NCT03189550

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
664

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 25, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

March 25, 2017

Last Update Submit

February 19, 2019

Conditions

Colorectal SurgeryQuality ImprovementPerioperative CareERAS

Outcome Measures

Primary Outcomes (1)

  • Incidence of surgical site infection

    Up to 30 days postoperative

Secondary Outcomes (11)

  • 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)

    Up to 30 days postoperative

  • Post operative anti emetic consumption

    Up to 30 days postoperative

  • Occurrence of postoperative complications

    Up to 30 days postoperative

  • +6 more secondary outcomes

Study Arms (3)

Historical control

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

Procedure: Standard perioperative care

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: ERAS perioperative careProcedure: Standard perioperative care

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: ERAS perioperative careProcedure: Standard perioperative careProcedure: Noninvasive hemodynamic monitoring

Interventions

ERAS perioperative carePROCEDURE

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 monitoringERAS without SOC noninvasive hemodynamic monitoring
Standard perioperative carePROCEDURE

Standard perioperative care prior to implementation of ERAS care pathway

ERAS with SOC noninvasive hemodynamic monitoringERAS without SOC noninvasive hemodynamic monitoringHistorical control
Noninvasive hemodynamic monitoringPROCEDURE

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

ERAS with SOC noninvasive hemodynamic monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients who underwent colorectal surgery at Vanderbilt University Medical Center

You may qualify if:

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

You may not qualify if:

  • Age \<18 years
  • Weight \<40 kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

  • 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.

    PMID: 33292514DERIVED

Study Officials

  • Matthew D McEvoy, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology

Study Record Dates

First Submitted

March 25, 2017

First Posted

June 16, 2017

Study Start

July 1, 2014

Primary Completion

February 15, 2017

Study Completion

February 17, 2017

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations

US(1)