospitalization times	differences between both groups in surgical hospitalization times	0-2 years
Reintervention due to IH	Differences between both groups in need for reintervention due to IH	0-2 years

Collaborators and Investigators

• Sponsor: Hospital Universitario Ramon y Cajal
• Investigators: Principal Investigator: Marta Fernandez Reyes Doallo, Hospital Universitario Ramon y Cajal

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Aortic aneurysm; Wound complication; Open repair; Prophylactic reinforcement; Small-bites closure; Vascular surgery outcomes
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Aortic Diseases; Aneurysm; Surgical Wound; Aortic Aneurysm; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Radiography; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Tomography, X-Ray Computed
• Other Study ID Numbers: 043-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No