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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05185791

Enrollment

288

Registered

2022-01-11

Start date

2021-10-01

Completion date

2022-08-31

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Diseases

Keywords

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

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.

Interventions

OTHERPre-ERAS® phase (current clinical practice)

Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.

OTHERPost-ERAS® implementation phase

Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada, Switzerland, United States

Contacts

Primary ContactOlivier Glehen, MD, PhD

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

Backup ContactAmaniel Kefleyesus, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026