An interventional study of ERAS protocol in Colorectal Cancer, Quality Improvement and Perioperative Care, sponsored by Ospedale Santa Croce-Carle Cuneo. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Ospedale Santa Croce-Carle Cuneo · Not applicable, Interventional, and Health services research
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.
5,738 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 2,397 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Ospedale Santa Croce-Carle Cuneo is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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.
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.
Also known as: ERAS (Enhanced Recovery After Surgery) protocol
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).
Time frame: 22 days after admission
Length of stay >22 days
Rate of patients with a length of stay \>22 days
Time frame: 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.
Time frame: 24 hours after surgery
Complications
Rate of surgical and medical complication after surgery For surgical complications: Comprehensive Complication Index
Time frame: 30 days after discharge
Transfer to intensive care unit
Rate of transfers to intensive care unit after surgery
Time frame: 30 days after surgery
Emergency visits after discharge
Rate of emergency visit in the first month after discharge
Time frame: 30 days after discharge
Hospital admissions after discharge
Rate of new admissions in the first month after discharge
Time frame: 30 days after discharge
Reintervention
Rate of reintervention in the first month after surgery, excluding planned interventions
Time frame: 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).
Time frame: 15 days after discharge
Healthcare costs
Mean healthcare costs from pre admission visit to 30 days after discharge
Time frame: 30 days after discharge
Plan to share: Yes — Anonymised data can be made available upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.
Supporting information: Study protocol
Time frame: Available after results publication
Access criteria: Upon reasonable request, with appropriate human research ethics approvals and data transfer agreements in place.
Ran from Sep 2019 to primary completion in May 2021, 20 months.
Of 801 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's 20 months is below that.
Counting every sponsor, half of 845 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Ospedale Santa Croce-Carle Cuneo