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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.
Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care pathway designed to reduce surgical stress and accelerate postoperative recovery through coordinated evidence-based interventions involving surgery, anesthesia, nutrition, and rehabilitation. In patients with peritoneal carcinomatosis undergoing cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC), postoperative morbidity and prolonged hospitalization remain clinically relevant issues. This study will evaluate the implementation of a selected ERAS protocol in this setting. The study is designed as a multicenter interventional pre-post study: during the first period (approximately 4 months; 100 patients), usual perioperative procedures will be documented; during the second period (approximately 8 months; 200 patients), centers will apply a predefined ERAS pathway. Monitored ERAS elements include prehabilitation and preoperative counseling, nutritional assessment and support, bowel preparation and antibiotic prophylaxis, perioperative fasting management, postoperative oral intake, fluid management, and intra-/postoperative analgesic management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Perioperative Management | No Intervention | Participants enrolled during the first study period (approximately 4 months; expected n=100) will undergo usual perioperative management for cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) as routinely practiced at each participating center. | |
| ERAS Perioperative Management Protocol | Other | Participants enrolled during the second study period (approximately 8 months; expected n=200) will undergo perioperative management according to a predefined Enhanced Recovery After Surgery (ERAS) protocol including preoperative counseling and prehabilitation, nutritional assessment and support, optimized fasting and carbohydrate loading, standardized antibiotic and antithrombotic prophylaxis, multimodal analgesia, goal-directed or restrictive fluid therapy, early oral intake, glycemic control, early mobilization, and discharge-readiness assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS Perioperative Management Protocol | Other | A 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Perioperative period, from preoperative assessment before surgery through hospital discharge during the index hospitalization, assessed up to 30 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuela Robella, MD | Contact | +390119933445 | manuela.robella@ircc.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia- IRCCS Istituto di Candiolo | Recruiting | Candiolo | Turin | 10060 | Italy | |
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Participants enrolled during the initial pre-intervention period will receive usual perioperative management. Participants enrolled during the subsequent intervention period will receive perioperative management according to a predefined Enhanced Recovery After Surgery (ERAS) protocol.
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| Incidence of Postoperative Complications | Incidence of postoperative complications defined according to the Clavien-Dindo classification. | From the date of surgery to 30 days after surgery |
| 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 | From postoperative ICU admission after the index surgery to ICU discharge, assessed up to 30 days after surgery |
| Incidence of Reinterventions | Incidence of surgical reinterventions after the index procedure. | From the date of surgery to 30 days after surgery |
| Incidence of Hospital Readmissions | Incidence of hospital readmissions after discharge following the index procedure. | From hospital discharge to 30 days after surgery. |
| Incidence of Emergency Department Visits | Incidence of emergency department visits after the index procedure. | From hospital discharge to 30 days after surgery. |
| Time to Recovery of Bowel Function | Time to recovery of bowel function, measured in days from the date of surgery to the first documented postoperative recovery of bowel function | From Day 0 (date of surgery) to first documented recovery of bowel function, assessed daily during the index hospitalization, up to 30 days after surgery |
| All-Cause Mortality | Incidence of death from any cause. | From the date of surgery to 30 days after surgery. |
| Quality of Postoperative Recovery | Mean quality of recovery score measured using the QoR-15 questionnaire. | Approximately 48 hours after surgery |
| Fondazione IRCCS Policlinico San Matteo |
| Not yet recruiting |
| Pavia |
| Italy |
| ID | Term |
|---|---|
| D010534 | Peritoneal Neoplasms |
| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
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