Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01353443
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2011-04-18
Brief Title:
Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair A Prospective Randomised Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None