Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Fondazione del Piemonte per l'Oncologia300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: From Day 0 (date of surgery) to hospital discharge, assessed up to 90 days after surgery

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

Time frame: Perioperative period, from preoperative assessment before surgery through hospital discharge during the index hospitalization, assessed up to 30 days after surgery

Incidence of Postoperative Complications

Incidence of postoperative complications defined according to the Clavien-Dindo classification.

Time frame: 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

Time frame: 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.

Time frame: From the date of surgery to 30 days after surgery

Incidence of Hospital Readmissions

Incidence of hospital readmissions after discharge following the index procedure.

Time frame: From hospital discharge to 30 days after surgery.

Incidence of Emergency Department Visits

Incidence of emergency department visits after the index procedure.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Approximately 48 hours after surgery

Enhanced Recovery After Surgery (ERAS) in Patients With Peritoneal Carcinomatosis Undergoing Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts