Incisional Hernia RepairIMFCNCT07843225
Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair
A study testing Integrated Mesh-Fascial Closure and Standard Fascial Closure with Mesh in people with Incisional Hernia Repair and Ventral Incisional Hernia, run by Hospital Zonal General De Agudos Mario V Larrain at 1 site in Argentina.
Trial summary
This study compares two surgical techniques for closing the abdominal wall in adult patients who have an incisional hernia (a weakness or opening in a previous surgical incision) or who require prophylactic mesh placement during a laparotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia Repair, Ventral Incisional Hernia
- What is being tested?
- Integrated Mesh-Fascial Closure and Standard Fascial Closure with Mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteArgentina
- Study dates
- 28 Sep 2026to 15 Oct 2032
- Phase
- Interventional
- 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
Who may be able to join
- Adults older than 18 years of age
- Patients with incisional (ventral) hernia
- Patients with recurrent incisional hernia
- Incisional hernias with a diameter greater than 4 cm
- Patients undergoing laparotomy with an indication for prophylactic mesh placement
Who cannot join
- Active surgical site infection
- Overt abdominal contamination
- Tissue necrosis or inability to achieve primary fascial closure
- Non-correctable loss of domain
- Pregnant women or women of childbearing potential planning pregnancy or not using contraception during the follow-up period
- Patients belonging to vulnerable populations, in accordance with Law 15.462 and applicable ethical guidelines
- Active oncologic disease (patients with a cured oncologic history may be included)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emiliano D Gargiulo, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Zonal General de Agudos "Dr. Mario V. Larrain
Berisso, Buenos Aires, 1923
Facundo B Mattano, MD, +54 9 2216117976, mattanofacundo@outlook.com
Emiliano D Gargiulo, MD, +54 9 221 5371371
About this study
Official title: Prospective Comparative Evaluation of the Integrated Mesh-Fascial Closure (IMFC) Technique Versus Standard Closure of the Abdominal Wall: A Quasi-Experimental, Non-Randomized Study
This study compares two surgical techniques for closing the abdominal wall in adult patients who have an incisional hernia (a weakness or opening in a previous surgical incision) or who require prophylactic mesh placement during a laparotomy.
In one group, the abdominal wall is closed using the standard technique, in which a polypropylene mesh is fixed independently from the fascial suture. In the other group, Integrated Mesh-Fascial Closure (IMFC) is used, a standardized execution of the technique of mesh incorporation into the fascial closure described by Jamal et al (Hernia, 2013).
The choice of technique is made by the patient after receiving information about both options and providing informed consent. Participants will be followed clinically and with imaging for 18 to 24 months to evaluate the safety, technical feasibility, and reproducibility of the IMFC technique, and to determine the incidence of hernia recurrence in both groups.
Read the detailed description
Incisional hernia is one of the most frequent complications of abdominal surgery, with a reported incidence of 10-20% after laparotomy, and recurrence rates after mesh repair reaching 20-30% in long-term follow-up. In conventional techniques, primary fascial closure and mesh fixation are performed as two mechanically independent steps, concentrating tension on the suture line during the acute postoperative period.
The Integrated Mesh-Fascial Closure (IMFC) technique integrates a macroporous polypropylene mesh within a continuous fascial suture line (pattern: mesh → right fascial edge → left fascial edge → mesh), aiming to distribute tensile load simultaneously between the fascia and the prosthesis, potentially reducing the incidence of hernia recurrence compared to standard closure. The principle of incorporating the mesh into the fascial closure was described by Jamal et al in a retrospective series of 72 patients. IMFC standardizes its execution (suture material, 5-mm bites in mesh and fascia, anchoring of the suture line in healthy aponeurosis, and optional minimal peripheral fixation) and evaluates it prospectively against standard closure.
This is a prospective, comparative, quasi-experimental (non-randomized) study conducted at a single center (Hospital Zonal General de Agudos "Dr. Mario V. Larrain," Berisso, Argentina). Eligible patients choose, after informed consent, between standard mesh closure (Group A) or IMFC (Group B). Both groups follow the same clinical and imaging follow-up schedule (days 7, 15, 30; months 2, 6, 12, 18; and a final visit between 18 and 24 months).
The study is designed as an initial, hypothesis-generating comparison of safety, technical feasibility, and reproducibility across surgeons, intended to support a future randomized trial.
- Being tested
- Integrated Mesh-Fascial Closure, Standard Fascial Closure with Mesh
- Keywords
- incisional hernia, ventral hernia, surgical mesh, fascial closure, abdominal wall surgery, hernia recurrence, IMFC
- Medical subject headings
- Incisional Hernia, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Mesh-Fascial ClosureProcedure or surgery
Same materials integrated into a single continuous suture line using the IMFC technique.
