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Purpose <p>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.</p> Methods <p>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&#xa0;L and Carolinas Comfort Scale (CCS) questionnaires.</p> Results <p>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&#xa0;L and CCS scores demonstrated progressive improvement in QoL and symptom reduction over time (<i>p</i> &lt; 0.0001).</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年9月18日

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  • Roberto Peltrini,
  • Carla Rognoni,
  • Giovanni Bellanova,
  • Marco Caricato,
  • Massimo Carlini,
  • Stefania Cimbanassi,
  • Francesco Corcione,
  • Federico Cozzani,
  • Diego Cuccurullo,
  • Giuseppe Faillace,
  • Silvia Neri,
  • Alberto Patriti,
  • Mauro Santarelli,
  • Vincenzo Trapani,
  • Gabriella Teresa Capolupo,
  • Gabriele Carbone,
  • Desiree Cianflocca,
  • Stefano Cioffi,
  • Maria Michela Di Nuzzo,
  • Davide Ferrara,
  • Paola Antonella Greco,
  • Biancamaria Iacone,
  • Francesca Pecchini,
  • Matteo Rossini,
  • Michele Sacco,
  • Stefano Sala,
  • Domenico Spoletini,
  • Salvatore Tramontano,
  • Rosanna Tarricone,
  • Giampiero Campanelli,
  • Giuseppe Cavallaro,
  • Micaela Piccoli,
  • Giorgio Soliani,
  • Cesare Stabilini,
  • Umberto Bracale

摘要

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.