Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair
Prospective Comparative Evaluation of the Integrated Mesh-Fascial Closure (IMFC) Technique Versus Standard Closure of the Abdominal Wall: A Quasi-Experimental, Non-Randomized Study
- Incisional Hernia Repair
- Ventral Incisional Hernia
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Hospital Zonal General De Agudos Mario V Larrain
- Enrolment target
- 60
- Started
- 18 September 2026
- Main results due
- 15 October 2030
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Hospital Zonal General de Agudos "Dr. Mario V. Larrain
Berisso, Buenos Aires, Argentina
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07843225. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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