Hernia IncisionalmeshprophNCT07433439
Prophylactic Mesh Placement Reduces the Incidence of Incisional Hernia in HBP Surgery.
A study testing mesh placement and conventional abdominal wall closure without mesh in people with Hernia Incisional and Incision Site Complication, run by Juan Bellido-Luque.MD at 1 site in Spain.
Trial summary
he goal of this observational study is to learn about prophylactic mesh placement in HBP incision. The main question it aims to answer is: will the incisional hernia rate be reduced with the use of mesh during the abdominal wall closuer? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia Incisional, Incision Site Complication
- What is being tested?
- mesh placement and conventional abdominal wall closure without mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2020to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Elective conventional or extensive right subcostal laparotomy.
- Two or more risk Factor for incisional hernia (IH): > 60 years, Body Mass Index > 27 kg/m2, Diabetes Mellitus, pulmonary/liver/renal disease, malignancy, preoperative chemotherapy, immunosuppression or smoking5.
- Life expectancy of at least 12 months.
- Signed informed consent with agreement to attend all study visits.
Who cannot join
- Emergency surgery.
- Previous right subcostal hernia or right subcostal incision.
- Metastatic disease or irresectable malignancy identified during the surgery with life expectancy less than 12 months.
- Active abdominal infection at the time of surgery
Trial locations and contacts
1 site in 1 country.
About this study
he goal of this observational study is to learn about prophylactic mesh placement in HBP incision. The main question it aims to answer is:
will the incisional hernia rate be reduced with the use of mesh during the abdominal wall closuer?
- Conditions
- Hernia Incisional, Incision Site Complication
- Being tested
- mesh placement, conventional abdominal wall closure without mesh
- 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 placementProcedure or surgery
mesh is placed in retromuscular space when abdominal wall is closed
conventional abdominal wall closure without meshOther
conventional AWC without mesh
| Study group | Role | What they receive |
|---|---|---|
| Mesh group | Experimental | group in which a mesh is placed Receives: Procedure: mesh placement |
| non mesh group | Active comparator | group in which a mesh is not placed Receives: Other: conventional abdominal wall closure without mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
image detected IH rate
incisional hernia rate after 12 and 24 posoperative months
Measured: 12 and 24 months
Secondary outcomes (2)
incision types
types of incisions used
Measured: day 1 (surgical procedure)
postoperative complications
complications after surgical procedure
Measured: 3-6-12-24 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Jul 2020
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
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 Hernia IncisionalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Bellido-Luque.MD
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena
- Responsible party
- Sponsor-investigator, Juan Bellido-Luque.MD, Hospital Quiron Sagrado Corazon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433439
- Sponsor's protocol ID
- Virgen Macarena Hospital
- Acronym
- meshproph
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol
Publications
Bellido-Luque J, Sanchez-Matamoros Martin I, Reguera-Rosal J, Balla A, Morales-Conde S, Nogales Munoz A. Prophylactic Mesh Placement and Incisional Hernia Incidence in Hepatobiliopancreatic Surgery: A Randomized Clinical Trial. JAMA Surg. 2026 Sep 9:e264012. doi: 10.1001/jamasurg.2026.4012. Online ahead of print.
PubMed 42714891
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Mesh Placement Reduces the Incidence of Incisional Hernia in HBP Surgery.
- ClinicalTrials.gov ID
- NCT07433439
- Acronym / sponsor ID
- meshproph / Virgen Macarena Hospital
- Conditions
- Hernia Incisional, Incision Site Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Juan Bellido-Luque.MDUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 25 Feb 2026 (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.
he goal of this observational study is to learn about prophylactic mesh placement in HBP incision. The main question it aims to answer is:
will the incisional hernia rate be reduced with the use of mesh during the abdominal wall closuer?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh group | Experimental | Procedure: mesh placementgroup in which a mesh is placed |
| non mesh group | Active comparator | Other: conventional abdominal wall closure without meshgroup in which a mesh is not placed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years or older.
- Elective conventional or extensive right subcostal laparotomy.
- Two or more risk Factor for incisional hernia (IH): > 60 years, Body Mass Index > 27 kg/m2, Diabetes Mellitus, pulmonary/liver/renal disease, malignancy, preoperative chemotherapy, immunosuppression or smoking5.
- Life expectancy of at least 12 months.
- Signed informed consent with agreement to attend all study visits.
Key exclusion criteria (4 listed)
- Emergency surgery.
- Previous right subcostal hernia or right subcostal incision.
- Metastatic disease or irresectable malignancy identified during the surgery with life expectancy less than 12 months.
- Active abdominal infection at the time of surgery
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 placementmesh is placed in retromuscular space when abdominal wall is closed | Procedure or surgery | Mesh group |
| conventional abdominal wall closure without meshconventional AWC without mesh | Other | non mesh group |
Primary outcome
image detected IH rate
Time frame: 12 and 24 months
incisional hernia rate after 12 and 24 posoperative months
2 secondary outcomes
incision types
Time frame: day 1 (surgical procedure)
postoperative complications
Time frame: 3-6-12-24 postoperative months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Derived from this study: PubMed 42714891Bellido-Luque J, Sanchez-Matamoros Martin I, Reguera-Rosal J, Balla A, Morales-Conde S, Nogales Munoz A. Prophylactic Mesh Placement and Incisional Hernia Incidence in Hepatobiliopancreatic Surgery: A Randomized Clinical Trial. JAMA Surg. 2026 Sep 9:e264012. doi: 10.1001/jamasurg.2026.4012. Online ahead of print.
- Individual participant dataSharing planned: Yes. study protocol
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mesh placement and conventional abdominal wall closure without mesh in people with Hernia Incisional and Incision Site Complication, run by Juan Bellido-Luque.MD at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
image detected IH rate (time frame: 12 and 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 NCT07433439, 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 25 Feb 2026.