Clinical trial NCT05185791: ERAS® Guidelines Validation of CRS With or Without HIPEC
Official title: Feasibility and Clinical Results of Implementation of ERAS® Guidelines for Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: an International Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Diseases
Keywords: CRS
HIPEC
ERAS®
Guidelines
Peritoneal metastasis
Colorectal
Gastric
ovarian
Peritoneal mesothelioma
Pseudomyxoma peritonei
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Compliance of ERAS® guidelines
timeFrame: 3 months
Secondary outcomes:
measure: Acceptance and feasibility of ERAS® guidelines
timeFrame: 3 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Calgary
country: Canada
facility: University of Calgary, Arnie Charbonneau Cancer Institute
state: Alberta
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
Study officials:
affiliation: Hospices Civils de Lyon
name: Olivier Glehen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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 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.