Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair
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|ClinicalTrials.gov Identifier: NCT01353443|
Recruitment Status : Unknown
Verified November 2014 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was: Active, not recruiting
First Posted : May 13, 2011
Last Update Posted : November 19, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Procedure: Optilene® Mesh Elastic||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||282 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair. A Prospective, Randomised, Controlled Study|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||September 2015|
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.
- Herniation rate [ Time Frame: 24 months ]As an indicator of efficacy, the reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|