NCT03105895

Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Henares University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Incisional Hernia

Interventions

Type	Name	Description
PROCEDURE	Mesh group	An onlay PDVF mesh will be placed as abdominal wall reinforcement

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-09-01
• Completion: 2020-09-01
• First posted: 2017-04-10
• Last updated: 2017-04-11

Locations

6 sites across 1 country: Spain