Colorectal SurgeryERASNCT03189550
Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project
An observational study of Colorectal Surgery and Quality Improvement, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery, Quality Improvement, Perioperative Care
- What is being tested?
- ERAS perioperative care, Standard perioperative care and Noninvasive hemodynamic monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 664 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2014to 17 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent colorectal surgery at Vanderbilt University Medical Center
Who may be able to join
- All patients who underwent colorectal surgery at Vanderbilt University Medical Center and whose data is stored in the perioperative data warehouse.
Who cannot join
- Age <18 years
- Weight <40 kg
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
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 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.
Read the 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
- Being tested
- ERAS perioperative care, Standard perioperative care, Noninvasive hemodynamic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS perioperative careProcedure or surgery
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 careProcedure or surgery
Standard perioperative care prior to implementation of ERAS care pathway
Noninvasive hemodynamic monitoringProcedure or surgery
Standard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences)
| Study group | Role | What they receive |
|---|---|---|
| Historical control | Patients who underwent colorectal surgery with standard perioperative care starting from June 2014 and progressing backward in time. Receives: 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 Receives: Procedure: ERAS perioperative care; Procedure: 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 Receives: Procedure: ERAS perioperative care; Procedure: Standard perioperative care; Procedure: Noninvasive hemodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
Measured: Up to 30 days postoperative
Secondary outcomes (11)
ICU length of stay
Measured: Up to 30 days postoperative
Time on ventilator
Measured: Up to 30 days postoperative
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.
Measured: Up to 30 days postoperative
Post operative anti emetic consumption
Measured: Up to 30 days postoperative
Occurrence of postoperative complications
Measured: Up to 30 days postoperative
Analgesia consumption
Total opioid and non-opioid medication use
Measured: Up to 30 days postoperative
Cardiac Index
Using time traces for cardiac index during the perioperative period, the time in range of pre-defined parameters will be measured.
Measured: 1 day
Stroke volume
Using time traces for stroke volume during the perioperative period, the time in range of pre-defined parameters will be measured.
Measured: 1 day
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.
Measured: 1 day
Heart rate
Using time traces for heart rate during the perioperative period, the time in range of pre-defined parameters will be measured.
Measured: 1 day
Hospital Length of stay (days)
Measured: Up to 30 days post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Jul 2014
- Primary completion15 Feb 2017
- Study completion17 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Matthew McEvoy, Vanderbilt University Medical Center
- Investigators
- Matthew D McEvoy, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189550
- Sponsor's protocol ID
- 140558
- Acronym
- ERAS
- Status last verified
- Feb 2019
- First submitted
- 25 Mar 2017
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33292514
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Surgery in Colorectal Surgery: A Large-Scale Quality Improvement Project
- ClinicalTrials.gov ID
- NCT03189550
- Acronym / sponsor ID
- ERAS / 140558
- Conditions
- Colorectal Surgery, Quality Improvement, Perioperative Care, ERAS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 17 Feb 2017 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Historical control | – | Procedure: Standard perioperative carePatients who underwent colorectal surgery with standard perioperative care starting from June 2014 and progressing backward in time. |
| ERAS without SOC noninvasive hemodynamic monitoring | – | Procedure: ERAS perioperative care, Procedure: Standard perioperative carePatients 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 | – | Procedure: ERAS perioperative care, Procedure: Standard perioperative care, Procedure: Noninvasive hemodynamic monitoringPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent colorectal surgery at Vanderbilt University Medical Center
Key inclusion criteria (1 listed)
- All patients who underwent colorectal surgery at Vanderbilt University Medical Center and whose data is stored in the perioperative data warehouse.
Key exclusion criteria (2 listed)
- Age <18 years
- Weight <40 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS perioperative careStandard 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 | Procedure or surgery | ERAS with SOC noninvasive hemodynamic monitoring, ERAS without SOC noninvasive hemodynamic monitoring |
| Standard perioperative careStandard perioperative care prior to implementation of ERAS care pathway | Procedure or surgery | ERAS with SOC noninvasive hemodynamic monitoring, ERAS without SOC noninvasive hemodynamic monitoring, Historical control |
| Noninvasive hemodynamic monitoringStandard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences) | Procedure or surgery | ERAS with SOC noninvasive hemodynamic monitoring |
Primary outcome
Incidence of surgical site infection
Time frame: Up to 30 days postoperative
11 secondary outcomes
ICU length of stay
Time frame: Up to 30 days postoperative
Time on ventilator
Time frame: Up to 30 days postoperative
Post operative pain assessment using 11-point Numeric Pain Rating Scale (NRS)
Time frame: Up to 30 days postoperative
Post operative anti emetic consumption
Time frame: Up to 30 days postoperative
Occurrence of postoperative complications
Time frame: Up to 30 days postoperative
Analgesia consumption
Time frame: Up to 30 days postoperative
Cardiac Index
Time frame: 1 day
Stroke volume
Time frame: 1 day
Systemic vascular resistance
Time frame: 1 day
Heart rate
Time frame: 1 day
Hospital Length of stay (days)
Time frame: Up to 30 days post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Derived from this study: PubMed 33292514McEvoy 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D McEvoy, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery and Quality Improvement, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: Up to 30 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.