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

NCT07843225 | Recruiting

• 2 other identifiers: IMFC-HL-2026DISPO-2026-226-GDEBA-DIYCTMSAL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Incisional Hernia Repair; Ventral Incisional Hernia

Keywords

incisional hernia; ventral hernia; surgical mesh; fascial closure; abdominal wall surgery; hernia recurrence; IMFC

Outcome Measures

Primary Outcomes (2)

• Recurrence rate of incisional hernia

  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.

  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.

  Throughout study participation (up to 24 months)

Secondary Outcomes (4)

• Operative time and fascial closure time

  Intraoperative (during the surgical procedure)

• Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11)

  Postoperative days 7, 15, and 30

• Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)

  Up to 30 days postoperative

• Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations

  Up to 24 months (exploratory)

Study Arms (2)

Standard Mesh Closure

ACTIVE COMPARATOR

Conventional fascial closure using a macroporous polypropylene mesh fixed independently from the closure suture

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

Procedure: Integrated Mesh-Fascial Closure

Interventions

Integrated Mesh-Fascial Closure PROCEDURE

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

Integrated Mesh-Fascial Closure - IMFC

Standard Fascial Closure with Mesh PROCEDURE

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

Standard Mesh Closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Zonal General De Agudos Mario V Larrain: lead

Study Sites (1)

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

Berisso, Buenos Aires, 1923, Argentina

RECRUITING

MeSH Terms

Conditions

Incisional Hernia; Hernia, Ventral

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Hernia, Abdominal

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Facundo B Mattano, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Facundo B Mattano, MD

CONTACT

+54 9 221 611-7976; mattanofacundo@outlook.com

Emiliano D Gargiulo, MD

CONTACT

+54 2215371371

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: When feasible, the ultrasound assessment used to determine hernia recurrence is performed by an evaluator independent of and unaware of the surgical technique assigned to the participant, in order to reduce outcome-assessment bias. Blinding of the participant, surgeon, and investigator is not feasible given the nature of the surgical intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon (General Surgery), Urologist, Principal Investigator

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 25, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): October 15, 2030
• Study Completion (Estimated): October 15, 2032
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)