NCT05185791

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
• Phase: —
• Study type: Observational
• Enrollment: 288 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Peritoneal Diseases

Interventions

Type	Name	Description
OTHER	Pre-ERAS® phase (current clinical practice)	Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
OTHER	Post-ERAS® implementation phase	Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-06-30
• Completion: 2022-08-31
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

3 sites across 3 countries: United States, Canada, Switzerland