CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,397 enrolled
Drug / intervention
ERAS protocolprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04037787
NCT04037787N/ACompleted

ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Colorectal Cancer Surgery. A Stepped-wedge Cluster Randomized Clinical Trial

Ospedale Santa Croce-Carle Cuneo·interventional·Posted Jul 30, 2019·Updated Oct 2, 2023

In Brief

A clinical study evaluating ERAS protocol for Colorectal Cancer and 3 related conditions. Completed, enrolled 2,397 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 30, 2019
Enrollment StartSep 1, 2019
Primary CompletionMay 31, 2021
Study CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.9 years ago

Interventions

ERAS protocolprocedure

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.