Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair
1 other identifier
interventional
282
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMay 23, 2023
April 1, 2023
4.5 years
April 18, 2011
May 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Herniation rate
As an indicator of efficacy, the reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.
24 months
Study Arms (3)
Group A
NO INTERVENTIONMonofilament absorbable MonoPlus® suture material will be used for closing of the midline incision.
Group B
OTHERAbdominal wall closure with monofilament absorbable MonoPlus® suture material and onlay placement of Optilene® Mesh Elastic fixed by sutures.
Group C
NO INTERVENTIONMonofilament, absorbable MonoMax suture material will be used for the closure of the abdominal cavity.
Interventions
A number of patients will receive a Optilene® Mesh Elastic mesh, which may not be clinically indicated.
Eligibility Criteria
You may qualify if:
- Male and female patients \>18 years of age.
- Patients undergoing an elective surgery for AAA repair.
- Patients who currently have no malignant disease requiring therapy.
- Patients who are able to fulfill all clinical investigation requirements
- Patients who have provided written informed consent.
You may not qualify if:
- Patients who require median laparotomy for AAA repair as an emergency procedure.
- Expected length of fascia incision \> 30 cm.
- Patients with coagulopathy
- Patients who have had previous median laparotomy and/or laparotomy crossing the incision necessary for AAA laparotomy.
- Patients with current immunosuppressive therapy (\>40 mg corticoid/day or azathioprine).
- Chemotherapy within the last 4 weeks.
- Radiotherapy on the treated region within the last 2 months.
- Pregnant and breast-feeding women.
- Known allergy against ingredients of the investigational products (polypropylene, poly-4-hydroxybutyrate, polydioxanone).
- Patients participating in other investigational drug or medical device studies within the preceding 4 weeks.
- Patients with an ongoing medical condition or social reason that may affect their ability to complete the two years follow-up period.
- Life expectancy less than 24 months.
- Severe psychiatric or neurologic disease.
- Lack of compliance.
- Drug abuse.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsklinikum Hamburg-Eppendorflead
- Aesculap AGcollaborator
Study Sites (9)
Klinikum Stuttgart - Katharinenhospital (KH)
Stuttgart, Baden-Wurttemberg, 70174, Germany
Klinikum Nürnberg Süd
Nuremberg, Bavaria, 90471, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Klinikum Bremen-Nord
Bremen, 28755, Germany
University Heart Center Hamburg-Eppendorf
Hamburg, 20246, Germany
Asklepios Klinik Wandsbek
Hamburg, 22043, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Klinikum Ludwigsburg
Ludwigsburg, 71640, Germany
Related Publications (1)
Honig S, Diener H, Kolbel T, Reinpold W, Zapf A, Bibiza-Freiwald E, Debus ES; for AIDA study group. Abdominal incision defect following AAA-surgery (AIDA): 2-year results of prophylactic onlay-mesh augmentation in a multicentre, double-blind, randomised controlled trial. Updates Surg. 2022 Jun;74(3):1105-1116. doi: 10.1007/s13304-021-01125-0. Epub 2021 Jul 21.
PMID: 34287760RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Debus, Prof. Dr.
University Heart Center Hamburg - Eppendorf
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2011
First Posted
May 13, 2011
Study Start
February 1, 2011
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
May 23, 2023
Record last verified: 2023-04