Incisional HerniaVISIBLENCT03105895
Prevention of Incisional Hernia With an Onlay Mesh Visible on MRI
An observational study of Incisional Hernia, run by Henares University Hospital at 5 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Mesh group
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 5 sitesSpain
- Study dates
- 1 Sep 2017to 1 Dec 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing midline laparotomy
Who may be able to join
None listed.
Who cannot join
- Previous supraumbilical midline laparotomy
- Previous incisional hernia
- Life expectancy of less than 12 months
- Patient´s rejection to participate
- Unable to understand and participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Sureste Hospital
Arganda, Madrid
San Agustín University Hospital
Avilés, Principality of Asturias
Puerta de Hierro University Hospital
Madrid
University Central Hospital of Asturias
Oviedo, Principality of Asturias
Nuestra Señora del Prado University Hospital
Talavera de la Reina, Toledo
About this study
Official title: Multicenter Study on Prevention of Incisional Hernia After Laparotomy 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.
- Conditions
- Incisional Hernia
- Being tested
- Mesh group
- Keywords
- Incisional hernia, Mesh prevention, Mesh augmentation
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh groupProcedure or surgery
An onlay PDVF mesh will be placed as abdominal wall reinforcement
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional Hernia
Development of an incisional hernia diagnosed clinically or radiologically
Measured: 24 months
Secondary outcomes (12)
Surgical site infection
Wound infection according to CDC guidelines
Measured: 30 days
Surgical site seroma
Seroma ocurrence in the wound
Measured: 30 days
Surgical site hematoma
Hematoma occurrence in the wound
Measured: 30 days
Mesh exposition
Mesh that can be seen during postoperative recovery without skin covarage
Measured: 30 days
Evisceration
Postoperative wound dehiscence
Measured: 30 days
Systemic complications
Any systemic complication occurred in the postoperative period
Measured: 30 days
Chronic mesh infection
Mesh chronically infected that need removal to solve
Measured: up to 2 years postoperative
Abdominal wall pain
VAS score in the follow-up
Measured: Up to 2 years
Length of mesh at MRI 6 weeks
Length of the mesh calculated at the MRI planned at 6 weeks
Measured: 6 weeks
Width of mesh at MRI 6 weeks
Width of the mesh calculated at the MRI planned at 6 weeks
Measured: 6 weeks
Length of mesh at MRI 1 year
Length of the mesh calculated at the MRI planned at 1 year
Measured: 1 year
Width of mesh at MRI 1 year
Width of the mesh calculated at the MRI planned at 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start1 Sep 2017
- Primary completion1 Jun 2022
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Henares University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CARDIOLINK
- Responsible party
- Principal investigator, Miguel A ngel Garci-a Urena, Henares University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105895
- Sponsor's protocol ID
- HH 02
- Acronym
- VISIBLE
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2017
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This is study to watch the behavior of an onlay mesh for incisional hernia prevention after laparotomy
Publications
Rodicio Miravalles JL, Mendez CSM, Lopez-Monclus J, Moreno Gijon M, Lopez Quindos P, Amoza Pais S, Lopez Lopez A, Garcia Bear I, Menendez de Llano Ortega R, Diez Perez de Las Vacas MI, Garcia-Urena MA. Short-term outcomes of a multicentre prospective study using a "visible" polyvinylidene fluoride onlay mesh for the prevention of midline incisional hernia. Langenbecks Arch Surg. 2024 Apr 23;409(1):136. doi: 10.1007/s00423-024-03307-x.
PubMed 38652308
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Prevention of Incisional Hernia After Laparotomy With an Onlay Mesh Visible on MRI
- ClinicalTrials.gov ID
- NCT03105895
- Acronym / sponsor ID
- VISIBLE / HH 02
- Conditions
- Incisional Hernia
- Keywords
- Incisional hernia, Mesh prevention, Mesh augmentation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henares University HospitalUniversity, hospital or other
- Collaborators
- CARDIOLINK
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing midline laparotomy
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Previous supraumbilical midline laparotomy
- Previous incisional hernia
- Life expectancy of less than 12 months
- Patient´s rejection to participate
- Unable to understand and participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesh groupAn onlay PDVF mesh will be placed as abdominal wall reinforcement | Procedure or surgery | – |
Primary outcome
Incisional Hernia
Time frame: 24 months
Development of an incisional hernia diagnosed clinically or radiologically
12 secondary outcomes
Surgical site infection
Time frame: 30 days
Surgical site seroma
Time frame: 30 days
Surgical site hematoma
Time frame: 30 days
Mesh exposition
Time frame: 30 days
Evisceration
Time frame: 30 days
Systemic complications
Time frame: 30 days
Chronic mesh infection
Time frame: up to 2 years postoperative
Abdominal wall pain
Time frame: Up to 2 years
Length of mesh at MRI 6 weeks
Time frame: 6 weeks
Width of mesh at MRI 6 weeks
Time frame: 6 weeks
Length of mesh at MRI 1 year
Time frame: 1 year
Width of mesh at MRI 1 year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 38652308Rodicio Miravalles JL, Mendez CSM, Lopez-Monclus J, Moreno Gijon M, Lopez Quindos P, Amoza Pais S, Lopez Lopez A, Garcia Bear I, Menendez de Llano Ortega R, Diez Perez de Las Vacas MI, Garcia-Urena MA. Short-term outcomes of a multicentre prospective study using a "visible" polyvinylidene fluoride onlay mesh for the prevention of midline incisional hernia. Langenbecks Arch Surg. 2024 Apr 23;409(1):136. doi: 10.1007/s00423-024-03307-x.
- Individual participant dataSharing planned: Yes. This is study to watch the behavior of an onlay mesh for incisional hernia prevention after laparotomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Henares University Hospital at 5 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional Hernia (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.