NCT06762561 Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair
| NCT ID | NCT06762561 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital Fribourgeois |
| Condition | Incisional Hernia |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-06-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06762561 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Incisional Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06762561 currently recruiting?
Yes, NCT06762561 is actively recruiting participants. Contact the research team at RaffaellaMaria.Sguinzi@h-fr.ch for enrollment information.
Where is the NCT06762561 trial being conducted?
This trial is being conducted at Villars-sur-Glâne, Switzerland.
Who is sponsoring the NCT06762561 clinical trial?
NCT06762561 is sponsored by Hôpital Fribourgeois. The trial plans to enroll 20 participants.