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

RecruitingNAAges 18 Years - anyAllHospital Zonal General De Agudos Mario V Larrain
NCT07843225 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 deter

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📋 Eligibility rules (as published)
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)
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What it tests

  • Integrated Mesh-Fascial Closure
  • Standard Fascial Closure with Mesh
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Where

1 site
Hospital Zonal General de Agudos "Dr. Mario V. Larrain
Berisso, Argentina
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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