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
{"title":"Prevention of incisional hernia with biosynthetic mesh at the site of temporary ileostomy closure (PRINCESS Study): Preliminary Results.","authors":"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","doi":"10.1007/s10029-025-03462-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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>","PeriodicalId":13168,"journal":{"name":"Hernia","volume":"29 1","pages":"277"},"PeriodicalIF":2.4000,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12446398/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hernia","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10029-025-03462-0","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍:
Hernia was founded in 1997 by Jean P. Chevrel with the purpose of promoting clinical studies and basic research as they apply to groin hernias and the abdominal wall . Since that time, a true revolution in the field of hernia studies has transformed the field from a ”simple” disease to one that is very specialized. While the majority of surgeries for primary inguinal and abdominal wall hernia are performed in hospitals worldwide, complex situations such as multi recurrences, complications, abdominal wall reconstructions and others are being studied and treated in specialist centers. As a result, major institutions and societies are creating specific parameters and criteria to better address the complexities of hernia surgery.
Hernia is a journal written by surgeons who have made abdominal wall surgery their specific field of interest, but we will consider publishing content from any surgeon who wishes to improve the science of this field. The Journal aims to ensure that hernia surgery is safer and easier for surgeons as well as patients, and provides a forum to all surgeons in the exchange of new ideas, results, and important research that is the basis of professional activity.