Actively Recruiting
Enhanced Recovery After Surgery (ERAS) Protocol in Perioperative Care for Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without HIPEC
Led by Fondazione del Piemonte per l'Oncologia · Updated on 2026-04-03
300
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of an Enhanced Recovery After Surgery (ERAS) protocol in patients with peritoneal carcinomatosis undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC). This prospective multicenter interventional pre-post study aims to compare the usual perioperative management against the ERAS protocol to assess its effect on postoperative recovery, particularly focusing on hospital length of stay. The study will enroll about 300 patients across 20 centers in Italy. During the initial pre-intervention phase, about 100 participants will receive the standard perioperative care as practiced routinely at their centers. In the subsequent intervention phase lasting around 8 months, approximately 200 patients will be treated with the ERAS protocol, which includes preoperative counseling and prehabilitation, nutritional assessment and support, optimized fasting and carbohydrate loading, standardized antibiotic and antithrombotic prophylaxis, multimodal pain relief, goal-directed fluid therapy, early oral intake, glycemic control, early mobilization, and readiness for discharge assessment. Participants will be monitored from the day of surgery through hospital discharge and up to 90 days afterward to assess hospital length of stay as the primary outcome. Additional evaluations include adherence to ERAS protocol items, postoperative complications, intensive care unit stay, reinterventions, hospital readmissions, emergency visits, bowel function recovery, mortality within 30 days, and quality of recovery approximately 48 hours after surgery. This comprehensive follow-up helps understand the effects of ERAS on recovery and safety in this population.
CONDITIONS
Brief Title
Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before the procedure
- Histological or cytological diagnosis of advanced solid tumor with documented peritoneal carcinomatosis from peritoneal mesothelioma, other primary malignant peritoneal tumor, gynecologic tumor, gastric tumor, or intestinal tumor
- Age over 18 years
- ECOG performance status of 1 or less
- ASA score of 3 or less
You will not qualify if you...
- Missing written informed consent
- ASA score of 4 or higher
- Planned palliative or other unplanned surgery
- Severe renal insufficiency, severe hepatic insufficiency, severe heart failure, recent myocardial infarction, or severe arrhythmia
- Immunocompromised status, receiving immunosuppressive therapy, or immune system diseases
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery
Participants undergo cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC), followed by immediate post-operative care including multimodal perioperative management aimed at reducing surgical stress and improving recovery.
1 hospital stay including surgery and immediate care
Duration - Up to 30 days after surgery
Participants are monitored for post-operative complications, recovery progress, and adherence to the ERAS protocol including assessments up to 30 days after surgery, with additional monitoring of hospital readmissions, emergency visits, and overall recovery.
Approximately 6 post-operative visits or assessments
Trial Site Locations
Total: 2 locations
1
Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo
Candiolo, Turin, Italy, 10060
Actively Recruiting
2
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Not Yet Recruiting
Research Team
M
Manuela Robella, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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