Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07493876

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

Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-04-03

300

Participants Needed

2

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo

Candiolo, Turin, Italy, 10060

Actively Recruiting

2

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Not Yet Recruiting

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Research Team

M

Manuela Robella, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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