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

Completed

• Conditions: Perioperative Care; Quality Improvement; Colorectal Surgery; ERAS
• Interventions: Procedure: Standard perioperative care; Procedure: ERAS perioperative care; Procedure: Noninvasive hemodynamic monitoring

• Registration Number: NCT03189550
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2017-02-15
• Study Completion: 2017-02-17
• Study First Submitted: 2017-03-25
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 664

Inclusion Criteria

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

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Exclusion Criteria

• Age <18 years
• Weight <40 kg

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Historical control	Standard perioperative care	Patients who underwent colorectal surgery with standard perioperative care starting from June 2014 and progressing backward in time.
ERAS without SOC noninvasive hemodynamic monitoring	Standard perioperative care	Patients who underwent colorectal surgery after implementation of standard of care (SOC) ERAS perioperative care from July 2014 to February 2015
ERAS with SOC noninvasive hemodynamic monitoring	ERAS perioperative care	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
ERAS with SOC noninvasive hemodynamic monitoring	Standard perioperative care	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
ERAS without SOC noninvasive hemodynamic monitoring	ERAS perioperative care	Patients who underwent colorectal surgery after implementation of standard of care (SOC) ERAS perioperative care from July 2014 to February 2015
ERAS with SOC noninvasive hemodynamic monitoring	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

Primary Outcome Measures

Name	Time	Method
Incidence of surgical site infection	Up to 30 days postoperative

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States