Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

Last updated: April 8, 2017
Sponsor: Henares University Hospital
Overall Status: Active - Enrolling

Phase

N/A

Condition

Hernia

Treatment

N/A

Clinical Study ID

NCT03105895
HH 02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: 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

Exclusion

Exclusion Criteria:

  • 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

Total Participants: 200
Study Start date:
September 01, 2016
Estimated Completion Date:
September 30, 2020

Connect with a study center

  • San Agustín University Hospital

    Aviles, Asturias
    Spain

    Site Not Available

  • University Central Hospital of Asturias

    Oviedo, Asturias
    Spain

    Site Not Available

  • Puerto Real University Hospital

    Puerto Real, Cádiz
    Spain

    Site Not Available

  • Sureste Hospital

    Arganda, Madrid
    Spain

    Site Not Available

  • Nuestra Señora del Prado University Hospital

    Talavera de la Reina, Toledo
    Spain

    Site Not Available

  • Puerta de Hierro University Hospital

    Madrid,
    Spain

    Site Not Available

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