Implementation of an enhanced recovery after surgery (ERAS) program in patients undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: study protocol for a prospective multicenter interventional trial (EPICH study).

IF 1.4 Q4 ONCOLOGY
Pleura and Peritoneum Pub Date : 2025-04-25 eCollection Date: 2025-06-01 DOI:10.1515/pp-2024-0033
Manuela Robella, Eva Pagano, Lisa Giacometti, Armando Cinquegrana, Luca Pellegrino, Andrea Evangelista, Alessandra Saliva, Alessandro Cerutti, Felice Borghi
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Abstract

Objectives: This study aims to evaluate the clinical impact of introducing an Enhanced Recovery After Surgery (ERAS) protocol in the management of patients undergoing cytoreductive surgery (CRS), with or without hyperthermic intraperitoneal chemotherapy (HIPEC). By addressing a population at high risk of postoperative complications and delayed recovery, the study seeks to determine whether ERAS can improve short-term outcomes, optimize perioperative care, and promote faster and safer recovery in a standardized, evidence-based manner across multiple centers.

Methods: The EPICH study is a multicenter, prospective, interventional trial conducted across 20 centers in Italy. A total of 300 patients undergoing CRS±HIPEC will be enrolled in two sequential phases: standard perioperative care followed by ERAS protocol implementation. The primary endpoint is the mean hospital length of stay (LOS). Secondary endpoints include postoperative complications, ICU admission, readmission rates, bowel function recovery, mortality, and patient-reported quality of recovery. The ERAS protocol includes prehabilitation, anemia and nutritional optimization, intraoperative fluid and pain management, and early mobilization and oral feeding. Data will be analyzed using random-effects linear models to account for center-level variation and confounding factors.

Results: Preliminary evidence suggests that the ERAS protocol may help reduce mean hospital LOS, postoperative complications, and ICU stays, as well as support faster bowel recovery and improved patient-reported outcomes-findings that this study seeks to validate.

Conclusions: The EPICH study could provide robust evidence supporting the adoption of ERAS as the standard of care for patients undergoing CRS±HIPEC, with potential benefits in terms of improved recovery, reduced complications, and decreased healthcare resource utilization.

在接受细胞减少手术和腹腔内高温化疗的患者中实施增强术后恢复(ERAS)计划:一项前瞻性多中心介入试验(EPICH研究)的研究方案。
目的:本研究旨在评估在接受细胞减少手术(CRS)的患者中引入增强术后恢复(ERAS)方案,并伴有或不伴有腹腔热化疗(HIPEC)的临床影响。通过解决术后并发症和延迟恢复的高风险人群,该研究旨在确定ERAS是否可以改善短期结果,优化围手术期护理,并在多个中心以标准化、循证的方式促进更快、更安全的恢复。方法:EPICH研究是一项多中心、前瞻性、介入性试验,在意大利的20个中心进行。总共300名接受CRS±HIPEC的患者将分为两个连续阶段:标准围手术期护理和ERAS方案实施。主要终点是平均住院时间(LOS)。次要终点包括术后并发症、ICU入院、再入院率、肠功能恢复、死亡率和患者报告的恢复质量。ERAS方案包括康复、贫血和营养优化、术中液体和疼痛管理、早期活动和口服喂养。数据将使用随机效应线性模型进行分析,以解释中心水平的变化和混杂因素。结果:初步证据表明ERAS方案可能有助于减少平均住院时间、术后并发症和ICU住院时间,并支持更快的肠道恢复和改善患者报告的结果——本研究试图验证这些发现。结论:EPICH研究可以为采用ERAS作为CRS±HIPEC患者的标准护理提供有力的证据,在改善康复、减少并发症和降低医疗资源利用率方面具有潜在的益处。
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
CiteScore
2.50
自引率
11.10%
发文量
23
审稿时长
9 weeks
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