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NCT Number: NCT07493876

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

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.

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS Perioperative Management Protocol

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. Incidence of Reinterventions

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

    Incidence of surgical reinterventions after the index procedure.

  5. Incidence of Hospital Readmissions

    Time frame: From hospital discharge to 30 days after surgery.

    Incidence of hospital readmissions after discharge following the index procedure.

  6. Incidence of Emergency Department Visits

    Time frame: From hospital discharge to 30 days after surgery.

    Incidence of emergency department visits after the index procedure.

  7. 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

  8. All-Cause Mortality

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

    Incidence of death from any cause.

  9. Quality of Postoperative Recovery

    Time frame: Approximately 48 hours after surgery

    Mean quality of recovery score measured using the QoR-15 questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Manuela Robella, MD

CONTACT

[email protected]

+390119933445

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study title

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)

Acronym: EPICH

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 25, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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