HFR Hopitaux Fribourgeois
Villars-sur-Glâne, Switzerland
Location status: Recruiting
Location contact
Melissa Lagger, med. dipl
CONTACT
Michel Adamina, Prof
PRINCIPAL_INVESTIGATOR
Sguinzi Raffaella, PhD
CONTACT
Recruiting
NCT Number: NCT06762561
Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Prophylactic retromuscular mesh reinforcement
ProcedureProphylactic 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.
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
Time frame: january-april 2025
Fascial dehiscence will be searched in the patient's records
-
Rate of seromas
Time frame: january-april 2025
will be searched in the patient's records
-
Rate of surgical site infection
Time frame: january-april 2025
will be searched in the patient's records
-
Rate of hematomas
Time frame: january-april 2025
will be searched in the patient's records
-
Operative time
Time frame: january-april 2025
will be searched in the operation protocols
Study contacts
Contact information is provided by the study sponsor or research team.
Melissa Lagger
CONTACT
Raffaella Sguinzi, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Hôpital Fribourgeois
Other
Registry information
Official study title
Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2026
- First posted
- Jan 7, 2025
- Registry last updated
- Jun 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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