search
Back to results

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

Primary Purpose

Colorectal Cancer, Quality Improvement, Perioperative Care

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ERAS protocol
Sponsored by
Ospedale Santa Croce-Carle Cuneo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Ospedale Santa Croce-Carle Cuneo

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

ERAS protocol

Arm Description

Perioperative care for colorectal cancer cancer is managed according to current hospital clinical practice.

Perioperative care for colorectal cancer surgery is managed according to ERAS protocol.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Length of stay >22 days
Rate of patients with a length of stay >22 days
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.
Complications
Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index
Transfer to intensive care unit
Rate of transfers to intensive care unit after surgery
Emergency visits after discharge
Rate of emergency visit in the first month after discharge
Hospital admissions after discharge
Rate of new admissions in the first month after discharge
Reintervention
Rate of reintervention in the first month after surgery, excluding planned interventions
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).
Healthcare costs
Mean healthcare costs from pre admission visit to 30 days after discharge

Full Information

First Posted
July 26, 2019
Last Updated
September 28, 2023
Sponsor
Ospedale Santa Croce-Carle Cuneo
Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Ministry of Health, Italy, Regione Piemonte
search

1. Study Identification

Unique Protocol Identification Number
NCT04037787
Brief Title
ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery
Acronym
ERAS-Colon
Official Title
ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery. A Stepped-wedge Cluster Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Santa Croce-Carle Cuneo
Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Ministry of Health, Italy, Regione Piemonte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Quality Improvement, Perioperative Care, Recovery of Function

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A stepped-wedge cluster randomized clinical trial. Each center starts as control group (usual care) and switch to experimental group (ERAS protocol implementation) according to a randomized order.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2397 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Perioperative care for colorectal cancer cancer is managed according to current hospital clinical practice.
Arm Title
ERAS protocol
Arm Type
Experimental
Arm Description
Perioperative care for colorectal cancer surgery is managed according to ERAS protocol.
Intervention Type
Procedure
Intervention Name(s)
ERAS protocol
Other Intervention Name(s)
ERAS (Enhanced Recovery After Surgery) protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of stay
Description
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).
Time Frame
22 days after admission
Secondary Outcome Measure Information:
Title
Length of stay >22 days
Description
Rate of patients with a length of stay >22 days
Time Frame
30 days after admission
Title
Recovery after surgery
Description
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.
Time Frame
24 hours after surgery
Title
Complications
Description
Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index
Time Frame
30 days after discharge
Title
Transfer to intensive care unit
Description
Rate of transfers to intensive care unit after surgery
Time Frame
30 days after surgery
Title
Emergency visits after discharge
Description
Rate of emergency visit in the first month after discharge
Time Frame
30 days after discharge
Title
Hospital admissions after discharge
Description
Rate of new admissions in the first month after discharge
Time Frame
30 days after discharge
Title
Reintervention
Description
Rate of reintervention in the first month after surgery, excluding planned interventions
Time Frame
30 days after surgery
Title
Patients' satisfaction
Description
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).
Time Frame
15 days after discharge
Title
Healthcare costs
Description
Mean healthcare costs from pre admission visit to 30 days after discharge
Time Frame
30 days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovannino Ciccone, MD
Organizational Affiliation
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Santa Croce-Carle Cuneo
City
Cuneo
ZIP/Postal Code
12100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
30426190
Citation
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.
Results Reference
background
PubMed Identifier
21468643
Citation
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.
Results Reference
background
PubMed Identifier
24368573
Citation
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.
Results Reference
background
PubMed Identifier
28289972
Citation
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.
Results Reference
background
PubMed Identifier
30086061
Citation
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.
Results Reference
background
PubMed Identifier
34083345
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs