Clinical Trial: Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational [Patient Registry]

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

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 Summary:
Sponsor: Henares University Hospital

Current Primary Outcome: Incisional Hernia [ Time Frame: 24 months ]

Development of an incisional hernia diagnosed clinically or radiologically


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Henares University Hospital

Dates:
Date Received: April 4, 2017
Date Started: September 2016
Date Completion: September 2020
Last Updated: April 8, 2017
Last Verified: April 2017