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

Colorectal Surgery Clinical Trial

— ERAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03189550
• Other study ID #: 140558
• Status: Completed
• Start date: July 1, 2014
• Est. completion date: February 17, 2017

Study information

• Verified date: February 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 664
• Est. completion date: February 17, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• ERAS
• Perioperative Care
• Quality Improvement

Intervention

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
• Standard perioperative care
Standard perioperative care prior to implementation of ERAS care pathway
• Noninvasive hemodynamic monitoring
Standard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences)

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of surgical site infection		Up to 30 days postoperative
Secondary	ICU length of stay		Up to 30 days postoperative
Secondary	Time on ventilator		Up to 30 days postoperative
Secondary	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
Secondary	Post operative anti emetic consumption		Up to 30 days postoperative
Secondary	Occurrence of postoperative complications		Up to 30 days postoperative
Secondary	Analgesia consumption	Total opioid and non-opioid medication use	Up to 30 days postoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Hospital Length of stay (days)		Up to 30 days post operative