Enhanced Recovery After Surgery for adults with peritoneal carcinomatosis undergoing cytoreductive surgery with or without HIPEC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.