Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI
- Conditions
- Incisional Hernia
- Registration Number
- NCT03105895
- Lead Sponsor
- Henares University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incisional Hernia 24 months Development of an incisional hernia diagnosed clinically or radiologically
- Secondary Outcome Measures
Name Time Method Length of mesh at MRI 1 year 1 year Length of the mesh calculated at the MRI planned at 1 year
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
Width of mesh at MRI 1 year 1 year Width of the mesh calculated at the MRI planned at 1 year
Trial Locations
- Locations (6)
San Agustín University Hospital
🇪🇸Aviles, Asturias, Spain
University Central Hospital of Asturias
🇪🇸Oviedo, Asturias, Spain
Puerto Real University Hospital
🇪🇸Puerto Real, Cádiz, Spain
Sureste Hospital
🇪🇸Arganda, Madrid, Spain
Nuestra Señora del Prado University Hospital
🇪🇸Talavera de la Reina, Toledo, Spain
Puerta de Hierro University Hospital
🇪🇸Madrid, Spain
San Agustín University Hospital🇪🇸Aviles, Asturias, Spain