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NCT Number: NCT07843225

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

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, a new technique called Integrated Mesh-Fascial Closure (IMFC), developed by the research team, is used: the mesh is incorporated directly within the same continuous suture line that closes the abdominal wall, aiming to better distribute tension across the surgical wound.

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.

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Key information

Conditions

Incisional Hernia Repair Hernia Hernia, Abdominal Hernia, Ventral Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Ventral Incisional Hernia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Zonal General de Agudos "Dr. Mario V. Larrain

Berisso, Buenos Aires, 1923, Argentina

Location status: Recruiting

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Integrated Mesh-Fascial Closure

Procedure

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

Standard Fascial Closure with Mesh

Procedure

Macroporous polypropylene mesh (FILAPROP™/MERIGROW™) plus non-absorbable polypropylene suture, placed using the conventional (independent) technique.

Primary outcomes

  1. 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 confirmed by abdominal wall ultrasound when clinically indicated. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

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Sponsors and collaborators

Lead sponsor

Hospital Zonal General De Agudos Mario V Larrain

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Registry information

Official study 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

Acronym: IMFC

Important dates

Study start
2026
Primary completion
2030
Study completion
2032
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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