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Completed

NCT Number: NCT03189550

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

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.

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Key information

Conditions

Colorectal Surgery ERAS Perioperative Care Quality Improvement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERAS perioperative care

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

Procedure

Standard perioperative care prior to implementation of ERAS care pathway

Noninvasive hemodynamic monitoring

Procedure

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

Primary outcomes

  1. Incidence of surgical site infection

    Time frame: Up to 30 days postoperative

Secondary outcomes

  1. ICU length of stay

    Time frame: Up to 30 days postoperative

  2. Time on ventilator

    Time frame: Up to 30 days postoperative

  3. Post operative pain assessment using 11-point Numeric Pain Rating Scale (NRS)

    Time frame: Up to 30 days postoperative

    Post operative pain assessed using NRS when 0 is no nausea and 10 is worst pain.

  4. Post operative anti emetic consumption

    Time frame: Up to 30 days postoperative

  5. Occurrence of postoperative complications

    Time frame: Up to 30 days postoperative

  6. Analgesia consumption

    Time frame: Up to 30 days postoperative

    Total opioid and non-opioid medication use

  7. Cardiac Index

    Time frame: 1 day

    Using time traces for cardiac index during the perioperative period, the time in range of pre-defined parameters will be measured.

  8. Stroke volume

    Time frame: 1 day

    Using time traces for stroke volume during the perioperative period, the time in range of pre-defined parameters will be measured.

  9. Systemic vascular resistance

    Time frame: 1 day

    Using time traces for systemic vascular resistance during the perioperative period, the time in range of pre-defined parameters will be measured.

  10. Heart rate

    Time frame: 1 day

    Using time traces for heart rate during the perioperative period, the time in range of pre-defined parameters will be measured.

  11. Hospital Length of stay (days)

    Time frame: Up to 30 days post operative

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • Edwards Lifesciences

Registry information

Acronym: ERAS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2017
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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