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Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair

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Disease Information

Descriptive Information
Brief Title † Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair
Official Title † Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair
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.
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.
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure † Incidence of incisional hernia
Secondary Outcome Measure † Rate of postoperative complications
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceUltrapro® Mesh implantation
Study Arms / Comparison Groups Mesh implantation Ultrapro® Mesh implantation Standard wound closure without a mesh Standard wound closure
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 9
Start Date † March 2008
Completion Date April 2011
Primary Completion Date April 2009
Eligibility Criteria † Inclusion Criteria: - Patient scheduled for elective or early elective open repair of aortic aneurysm Exclusion Criteria: - Emergency surgery - EVAR (endovascular procedure) - Patients with previous midline laparotomy - Patients with in situ abdominal mesh after previous hernia repair - Patients with large diastasis of abdominal wall - Allergy to penicillin - Women before menopause (mesh can interfere with potential future pregnancies)
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Switzerland
Administrative Information
NCT ID † NCT01189708
Organization ID EKSG08/006
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † Cantonal Hospital of St. Gallen
Collaborators ††
Investigators † Principal Investigator: Wolfgang Nagel, MD, KSSG
Information Provided By
Verification Date July 2015
First Received Date † February 20, 2008
Last Updated Date July 9, 2015
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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