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Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI (VISIBLE)

H

Henares University Hospital

Status

Unknown

Conditions

Incisional Hernia

Treatments

Procedure: Mesh group

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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