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Completed

NCT Number: NCT07416422

Onlay Mesh in 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.

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Key information

Conditions

Incisional Hernia of Midline of Abdomen Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Surgical Wound Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Ramón y Cajal

Madrid, 28034, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abdominal Ultrasound or computed tomography

Diagnostic 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

Primary outcomes

  1. 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

Secondary outcomes

  1. Wound complications.

    Time frame: 0-2 years

    Differences between both groups in surgical wound complications

  2. Surgical Hospitalization times

    Time frame: 0-2 years

    differences between both groups in surgical hospitalization times

  3. Reintervention due to IH

    Time frame: 0-2 years

    Differences between both groups in need for reintervention due to IH

Sponsors and collaborators

Lead sponsor

Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Feb 18, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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