Peritoneal DiseasesNCT05185791
ERAS® Guidelines Validation of CRS With or Without HIPEC
An observational study of Peritoneal Diseases, run by Hospices Civils de Lyon at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Diseases
- What is being tested?
- Pre-ERAS® phase (current clinical practice) and Post-ERAS® implementation phase
- How many people
- 288 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Oct 2021to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All adults patients suffering from cancer with peritoneal cancer eligible for surgery after passing a multidisciplinary team validation requiring CRS with or without HIPEC.
Who may be able to join
- 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
Who cannot join
- Patients without peritoneal cancer
- Patients with peritoneal cancer and extended extraperitoneal metastases contraindicating for CRS with or without HIPEC
- No informed consent signed
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Anupama Wadhwa, Prof., MD., 214-645-8300, Anupama.Wadhwa@UTSouthwestern.edu
Canada1 site, 1 recruiting
- Recruiting
University of Calgary, Arnie Charbonneau Cancer Institute
Calgary, Alberta, T2N 1N4
Gregg Nelson, MD, PhD, +1 403 521 3721, gsnelson@ucalgary.ca
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital
Lausanne, 1011
Martin Hübner, Prof., MD, +41 21 314 25 36, martin.hubner@chuv.ch
About this study
Official title: Feasibility and Clinical Results of Implementation of ERAS® Guidelines for Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: an International Prospective Cohort Study
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.
Read the detailed description
The study includes two succesive phases interrupted by a stage to implement ERAS® guidelines.
- Conditions
- Peritoneal Diseases
- Being tested
- Pre-ERAS® phase (current clinical practice), Post-ERAS® implementation phase
- Keywords
- CRS, HIPEC, ERAS®, Guidelines, Peritoneal metastasis, Colorectal, Gastric, ovarian, Peritoneal mesothelioma, Pseudomyxoma peritonei
- Medical subject headings
- Peritoneal Diseases, Pseudomyxoma Peritonei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-ERAS® phase (current clinical practice)Other
Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
Post-ERAS® implementation phaseOther
Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Pre-ERAS® phase (current clinical practice) | |
| 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. Receives: Other: Post-ERAS® implementation phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of ERAS® guidelines
Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines
Measured: 3 months
Secondary outcomes (1)
Acceptance and feasibility of ERAS® guidelines
Pre-ERAS® phase (current clinical practice): current compliance rate towards the ERAS guidelines
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Oct 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peritoneal DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Glehen, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185791
- Sponsor's protocol ID
- 436
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32873454Hubner 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.
PubMed 32826114
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Clinical Results of Implementation of ERAS® Guidelines for Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy: an International Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05185791
- Acronym / sponsor ID
- 436
- Conditions
- Peritoneal Diseases
- Keywords
- CRS, HIPEC, ERAS®, Guidelines, Peritoneal metastasis, Colorectal, Gastric, ovarian
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-ERAS® implementation phase | – | Other: 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 | – | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adults patients suffering from cancer with peritoneal cancer eligible for surgery after passing a multidisciplinary team validation requiring CRS with or without HIPEC.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients without peritoneal cancer
- Patients with peritoneal cancer and extended extraperitoneal metastases contraindicating for CRS with or without HIPEC
- No informed consent signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-ERAS® phase (current clinical practice)Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters. | Other | Pre-ERAS® implementation phase |
| Post-ERAS® implementation phaseDescriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters. | Other | Post-ERAS® implementation phase |
Primary outcome
Compliance of ERAS® guidelines
Time frame: 3 months
Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines
1 secondary outcome
Acceptance and feasibility of ERAS® guidelines
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Results publication: PubMed 32873454Hubner 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.
- Results publication: PubMed 32826114Hubner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Glehen, MD, PhD principal investigator
Hospices Civils de Lyon
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Diseases, run by Hospices Civils de Lyon at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Glehen, MD, PhD (+33 478 862 371, olivier.glehen@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of ERAS® guidelines (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185791, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.