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

NCT07493876 | Recruiting

• 1 other identifier: 002-FPO24
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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

Peritoneal Carcinomatosis

Keywords

Cytoreductive Surgery; HIPEC; Enhanced Recovery After Surgery; ERAS; Peritoneal Surface Malignancies

Outcome Measures

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

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

Secondary Outcomes (9)

• Adherence to Selected ERAS Protocol Items

  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

  From the date of surgery to 30 days after surgery

• Postoperative Intensive Care Unit Length of Stay

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

• Incidence of Reinterventions

  From the date of surgery to 30 days after surgery

• Incidence of Hospital Readmissions

  From hospital discharge to 30 days after surgery.

Study Arms (2)

Usual Perioperative Management

NO INTERVENTION

Participants enrolled during the first study period (approximately 4 months; expected n=100) will undergo usual perioperative management for cytoreductive surgery with or without HIPEC as routinely practiced at each participating center.

ERAS Perioperative Management Protocol

OTHER

Participants enrolled during the second study period (approximately 8 months; expected n=200) will undergo perioperative management according to a predefined 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

Interventions

ERAS Perioperative Management Protocol OTHER

A multimodal perioperative care pathway for patients undergoing cytoreductive surgery with or without HIPEC, implemented by a multidisciplinary ERAS team and including coordinated preoperative, intraoperative, and postoperative measures aimed at reducing surgical stress and improving recovery.

ERAS Perioperative Management Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (2)

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

Candiolo, Turin, 10060, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Manuela Robella, MD

CONTACT

+390119933445; manuela.robella@ircc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants enrolled during the initial pre-intervention period will receive usual perioperative management. Participants enrolled during the subsequent intervention period will receive perioperative management according to a predefined ERAS protocol.

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 25, 2026
• Study Start: January 23, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)