Aortic Aneurysm
Conditions
Brief summary
The research hypothesis for this study is to possibly reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a prospective randomised multi-centre trial, randomising patients in 2 groups concerning the surgical technique of the closure of the abdominal wall.
Interventions
PROCEDUREConventional laparotomy closure
Recommended technique: The laparotomy is closed with a slowly resorbable running suture (f.e. PDS) in a single layer. The length of the suture should approximately be four (4) times the length of the fascial incision. The skin is closed with the usual technique of the department
PROCEDURELaparotomy closure with mesh augmentation
Recommended technique: Mesh augmentation can be done in a retromuscular or a prefascial position. By consensus of the initial primary investigators a retromuscular (sublay) position of the mesh was chosen and as a mesh a light weight polypropylene mesh will be used. Retromuscular (sublay): (see reference no. 11: Rogers et al.) At the end of the vascular procedure the plane behind the rectus muscles (retromuscular-preperitoneal) is dissected as in a Stoppa repair for incisional hernias
Sponsors
Johnson & Johnson
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients undergoing elective Abdominal Aorta Aneurysm treatment through a midline laparotomy are eligible for the trial. * All patients should sign the informed consent.
Exclusion criteria
* Patients below 18 years. * Pregnancy. * Emergency surgery for aortic aneurysm. * Presence of mesh in the abdominal wall on the midline from previous operations ASA score 4 or more.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy Incidence of incisonal hernia | 2 years postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of incisonal hernia | 1 year and 5 years after surgery |
| VAS scores of pain at rest | 12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery |
| Duration of surgery | After surgery |
| Occurrence of post-operative complications | After 1 month |
Countries
Belgium
Outcome results
None listed