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. Issue 6 (3rd June 2021)

• Record Type: Journal Article
• Authors: Pagano, Eva; Pellegrino, Luca; Rinaldi, Federica; Palazzo, Valentina; Donati, Danilo; Meineri, Maurizio; Palmisano, Sarah; Rolfo, Monica; Bachini, Ilaria; Bertetto, Oscar; Borghi, Felice; Ciccone, Giovannino
• Other Names: author non-byline.; Borromeo Federica author non-byline.; Priora Fabio author non-byline.; Gentilli Sergio author non-byline.; Portigliotti Luca author non-byline.; Massucco Paolo author non-byline.; Palisi Marco author non-byline.; Giuli Maurizio De author non-byline.; Resendiz Aridai author non-byline.; Bellomo Paola author non-byline.; Marola Silvia author non-byline.; Mellano Alfredo author non-byline.; Ribero Dario author non-byline.; Polastri Roberto author non-byline.; Muratore Andrea author non-byline.; Pipitone Nicoletta Sveva author non-byline.; Garino Mauro author non-byline.; Castagna Elisabetta author non-byline.; Pozzo Gabriele author non-byline.; Caneparo Andrea author non-byline.; Ginardi Adriana author non-byline.; Lagana Reggina author non-byline.; Carrera Monica author non-byline.; Muzio Stefania author non-byline.; Suffat Luca Panier author non-byline.; Lettini Ivan author non-byline.; Kiss Alberto author non-byline.; Gentile Valentina author non-byline.; Saracco Roberto author non-byline.; Scaglione Donatella author non-byline.; Gattolin Andrea author non-byline.; Rimonda Roberto author non-byline.; Battafarano Francesco author non-byline.; Oragano Luigi author non-byline.; Lorenzin Luca author non-byline.; Palenzona Carlo author non-byline.; Somma Carmine Gianfranco Di author non-byline.; Giaminardi Eliana author non-byline.; Calgaro Marco author non-byline.; Naddeo Marco author non-byline.; Cumbo Piero author non-byline.; Marchigiano Emma author non-byline.; Cravero Francesca author non-byline.; Amisano Marco author non-byline.; Lemut Francesco author non-byline.; Viora Tiziana author non-byline.; Bonaccorsi Luciano author non-byline.; Testa Silvio author non-byline.; Rosa Clemente De author non-byline.; Brunetti Marco author non-byline.; Gatti Matteo author non-byline.; Bima Carlo author non-byline.; Gibin Enrico author non-byline.; Quaglino Francesco author non-byline.; Festa Federico author non-byline.; Bonatti Luca author non-byline.; Morino Mario author non-byline.; Allaix Marco Ettore author non-byline.; Paolis Paolo De author non-byline.; Raciti Ida Marina author non-byline.; Santarelli Mauro author non-byline.; Scozzari Gitana author non-byline.; Galletti Rosalba author non-byline.; Sandrucci Sergio author non-byline.; Bachini Ilaria author non-byline.; Magistris Anna De author non-byline.; Mitola Barbara author non-byline.; Massucco Paolo author non-byline.; Rizzo Alessio author non-byline.; Caironi Pietro author non-byline.; Orlando Anna author non-byline.; Brunetti Francesco author non-byline.; Defilè Corinna author non-byline.; Martins Vitor Hugo author non-byline.; Giacometti Lisa author non-byline.; Papurello Matteo author non-byline.; Saccona Fabio author non-byline.; Turco Danila author non-byline.;
• Is Part Of: BMJ open. Volume 11:Issue 6(2021)
• Publication Date: 2021-06-03
• Subjects: audit -- colorectal surgery -- quality in health care; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-047491
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: The ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway aimed to reduce surgical stress and to allow a rapid postoperative recovery. Application of the ERAS protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the true impact of the protocol on a large, unselected population. Methods: A multicentre stepped wedge cluster randomised trial is designed for comparison between standard perioperative management and the management according to the ERAS protocol. The primary outcome is the length of hospital stay (LOS). Secondary outcomes are: incidence of postoperative complications, time to patients' recovery, control of pain and patients' satisfaction. With an A&F approach the adherence to the ERAS items is monitored through a dedicated area in the study web site. The study includes 28 surgical centres, stratified by activity volume and randomly divided into four groups. Each group is randomly assigned to a different activation period of the ERAS protocol. There are four activation periods, one every 3 months. However, the planned calendar and the total duration of the study have been extended by 6 months due to the COVID-19 pandemic. The expected sample size of about 2200 patients has a high statistical power (98%) to detect a reduction of LOS of 1 day and to estimate clinically meaningful changes in the other endpoints. Ethics and dissemination: The study protocol has been approved by the Ethical Committee of the coordinating centre and by all participating centres. Study results will be timely circulated within the hospital network and published in peer-reviewed journals. Trial registration number: NCT04037787 .