Abdominal Aortic Aneurysm
Conditions
Keywords
Abdominal aortic aneurysm, Abdominal hernia
Brief summary
The aim of this study is to investigate the effect of the implantation of an Ultrapro® Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair. According to the literature these patients have an increased risk for an incisional hernia. By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair, the risk can be reduced dramatically. In small feasibility studies incisional hernia rates as low as 0% have been achieved. Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups, one receiving an onlay mesh, the other conventional wound closure with sutures.
Detailed description
Prospective randomized controlled study with two study arms. Arm 1: Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair. Arm 2: Abdominal wall will be closed with standard sutures (without mesh implantation) After the patients gave their informed consent to participate in the study, they will be randomized to one of the two treatment arms. Allocation is carried out based on a prepared randomization list. Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years. Secondary endpoints are postoperative complications and adverse events during the follow-up period. Study enrollment was prematurely terminated on 30. Apr 2009. Already enrolled patients will be followed for 24 months according to protocol.
Interventions
DEVICEUltrapro® Mesh implantation
After the aortic procedure (aortic aneurysm repair) an Ultrapro absorbable mesh will be used for the wound closure of the abdominal wall using an onlay technique.
Abdominal closure will be performed with standard sutures without a mesh.
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for elective or early elective open repair of aortic aneurysm
Exclusion criteria
* Emergency surgery * EVAR (endovascular procedure) * Patients with previous midline laparotomy * Patients with in situ abdominal mesh after previous hernia repair * Patients with large diastasis of abdominal wall * Allergy to penicillin * Women before menopause (mesh can interfere with potential future pregnancies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of incisional hernia | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative complications | 7 days | — |
| operation time | 4 hours | — |
| Rate of adverse events | 24 months | Adverse events related to mesh implantation |
Countries
Switzerland
Outcome results
None listed