ERAS® Guidelines Validation of CRS With or Without HIPEC
NCT ID: NCT05185791
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
288 participants
OBSERVATIONAL
2021-10-01
2022-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
Pre-ERAS® phase (current clinical practice)
Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
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.
Post-ERAS® implementation phase
Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 with peritoneal cancer and extended extraperitoneal metastases contraindicating for CRS with or without HIPEC
* No informed consent signed
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Olivier Glehen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Calgary, Arnie Charbonneau Cancer Institute
Calgary, Alberta, Canada
Lausanne University Hospital
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Hubner 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.
Hubner 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.
Other Identifiers
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436
Identifier Type: -
Identifier Source: org_study_id
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