Clinical trial NCT04037787: ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery
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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Quality Improvement
Perioperative Care
Recovery of Function
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
Collaborators: name: A.O.U. Città della Salute e della Scienza
name: Ministry of Health, Italy
name: Regione Piemonte
First posted: 2019-07-30
Enrollment: 2397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: Length of stay
timeFrame: 22 days after admission
Secondary outcomes:
measure: Length of stay >22 days
timeFrame: 30 days after admission
measure: Recovery after surgery
timeFrame: 24 hours after surgery
measure: Complications
timeFrame: 30 days after discharge
measure: Transfer to intensive care unit
timeFrame: 30 days after surgery
measure: Emergency visits after discharge
timeFrame: 30 days after discharge
measure: Hospital admissions after discharge
timeFrame: 30 days after discharge
measure: Reintervention
timeFrame: 30 days after surgery
measure: Patients' satisfaction
timeFrame: 15 days after discharge
measure: Healthcare costs
timeFrame: 30 days after discharge
Other outcomes:
Locations:
city: Cuneo
country: Italy
facility: Ospedale Santa Croce-Carle Cuneo
Study officials:
affiliation: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
name: Giovannino Ciccone, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.