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ACTIVE NOT RECRUITING
NCT03105895

Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

Sponsor: Henares University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2017-09-01

Completion Date

2030-12-01

Last Updated

2026-08-19

Healthy Volunteers

No

Interventions

PROCEDURE

Mesh group

An onlay PDVF mesh will be placed as abdominal wall reinforcement

Locations (5)

Sureste Hospital

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