Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair

Recruiting

• Conditions: Incisional Hernia; Aortic Aneurysm

• Registration Number: NCT06762561
• Lead Sponsor: Hôpital Fribourgeois

Brief Summary

The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are:

* Does mesh reinforcement reduce the incidence of incisional hernias?

* What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications.

Participants will:

* Undergo clinical follow-ups and abdominal ultrasounds to detect IH.

* Complete quality-of-life questionnaires (EQ-5D and PROMIS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Study First Posted: 2025-01-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Study Start: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement between January 2019 and January 2024
• Availability of complete medical records, including preoperative history, surgical details, and postoperative follow-up data
• Attendance at a clinical follow-up examination at least one year after the procedure
• General informed consent signed for the use of medical data for research purposes

Exclusion Criteria

• Patients with incomplete or missing medical records, including preoperative, intraoperative, or follow-up data
• Patients who required a re-laparotomy involving incision or suture of the prophylactic mesh and subsequently developed an incisional hernia.
• Patients who did not attend the required clinical follow-up examination at least one year postoperatively.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of incisional hernias	january-april 2025	Incisional hernia will be evaluated trough clinical examination and ultrasound assessement

Secondary Outcome Measures

Name	Time	Method
Rate of fascial dehiscence	january-april 2025	Fascial dehiscence will be searched in the patient's records
Rate of seromas	january-april 2025	will be searched in the patient's records
Rate of surgical site infection	january-april 2025	will be searched in the patient's records
Rate of hematomas	january-april 2025	will be searched in the patient's records
Operative time	january-april 2025	will be searched in the operation protocols

Trial Locations

Locations (1)

HFR Hopitaux Fribourgeois; 🇨🇭 Villars-sur-Glane, Switzerland