Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

Study Overview
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Brief Summary
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It has been demonstrated that incisional hernia incidence after laparotomy can be safely reduced with the addition of a mesh to the conventional closure of the abdominal wall. There still some debate about which is the best position to place this mesh: onlay or sublay. In Europe we have now meshes with CEE approval to be used as reinforcement of abdominal wall closure. The investigators have planned to include 200 patients in a multi center study using an onlay PDVF mesh that can be tracked by magnetic resonance. The patients included will be patients with risk factors for the development of an incisional hernia. The incidence of incisional hernia will be assessed clinically and radiologically after 1 and 2 years follow-up. The incidence of surgical sites occurrences and pain will be also assessed.

Official Title
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Multicenter Study on Prevention of Incisional Hernia After Laparotomy With an Onlay Mesh Visible on MRI

Conditions
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Incisional Hernia

Intervention / Treatment
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* Procedure: Mesh group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any known risk factor for development of incisional hernia > 60 years BMI > 30 DM Chronic bronquitis Smoking Neoplasia Renal failure Liver failure Immnusupression Urgent operation Exclusion Criteria: Previous supraumbilical midline laparotomy Previous incisional hernia Emergency surgery Life expectancy of less than 12 months Patient´s rejection to participate Unable to understand and participate

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Mesh group|An onlay PDVF mesh will be placed as abdominal wall reinforcement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional Hernia | Development of an incisional hernia diagnosed clinically or radiologically | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Wound infection according to CDC guidelines | 30 days | 
| Surgical site seroma | Seroma ocurrence in the wound | 30 days | 
| Surgical site hematoma | Hematoma occurrence in the wound | 30 days | 
| Mesh exposition | Mesh that can be seen during postoperative recovery without skin covarage | 30 days | 
| Evisceration | Postoperative wound dehiscence | 30 days | 
| Systemic complications | Any systemic complication occurred in the postoperative period | 30 days | 
| Chronic mesh infection | Mesh chronically infected that need removal to solve | up to 2 years postoperative | 
| Abdominal wall pain | VAS score in the follow-up | Up to 2 years | 
| Length of mesh at MRI 6 weeks | Length of the mesh calculated at the MRI planned at 6 weeks | 6 weeks | 
| Width of mesh at MRI 6 weeks | Width of the mesh calculated at the MRI planned at 6 weeks | 6 weeks | 
| Length of mesh at MRI 1 year | Length of the mesh calculated at the MRI planned at 1 year | 1 year | 
| Width of mesh at MRI 1 year | Width of the mesh calculated at the MRI planned at 1 year | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incisional hernia, Mesh prevention, Mesh augmentation