CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Enhanced recovery protocolother
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/NCT03382210
NCT03382210N/ACompleted

Impact of a Colorectal Enhanced Recovery Program Implementation on Clinical Outcomes and Institutional Costs: A Prospective Cohort Study With Retrospective Control

University Hospital of Ferrara·observational·Posted Dec 22, 2017·Updated Dec 22, 2017

In Brief

An observational study evaluating Enhanced recovery protocol for Colorectal Surgery and 2 related conditions. Completed, enrolled 200 participants.

Detailed Summary

Importance: The Enhanced Recovery Program (ERP) for perioperative care of the surgical patient reduces the postoperative metabolic response and organ dysfunction thereby accelerating functional recovery. Consequently, the hospital length of stay (LOS) may be reduced, with no increase in morbidity and mortality rates resulting in a potential economic benefit. Objective: To determine impact on postoperative recovery and cost-effectiveness of implementing an ERP for colorectal surgery in an Italian academic center. Design, Setting, and Participants: A prospective consecutive series of patients (N=100) undergoing elective colorectal resection completing a standardized ERP in 2013-2015 (ERP group) will be compared to patients (N=100) operated on at the same Italian University hospital in 2010-2011 (Pre-ERP group) before introducing ERP program. The exclusion criteria are: age\>80 years old, ASA score IV, tumour stage IV, and inflammatory bowel disease. Exposures: ERP for perioperative care. Main Outcomes and Measures: To evaluate the impact of colorectal ERP implementation on hospital LOS proxy of functional recovery. Secondary outcomes include: postoperative complications, 30-day readmission and mortality, protocol adherence, nursing workload, cost-effectiveness, and factors predicting prolonged hospital LOS. Patients' satisfaction in ERP group will also be prospectively evaluated.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 22, 2017
Enrollment StartJan 11, 2013
Primary CompletionDec 18, 2015
Study CompletionApr 11, 2016
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.5 years ago

Interventions

Enhanced recovery protocolother

Standardized enhanced recovery protocol including 21 perioperative items.