Onlay Mesh in Abdominal Aortic Aneurysm Repair.

NCT07416422 | Completed

• 1 other identifier: 043-22
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia of Midline of Abdomen; Surgical Wound

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Wound complications.

  0-2 years

• Surgical Hospitalization times

  0-2 years

• Reintervention due to IH

  0-2 years

Study Arms (2)

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

Primary closure

Patients received primary fascial closure with small-bites alone.

Diagnostic Test: Abdominal Ultrasound or computed tomography

Interventions

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 closure; Prophylactic mesh reinforcement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Surgical Wound; Aortic Aneurysm

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Wounds and Injuries; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Marta Fernandez Reyes Doallo

  Hospital Universitario Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: May 30, 2023
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)