RecruitingNot Applicable

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

Italy300 participantsStarted 2025-01-23

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Postoperative Hospital Length of Stay

Timeframe: From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery

Trial details

NCT IDNCT07493876

SponsorFondazione del Piemonte per l'Oncologia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

Contact for this trial

Manuela Robella, MD

+390119933445 manuela.robella@ircc.it