Incisional Hernia
Conditions
Keywords
Incisional hernia, Mesh prevention, Mesh augmentation
Brief summary
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.
Interventions
PROCEDUREMesh group
An onlay PDVF mesh will be placed as abdominal wall reinforcement
Sponsors
Henares University Hospital
CARDIOLINK
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 or emergency operation
Exclusion criteria
* Previous supraumbilical midline laparotomy * Previous incisional hernia * Life expectancy of less than 12 months * Patient´s rejection to participate * Unable to understand and participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Hernia | 24 months | Development of an incisional hernia diagnosed clinically or radiologically |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30 days | Wound infection according to CDC guidelines |
| Surgical site seroma | 30 days | Seroma ocurrence in the wound |
| Surgical site hematoma | 30 days | Hematoma occurrence in the wound |
| Mesh exposition | 30 days | Mesh that can be seen during postoperative recovery without skin covarage |
| Evisceration | 30 days | Postoperative wound dehiscence |
| Systemic complications | 30 days | Any systemic complication occurred in the postoperative period |
| Chronic mesh infection | up to 2 years postoperative | Mesh chronically infected that need removal to solve |
| Abdominal wall pain | Up to 2 years | VAS score in the follow-up |
| Length of mesh at MRI 6 weeks | 6 weeks | Length of the mesh calculated at the MRI planned at 6 weeks |
| Width of mesh at MRI 6 weeks | 6 weeks | Width of the mesh calculated at the MRI planned at 6 weeks |
| Length of mesh at MRI 1 year | 1 year | Length of the mesh calculated at the MRI planned at 1 year |
| Width of mesh at MRI 1 year | 1 year | Width of the mesh calculated at the MRI planned at 1 year |
Countries
Spain
Outcome results
None listed