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Colorectal CancerERAS-ColonNCT04037787

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

A study testing ERAS protocol in people with Colorectal Cancer and Quality Improvement, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ERAS protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,397 participants
Where
1 siteItaly
Study dates
1 Sep 2019to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedale Santa Croce-Carle Cuneo

    Cuneo, 12100

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
ERAS protocol
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ERAS protocolProcedure or surgery

    Also called ERAS (Enhanced Recovery After Surgery) 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.

Study groups in NCT04037787
Study groupRoleWhat they receive
Usual careNo interventionPerioperative care for colorectal cancer cancer is managed according to current hospital clinical practice.
ERAS protocolExperimentalPerioperative care for colorectal cancer surgery is managed according to ERAS protocol.
Receives: Procedure: ERAS protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 22 days after admission

Secondary outcomes (9)

  1. Length of stay >22 days

    Rate of patients with a length of stay >22 days

    Measured: 30 days after admission

  2. 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.

    Measured: 24 hours after surgery

  3. Complications

    Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index

    Measured: 30 days after discharge

  4. Transfer to intensive care unit

    Rate of transfers to intensive care unit after surgery

    Measured: 30 days after surgery

  5. Emergency visits after discharge

    Rate of emergency visit in the first month after discharge

    Measured: 30 days after discharge

  6. Hospital admissions after discharge

    Rate of new admissions in the first month after discharge

    Measured: 30 days after discharge

  7. Reintervention

    Rate of reintervention in the first month after surgery, excluding planned interventions

    Measured: 30 days after surgery

  8. 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).

    Measured: 15 days after discharge

  9. Healthcare costs

    Mean healthcare costs from pre admission visit to 30 days after discharge

    Measured: 30 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2019
  2. Study start1 Sep 2019
  3. Primary completion31 May 2021
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
2,397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04037787
Sponsor's protocol ID
ERAS-Colon-Piemonte
Acronym
ERAS-Colon
Status last verified
Sep 2023
First submitted
26 Jul 2019
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised data can be made available upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.

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.

    PubMed 30426190

  • 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.

    PubMed 21468643

  • 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.

    PubMed 24368573

  • 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.

    PubMed 28289972

  • 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.

    PubMed 30086061

  • Pagano E, Pellegrino L, Robella M, Castiglione A, Brunetti F, Giacometti L, Rolfo M, Rizzo A, Palmisano S, Meineri M, Bachini I, Morino M, Allaix ME, Mellano A, Massucco P, Bellomo P, Polastri R, Ciccone G, Borghi F; ERAS-colorectal Piemonte group. Implementation of an enhanced recovery after surgery protocol for colorectal cancer in a regional hospital network supported by audit and feedback: a stepped wedge, cluster randomised trial. BMJ Qual Saf. 2024 May 17;33(6):363-374. doi: 10.1136/bmjqs-2023-016594.

    PubMed 38423752

  • 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.

    PubMed 34083345

Questions about this trial

What is this clinical trial studying?

A study testing ERAS protocol in people with Colorectal Cancer and Quality Improvement, run by Ospedale Santa Croce-Carle Cuneo at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of stay (time frame: 22 days after admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04037787, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

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