Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital Fribourgeois
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Prophylactic retromuscular mesh reinforcement
Procedure/SurgeryProphylactic retromuscular mesh placement involves reinforcing the abdominal wall during closure after open abdominal aortic aneurysm (AAA) repair to prevent incisional hernias. This technique creates a retro-muscular space by carefully dissecting the rectus abdominis muscles from the posterior rectus sheath. A self-gripping polyester mesh or composite mesh is placed in this space, extending 4 cm beyond the midline on each side, ensuring tension-free coverage. The mesh is secured at key points, and the rectus sheaths are closed with continuous sutures. This approach leverages the anatomical integrity of the abdominal wall to reduce hernia risk without increasing postoperative complications.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Prophylactic mesh reinforcement after open aortic aneurysm repair1 intervention
Trial outcomes
Primary outcomes
1
Rate of incisional hernias
Incisional hernia will be evaluated trough clinical examination and ultrasound assessement
Time frame
january-april 2025Secondary outcomes
1
Rate of fascial dehiscence
Fascial dehiscence will be searched in the patient's records
Time frame
january-april 20252
Rate of seromas
will be searched in the patient's records
Time frame
january-april 20253
Rate of surgical site infection
will be searched in the patient's records
Time frame
january-april 20254
Rate of hematomas
will be searched in the patient's records
Time frame
january-april 2025Sponsors and contacts
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Source ClinicalTrials.gov