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BMJ Open Is Committed to Open Peer Review. As Part of This Commitment We Make the Peer Review History of Every Article We Publish Publicly Available BMJ Open: first published as 10.1136/bmjopen-2020-047491 on 3 June 2021. Downloaded from BMJ Open is committed to open peer review. As part of this commitment we make the peer review history of every article we publish publicly available. When an article is published we post the peer reviewers’ comments and the authors’ responses online. We also post the versions of the paper that were used during peer review. These are the versions that the peer review comments apply to. The versions of the paper that follow are the versions that were submitted during the peer review process. They are not the versions of record or the final published versions. They should not be cited or distributed as the published version of this manuscript. BMJ Open is an open access journal and the full, final, typeset and author-corrected version of record of the manuscript is available on our site with no access controls, subscription charges or pay-per-view fees (http://bmjopen.bmj.com). If you have any questions on BMJ Open’s open peer review process please email [email protected] http://bmjopen.bmj.com/ on September 29, 2021 by guest. Protected copyright. BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-047491 on 3 June 2021. Downloaded from 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. ForA peerstudy of thereview EASY-NET project.only Journal: BMJ Open Manuscript ID bmjopen-2020-047491 Article Type: Protocol Date Submitted by the 03-Dec-2020 Author: Complete List of Authors: Pagano, Eva; Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Clinical Epidemiology Unit Pellegrino, Luca; Santa Croce e Carle Hospital, Department of Surgery, General and Oncologic Surgery Unit Rinaldi, Federica; University of Turin Palazzo, Valentina; University of Turin Donati, Danilo; Santa Croce e Carle Hospital, Department of Surgery, General and Oncologic Surgery Unit Meineri, Maurizio; Santa Croce e Carle Hospital, Department of http://bmjopen.bmj.com/ Anesthesiology and Intensive Care Palmisano, Sarah; Santa Croce e Carle Hospital, Department of Anesthesiology and Intensive Care Rolfo, Monica; Humanitas, Torino, Healthcare Services Direction Bachini, Ilaria; Ordine Mauriziano Hospital, Unit of Dietetic and Clinical Nutrition Bertetto, Oscar; Dipartimento Interaziendale Interregionale Rete Oncologica Piemonte-Valle d’Aosta Borghi, Felice; ASO Santa Croce e Carle, Department of Surgery, General and Oncologic Surgery Unit on September 29, 2021 by guest. Protected copyright. Ciccone, Giovannino; Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Clinical Epidemiology Unit AUDIT, Colorectal surgery < SURGERY, Quality in health care < HEALTH Keywords: SERVICES ADMINISTRATION & MANAGEMENT For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 23 BMJ Open 1 2 3 4 BMJ Open: first published as 10.1136/bmjopen-2020-047491 on 3 June 2021. Downloaded from 5 6 7 8 9 I, the Submitting Author has the right to grant and does grant on behalf of all authors of the Work (as defined 10 in the below author licence), an exclusive licence and/or a non-exclusive licence for contributions from authors 11 who are: i) UK Crown employees; ii) where BMJ has agreed a CC-BY licence shall apply, and/or iii) in accordance 12 with the terms applicable for US Federal Government officers or employees acting as part of their official 13 duties; on a worldwide, perpetual, irrevocable, royalty-free basis to BMJ Publishing Group Ltd (“BMJ”) its 14 licensees and where the relevant Journal is co-owned by BMJ to the co-owners of the Journal, to publish the 15 Work in this journal and any other BMJ products and to exploit all rights, as set out in our licence. 16 17 The Submitting Author accepts and understands that any supply made under these terms is made by BMJ to 18 the Submitting Author Forunless you peer are acting as review an employee on behalf only of your employer or a postgraduate 19 student of an affiliated institution which is paying any applicable article publishing charge (“APC”) for Open 20 Access articles. Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 23 1 2 3 Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal 4 BMJ Open: first published as 10.1136/bmjopen-2020-047491 on 3 June 2021. Downloaded from 5 cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol 6 7 for a stepped wedge cluster randomised trial. A study of the EASY-NET project. 8 9 10 Pagano E1, Pellegrino L2, Rinaldi F3, Palazzo V3, Donati D2, Meineri M4, Palmisano S4, Rolfo M5, 11 12 Bachini I6, Bertetto O7, Borghi F2, Ciccone G1 and the ERAS Colon-Rectum Piemonte group 13 14 15 1. Clinical Epidemiology Unit, Città della Salute e della Scienza Hospital, Torino, Italy 16 17 2. Department of Surgery, General and Oncologic Surgery Unit, Santa Croce e Carle Hospital, Cuneo, Italy 18 3. University of Torino, ItalyFor peer review only 19 4. Department of Anesthesiology and Intensive Care, S. Croce e Carle Hospital, Cuneo, Italy 20 21 5. Healthcare Services Direction, Humanitas, Torino, Italy 22 6. Unit of Dietetic and Clinical Nutrition, Ordine Mauriziano Hospital, Torino, Italy 23 24 7. Department of Rete Oncologica del Piemonte e Valle d’Aosta, Città della Salute e della Scienza Hospital, Torino, 25 Italy 26 27 28 Corresponding author 29 30 Eva Pagano 31 Unit of Clinical Epidemiology 32 33 “Città della Salute e della Scienza” Hospital 34 Via Santena 5, 10126, Torino 35 36 Tel. 0039 011 633 68 55 http://bmjopen.bmj.com/ 37 38 [email protected] 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 23 BMJ Open 1 2 3 Abstract 4 BMJ Open: first published as 10.1136/bmjopen-2020-047491 on 3 June 2021. Downloaded from 5 Introduction: The ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway 6 7 aimed to reduce surgical stress and to allow a rapid post-operative recovery. Application of the ERAS 8 protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote 9 10 the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and 11 12 Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the 13 14 true impact of the protocol on a large, unselected population: . 15 Methods: A multicenter stepped wedge cluster randomised trial is designed for comparison between 16 17 standard perioperative management and the management according to the ERAS protocol. The 18 For peer review only 19 primary outcome is the length of hospital stay (LOS). Secondary outcomes are: incidence of post- 20 operative complications, time to patients’ recovery, control of pain and patients’ satisfaction. With 21 22 an A&F approach the adherence to the ERAS items is monitored through a dedicated area in the study 23 24 web site. 25 26 The study includes 28 surgical centers, stratified by activity volume and randomly divided into four 27 groups. Each group is randomly assigned to a different activation period of the ERAS protocol. There 28 29 are four activation periods, one every three months. However, the planned calendar and the total 30 31 duration of the study have been extended by three months due to the COVID-19 pandemic. 32 33 The expected sample size of about 2200 patients has a high statistical power (98%) to detect a 34 reduction of LOS of 1 day and to estimate clinically meaningful changes in the other endpoints. 35 36 Ethics and dissemination: The study protocol has been approved by the Ethical Committee of the http://bmjopen.bmj.com/ 37 38 coordinating Center and by all participating centers. Study results will be timely circulated within the 39 hospital network and published in peer-reviewed journals. 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 23 1 2 3 Trial registration: NCT04037787 4 BMJ Open: first published as 10.1136/bmjopen-2020-047491 on 3 June 2021.
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