ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery
ERAS-Colon
1 other identifier
interventional
2,397
1 country
1
Brief Summary
The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedOctober 2, 2023
September 1, 2023
1.7 years
July 26, 2019
September 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Length of stay
Mean length of stay calculated as difference between date of discharge and date of admission of the hospitalization for surgery, excluding length of stay \>94th percentile of the expected distribution (expected 22 days).
22 days after admission
Secondary Outcomes (9)
Length of stay >22 days
30 days after admission
Recovery after surgery
24 hours after surgery
Complications
30 days after discharge
Transfer to intensive care unit
30 days after surgery
Emergency visits after discharge
30 days after discharge
- +4 more secondary outcomes
Study Arms (2)
Usual care
NO INTERVENTIONPerioperative care for colorectal cancer cancer is managed according to current hospital clinical practice.
ERAS protocol
EXPERIMENTALPerioperative care for colorectal cancer surgery is managed according to ERAS protocol.
Interventions
In colorectal cancer surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting with administration of oral carbohydrates before surgery, use of intestinal preparation for selected cases only (rectal surgery), the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia, prevention of volume overload, preference for minimally invasive surgery, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early post-operative feeding, to promote rapid recovery of gastro-intestinal functions.
Eligibility Criteria
You may qualify if:
- All the hospital wards within the Piemonte Region performing colorectal cancer surgery
- All the patients receiving an elective surgery for colorectal cancer, with or without protective stoma.
You may not qualify if:
- Hospital wards performing less than 30 expected cases per year
- Emergency surgery
- High severity cases not allowing ERAS protocol implementation (i.e. American Society of Anesthesiologists score: ASA V).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ospedale Santa Croce-Carle Cuneolead
- A.O.U. Città della Salute e della Scienzacollaborator
- Ministry of Health, Italycollaborator
- Regione Piemontecollaborator
Study Sites (1)
Ospedale Santa Croce-Carle Cuneo
Cuneo, 12100, Italy
Related Publications (7)
Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
PMID: 30426190BACKGROUNDKehlet H. Fast-track surgery-an update on physiological care principles to enhance recovery. Langenbecks Arch Surg. 2011 Jun;396(5):585-90. doi: 10.1007/s00423-011-0790-y. Epub 2011 Apr 6.
PMID: 21468643BACKGROUNDGreco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014 Jun;38(6):1531-41. doi: 10.1007/s00268-013-2416-8.
PMID: 24368573BACKGROUNDBraga M, Borghi F, Scatizzi M, Missana G, Guicciardi MA, Bona S, Ficari F, Maspero M, Pecorelli N; PeriOperative Italian Society. Impact of laparoscopy on adherence to an enhanced recovery pathway and readiness for discharge in elective colorectal surgery: Results from the PeriOperative Italian Society registry. Surg Endosc. 2017 Nov;31(11):4393-4399. doi: 10.1007/s00464-017-5486-0. Epub 2017 Mar 13.
PMID: 28289972BACKGROUNDGreer NL, Gunnar WP, Dahm P, Lee AE, MacDonald R, Shaukat A, Sultan S, Wilt TJ. Enhanced Recovery Protocols for Adults Undergoing Colorectal Surgery: A Systematic Review and Meta-analysis. Dis Colon Rectum. 2018 Sep;61(9):1108-1118. doi: 10.1097/DCR.0000000000001160.
PMID: 30086061BACKGROUNDPagano E, Pellegrino L, Robella M, Castiglione A, Brunetti F, Giacometti L, Rolfo M, Rizzo A, Palmisano S, Meineri M, Bachini I, Morino M, Allaix ME, Mellano A, Massucco P, Bellomo P, Polastri R, Ciccone G, Borghi F; ERAS-colorectal Piemonte group. Implementation of an enhanced recovery after surgery protocol for colorectal cancer in a regional hospital network supported by audit and feedback: a stepped wedge, cluster randomised trial. BMJ Qual Saf. 2024 May 17;33(6):363-374. doi: 10.1136/bmjqs-2023-016594.
PMID: 38423752DERIVEDPagano E, Pellegrino L, Rinaldi F, Palazzo V, Donati D, Meineri M, Palmisano S, Rolfo M, Bachini I, Bertetto O, Borghi F, Ciccone G; ERAS Colon-Rectum Piemonte study group members. Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project. BMJ Open. 2021 Jun 3;11(6):e047491. doi: 10.1136/bmjopen-2020-047491.
PMID: 34083345DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giovannino Ciccone, MD
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Surgeon
Study Record Dates
First Submitted
July 26, 2019
First Posted
July 30, 2019
Study Start
September 1, 2019
Primary Completion
May 31, 2021
Study Completion
November 30, 2021
Last Updated
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Available after results publication
- Access Criteria
- Upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.
Anonymised data can be made available upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.