NCT06762561
Recruiting
Not Applicable
Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study
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).
Investigators
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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