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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Hospital Zonal General De Agudos Mario V Larrain • ClinicalTrials.gov ID: NCT07843225

Registry updated: 2026-10-14
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Description

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.

Interventions

  • 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.

Eligibility criteria

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)

Conditions

Incisional Hernia Repair Ventral Incisional Hernia

Locations

  • Hospital Zonal General de Agudos "Dr. Mario V. Larrain — Berisso, Buenos Aires, Argentina
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record