Feasibility and Clinical Results of Implementation of ERAS® Guidelines for Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: an International Prospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peritoneal Diseases
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 288
- Locations
- 3
- Primary Endpoint
- Compliance of ERAS® guidelines
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Compliance of ERAS® guidelines
Time Frame: 3 months
Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines
Secondary Outcomes
- Acceptance and feasibility of ERAS® guidelines(3 months)