ERAS® Guidelines Validation of CRS With or Without HIPEC

• Conditions: Peritoneal Diseases
• Interventions: Other: Pre-ERAS® phase (current clinical practice); Other: Post-ERAS® implementation phase

• Registration Number: NCT05185791
• Lead Sponsor: Hospices Civils de Lyon

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-22
• Last Update Submitted: 2021-12-22
• Study First Posted: 2022-01-11
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-ERAS® implementation phase	Pre-ERAS® phase (current clinical practice)	* 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	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

University of Calgary, Arnie Charbonneau Cancer Institute; 🇨🇦 Calgary, Alberta, Canada

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Lausanne University Hospital; 🇨🇭 Lausanne, Switzerland