ERAS® Guidelines Validation of CRS With or Without HIPEC

Feasibility and Clinical Results of Implementation of ERAS® Guidelines for Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: an International Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Diseases
• Intervention / Treatment: Other: Pre-ERAS® phase (current clinical practice); Other: Post-ERAS® implementation phase

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 288

Contacts and Locations

• Study Contact: Name: Olivier Glehen, MD, PhD; Phone Number: +33 478 862 371; Email: olivier.glehen@chu-lyon.fr
• Study Contact Backup: Name: Amaniel Kefleyesus, MD; Phone Number: +33 478 862 859; Email: amaniel.kefleyesus@ik.me

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Recruiting
      • University of Calgary, Arnie Charbonneau Cancer Institute
      • Contact: Gregg Nelson, MD, PhD; Phone Number: +1 403 521 3721; Email: gsnelson@ucalgary.ca
• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Lausanne University Hospital
    • Contact: Martin Hübner, Prof., MD; Phone Number: +41 21 314 25 36; Email: martin.hubner@chuv.ch
• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Anupama Wadhwa, Prof., MD.; Phone Number: 214-645-8300; Email: Anupama.Wadhwa@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adults patients suffering from cancer with peritoneal cancer eligible for surgery after passing a multidisciplinary team validation requiring CRS with or without HIPEC.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-ERAS® implementation phase; Current clinical practice; Current perioperative management; All consecutive patients included for CRS+-HIPEC treatment; Period of inclusion : 3 months (01.10.2021 - 31.12.2021); Survey of intended changes in clinical practice will be sent to each leader center No specific intervention. Only descriptive recordings of pre-intra-post-operative clinical endpoints ("ERAS® core items") and demographic parameters. Clinical and surgical outcomes will be recorded until 30 postoperative days (POD). Functional recovery parameters will be recorded for the first 5 POD	Other: Pre-ERAS® phase (current clinical practice); Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
Post-ERAS® implementation phase; After implementation 2 months of delay before starting the recordings; Clinical practice and perioperative management with new practice according guidelines and local commitment for the new change; All consecutive patients included for CRS±HIPEC treatment; Period of inclusion : 3 months (01.03.2022 - 31.05.2022); Max 2 months of delay allowed between the two phases Intervention will take place during an implementation period of 2 months. This period will let the centers to set the newly implemented clinical practices. After that, the remaining 3 months of the study will consist in descriptive recordings of pre-intra and post-operative clinical endpoints and demographic parameters ("ERAS® core items"). Clinical and surgical outcomes will be recorded until 30 postoperative days (POD). Functional recovery parameters will be recorded for the first 5 POD.	Other: Post-ERAS® implementation phase; Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance of ERAS® guidelines	Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance and feasibility of ERAS® guidelines	Pre-ERAS® phase (current clinical practice): current compliance rate towards the ERAS guidelines	3 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Olivier Glehen, MD, PhD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Hübner M, Kusamura S, Villeneuve L, Al-Niaimi A, Alyami M, Balonov K, Bell J, Bristow R, Guiral DC, Fagotti A, Falcão LFR, Glehen O, Lambert L, Mack L, Muenster T, Piso P, Pocard M, Rau B, Sgarbura O, Somashekhar SP, Wadhwa A, Altman A, Fawcett W, Veerapong J, Nelson G. Guidelines for Perioperative Care in Cytoreductive Surgery (CRS) with or without hyperthermic IntraPEritoneal chemotherapy (HIPEC): Enhanced recovery after surgery (ERAS®) Society Recommendations - Part I: Preoperative and intraoperative management. Eur J Surg Oncol. 2020 Dec;46(12):2292-2310. doi: 10.1016/j.ejso.2020.07.041. Epub 2020 Aug 25.
• Hübner M, Kusamura S, Villeneuve L, Al-Niaimi A, Alyami M, Balonov K, Bell J, Bristow R, Guiral DC, Fagotti A, Falcão LFR, Glehen O, Lambert L, Mack L, Muenster T, Piso P, Pocard M, Rau B, Sgarbura O, Somashekhar SP, Wadhwa A, Altman A, Fawcett W, Veerapong J, Nelson G. Guidelines for Perioperative Care in Cytoreductive Surgery (CRS) with or without hyperthermic IntraPEritoneal chemotherapy (HIPEC): Enhanced Recovery After Surgery (ERAS®) Society Recommendations - Part II: Postoperative management and special considerations. Eur J Surg Oncol. 2020 Dec;46(12):2311-2323. doi: 10.1016/j.ejso.2020.08.006. Epub 2020 Aug 13.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: HIPEC; ovarian; Peritoneal metastasis; CRS; Guidelines; Colorectal; Gastric; ERAS®; Peritoneal mesothelioma; Pseudomyxoma peritonei
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases
• Other Study ID Numbers: 436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No