Mesh may prevent hernias after surgery, but trial cut short
NCT ID NCT03912662
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a special mesh placed during abdominal surgery to prevent incisional hernias, which can occur in 10-50% of patients. The trial enrolled 32 adults undergoing elective midline laparotomy and tracked hernia development for 24 months using CT scans and exams. However, the study was terminated early, limiting what can be concluded.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ProGrip self-gripping polyester mesh
- What this could lead to
- If successful, this mesh could reduce the risk of incisional hernias after abdominal surgery, lowering the need for additional operations.
- What could go wrong
- The trial was terminated early with only 32 participants, so results are limited. The mesh may not work for everyone and carries risks like infection or pain.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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32 people
The number who actually took part.
- Started
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Sep 2019
- Finished
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Sep 2022
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Subject has provided informed consent. 2. Subject is ≥ 18 years of age at the time of consent. 3. Subject will be undergoing an elective midline laparotomy. 4. Subject may have a combination of low- and high-risk factors but cannot exceed a total of 5 risk factors or have more than 2 high-risk factors. Subject must have at least 2 low-risk factors if subject does not have any high-risk factors. High- and low-risk factors include: 1. High-Risk Factors (maximum of 2): i.BMI≥ 35; ii.Prior open abdominal surgery; iii.Daily active smoker or Chronic Obstructive Pulmonary disease (COPD) diagnosis; iv. Current or recent (within 1 year) cancer diagnosis or chemotherapy treatment; v.History of or current abdominal aorta aneurism or surgery for abdominal aortaaneurism 2. Low-Risk Factors (minimum of 2, if no high-risk factors): i.25 ≤ BMI \< 35; ii.Age \> 45; iii.Uncontrolled diabetes; iv.Malnutrition as defined by 10% weight loss within the last 3 months; v.Current immunosuppressive treatment; vi.Undergoing colorectal surgery Exclusion Criteria: 1. Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where subject is in imminent danger of death. 2. Subject for which the device is used outside the product IFU, including; 1. Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period 2. Subject who has an infection within 30 days of enrollment or, at the time of the surgery, has any active, acute or chronic infection(s) that are uncontrolled and/or requiring treatment such as antibiotics 3. Subject whose surgical site is contaminated or dirty/infected intraoperatively, as assessed by the Investigator (Exclude Altemeier classification III-IV). 3. Subject who had received a mesh in a previous ventral hernia repair or has a ventral hernia. 4. Investigator determined that a planned future surgery would interfere with application of mesh reinforcement. 5. Subject has participated in an investigational drug or device research study within 30 days of enrollment. 6. Subject has a life expectancy of \<2 years. 7. Subject has an ASA Physical Status Classification System score \>3. 8. Subject has \>5 total risk factors or \>2 high-risk factors
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Besançon
Besançon, France
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CHU Hopitaux de Rouen
Rouen, France
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CHU Lille
Lille, France
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CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67000, France
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CHU de Bordeaux
Bordeaux, 33076, France
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CHU de Bordeaux - Hôpital Haut-Lévêque
Bordeaux, France
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CHU de Nantes
Nantes, 44000, France
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CHU de Nîmes
Nîmes, 30029, France
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CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033, France
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Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310, France
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HCL Louis Pradel
Lyon, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A mesh shield: could a simple addition during surgery prevent painful hernias?
- Can we predict mesh infections before they happen? a new study aims to find out
- Can a robot help heal large hernias faster? a trial puts it to the test
- Can a flap made from the hernia sac itself prevent mesh complications?
- New stitch may stop hernias after stoma reversal surgery
- Can removing colon tissue through the anus prevent hernias? new study aims to find out.