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OpenTrials
Active, not recruiting

NCT Number: NCT03105895

Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sureste Hospital, Arganda, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 or emergency operation

Exclusion criteria

  • Previous supraumbilical midline laparotomy
  • Previous incisional hernia
  • Life expectancy of less than 12 months
  • Patient´s rejection to participate
  • Unable to understand and participate

Treatment and study plan

Mesh group

Procedure

An onlay PDVF mesh will be placed as abdominal wall reinforcement

Primary outcomes

  1. Incisional Hernia

    Time frame: 24 months

    Development of an incisional hernia diagnosed clinically or radiologically

Secondary outcomes

  1. Surgical site infection

    Time frame: 30 days

    Wound infection according to CDC guidelines

  2. Surgical site seroma

    Time frame: 30 days

    Seroma ocurrence in the wound

  3. Surgical site hematoma

    Time frame: 30 days

    Hematoma occurrence in the wound

  4. Mesh exposition

    Time frame: 30 days

    Mesh that can be seen during postoperative recovery without skin covarage

  5. Evisceration

    Time frame: 30 days

    Postoperative wound dehiscence

  6. Systemic complications

    Time frame: 30 days

    Any systemic complication occurred in the postoperative period

  7. Chronic mesh infection

    Time frame: up to 2 years postoperative

    Mesh chronically infected that need removal to solve

  8. Abdominal wall pain

    Time frame: Up to 2 years

    VAS score in the follow-up

  9. Length of mesh at MRI 6 weeks

    Time frame: 6 weeks

    Length of the mesh calculated at the MRI planned at 6 weeks

  10. Width of mesh at MRI 6 weeks

    Time frame: 6 weeks

    Width of the mesh calculated at the MRI planned at 6 weeks

  11. Length of mesh at MRI 1 year

    Time frame: 1 year

    Length of the mesh calculated at the MRI planned at 1 year

  12. Width of mesh at MRI 1 year

    Time frame: 1 year

    Width of the mesh calculated at the MRI planned at 1 year

Sponsors and collaborators

Lead sponsor

Henares University Hospital

Other

Collaborators

  • CARDIOLINK

Registry information

Official study title

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

Acronym: VISIBLE

Important dates

Study start
2017
Primary completion
2022
Study completion
2030
First posted
Apr 10, 2017
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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