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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.
The study includes two succesive phases interrupted by a stage to implement ERAS® guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-ERAS® implementation phase |
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 |
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-ERAS® phase (current clinical practice) | Other | Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Compliance of ERAS® guidelines | Post-ERAS® implementation phase: compliance rate towards the relevant core items from ERAS guidelines | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance and feasibility of ERAS® guidelines | Pre-ERAS® phase (current clinical practice): current compliance rate towards the ERAS guidelines | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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All adults patients suffering from cancer with peritoneal cancer eligible for surgery after passing a multidisciplinary team validation requiring CRS with or without HIPEC.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier Glehen, MD, PhD | Contact | +33 478 862 371 | olivier.glehen@chu-lyon.fr | |
| Amaniel Kefleyesus, MD | Contact | +33 478 862 859 | amaniel.kefleyesus@ik.me |
| Name | Affiliation | Role |
|---|---|---|
| Olivier Glehen, MD, PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32873454 | Result | 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. | |
| 32826114 |
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| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D011553 | Pseudomyxoma Peritonei |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D002288 | Adenocarcinoma, Mucinous |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
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| Post-ERAS® implementation phase | Other | Descriptive recordings of pre-intra-post-operative clinical endpoints and demographic parameters. |
|
| University of Calgary, Arnie Charbonneau Cancer Institute | Recruiting | Calgary | Alberta | T2N 1N4 | Canada |
|
| Lausanne University Hospital | Recruiting | Lausanne | 1011 | Switzerland |
|
| Result |
| 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. |
| D009375 |
| Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |