Enhanced Recovery After Surgery for adults with peritoneal carcinomatosis undergoing cytoreductive surgery with or without HIPEC
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 project will try an Enhanced Recovery After Surgery (ERAS) program to see if it shortens hospital stays after cytoreductive surgery with or without HIPEC for adults with peritoneal carcinomatosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Candiolo, Turin and 1 other locations) |
| Trial ID | NCT07493876 on ClinicalTrials.gov |
What this trial studies
Enhanced Recovery After Surgery (ERAS) is a coordinated, evidence-based perioperative pathway that aims to reduce surgical stress and speed recovery through interventions in surgery, anesthesia, nutrition, and rehabilitation. This multicenter pre-post interventional study will compare usual perioperative care (approximately 100 patients over ~4 months) with a predefined ERAS protocol applied subsequently to ~200 patients over ~8 months, enrolling about 300 patients across 20 Italian centers. The primary objective is to measure the effect of ERAS on mean postoperative hospital length of stay after cytoreductive surgery with or without HIPEC. Monitored ERAS elements include prehabilitation and counseling, nutritional assessment and support, bowel preparation and antibiotic prophylaxis, perioperative fasting and postoperative oral intake management, fluid management, and intra-/postoperative analgesic strategies.
Who should consider this trial
Good fit: Adults over 18 with histologically or cytologically confirmed peritoneal carcinomatosis from peritoneal mesothelioma, gynecologic, gastric, or intestinal tumors who are scheduled for cytoreductive surgery with or without HIPEC, have ECOG ≤1 and ASA ≤3, and can give informed consent.
Not a fit: Patients undergoing palliative or unplanned surgery, those with severe organ failure, immunocompromised status, or very poor functional status (ASA ≥4) are unlikely to benefit from this ERAS pathway.
Why it matters
Potential benefit: If successful, patients could experience shorter hospital stays, faster recovery, and fewer postoperative complications.
How similar studies have performed: ERAS pathways have improved recovery and reduced length of stay in many abdominal and oncologic surgeries, but application to cytoreductive surgery with HIPEC is relatively novel and supported mainly by limited observational data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Candiolo, Turin and 1 other locations
- Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo — Candiolo, Turin, Italy (Recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Manuela Robella, MD
- Email: manuela.robella@ircc.it
- Phone: +390119933445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.