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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione del Piemonte per l'Oncologia

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ERAS Perioperative Management Protocol

Treatment groups

300 Participants
are divided into 2 treatment groups