ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery (ERAS-Colon)

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Perioperative Care; Quality Improvement; Recovery of Function
• Intervention / Treatment: Procedure: ERAS protocol

Detailed Description

ERAS (Enhanced Recovery After Surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Even if efficacy and safety of ERAS protocol in colorectal surgery is well-established in the literature, its implementation is limited to few selected centres in Piemonte. The aim of the study is to extend the implementation of the ERAS protocol to whole regional network of hospitals. Specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.

• Study Type: Interventional
• Enrollment (Actual): 2397
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Felice Borghi, MD; Phone Number: +390171641763; Email: borghi.f@ospedale.cuneo.it

Study Locations

• Italy
  • Cuneo, Italy, 12100
    • Ospedale Santa Croce-Carle Cuneo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Perioperative care for colorectal cancer cancer is managed according to current hospital clinical practice.
Experimental: ERAS protocol; Perioperative care for colorectal cancer surgery is managed according to ERAS protocol.	Procedure: ERAS protocol; 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.; Other Names: ERAS (Enhanced Recovery After Surgery) protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery after surgery	Score of quality of recovery at 24 hours after surgery, assessed with the questionnaire Quality of Recovery (QoR-15), a 15-items instrument, with responses recorded on a 11-point Likert-type scale form 0 (worst scenario) to 10 (best scenario) and an overall score ranging from 0 (poor recovey) to 150 (excellent recovery). A visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 10 (worst imaginable health state) is also supplied as summary evaluation.	24 hours after surgery
Complications	Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index	30 days after discharge
Transfer to intensive care unit	Rate of transfers to intensive care unit after surgery	30 days after surgery
Emergency visits after discharge	Rate of emergency visit in the first month after discharge	30 days after discharge
Hospital admissions after discharge	Rate of new admissions in the first month after discharge	30 days after discharge
Reintervention	Rate of reintervention in the first month after surgery, excluding planned interventions	30 days after surgery
Patients' satisfaction	Score of patients' satisfaction measured 2 weeks after discharge, assessed with the questionnaire Surgical Satisfaction Questionnaire (SSQ8) supplied by telephone. SSQ8 is a 8-items instrument, with responses recorded on a 5-point Likert-type scale from 0 (worst scenario) to 4 (best scenario) and an overall score ranging from 0 (very unsatisfied) to 32 (very satisfied).	15 days after discharge
Healthcare costs	Mean healthcare costs from pre admission visit to 30 days after discharge	30 days after discharge
Length of stay >22 days	Rate of patients with a length of stay >22 days	30 days after admission

Collaborators and Investigators

• Sponsor: Ospedale Santa Croce-Carle Cuneo
• Collaborators: Azienda Ospedaliera Città della Salute e della Scienza di Torino; Ministry of Health, Italy; Regione Piemonte
• Investigators: Study Chair: Giovannino Ciccone, MD, Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Publications and helpful links

General Publications

• 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.
• Kehlet 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.
• Greco 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.
• Braga 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.
• Greer 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.
• Pagano 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ERAS-Colon-Piemonte

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised data can be made available upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.
• IPD Sharing Time Frame: Available after results publication
• IPD Sharing Access Criteria: Upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No