Abdominal Aortic AneurysmNCT01353443
Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair
A study testing Optilene® Mesh Elastic in people with Abdominal Aortic Aneurysm, run by Universitätsklinikum Hamburg-Eppendorf at 9 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Optilene® Mesh Elastic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 9 sitesGermany
- Study dates
- Feb 2011to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Inability to understand and follow the instructions given by the investigator (e.g. dementia, lack of time, insufficient command of language).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Universitätsklinikum Aachen
Aachen, North Rhine-Westphalia, 52074
Klinikum Bremen-Nord
Bremen, 28755
University Heart Center Hamburg-Eppendorf
Hamburg, 20246
Asklepios Klinik Wandsbek
Hamburg, 22043
Asklepios Klinik Altona
Hamburg, 22763
Klinikum Ludwigsburg
Ludwigsburg, 71640
Klinikum Nürnberg Süd
Nuremberg, Bavaria, 90471
Klinikum Stuttgart - Katharinenhospital (KH)
Stuttgart, Baden-Wurttemberg, 70174
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080
About this study
Official title: Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair. A Prospective, Randomised, Controlled Study
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.
Read the detailed description
One of the late complications of the elective surgery of an Abdominal Aortic Aneurysms (AAA) is the formation of an incisional hernia following the AAA repair.
The high frequency of incisional hernia formation in the AAA patients suggests the presence of a structural defect within the fascia.
As a result of these information and that obtained from a small pilot study using mesh prophylactically in high risk group of patients, the concept of using a mesh prophylactically for AAA repairs seems an area worth further exploration.
Owing to the availability of the new generation of meshes with proven good biocompatibility it would seem that this could be a viable means of reducing the herniation rate and therefore re-operation in this high risk population.
Within the investigation Patients requiring elective surgical repair of an AAA will be randomized in one of the following three different groups:
- Group A: Monofilament absorbable MonoPlus® suture material will be used for closing of the midline incision.
- Group B: Abdominal wall closure with monofilament absorbable MonoPlus® suture material and onlay placement of Optilene® Mesh Elastic fixed by sutures.
- Group C: Monofilament, absorbable MonoMax® suture material will be used for the closure of the abdominal cavity.
A total of 282 patients who meet the eligibility criteria will be entered into the clinical investigation (Group A = 94 patients, Group B = 94 patients and Group C = 94 patients).
All patients will have follow-up clinical visits 2 days after surgery, at day of discharge, at 3, 6, and 12 months and a final visit at 24 months. All patients will be asked to complete the health status patient questionnaire EQ-5D preoperatively and at 3, 6, 12 and 24 months postoperatively. As all patients routinely receive an ultrasound at 3, 6, 12, and 24 months, this information will be used to confirm if a hernia is present.
The primary objective of the clinical investigation is to test the hypothesis that insertion of an Optilene® Mesh Elastic mesh is superior to suturing alone and will reduce the hernia formation rate within the first 2 years.
Secondary objectives include:
- Lower herniation rate in the 12 months after mesh implantation in group B as compared to group A
- Non-inferiority of MonoMax suture material (group C) in comparison to MonoPlus suture material (group A) concerning the rate of incisional hernia after abdominal wall closure at 3, 6, 12, and 24 months after surgery.
- Mean time, in days, to return to normal activities as determined by CRF question (comparison of groups A, B, C).
- Mean time, in days, to return to work as determined by CRF question (comparison of groups A, B, C).
- Differences in mean patient health status as determined by using a patient questionnaire (EQ-5D) at 3, 6, 12 and 24 months post-operatively; pre-operative baseline will be recorded (groups A-C).
- Number of wound complications (groups A-C) as determined by medical assessment post-operatively immediately prior to discharge, and at the clinical visits at 3, 6, 12 and 24 months, including infections, seromas, haematomas, and hernia formation, confirmed by ultrasound examination.
- Safety as determined by collection of adverse events in the CRF (groups A-C).
