Prevention of incisional hernia in high-risk patients
Conditions
Interventions
Patients with an AAA undergoing an elective midline laparotomy will receive closure of the fascia with the aid of a prosthetic mesh. Patients will receive prophylactic mesh augmentation with synthetic
Sponsors
Novus Scientific AB, Uppsala Sweden
Eligibility
Inclusion criteria
Inclusion criteria: - Elective midline laparotomy for patients with Abdominal Aortic Aneurysm. - Age = 18 years. - Signed informed consent by patient.
Exclusion criteria
Exclusion criteria: - Pregnancy. - Emergency procedures. - Inclusion in other trials with interference of the primary endpoint. - Life expectancy less than 24 months (as estimated by the attending physician). - Immune suppression therapy within 2 weeks before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to examine the effectiveness of incisional hernia prevention with synthetic, slowly-resorbable TIGR® Matrix mesh placement in patients with AAA undergoing midline laparotomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to measure relevant postoperative complications, postoperative pain, sensitivity of the skin in the area of the mesh placement and quality of life. | — |
Contacts
Public ContactGijs de Smet
Erasmus MC, University Medical Center
Outcome results
None listed