Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| A.O.U. Città della Salute e della Scienza | OTHER |
| Ministry of Health, Italy | OTHER_GOV |
| Regione Piemonte | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Perioperative care for colorectal cancer cancer is managed according to current hospital clinical practice. | |
| ERAS protocol | Experimental | Perioperative care for colorectal cancer surgery is managed according to ERAS protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS protocol | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay >22 days | Rate of patients with a length of stay >22 days | 30 days after admission |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giovannino Ciccone, MD | Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Santa Croce-Carle Cuneo | Cuneo | 12100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30426190 | Background | 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. | |
| 21468643 |
Not provided
Not provided
Anonymised data can be made available upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.
Available after results publication
Upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| Background |
| 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. |
| 24368573 | Background | 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. |
| 28289972 | Background | 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. |
| 30086061 | Background | 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. |
| 38423752 | Derived | 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. |
| 34083345 | Derived | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |