Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01353443 |
| Other study ID # |
AIDA Study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2011 |
| Est. completion date |
September 2015 |
Study information
| Verified date |
April 2023 |
| Source |
Universitätsklinikum Hamburg-Eppendorf |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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, 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.
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:
1. Lower herniation rate in the 12 months after mesh implantation in group B as compared to
group A
2. 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.
3. Mean time, in days, to return to normal activities as determined by CRF question
(comparison of groups A, B, C).
4. Mean time, in days, to return to work as determined by CRF question (comparison of
groups A, B, C).
5. 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).
6. 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.
7. Safety as determined by collection of adverse events in the CRF (groups A-C).
