Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Официальное название

Prospective Multicenter Interventional Pre-Post Study of an Enhanced Recovery After Surgery (ERAS) Protocol in the Perioperative Management of Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without HIPEC (EPICH)

Обзор

This prospective multicenter interventional pre-post study aims to evaluate the effect of implementing an Enhanced Recovery After Surgery (ERAS) protocol in patients with peritoneal carcinomatosis undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC). Approximately 300 patients will be enrolled across 20 Italian centers. During an initial pre-intervention period, usual perioperative management will be described; during a subsequent intervention period, participating centers will apply a predefined ERAS protocol. The primary objective is to assess the effect of ERAS implementation on mean postoperative hospital length of stay.

Подробное описание

Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care pathway designed to reduce surgical stress and accelerate postoperative recovery through coordinated evidence-based interventions involving surgery, anesthesia, nutrition, and rehabilitation. In patients with peritoneal carcinomatosis undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC), postoperative morbidity and prolonged hospitalization remain clinically relevant issues. This study will evaluate the implementation of a selected ERAS protocol in this setting. The study is designed as a multicenter interventional pre-post study: during the first period (approximately 4 months; 100 patients), usual perioperative procedures will be documented; during the second period (approximately 8 months; 200 patients), centers will apply a predefined ERAS pathway. Monitored ERAS elements include prehabilitation and preoperative counseling, nutritional assessment and support, bowel preparation and antibiotic prophylaxis, perioperative fasting management, postoperative oral intake, fluid management, and intra-/postoperative analgesic management.

Вмешательства

• Другое ERAS Perioperative Management Protocol
  A multimodal perioperative care pathway for patients undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC), implemented by a multidisciplinary Enhanced Recovery After Surgery (ERAS) team and including coordinated preoperative, intraoperative, and postoperative measures aimed at reducing surgical stress and improving recovery.

Первичные конечные точки

• Postoperative Hospital Length of Stay [Срок оценки: From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery]

Вторичные конечные точки (9)

• Adherence to Selected ERAS Protocol Items [Срок оценки: Perioperative period, from preoperative assessment before surgery through hospital discharge during the index hospitalization, assessed up to 30 days after surgery]
• Incidence of Postoperative Complications [Срок оценки: From the date of surgery to 30 days after surgery]
• Postoperative Intensive Care Unit Length of Stay [Срок оценки: From postoperative ICU admission after the index surgery to ICU discharge, assessed up to 30 days after surgery]
• Incidence of Reinterventions [Срок оценки: From the date of surgery to 30 days after surgery]
• Incidence of Hospital Readmissions [Срок оценки: From hospital discharge to 30 days after surgery.]
• Incidence of Emergency Department Visits [Срок оценки: From hospital discharge to 30 days after surgery.]
• Time to Recovery of Bowel Function [Срок оценки: From Day 0 (date of surgery) to first documented recovery of bowel function, assessed daily during the index hospitalization, up to 30 days after surgery]
• All-Cause Mortality [Срок оценки: From the date of surgery to 30 days after surgery.]
• Quality of Postoperative Recovery [Срок оценки: Approximately 48 hours after surgery]

Критерии участия

Критерии включения

• Written informed consent signed before the procedure
• Histological or cytological diagnosis of advanced solid tumor with documented peritoneal carcinomatosis originating from one of the following: peritoneal mesothelioma or other primary malignant peritoneal tumor, gynecologic tumor, gastric tumor, or intestinal tumor
• Age >18 years
• ECOG performance status ≤1
• ASA score ≤3

Критерии исключения

• Missing written informed consent
• ASA score ≥4
• Palliative surgery or other unplanned surgery
• Severe renal insufficiency, severe hepatic insufficiency, severe heart failure, recent myocardial infarction, or severe arrhythmia
• Immunocompromised patients, patients receiving immunosuppressive therapy, or patients with immune system diseases

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 2 центра

• Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo — Candiolo
• Fondazione IRCCS Policlinico San Matteo — Pavia

Идентификаторы

NCT: NCT07493876 · 002-FPO24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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