Prevention of incisional hernia with biosynthetic mesh at the site of temporary ileostomy closure (PRINCESS Study): Preliminary Results

Purpose: Incisional hernia after ileostomy closure is a complication that adversely affects patient outcomes, quality of life (QoL), healthcare resources, and related costs. Prophylactic mesh reinforcement, both biological and synthetic, has been shown to be safe and effective in preventing stoma site incisional hernia (SSIH). This study aimed to evaluate the use of a slowly absorbable biosynthetic mesh at the site of temporary ileostomy closure to prevent SSIH. Methods: This prospective, single-arm observational study was conducted across 14 Italian hospitals. Patients undergoing ileostomy reversal with retromuscular placement of a poly-4-hydroxybutyrate (Phasix™) mesh were enrolled. Endpoints included the incidence of radiologically and clinically detected SSIH at 1-year, postoperative morbidity, wound complications, and QoL assessed using the EuroQoL 5D-5 L and Carolinas Comfort Scale (CCS) questionnaires. Results: A total of 115 patients completed at least 1 year of follow-up and were included in the analysis. Seromas was the most frequent complication (8.6%). Superficial and deep SSIs occurred in 6% and 1.7% of patients, respectively. Three complications required intervention (2.6%), including one mesh removal. The 1-year SSIH rate was 1.7%, with a median follow-up of 477 d (range: 263–880). Considering the 55 patients (47.8%) who completed 2-year follow-up, the cumulative SSIH rate was 4.3%. EuroQoL 5D-5 L and CCS scores demonstrated progressive improvement in QoL and symptom reduction over time (p < 0.0001). Conclusion: These preliminary findings suggest that prophylactic placement of a slowly absorbable biosynthetic mesh (Phasix™) is safe and effective for SSIH prevention following ileostomy closure, without negatively impacting the patient’s QoL. The use of biosynthetic meshes may be considered a valid alternative to biological or synthetic meshes in this setting.