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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm Repair

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Ultrapro® Mesh implantation
* Other: Standard wound closure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesh implantation<br>Ultrapro® Mesh implantation | Device: Ultrapro® Mesh implantation<br>* 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.<br>|
| Active Comparator: Standard wound closure without a mesh<br>Standard wound closure | Other: Standard wound closure<br>* Abdominal closure will be performed with standard sutures without a mesh.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of incisional hernia |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative complications |  | 7 days | 
| operation time |  | 4 hours | 
| Rate of adverse events | Adverse events related to mesh implantation | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal aortic aneurysm, Abdominal hernia