Ignite Creation Date:
2024-05-05 @ 10:45 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01189708
Status:
TERMINATED
Last Update Posted:
2023-09-18
First Post:
2008-02-20
Brief Title:
Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm AAA Repair
Sponsor:
Cantonal Hospital of St Gallen
Organization:
Cantonal Hospital of St Gallen
Study Overview
Official Title:
Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Treatment without success low enrollment one serious adverse event
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the effect of the implantation of an Ultrapro Mesh as prevention of incisional hernia after elective open abdominal aortic aneurysm repair According to the literature these patients have an increased risk for an incisional hernia By the implantation of an artificial mesh into the abdominal wall during the first abdominal aortic aneurysm repair the risk can be reduced dramatically In small feasibility studies incisional hernia rates as low as 0 have been achieved
Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups one receiving an onlay mesh the other conventional wound closure with sutures
Patients scheduled for elective open abdominal aortic aneurysm repair will be randomized into two groups one receiving an onlay mesh the other conventional wound closure with sutures
Detailed Description:
Prospective randomized controlled study with two study arms
Arm 1 Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair
Arm 2 Abdominal wall will be closed with standard sutures without mesh implantation
After the patients gave their informed consent to participate in the study they will be randomized to one of the two treatment arms Allocation is carried out based on a prepared randomization list
Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years Secondary endpoints are postoperative complications and adverse events during the follow-up period
Study enrollment was prematurely terminated on 30 Apr 2009 Already enrolled patients will be followed for 24 months according to protocol
Arm 1 Abdominal wall will be closed with a prophylactic mesh implantation in onlay technique after elective open abdominal aortic aneurysm repair
Arm 2 Abdominal wall will be closed with standard sutures without mesh implantation
After the patients gave their informed consent to participate in the study they will be randomized to one of the two treatment arms Allocation is carried out based on a prepared randomization list
Primary endpoint is the rate of incisional hernias within the follow-up period of 2 years Secondary endpoints are postoperative complications and adverse events during the follow-up period
Study enrollment was prematurely terminated on 30 Apr 2009 Already enrolled patients will be followed for 24 months according to protocol
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