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Optilene® Mesh Elastic
- Keywords
- Abdominal Aortic Aneurysm, AAA
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optilene® Mesh ElasticProcedure or surgery
A number of patients will receive a Optilene® Mesh Elastic mesh, which may not be clinically indicated.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Monofilament absorbable MonoPlus® suture material will be used for closing of the midline incision. |
| Group B | Other | Abdominal wall closure with monofilament absorbable MonoPlus® suture material and onlay placement of Optilene® Mesh Elastic fixed by sutures. Receives: Procedure: Optilene® Mesh Elastic |
| Group C | No intervention | Monofilament, absorbable MonoMax suture material will be used for the closure of the abdominal cavity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Herniation rate
As an indicator of efficacy, the reduction of herniation rate will be verified by clinical examination and confirmed by Ultrasound.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Aesculap AG
- Responsible party
- Sponsor
- Investigators
- Sebastian Debus, Prof. Dr., Principal investigator, University Heart Center Hamburg - Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353443
- Sponsor's protocol ID
- AIDA Study
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2011
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34287760
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair. A Prospective, Randomised, Controlled Study
- ClinicalTrials.gov ID
- NCT01353443
- Acronym / sponsor ID
- AIDA Study
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, AAA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Aesculap AG
- Study start
- Feb 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
One of the late complications of the elective surgery of an Abdominal Aortic Aneurysms (AAA) is the formation of an incisional hernia following the AAA repair.
The high frequency of incisional hernia formation in the AAA patients suggests the presence of a structural defect within the fascia.
As a result of these information and that obtained from a small pilot study using mesh prophylactically in high risk group of patients, the concept of using a mesh prophylactically for AAA repairs seems an area worth further exploration.
Owing to the availability of the new generation of meshes with proven good biocompatibility it would seem that this could be a viable means of reducing the herniation rate and therefore re-operation in this high risk population.
Within the investigation Patients requiring elective surgical repair of an AAA will be randomized in one of the following three different groups:
- Group A: Monofilament absorbable MonoPlus® suture material will be used for closing of the midline incision.
- Group B: Abdominal wall closure with monofilament absorbable MonoPlus® suture material and onlay placement of Optilene® Mesh Elastic fixed by sutures.
- Group C: Monofilament, absorbable MonoMax® suture material will be used for the closure of the abdominal cavity.
A total of 282 patients who meet the eligibility criteria will be entered into the clinical investigation (Group A = 94 patients, Group B = 94 patients and Group C = 94 patients).
All patients will have follow-up clinical visits 2 days after surgery, at day of discharge, at 3, 6, and 12 months and a final visit at 24 months. All patients will be asked to complete the health status patient questionnaire EQ-5D preoperatively and at 3, 6, 12 and 24 months postoperatively. As all patients routinely receive an ultrasound at 3, 6, 12, and 24 months, this information will be used to confirm if a hernia is present.
The primary objective of the clinical investigation is to test the hypothesis that insertion of an Optilene® Mesh Elastic mesh is superior to suturing alone and will reduce the hernia formation rate within the first 2 years.
Secondary objectives include:
- Lower herniation rate in the 12 months after mesh implantation in group B as compared to group A
- Non-inferiority of MonoMax suture material (group C) in comparison to MonoPlus suture material (group A) concerning the rate of incisional hernia after abdominal wall closure at 3, 6, 12, and 24 months after surgery.
- Mean time, in days, to return to normal activities as determined by CRF question (comparison of groups A, B, C).
- Mean time, in days, to return to work as determined by CRF question (comparison of groups A, B, C).
- Differences in mean patient health status as determined by using a patient questionnaire (EQ-5D) at 3, 6, 12 and 24 months post-operatively; pre-operative baseline will be recorded (groups A-C).
- Number of wound complications (groups A-C) as determined by medical assessment post-operatively immediately prior to discharge, and at the clinical visits at 3, 6, 12 and 24 months, including infections, seromas, haematomas, and hernia formation, confirmed by ultrasound examination.
- Safety as determined by collection of adverse events in the CRF (groups A-C).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Monofilament absorbable MonoPlus® suture material will be used for closing of the midline incision. |
| Group B | Other | Procedure: Optilene® Mesh ElasticAbdominal wall closure with monofilament absorbable MonoPlus® suture material and onlay placement of Optilene® Mesh Elastic fixed by sutures. |
| Group C | No intervention | –Monofilament, absorbable MonoMax suture material will be used for the closure of the abdominal cavity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optilene® Mesh ElasticA number of patients will receive a Optilene® Mesh Elastic mesh, which may not be clinically indicated. | Procedure or surgery | Group B |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 34287760Honig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Debus, Prof. Dr. principal investigator
University Heart Center Hamburg - Eppendorf
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optilene® Mesh Elastic in people with Abdominal Aortic Aneurysm, run by Universitätsklinikum Hamburg-Eppendorf at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Herniation rate (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01353443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.