Recruiting

CRS with HIPEC

Sponsor:

Hospices Civils de Lyon

Code:

NCT05185791

Conditions

Peritoneal Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pre-ERAS® phase (current clinical practice)

Post-ERAS® implementation phase

Study Details

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.

Conditions

Peritoneal Diseases

Study ID

NCT05185791

Start date

Oct 1, 2021

Status verified date

Nov, 2021

Completion date

Aug 31, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

288 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

Primary outcome measure

  • Compliance of ERAS® guidelines [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Olivier Glehen, MD, PhD

+33 478 862 371olivier.glehen@chu-lyon.fr

Amaniel Kefleyesus, MD

+33 478 862 859amaniel.kefleyesus@ik.me

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Anupama Wadhwa, Prof., MD.

214-645-8300Anupama.Wadhwa@UTSouthwestern.edu

University of Calgary, Arnie Charbonneau Cancer Institute

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Gregg Nelson, MD, PhD

+1 403 521 3721gsnelson@ucalgary.ca

More Information

Sponsor

Hospices Civils de Lyon

Last update posted

Jan 11, 2022

Last verified

Nov, 2021

Keywords

  • CRS
  • HIPEC
  • ERAS®
  • Guidelines
  • Peritoneal metastasis
  • Colorectal
  • Gastric
  • ovarian
  • Peritoneal mesothelioma
  • Pseudomyxoma peritonei

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospices Civils de Lyon on 2022-01-11.