Evidence map›Paper›PMID 34083345›Full record

ArticleBMJ open2021

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, Luca Pellegrino, Federica Rinaldi, Valentina Palazzo, Danilo Donati, Maurizio Meineri, Sarah Palmisano, Monica Rolfo, Ilaria Bachini, Oscar Bertetto and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04037787 (ERAS), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04037787 nacompletednot on this map

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery. A Stepped-wedge Cluster Randomized Clinical Trial

TypeinterventionalSponsorOspedale Santa Croce-Carle CuneoRan2019 to 2021Enrolled2,397ConditionsColorectal Cancer, Quality Improvement, Perioperative Care, Recovery of FunctionArmsERAS protocol
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 2 countries.

Eva PaganoClinical Epidemiology Unit and CPO Piemonte, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Torino, Italy evapagano@yahoo.com.ORCID 0000-0001-7552-2901
Luca PellegrinoDepartment of Surgery, General and Oncologic Surgery Unit, Santa Croce e Carle Hospital, Cuneo, Italy.
Federica RinaldiScuola di Medicina, University of Turin, Torino, Italy.
Valentina PalazzoScuola di Medicina, University of Turin, Torino, Italy.
Danilo DonatiDepartment of Surgery, General and Oncologic Surgery Unit, Santa Croce e Carle Hospital, Cuneo, Italy.
Maurizio MeineriDepartment of Anesthesiology and Intensive Care, Santa Croce e Carle Hospital, Cuneo, Italy.
Sarah PalmisanoDepartment of Anesthesiology and Intensive Care, Santa Croce e Carle Hospital, Cuneo, Italy.
Monica RolfoHealthcare Services Direction, Humanitas, Torino, Italy.
Ilaria BachiniUnit of Dietetic and Clinical Nutrition, Ordine Mauriziano Hospital, Torino, Italy.
Oscar BertettoDipartimento Interaziendale Interregionale Rete Oncologica Piemonte-Valle d'Aosta, Torino, Italy.
Felice BorghiDepartment of Surgery, General and Oncologic Surgery Unit, Santa Croce e Carle Hospital, Cuneo, Italy.
Giovannino CicconeClinical Epidemiology Unit and CPO Piemonte, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
ERAS Colon-Rectum Piemonte study group members
Carle Foundation Hospital · USAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITUniversity of Turin · ITAcademy of Nutrition and Dietetics · USHumanitas University · ITIstituto Zooprofilattico Sperimentale del Piemonte Liguria e Valle d'Aosta · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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.

methodsA 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.

Indexed as

Colorectal NeoplasmsCOVID-19Enhanced Recovery After SurgeryFeedbackHumansItalyLength of StayMulticenter Studies as TopicPandemicsPostoperative ComplicationsRandomized Controlled Trials as TopicSARS-CoV-2auditcolorectal surgeryquality in health care

Identifiers

PMID34083345
PMCPMC8183289
OpenAlexW3164740143

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.