Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-ERAS® implementation phase | Other | — | UNRESOLVED |
| Pre-ERAS® phase (current clinical practice) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pre-ERAS® implementation phase
- description
- * 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
- interventionNames
- Other: Pre-ERAS® phase (current clinical practice)
- label
- Post-ERAS® implementation phase
- description
- * 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTHubner M, Kusamura S, Villeneuve L, Al-Niaimi A, Alyami M, Balonov K, Bell J, Bristow R, Guiral DC, Fagotti A, Falcao 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, Veerapong J, Nelson G. Guidelines for Perioperative Care in Cytoreductive Surgery (CRS) with or without hyperthermic IntraPEritoneal chemotherapy (HIPEC): Enhanced recovery after surgery (ERAS(R)) Society Recommendations - Part I: Preoperative and intraoperative management. Eur J Surg Oncol. 2020 Dec;46(12):2292-2310. doi: 10.1016/j.ejso.2020.07.041. Epub 2020 Aug 25. PMID 32873454
- RESULTHubner M, Kusamura S, Villeneuve L, Al-Niaimi A, Alyami M, Balonov K, Bell J, Bristow R, Guiral DC, Fagotti A, Falcao 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, Veerapong J, Nelson G. Guidelines for Perioperative Care in Cytoreductive Surgery (CRS) with or without hyperthermic IntraPEritoneal chemotherapy (HIPEC): Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations - Part II: Postoperative management and special considerations. Eur J Surg Oncol. 2020 Dec;46(12):2311-2323. doi: 10.1016/j.ejso.2020.08.006. Epub 2020 Aug 13. PMID 32826114