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Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06762561
Enrollment
20
Registered
2025-01-07
Start date
2025-06-01
Completion date
2026-10-31
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Incisional Hernia

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).

Interventions

PROCEDUREProphylactic retromuscular mesh reinforcement

Prophylactic 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.

Sponsors

Hôpital Fribourgeois
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of incisional herniasjanuary-april 2025Incisional hernia will be evaluated trough clinical examination and ultrasound assessement

Secondary

MeasureTime frameDescription
Rate of fascial dehiscencejanuary-april 2025Fascial dehiscence will be searched in the patient's records
Rate of seromasjanuary-april 2025will be searched in the patient's records
Rate of surgical site infectionjanuary-april 2025will be searched in the patient's records
Rate of hematomasjanuary-april 2025will be searched in the patient's records
Operative timejanuary-april 2025will be searched in the operation protocols

Countries

Switzerland

Contacts

Primary ContactRaffaella Sguinzi, PhD
RaffaellaMaria.Sguinzi@h-fr.ch0041263062584
Backup ContactMelissa Lagger
melissa.lagger@h-fr.ch0041263062608

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026