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
1 other identifier
observational
288
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 22, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedJanuary 11, 2022
November 1, 2021
9 months
November 22, 2021
December 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compliance of ERAS® guidelines
Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines
3 months
Secondary Outcomes (1)
Acceptance and feasibility of ERAS® guidelines
3 months
Study Arms (2)
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
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.
Interventions
Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
Eligibility Criteria
All adults patients suffering from cancer with peritoneal cancer eligible for surgery after passing a multidisciplinary team validation requiring CRS with or without HIPEC.
You may qualify if:
- 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
You may not qualify if:
- Patients without peritoneal cancer
- Patients with peritoneal cancer and extended extraperitoneal metastases contraindicating for CRS with or without HIPEC
- No informed consent signed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Calgary, Arnie Charbonneau Cancer Institute
Calgary, Alberta, T2N 1N4, Canada
Lausanne University Hospital
Lausanne, 1011, Switzerland
Related Publications (2)
Hubner M, Kusamura S, Villeneuve L, Al-Niaimi A, Alyami M, Balonov K, Bell J, Bristow R, Guiral DC, Fagotti A, Falcao 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(R)) 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.
PMID: 32873454RESULTHubner M, Kusamura S, Villeneuve L, Al-Niaimi A, Alyami M, Balonov K, Bell J, Bristow R, Guiral DC, Fagotti A, Falcao 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(R)) 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.
PMID: 32826114RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier Glehen, MD, PhD
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2021
First Posted
January 11, 2022
Study Start
October 1, 2021
Primary Completion
June 30, 2022
Study Completion
August 31, 2022
Last Updated
January 11, 2022
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share