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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • ERAS Perioperative Management Protocol

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Usual Perioperative ManagementNo intervention 0 interventions
Group B: ERAS Perioperative Management ProtocolOther 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Hospital Length of Stay

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

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

Secondary outcomes

1

Adherence to Selected ERAS Protocol Items

Adherence to the predefined ERAS perioperative items selected for monitoring, assessed across the preoperative, intraoperative, and postoperative phases of care

Time frame
Perioperative period, from preoperative assessment before surgery through hospital discharge during the index hospitalization, assessed up to 30 days after surgery
2

Incidence of Postoperative Complications

Incidence of postoperative complications defined according to the Clavien-Dindo classification.

Time frame
From the date of surgery to 30 days after surgery
3

Postoperative Intensive Care Unit Length of Stay

Length of postoperative intensive care unit (ICU) stay among participants admitted to the ICU after the index surgery, measured as the number of nights spent in intensive care

Time frame
From postoperative ICU admission after the index surgery to ICU discharge, assessed up to 30 days after surgery
4

Incidence of Reinterventions

Incidence of surgical reinterventions after the index procedure.

Time frame
From the date of surgery to 30 days after surgery

Other outcomes

Sponsors and contacts

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