Clinical trial NCT06762561: Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair
Official title: Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Incisional Hernia
Aortic Aneurysm
Lead sponsor: Hôpital Fribourgeois
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement at the Fribourg Cantonal Hospital between 2019 and 2024.

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.

Primary outcomes:
measure: Rate of incisional hernias
timeFrame: january-april 2025
Secondary outcomes:
measure: Rate of fascial dehiscence
timeFrame: january-april 2025
measure: Rate of seromas
timeFrame: january-april 2025
measure: Rate of surgical site infection
timeFrame: january-april 2025
measure: Rate of hematomas
timeFrame: january-april 2025
measure: Operative time
timeFrame: january-april 2025
Other outcomes:
Locations:
city: Villars-sur-Glane
country: Switzerland
facility: HFR Hopitaux Fribourgeois
Study officials:
References:
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