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| Name | Class |
|---|---|
| CARDIOLINK | UNKNOWN |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh group | Procedure | An onlay PDVF mesh will be placed as abdominal wall reinforcement |
| Measure | Description | Time Frame |
|---|---|---|
| Incisional Hernia | Development of an incisional hernia diagnosed clinically or radiologically | 24 months |
| 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 |
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Inclusion Criteria: Any known risk factor for development of incisional hernia
Exclusion Criteria:
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Patients undergoing midline laparotomy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puerto Real University Hospital | Puerto Real | Cádiz | Spain | |||
| Sureste Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38652308 | Derived | Rodicio Miravalles JL, Mendez CSM, Lopez-Monclus J, Moreno Gijon M, Lopez Quindos P, Amoza Pais S, Lopez Lopez A, Garcia Bear I, Menendez de Llano Ortega R, Diez Perez de Las Vacas MI, Garcia-Urena MA. Short-term outcomes of a multicentre prospective study using a "visible" polyvinylidene fluoride onlay mesh for the prevention of midline incisional hernia. Langenbecks Arch Surg. 2024 Apr 23;409(1):136. doi: 10.1007/s00423-024-03307-x. |
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This is study to watch the behavior of an onlay mesh for incisional hernia prevention after laparotomy
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| 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 |
| Arganda |
| Madrid |
| Spain |
| San Agustín University Hospital | Avilés | Principality of Asturias | Spain |
| University Central Hospital of Asturias | Oviedo | Principality of Asturias | Spain |
| Nuestra Señora del Prado University Hospital | Talavera de la Reina | Toledo | Spain |
| Puerta de Hierro University Hospital | Madrid | Spain |
| D010335 | Pathologic Processes |