Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project (ERAS)

Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Perioperative Care; Quality Improvement; ERAS
• Intervention / Treatment: Procedure: Standard perioperative care; Procedure: ERAS perioperative care; Procedure: Noninvasive hemodynamic monitoring

Detailed Description

Multimodal perioperative care pathways have evolved into enhanced recovery after surgery (ERAS). ERAS pathways improve the quality of patient care, reduce morbidity, and shorten length of stay. This large quality improvement project will compare outcomes after standard perioperative practice with those after the implementation of a multi-modal evidence based care pathway, including standardized preoperative preparation, perioperative goal-directed fluid therapy (GFDT), multi-modal perioperative pain management, post operative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention. This project will test the hypothesis that implementation of a multi-modal ERAS perioperative care protocol in colorectal surgical patients will result in significantly reduced perioperative morbidity and mortality.

• Study Type: Observational
• Enrollment (Actual): 664

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients who underwent colorectal surgery at Vanderbilt University Medical Center

Description

Inclusion Criteria:

• All patients who underwent colorectal surgery at Vanderbilt University Medical Center and whose data is stored in the perioperative data warehouse.

Exclusion Criteria:

• Age <18 years
• Weight <40 kg

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Historical control; Patients who underwent colorectal surgery with standard perioperative care starting from June 2014 and progressing backward in time.	Procedure: Standard perioperative care; Standard perioperative care prior to implementation of ERAS care pathway
ERAS without SOC noninvasive hemodynamic monitoring; Patients who underwent colorectal surgery after implementation of standard of care (SOC) ERAS perioperative care from July 2014 to February 2015	Procedure: Standard perioperative care; Standard perioperative care prior to implementation of ERAS care pathway; Procedure: ERAS perioperative care; Standard of care implementation of multi-modal evidence-based care pathway, including standardized preoperative preparation (medical and diet), perioperative goal-directed fluid therapy, multi-modal perioperative pain management, postoperative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention
ERAS with SOC noninvasive hemodynamic monitoring; Patients who underwent colorectal surgery after implementation of standard of care ERAS perioperative care with standard of care noninvasive hemodynamic monitoring (with the ClearSight System, Edwards Lifesciences) after February 2015	Procedure: Standard perioperative care; Standard perioperative care prior to implementation of ERAS care pathway; Procedure: ERAS perioperative care; Standard of care implementation of multi-modal evidence-based care pathway, including standardized preoperative preparation (medical and diet), perioperative goal-directed fluid therapy, multi-modal perioperative pain management, postoperative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention; Procedure: Noninvasive hemodynamic monitoring; Standard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of surgical site infection	Up to 30 days postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay		Up to 30 days postoperative
Time on ventilator		Up to 30 days postoperative
Post operative pain assessment using 11-point Numeric Pain Rating Scale (NRS)	Post operative pain assessed using NRS when 0 is no nausea and 10 is worst pain.	Up to 30 days postoperative
Post operative anti emetic consumption		Up to 30 days postoperative
Occurrence of postoperative complications		Up to 30 days postoperative
Analgesia consumption	Total opioid and non-opioid medication use	Up to 30 days postoperative
Cardiac Index	Using time traces for cardiac index during the perioperative period, the time in range of pre-defined parameters will be measured.	1 day
Stroke volume	Using time traces for stroke volume during the perioperative period, the time in range of pre-defined parameters will be measured.	1 day
Systemic vascular resistance	Using time traces for systemic vascular resistance during the perioperative period, the time in range of pre-defined parameters will be measured.	1 day
Heart rate	Using time traces for heart rate during the perioperative period, the time in range of pre-defined parameters will be measured.	1 day
Hospital Length of stay (days)		Up to 30 days post operative

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: Edwards Lifesciences

Publications and helpful links

General Publications

• McEvoy MD, Wanderer JP, Shi Y, Ramanujan KS, Geiger TM, Shotwell MS, Shaw AD, Hawkins AT, Martin BJ, Mythen MG, Sandberg WS. The effect of adding goal-directed hemodynamic management for elective patients in an established enhanced recovery program for colorectal surgery: results of quasi-experimental pragmatic trial. Perioper Med (Lond). 2020 Nov 23;9(1):35. doi: 10.1186/s13741-020-00163-3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): February 15, 2017
• Study Completion (ACTUAL): February 17, 2017

Study Registration Dates

• First Submitted: March 25, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (ACTUAL): June 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 140558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No