ERAS® Guidelines Validation of CRS With or Without HIPEC

Peritoneal Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05185791
• Other study ID #: 436
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2021
• Source: Hospices Civils de Lyon
• Contact: Olivier Glehen, MD, PhD
• Phone: +33 478 862 371
• Email: olivier.glehen[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: August 31, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Diseases

Intervention

Other:
• Pre-ERAS® phase (current clinical practice)
Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
• Post-ERAS® implementation phase
Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.

Locations

Country	Name	City	State
Canada	University of Calgary, Arnie Charbonneau Cancer Institute	Calgary	Alberta
Switzerland	Lausanne University Hospital	Lausanne
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

United States,  Canada,  Switzerland, 

References & Publications (2)

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, Veerapo — View Citation

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, Veerapo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance of ERAS® guidelines	Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines	3 months
Secondary	Acceptance and feasibility of ERAS® guidelines	Pre-ERAS® phase (current clinical practice): current compliance rate towards the ERAS guidelines	3 months