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

IF 2.4 2区 医学 Q1 SURGERY
Hernia Pub Date : 2025-09-18 DOI:10.1007/s10029-025-03462-0
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
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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.

Abstract Image

在临时回肠造口闭合部位使用生物合成补片预防切口疝(PRINCESS研究):初步结果。
目的:回肠造口术后切口疝是一种影响患者预后、生活质量(QoL)、医疗资源和相关费用的并发症。预防性补片加固,无论是生物的还是合成的,已经被证明是安全有效的预防造口切口疝(SSIH)。本研究旨在评估在临时回肠造口处使用可缓慢吸收的生物合成补片来预防SSIH。方法:这项前瞻性单臂观察性研究在意大利14家医院进行。患者接受回肠造口逆转,并在肌肉后放置聚4-羟基丁酸酯(Phasix™)补片。终点包括1年放射学和临床检测到的SSIH发生率、术后发病率、伤口并发症以及使用EuroQoL 5d - 5l和carolina Comfort Scale (CCS)问卷评估的生活质量。结果:共有115例患者完成了至少1年的随访,并被纳入分析。血清瘤是最常见的并发症(8.6%)。浅表和深部ssi分别发生在6%和1.7%的患者中。3例并发症需要干预(2.6%),包括1例取网。1年的SSIH率为1.7%,中位随访时间为477 d(范围:263-880)。55例患者(47.8%)完成2年随访,累计SSIH率为4.3%。EuroQoL 5d - 5l和CCS评分显示,随着时间的推移,患者的生活质量逐步改善,症状减轻(p结论:这些初步研究结果表明,预防性放置可缓慢吸收的生物合成补片(Phasix™)对于回肠造口术后预防SSIH是安全有效的,不会对患者的生活质量产生负面影响。在这种情况下,生物合成网的使用可能被认为是生物或合成网的有效替代品。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Hernia
Hernia SURGERY-
CiteScore
4.90
自引率
26.10%
发文量
171
审稿时长
4-8 weeks
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.
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