Actively Recruiting
Study of Enhanced Recovery After Surgery ERAS Protocol in 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
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)
Research Team
M
Manuela Robella, MD
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