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)

对接受细胞减灭术和腹腔热灌注化疗的患者实施术后加速康复(ERAS)方案:一项前瞻性多中心干预试验的研究方案(EPICH 研究)

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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.

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