About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
ERAS Perioperative Management Protocol
Other interventionA multimodal perioperative care pathway for patients undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC), implemented by a multidisciplinary Enhanced Recovery After Surgery (ERAS) team and including coordinated preoperative, intraoperative, and postoperative measures aimed at reducing surgical stress and improving recovery.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Adherence to Selected ERAS Protocol Items
Adherence to the predefined ERAS perioperative items selected for monitoring, assessed across the preoperative, intraoperative, and postoperative phases of care
Incidence of Postoperative Complications
Incidence of postoperative complications defined according to the Clavien-Dindo classification.
Postoperative Intensive Care Unit Length of Stay
Length of postoperative intensive care unit (ICU) stay among participants admitted to the ICU after the index surgery, measured as the number of nights spent in intensive care
Incidence of Reinterventions
Incidence of surgical reinterventions after the index procedure.
Sponsors and contacts
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