Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair
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|ClinicalTrials.gov Identifier: NCT01189708|
Recruitment Status : Terminated (Treatment without success, low enrollment, one serious adverse event)
First Posted : August 27, 2010
Last Update Posted : July 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Device: Ultrapro® Mesh implantation Other: Standard wound closure||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2011|
Experimental: Mesh implantation
Ultrapro® Mesh implantation
Device: Ultrapro® Mesh implantation
After the aortic procedure (aortic aneurysm repair) an Ultrapro absorbable mesh will be used for the wound closure of the abdominal wall using an onlay technique.
Active Comparator: Standard wound closure without a mesh
Standard wound closure
Other: Standard wound closure
Abdominal closure will be performed with standard sutures without a mesh.
- Incidence of incisional hernia [ Time Frame: 24 months ]
- Rate of postoperative complications [ Time Frame: 7 days ]
- operation time [ Time Frame: 4 hours ]
- Rate of adverse events [ Time Frame: 24 months ]Adverse events related to mesh implantation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189708
|Kantonsspital St. Gallen, Department of Surgery|
|St. Gallen, Switzerland, 9007|
|Principal Investigator:||Wolfgang Nagel, MD||KSSG|