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

March 30, 2026 updated by: Fondazione del Piemonte per l'Oncologia

Prospective Multicenter Interventional Pre-Post Study of an Enhanced Recovery After Surgery (ERAS) Protocol in the Perioperative Management of Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without HIPEC (EPICH)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care pathway designed to reduce surgical stress and accelerate postoperative recovery through coordinated evidence-based interventions involving surgery, anesthesia, nutrition, and rehabilitation. In patients with peritoneal carcinomatosis undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC), postoperative morbidity and prolonged hospitalization remain clinically relevant issues. This study will evaluate the implementation of a selected ERAS protocol in this setting. The study is designed as a multicenter interventional pre-post study: during the first period (approximately 4 months; 100 patients), usual perioperative procedures will be documented; during the second period (approximately 8 months; 200 patients), centers will apply a predefined ERAS pathway. Monitored ERAS elements include prehabilitation and preoperative counseling, nutritional assessment and support, bowel preparation and antibiotic prophylaxis, perioperative fasting management, postoperative oral intake, fluid management, and intra-/postoperative analgesic management.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pavia, Italy
        • Not yet recruiting
        • Fondazione IRCCS Policlinico San Matteo
    • Turin
      • Candiolo, Turin, Italy, 10060
        • Recruiting
        • Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Perioperative Management
Participants enrolled during the first study period (approximately 4 months; expected n=100) will undergo usual perioperative management for cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) as routinely practiced at each participating center.
Other: ERAS Perioperative Management Protocol
Participants enrolled during the second study period (approximately 8 months; expected n=200) will undergo perioperative management according to a predefined Enhanced Recovery After Surgery (ERAS) protocol including preoperative counseling and prehabilitation, nutritional assessment and support, optimized fasting and carbohydrate loading, standardized antibiotic and antithrombotic prophylaxis, multimodal analgesia, goal-directed or restrictive fluid therapy, early oral intake, glycemic control, early mobilization, and discharge-readiness assessment.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Hospital Length of Stay
Time Frame: 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
From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Selected ERAS Protocol Items
Time Frame: Perioperative period, from preoperative assessment before surgery through hospital discharge during the index hospitalization, assessed up to 30 days after surgery
Adherence to the predefined ERAS perioperative items selected for monitoring, assessed across the preoperative, intraoperative, and postoperative phases of care
Perioperative period, from preoperative assessment before surgery through hospital discharge during the index hospitalization, assessed up to 30 days after surgery
Incidence of Postoperative Complications
Time Frame: From the date of surgery to 30 days after surgery
Incidence of postoperative complications defined according to the Clavien-Dindo classification.
From the date of surgery to 30 days after surgery
Postoperative Intensive Care Unit Length of Stay
Time Frame: From postoperative ICU admission after the index surgery to ICU discharge, assessed up to 30 days after surgery
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
From postoperative ICU admission after the index surgery to ICU discharge, assessed up to 30 days after surgery
Incidence of Reinterventions
Time Frame: From the date of surgery to 30 days after surgery
Incidence of surgical reinterventions after the index procedure.
From the date of surgery to 30 days after surgery
Incidence of Hospital Readmissions
Time Frame: From hospital discharge to 30 days after surgery.
Incidence of hospital readmissions after discharge following the index procedure.
From hospital discharge to 30 days after surgery.
Incidence of Emergency Department Visits
Time Frame: From hospital discharge to 30 days after surgery.
Incidence of emergency department visits after the index procedure.
From hospital discharge to 30 days after surgery.
Time to Recovery of Bowel Function
Time Frame: From Day 0 (date of surgery) to first documented recovery of bowel function, assessed daily during the index hospitalization, up to 30 days after surgery
Time to recovery of bowel function, measured in days from the date of surgery to the first documented postoperative recovery of bowel function
From Day 0 (date of surgery) to first documented recovery of bowel function, assessed daily during the index hospitalization, up to 30 days after surgery
All-Cause Mortality
Time Frame: From the date of surgery to 30 days after surgery.
Incidence of death from any cause.
From the date of surgery to 30 days after surgery.
Quality of Postoperative Recovery
Time Frame: Approximately 48 hours after surgery
Mean quality of recovery score measured using the QoR-15 questionnaire.
Approximately 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione del Piemonte per l'Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002-FPO24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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