Standard Fascial Closure with MeshProcedure or surgery
Macroporous polypropylene mesh (FILAPROP™/MERIGROW™) plus non-absorbable polypropylene suture, placed using the conventional (independent) technique.
| Study group | Role | What they receive |
|---|---|---|
| Standard Mesh Closure | Active comparator | Conventional fascial closure using a macroporous polypropylene mesh fixed independently from the closure suture Receives: Procedure: Standard Fascial Closure with Mesh |
| Integrated Mesh-Fascial Closure - IMFC | Experimental | Fascial closure using the Integrated Mesh-Fascial Closure (IMFC) technique: the mesh is incorporated within the trajectory of a single continuous fascial suture (pattern: mesh → right fascial edge → left fascial edge → mesh Receives: Procedure: Integrated Mesh-Fascial Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate of incisional hernia
Proportion of participants with hernia recurrence, assessed by clinical physical examination and abdominal wall ultrasound, performed in all participants at 6 months and at the final visit (18-24 months). All ultrasound evaluations performed by the same sonographer throughout the study; the sonographer is aware of study participation but blinded to the specific surgical technique (IMFC vs. standard closure) received by each participant.
Measured: 18-24 months (final follow-up visit)
Rate of Major Intraoperative and Postoperative Complications
Proportion of participants experiencing a serious adverse event (SAE), defined per ICH E6(R3) as death, a life-threatening event, hospitalization or prolongation of hospitalization, persistent or significant disability, or an unplanned surgical reintervention. Postoperative complications additionally graded using the Clavien-Dindo classification system (Grade I-V) to assess severity.
Measured: Throughout study participation (up to 24 months)
Secondary outcomes (4)
Operative time and fascial closure time
Total operative time (from skin incision to skin closure) and fascial closure time (from start to completion of the mesh-fascial suture line), both measured in minutes and recorded intraoperatively by the surgical team using the operating room clock.
Measured: Intraoperative (during the surgical procedure)
Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11)
Self-reported postoperative pain intensity measured using the 11-point Numeric Pain Rating Scale (NRS-11), an unabbreviated verbally- or visually-administered numeric scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable." Higher scores indicate worse (more severe) pain. Assessed at rest.
Measured: Postoperative days 7, 15, and 30
Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)
Proportion of participants with surgical site infection, seroma, wound dehiscence, or hematoma, identified by clinical examination at scheduled postoperative visits (days 7, 15, and 30) and graded according to the Clavien-Dindo classification.
Measured: Up to 30 days postoperative
Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations
Total direct hospital costs, expressed in Argentine pesos (ARS), attributable to management of complications or unplanned reoperations, extracted from institutional administrative and billing records. Exploratory outcome; not powered for formal statistical comparison between groups.
Measured: Up to 24 months (exploratory)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start28 Sep 2026
- Primary completion15 Oct 2030 (estimated)
- Study completion15 Oct 2032 (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 Hernia RepairStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Zonal General De Agudos Mario V Larrain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bovino Mattano Facundo, Hospital Zonal General De Agudos Mario V Larrain
- Investigators
- Facundo B Mattano, MD, Principal investigator, Hospital Zonal General de Agudos "Dr. Mario V. Larrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843225
- Sponsor's protocol ID
- IMFC-HL-2026
- Other IDs
- DISPO-2026-226-GDEBA-DIYCTMSAL
- Acronym
- IMFC
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jamal K, Ratnasingham K, Shaunak S, Ravindran K, Nehra D. A novel technique for modified onlay incisional hernia repair with mesh incorporation into the fascial defect: a method for addressing suture line failure. Hernia. 2015 Jun;19(3):473-7. doi: 10.1007/s10029-013-1195-3. Epub 2013 Dec 19.
PubMed 24352638
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Evaluation of the Integrated Mesh-Fascial Closure (IMFC) Technique Versus Standard Closure of the Abdominal Wall: A Quasi-Experimental, Non-Randomized Study
- ClinicalTrials.gov ID
- NCT07843225
- Acronym / sponsor ID
- IMFC / IMFC-HL-2026
- Keywords
- incisional hernia, ventral hernia, surgical mesh, fascial closure, abdominal wall surgery, hernia recurrence, IMFC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Zonal General De Agudos Mario V LarrainUniversity, hospital or other
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 15 Oct 2030 (estimated)
- Study completion
- 15 Oct 2032 (estimated)
- First posted
- 25 Sep 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.
This study compares two surgical techniques for closing the abdominal wall in adult patients who have an incisional hernia (a weakness or opening in a previous surgical incision) or who require prophylactic mesh placement during a laparotomy.
In one group, the abdominal wall is closed using the standard technique, in which a polypropylene mesh is fixed independently from the fascial suture. In the other group, Integrated Mesh-Fascial Closure (IMFC) is used, a standardized execution of the technique of mesh incorporation into the fascial closure described by Jamal et al (Hernia, 2013).
The choice of technique is made by the patient after receiving information about both options and providing informed consent. Participants will be followed clinically and with imaging for 18 to 24 months to evaluate the safety, technical feasibility, and reproducibility of the IMFC technique, and to determine the incidence of hernia recurrence in both groups.
Detailed description
Incisional hernia is one of the most frequent complications of abdominal surgery, with a reported incidence of 10-20% after laparotomy, and recurrence rates after mesh repair reaching 20-30% in long-term follow-up. In conventional techniques, primary fascial closure and mesh fixation are performed as two mechanically independent steps, concentrating tension on the suture line during the acute postoperative period.
