Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Postoperative Hospital Length of Stay — From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery Hospital length of stay measured in days from the date of surgery (Day 0) to the date of discharge from the index hospitalization. For the primary analysis, outliers with a hospital stay greater than the 95th percentile of the distribution will be excluded
Trial sites (2)
Facility
City
Region
Status
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo
Candiolo
Turin
Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Italy
Not Yet Recruiting
More Fondazione del Piemonte per l'Oncologia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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