Peritoneal Carcinomatosis
Conditions
Keywords
Cytoreductive Surgery, HIPEC, Enhanced Recovery After Surgery, ERAS, Peritoneal Surface Malignancies
Brief summary
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.
Detailed description
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.
Interventions
OTHERERAS Perioperative Management Protocol
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.
Sponsors
Fondazione del Piemonte per l'Oncologia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Hospital Length of Stay | From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Selected ERAS Protocol Items | Perioperative period, from preoperative assessment before surgery through hospital discharge during the index hospitalization, assessed up to 30 days after surgery | Adherence to the predefined ERAS perioperative items selected for monitoring, assessed across the preoperative, intraoperative, and postoperative phases of care |
| Incidence of Postoperative Complications | From the date of surgery to 30 days after surgery | Incidence of postoperative complications defined according to the Clavien-Dindo classification. |
| Postoperative Intensive Care Unit Length of Stay | From postoperative ICU admission after the index surgery to ICU discharge, assessed up to 30 days after surgery | 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 | From the date of surgery to 30 days after surgery | Incidence of surgical reinterventions after the index procedure. |
| Incidence of Hospital Readmissions | From hospital discharge to 30 days after surgery. | Incidence of hospital readmissions after discharge following the index procedure. |
| Incidence of Emergency Department Visits | From hospital discharge to 30 days after surgery. | Incidence of emergency department visits after the index procedure. |
| Time to 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 | Time to recovery of bowel function, measured in days from the date of surgery to the first documented postoperative recovery of bowel function |
| All-Cause Mortality | From the date of surgery to 30 days after surgery. | Incidence of death from any cause. |
| Quality of Postoperative Recovery | Approximately 48 hours after surgery | Mean quality of recovery score measured using the QoR-15 questionnaire. |
Countries
Italy
Contacts
CONTACTManuela Robella, MD
Outcome results
None listed