Standard Closure vs. Integrated Mesh-Fascial Closure (IMFC) for Incisional Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Zonal General De Agudos Mario V Larrain
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active surgical site infection
Overt abdominal contamination
Tissue necrosis or inability to achieve primary fascial closure
Non-correctable loss of domain
Trial design
Design model
Parallel
Treatments tested in this trial
Integrated Mesh-Fascial Closure
Procedure/SurgerySame materials integrated into a single continuous suture line using the IMFC technique.
Standard Fascial Closure with Mesh
Procedure/SurgeryMacroporous polypropylene mesh (FILAPROP™/MERIGROW™) plus non-absorbable polypropylene suture, placed using the conventional (independent) technique.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Standard Mesh ClosureActive comparator 1 intervention
Group B: Integrated Mesh-Fascial Closure - IMFCExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
18-24 months (final follow-up visit)2
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.
Time frame
Throughout study participation (up to 24 months)Secondary outcomes
1
Operative time and fascial closure time
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.
Time frame
Intraoperative (during the surgical procedure)2
Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11)
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.
Time frame
Postoperative days 7, 15, and 303
Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma)
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.
Time frame
Up to 30 days postoperative4
Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations
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.
Time frame
Up to 24 months (exploratory)Sponsors and contacts
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Source ClinicalTrials.gov