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A mesh shield: could a simple addition during surgery prevent painful hernias?

NCT ID NCT03105895

Prevention Sponsor: Henares University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial tests whether placing a special mesh (visible on MRI) during abdominal surgery can prevent incisional hernias in patients at higher risk. About 200 participants with risk factors like obesity, diabetes, or older age will receive the mesh as part of their standard closure. The study tracks hernia development over two years using both clinical exams and imaging, along with monitoring for complications like infection or pain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
An onlay PVDF mesh placed during abdominal surgery to reinforce the abdominal wall
What this could lead to
If effective, this approach could reduce the risk of incisional hernias after abdominal surgery, potentially improving recovery and reducing the need for additional surgeries.
What could go wrong
The trial is relatively small and early, and results may not apply to all patients. Mesh placement carries risks such as infection, seroma, or mesh exposure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients undergoing midline laparotomy

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Incisional Hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Incisional hernia

Contacts and locations

Locations

  • Nuestra Señora del Prado University Hospital

    Talavera de la Reina, Toledo, Spain

  • Puerta de Hierro University Hospital

    Madrid, Spain

  • San Agustín University Hospital

    Avilés, Principality of Asturias, Spain

  • Sureste Hospital

    Arganda, Madrid, Spain

  • University Central Hospital of Asturias

    Oviedo, Principality of Asturias, Spain

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