ERAS® Guidelines Validation of CRS With or Without HIPEC

• Conditions: Peritoneal Diseases

• Registration Number: NCT05185791
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Enhanced recovery after surgery (ERAS®) pathways have been shown to considerably reduce complications, length of stay and costs after most of surgical procedures by standardised application of best evidence-based perioperative care. Recently an international panel of expert have succeeded to elaborate dedicated recommendations for cytoreductive surgery (CRS) ± hyperthermic intraperitoneal chemotherapy (HIPEC) in a two-part series of guidelines based on expert consensus (Hübner et al., EJSO, 2020). The aim of this prospective validation study was therefore to study acceptance, feasibility and clinical results of these guidelines in clinical practice.

Hypothesis of the study: Introduction of ERAS® guidelines is feasible and safe. Increasing compliance with ERAS® guidelines (after implementation) will improve recovery and early clinical outcomes of patients undergoing CRS/HIPEC.

Detailed Description

The study includes two succesive phases interrupted by a stage to implement ERAS® guidelines.

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-22
• Last Update Submitted: 2021-12-22
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• Adults female and male patients (> 18 year-old)
• Peritoneal cancer from colorectal, ovarian, gastric, appendix origin and primitive peritoneal cancer (peritoneal mesothelioma)
• Multidisciplinary team meeting validation for CRS/HIPEC
• Informed and signed surgical consent

Exclusion Criteria

• Patients without peritoneal cancer
• Patients with peritoneal cancer and extended extraperitoneal metastases contraindicating for CRS with or without HIPEC
• No informed consent signed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance of ERAS® guidelines	3 months	Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines

Secondary Outcome Measures

Name	Time	Method
Acceptance and feasibility of ERAS® guidelines	3 months	Pre-ERAS® phase (current clinical practice): current compliance rate towards the ERAS guidelines

Trial Locations

Locations (3)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

University of Calgary, Arnie Charbonneau Cancer Institute; 🇨🇦 Calgary, Alberta, Canada

Lausanne University Hospital; 🇨🇭 Lausanne, Switzerland