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Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

NCT03105895 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2017-04-11

No results posted yet for this 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.

Conditions

  • Incisional Hernia

Interventions

PROCEDURE

Mesh group

An onlay PDVF mesh will be placed as abdominal wall reinforcement

Sponsors & Collaborators

  • CARDIOLINK

    collaborator UNKNOWN

  • Henares University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2020-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03105895 on ClinicalTrials.gov