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

Incisional hernia is one of the most frequent complications of abdominal surgery, with a reported incidence of 10-20% after laparotomy, and recurrence rates after mesh repair reaching 20-30% in long-term follow-up. In conventional techniques, primary fascial closure and mesh fixation are performed as two mechanically independent steps, concentrating tension on the suture line during the acute postoperative period.

The Integrated Mesh-Fascial Closure (IMFC) technique integrates a macroporous polypropylene mesh within a continuous fascial suture line (pattern: mesh → right fascial edge → left fascial edge → mesh), aiming to distribute tensile load simultaneously between the fascia and the prosthesis, potentially reducing the incidence of hernia recurrence compared to standard closure. The principle of incorporating the mesh into the fascial closure was described by Jamal et al in a retrospective series of 72 patients. IMFC standardizes its execution (suture material, 5-mm bites in mesh and fascia, anchoring of the suture line in healthy aponeurosis, and optional minimal peripheral fixation) and evaluates it prospectively against standard closure.

This is a prospective, comparative, quasi-experimental (non-randomized) study conducted at a single center (Hospital Zonal General de Agudos "Dr. Mario V. Larrain," Berisso, Argentina). Eligible patients choose, after informed consent, between standard mesh closure (Group A) or IMFC (Group B). Both groups follow the same clinical and imaging follow-up schedule (days 7, 15, 30; months 2, 6, 12, 18; and a final visit between 18 and 24 months).

The study is designed as an initial, hypothesis-generating comparison of safety, technical feasibility, and reproducibility across surgeons, intended to support a future randomized trial.

• 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.

Primary outcomes

• Recurrence rate of incisional hernia [18-24 months (final follow-up visit)]: Proportion of participants with hernia recurrence, assessed by clinical physical examination and abdominal wall ultrasound, performed in all participants at 6 months and at the final visit (18-24 months). 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.
• Rate of Major Intraoperative and Postoperative Complications [Throughout study participation (up to 24 months)]: 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.

Secondary outcomes

• Operative time and fascial closure time [Intraoperative (during the surgical procedure)]: 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.
• Postoperative Pain Assessed by the 0-10 Numeric Pain Rating Scale (NRS-11) [Postoperative days 7, 15, and 30]: 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.
• Rate of Early Postoperative Complications (Infection, Seroma, Dehiscence, Hematoma) [Up to 30 days postoperative]: 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.
• Total Direct Hospital Costs (ARS) Associated with Complications or Reoperations [Up to 24 months (exploratory)]: 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.

Sex: All, ages: 18 Years to any

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)

• Jamal K, Ratnasingham K, Shaunak S, Ravindran K, Nehra D. A novel technique for modified onlay incisional hernia repair with mesh incorporation into the fascial defect: a method for addressing suture line failure. Hernia. 2015 Jun;19(3):473-7. doi: 10.1007/s10029-013-1195-3. Epub 2013 Dec 19. PMID 24352638

• Facundo B Mattano, MD, Principal investigator, Hospital Zonal General de Agudos "Dr. Mario V. Larrain