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

NCT ID: NCT03189550

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 664 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2017-02-17

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.

Conditions

Colorectal Surgery; Quality Improvement; Perioperative Care; ERAS

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Historical control

Patients who underwent colorectal surgery with standard perioperative care starting from June 2014 and progressing backward in time.

Standard perioperative care

Intervention Type: PROCEDURE

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

ERAS perioperative care

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Standard perioperative care prior to implementation of ERAS care pathway

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

ERAS perioperative care

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Standard perioperative care prior to implementation of ERAS care pathway

Noninvasive hemodynamic monitoring

Intervention Type: PROCEDURE

Standard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences)

Interventions

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

Intervention Type: PROCEDURE

Standard perioperative care

Standard perioperative care prior to implementation of ERAS care pathway

Intervention Type: PROCEDURE

Noninvasive hemodynamic monitoring

Standard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Matthew McEvoy

Associate Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew D McEvoy, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33292514 (View on PubMed)

Other Identifiers

140558

Identifier Type: -

Identifier Source: org_study_id