Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair
AIDA Study is a prospective, multicentre, randomized, controlled clinical investigation with patients undergoing median laparotomy for Abdominal Aortic Aneurysm (AAA) repair.
The primary objective of the clinical investigation is to test the hypothesis that insertion of an Optilene® Mesh Elastic mesh - a monofilament, light-weight, large pore sized, polypropylene mesh manufactured by Aesculap AG - is superior to suturing alone and will reduce the hernia formation rate within the first 2 years.
A reduction from 30% to 10% of the patient population is assumed.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair. A Prospective, Randomised, Controlled Study|
- Herniation rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]As an indicator of efficacy, the reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
No Intervention: Group A
Monofilament absorbable MonoPlus® suture material will be used for closing of the midline incision.
Abdominal wall closure with monofilament absorbable MonoPlus® suture material and onlay placement of Optilene® Mesh Elastic fixed by sutures.
Procedure: Optilene® Mesh Elastic
A number of patients will receive a Optilene® Mesh Elastic mesh, which may not be clinically indicated.
No Intervention: Group C
Monofilament, absorbable MonoMax suture material will be used for the closure of the abdominal cavity.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01353443
|Klinikum Stuttgart - Katharinenhospital (KH)|
|Stuttgart, Baden-Wurttemberg, Germany, 70174|
|Klinikum Nürnberg Süd|
|Nürnberg, Bavaria, Germany, 90471|
|Würzburg, Bavaria, Germany, 97080|
|Bermen, Bremen, Germany, 28755|
|Aachen, North Rhine-Westphalia, Germany, 52074|
|University Heart Center Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Asklepios Klinik Wandsbek|
|Hamburg, Germany, 22043|
|Asklepios Klinik Altona|
|Hamburg, Germany, 22763|
|Ludwigsburg, Germany, 71640|
|Principal Investigator:||Sebastian Debus, Prof. Dr.||University Heart Center Hamburg - Eppendorf|