Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair (IMFC)

October 8, 2026 updated by: Bovino Mattano Facundo, Hospital Zonal General De Agudos Mario V Larrain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Emiliano D Gargiulo, MD
  • Phone Number: +54 2215371371

Study Locations

  • Argentina
    • Buenos Aires
      • Berisso, Buenos Aires, Argentina, 1923
        • Recruiting
        • Hospital Zonal General de Agudos "Dr. Mario V. Larrain
        • Contact:
        • Contact:
          • Emiliano D Gargiulo, MD
          • Phone Number: +54 9 221 5371371

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Mesh Closure

Conventional fascial closure using a macroporous polypropylene mesh fixed independently from the closure suture
Procedure: Standard Fascial Closure with Mesh

Macroporous polypropylene mesh (FILAPROP™/MERIGROW™) plus non-absorbable polypropylene suture, placed using the conventional (independent) technique.
Experimental: Integrated Mesh-Fascial Closure - IMFC

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
Procedure: Integrated Mesh-Fascial Closure

Same materials integrated into a single continuous suture line using the IMFC technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18-24 months (final follow-up visit)
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.
Throughout study participation (up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time and fascial closure time
Time Frame: Intraoperative (during the surgical procedure)

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.
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

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.
Postoperative days 7, 15, and 30
Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)
Time Frame: Up to 30 days postoperative

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.
Up to 30 days postoperative
Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations
Time Frame: Up to 24 months (exploratory)

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.
Up to 24 months (exploratory)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Zonal General De Agudos Mario V Larrain

Investigators

  • Principal Investigator: Facundo B Mattano, MD, Hospital Zonal General de Agudos "Dr. Mario V. Larrain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2026

Primary Completion (Estimated)

October 15, 2030

Study Completion (Estimated)

October 15, 2032

Study Registration Dates

First Submitted

September 18, 2026

First Submitted That Met QC Criteria

September 23, 2026

First Posted (Actual)

September 25, 2026

Study Record Updates

Last Update Posted (Actual)

October 14, 2026

Last Update Submitted That Met QC Criteria

October 8, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMFC-HL-2026
  • DISPO-2026-226-GDEBA-DIYCTMSAL (Other Identifier: Comisión Conjunta de Investigaciones en Salud (CCIS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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