Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
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)
Fondazione del Piemonte per l'Oncologia
300 participants
Jan 23, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria5
- 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
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Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07493876