The Integrated Mesh-Fascial Closure (IMFC) technique integrates a macroporous polypropylene mesh within a continuous fascial suture line (pattern: mesh → right fascial edge → left fascial edge → mesh), aiming to distribute tensile load simultaneously between the fascia and the prosthesis, potentially reducing the incidence of hernia recurrence compared to standard closure. The principle of incorporating the mesh into the fascial closure was described by Jamal et al in a retrospective series of 72 patients. IMFC standardizes its execution (suture material, 5-mm bites in mesh and fascia, anchoring of the suture line in healthy aponeurosis, and optional minimal peripheral fixation) and evaluates it prospectively against standard closure.
This is a prospective, comparative, quasi-experimental (non-randomized) study conducted at a single center (Hospital Zonal General de Agudos "Dr. Mario V. Larrain," Berisso, Argentina). Eligible patients choose, after informed consent, between standard mesh closure (Group A) or IMFC (Group B). Both groups follow the same clinical and imaging follow-up schedule (days 7, 15, 30; months 2, 6, 12, 18; and a final visit between 18 and 24 months).
The study is designed as an initial, hypothesis-generating comparison of safety, technical feasibility, and reproducibility across surgeons, intended to support a future randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Mesh Closure | Active comparator | Procedure: Standard Fascial Closure with MeshConventional fascial closure using a macroporous polypropylene mesh fixed independently from the closure suture |
| Integrated Mesh-Fascial Closure - IMFC | Experimental | Procedure: Integrated Mesh-Fascial ClosureFascial closure using the Integrated Mesh-Fascial Closure (IMFC) technique: the mesh is incorporated within the trajectory of a single continuous fascial suture (pattern: mesh → right fascial edge → left fascial edge → mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults older than 18 years of age
- Patients with incisional (ventral) hernia
- Patients with recurrent incisional hernia
- Incisional hernias with a diameter greater than 4 cm
- Patients undergoing laparotomy with an indication for prophylactic mesh placement
Key exclusion criteria (7 listed)
- Active surgical site infection
- Overt abdominal contamination
- Tissue necrosis or inability to achieve primary fascial closure
- Non-correctable loss of domain
- Pregnant women or women of childbearing potential planning pregnancy or not using contraception during the follow-up period
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 |
|---|---|---|
| Integrated Mesh-Fascial ClosureSame materials integrated into a single continuous suture line using the IMFC technique. | Procedure or surgery | Integrated Mesh-Fascial Closure - IMFC |
| Standard Fascial Closure with MeshMacroporous polypropylene mesh (FILAPROP™/MERIGROW™) plus non-absorbable polypropylene suture, placed using the conventional (independent) technique. | Procedure or surgery | Standard Mesh Closure |
Primary outcome
Recurrence rate of incisional hernia
Time frame: 18-24 months (final follow-up visit)
Proportion of participants with hernia recurrence, assessed by clinical physical examination and abdominal wall ultrasound, performed in all participants at 6 months and at the final visit (18-24 months). All ultrasound evaluations performed by the same sonographer throughout the study; the sonographer is aware of study participation but blinded to the specific surgical technique (IMFC vs. standard closure) received by each participant.
Rate of Major Intraoperative and Postoperative Complications
Time frame: Throughout study participation (up to 24 months)
Proportion of participants experiencing a serious adverse event (SAE), defined per ICH E6(R3) as death, a life-threatening event, hospitalization or prolongation of hospitalization, persistent or significant disability, or an unplanned surgical reintervention. Postoperative complications additionally graded using the Clavien-Dindo classification system (Grade I-V) to assess severity.
4 secondary outcomes
Operative time and fascial closure time
Time frame: Intraoperative (during the surgical procedure)
Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11)
Time frame: Postoperative days 7, 15, and 30
Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)
Time frame: Up to 30 days postoperative
Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations
Time frame: Up to 24 months (exploratory)
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 14 Oct 2026.
- Background: PubMed 24352638Jamal K, Ratnasingham K, Shaunak S, Ravindran K, Nehra D. A novel technique for modified onlay incisional hernia repair with mesh incorporation into the fascial defect: a method for addressing suture line failure. Hernia. 2015 Jun;19(3):473-7. doi: 10.1007/s10029-013-1195-3. Epub 2013 Dec 19.
- Individual participant dataSharing planned: No
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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.
Emiliano D Gargiulo, MD contact
Facundo B Mattano, MD principal investigator
Hospital Zonal General de Agudos "Dr. Mario V. Larrain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Mesh-Fascial Closure and Standard Fascial Closure with Mesh in people with Incisional Hernia Repair and Ventral Incisional Hernia, run by Hospital Zonal General De Agudos Mario V Larrain at 1 site in Argentina.
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 7 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: looking for participants now, as of the sponsor's last update on 14 Oct 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 Argentina. 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?
Contact Facundo B Mattano, MD (+54 9 221 611-7976, mattanofacundo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of incisional hernia (time frame: 18-24 months (final follow-up visit)). The study lists 2 primary outcomes in all. 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 NCT07843225, 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 14 Oct 2026.