Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment

Study Overview
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Brief Summary
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The research hypothesis for this study is to possibly reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy. The study is designed as a prospective randomised multi-centre trial, randomising patients in 2 groups concerning the surgical technique of the closure of the abdominal wall.

Official Title
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Prevention of Incisional Hernia by Mesh Augmentation After Midline Laparotomy for Aortic Aneurysm Treatment.

Conditions
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Aortic Aneurysm

Intervention / Treatment
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* Procedure: Conventional laparotomy closure
* Procedure: Laparotomy closure with mesh augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing elective Abdominal Aorta Aneurysm treatment through a midline laparotomy are eligible for the trial. All patients should sign the informed consent. Exclusion Criteria: Patients below 18 years. Pregnancy. Emergency surgery for aortic aneurysm. Presence of mesh in the abdominal wall on the midline from previous operations ASA score 4 or more.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Conventional laparotomy closure | Procedure: Conventional laparotomy closure<br>* Recommended technique: The laparotomy is closed with a slowly resorbable running suture (f.e. PDS) in a single layer. The length of the suture should approximately be four (4) times the length of the fascial incision. The skin is closed with the usual technique of the department<br>|
| Active Comparator: 2<br>Laparotomy closure with mesh augmentation | Procedure: Laparotomy closure with mesh augmentation<br>* Recommended technique: Mesh augmentation can be done in a retromuscular or a prefascial position. By consensus of the initial primary investigators a retromuscular (sublay) position of the mesh was chosen and as a mesh a light weight polypropylene mesh will be used. Retromuscular (sublay): (see reference no. 11: Rogers et al.) At the end of the vascular procedure the plane behind the rectus muscles (retromuscular-preperitoneal) is dissected as in a Stoppa repair for incisional hernias<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To reduce the incidence of incisional hernia 2 years postoperatively after midline laparotomy for treatment of aortic aneurysm from 25% to 5% by mesh augmentation during closure of the laparotomy Incidence of incisonal hernia |  | 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of incisonal hernia |  | 1 year and 5 years after surgery | 
| VAS scores of pain at rest |  | 12, 24, 48, 72, 96, 120 hours , 4 weeks and 3 months after surgery | 
| Duration of surgery |  | After surgery | 
| Occurrence of post-operative complications |  | After 1 month |