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Clinical Trials/NCT06762561
NCT06762561
Recruiting
Not Applicable

Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study

Hôpital Fribourgeois1 site in 1 country20 target enrollmentJune 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Incisional Hernia
Sponsor
Hôpital Fribourgeois
Enrollment
20
Locations
1
Primary Endpoint
Rate of incisional hernias
Status
Recruiting
Last Updated
11 months ago

Overview

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).
Registry
clinicaltrials.gov
Start Date
June 1, 2025
End Date
October 31, 2026
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Rate of incisional hernias

Time Frame: january-april 2025

Incisional hernia will be evaluated trough clinical examination and ultrasound assessement

Secondary Outcomes

  • Rate of fascial dehiscence(january-april 2025)
  • Rate of seromas(january-april 2025)
  • Rate of surgical site infection(january-april 2025)
  • Rate of hematomas(january-april 2025)
  • Operative time(january-april 2025)

Study Sites (1)

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