BMJ Open (Jun 2021)
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
- ,
- Eva Pagano,
- Dario Ribero,
- Oscar Bertetto,
- Paolo Massucco,
- Giovannino Ciccone,
- Fabio Saccona,
- Mauro Santarelli,
- Monica Carrera,
- Marco Brunetti,
- Roberto Rimonda,
- Francesca Cravero,
- Eliana Giaminardi,
- Francesco Battafarano,
- Alfredo Mellano,
- Enrico Gibin,
- Paola Bellomo,
- Sarah Palmisano,
- Luca Pellegrino,
- Federica Rinaldi,
- Valentina Palazzo,
- Danilo Donati,
- Maurizio Meineri,
- Monica Rolfo,
- Ilaria Bachini,
- Felice Borghi,
- Federica Borromeo,
- Fabio Priora,
- Sergio Gentilli,
- Luca Portigliotti,
- Marco Palisi,
- Maurizio De Giuli,
- Aridai Resendiz,
- Silvia Marola,
- Roberto Polastri,
- Andrea Muratore,
- Nicoletta Sveva Pipitone,
- Mauro Garino,
- Elisabetta Castagna,
- Gabriele Pozzo,
- Andrea Caneparo,
- Adriana Ginardi,
- Reggina Lagana,
- Stefania Muzio,
- Luca Panier Suffat,
- Ivan Lettini,
- Alberto Kiss,
- Valentina Gentile,
- Roberto Saracco,
- Donatella Scaglione,
- Andrea Gattolin,
- Luigi Oragano,
- Luca Lorenzin,
- Carlo Palenzona,
- Carmine Gianfranco Di Somma,
- Marco Calgaro,
- Marco Naddeo,
- Piero Cumbo,
- Emma Marchigiano,
- Marco Amisano,
- Francesco Lemut,
- Tiziana Viora,
- Luciano Bonaccorsi,
- Silvio Testa,
- Clemente De Rosa,
- Matteo Gatti,
- Carlo Bima,
- Francesco Quaglino,
- Federico Festa,
- Luca Bonatti,
- Mario Morino,
- Marco Ettore Allaix,
- Paolo De Paolis,
- Ida Marina Raciti,
- Gitana Scozzari,
- Rosalba Galletti,
- Sergio Sandrucci,
- Anna De Magistris,
- Barbara Mitola,
- Alessio Rizzo,
- Pietro Caironi,
- Anna Orlando,
- Francesco Brunetti,
- Corinna Defilè,
- Vitor Hugo Martins,
- Lisa Giacometti,
- Matteo Papurello,
- Danila Turco
Affiliations
- 3University College London
- Eva Pagano
- 1 Unit of Clinical Epidemiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
- Dario Ribero
- Oscar Bertetto
- 7 Dipartimento Interaziendale Interregionale Rete Oncologica Piemonte-Valle d’Aosta, Torino, Italy
- Paolo Massucco
- 4 General Surgery and Oncology Unit, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy
- Giovannino Ciccone
- 1 Unit of Clinical Epidemiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
- Fabio Saccona
- Clinical Epidemiology Unit, Azienda Ospedaliero Universitaria Citta della Salute e della Scienza, Torino, Italy
- Mauro Santarelli
- Monica Carrera
- Department of Surgery, Ospedale di Ciriè, Ciriè (TO), Italy
- Marco Brunetti
- Department of Surgery, Ospedale SS Annunziata, Savigliano (CN), Italy
- Roberto Rimonda
- Department of Surgery, Ospedale Regina Montis, Mondovì (CN), Italy
- Francesca Cravero
- Department of Surgery, Ospedale Santo Spirito, Casale Monferrato (AL), Italy
- Eliana Giaminardi
- Department of Surgery, Ospedale San Giacomo, Novi Ligure (AL), Italy
- Francesco Battafarano
- Department of Surgery, Ospedale S. Biagio, Domodossola (VB), Italy
- Alfredo Mellano
- 2 Surgical Oncology Department, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Torino, Italy
- Enrico Gibin
- Department of Surgery, Presidio Sanitario Ospedale Cottolengo, Torino, Italy
- Paola Bellomo
- 8 General Surgery, Presidio Sanitario Gradenigo, Torino, Italy
- Sarah Palmisano
- 5 Anaesthesia and Intensive Care Unit, S Croce and Carle Cuneo Hospital Districts, Cuneo, Italy
- Luca Pellegrino
- 2 Surgical Oncology Department, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Torino, Italy
- Federica Rinaldi
- 3 Scuola di Medicina, University of Turin, Torino, Italy
- Valentina Palazzo
- 3 Scuola di Medicina, University of Turin, Torino, Italy
- Danilo Donati
- 2 Department of Surgery, General and Oncologic Surgery Unit, Santa Croce e Carle Hospital, Cuneo, Italy
- Maurizio Meineri
- 5 Anaesthesia and Intensive Care Unit, S Croce and Carle Cuneo Hospital Districts, Cuneo, Italy
- Monica Rolfo
- 3 Presidio Sanitario Gradenigo, Torino, Italy
- Ilaria Bachini
- 6 Clinical Nutrition and Dietetics Department, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy
- Felice Borghi
- 2 Surgical Oncology Department, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Torino, Italy
- Federica Borromeo
- Fabio Priora
- Sergio Gentilli
- Luca Portigliotti
- Marco Palisi
- Maurizio De Giuli
- Aridai Resendiz
- Silvia Marola
- Roberto Polastri
- 9 Department of Surgery, General Surgery Unit, Hospital of Biella, Ponderano, Biella, Italy
- Andrea Muratore
- Nicoletta Sveva Pipitone
- Mauro Garino
- Elisabetta Castagna
- Gabriele Pozzo
- Andrea Caneparo
- Adriana Ginardi
- Reggina Lagana
- Stefania Muzio
- Luca Panier Suffat
- Ivan Lettini
- Alberto Kiss
- Valentina Gentile
- Roberto Saracco
- Donatella Scaglione
- Andrea Gattolin
- Luigi Oragano
- Luca Lorenzin
- Carlo Palenzona
- Carmine Gianfranco Di Somma
- Marco Calgaro
- Marco Naddeo
- Piero Cumbo
- Emma Marchigiano
- Marco Amisano
- Francesco Lemut
- Tiziana Viora
- Luciano Bonaccorsi
- Silvio Testa
- Clemente De Rosa
- Matteo Gatti
- Carlo Bima
- Francesco Quaglino
- Federico Festa
- Luca Bonatti
- Mario Morino
- 7 Digestive and Oncological Surgery, Center for Minimal Invasive Surgery, Department of Surgery, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
- Marco Ettore Allaix
- 7 Digestive and Oncological Surgery, Center for Minimal Invasive Surgery, Department of Surgery, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
- Paolo De Paolis
- Ida Marina Raciti
- Gitana Scozzari
- Rosalba Galletti
- Sergio Sandrucci
- Anna De Magistris
- Barbara Mitola
- Alessio Rizzo
- 4 General Surgery and Oncology Unit, Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy
- Pietro Caironi
- Anna Orlando
- Francesco Brunetti
- 1 Unit of Clinical Epidemiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
- Corinna Defilè
- Vitor Hugo Martins
- Lisa Giacometti
- 1 Unit of Clinical Epidemiology, Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Torino, Italy
- Matteo Papurello
- Danila Turco
- DOI
- https://doi.org/10.1136/bmjopen-2020-047491
- Journal volume & issue
-
Vol. 11,
no. 6
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.
