ColoRectal Cancer and Inflammatory Bowel DiseaseNCT02997293
Impact of the Enhanced Recovery After Surgery System for Colorectal Surgery
An observational study of ColoRectal Cancer and Inflammatory Bowel Disease, run by University of Arkansas at 1 site in United States.
Trial summary
This is an observational study to look at the impact of the Enhanced Recovery After Surgery system for colorectal surgery (Group 1) in shortening hospital length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale scores, decreasing the incidence of postoperative nausea and vomiting, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ColoRectal Cancer and Inflammatory Bowel Disease
- What is being tested?
- Enhanced Recovery protocol
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All men and women 18 years and older who underwent major colorectal surgery at the University of Arkansas for Medical Sciences between January 1, 2014 to December 31, 2014 and June 1, 2015 to November 30, 2016, and were American Society of Anesthesiologist physical status classification 1-3 at the time of surgery.
Who may be able to join
- All men and women 18 years and older who underwent major colorectal surgery at University of Arkansas for Medical Sciences between January 1, 2014 to December 31, 2014 and June 1, 2015 to November 30, 2016, and were American Society of Anesthesiologist physical status classification 1-3 at the time of surgery.
Who cannot join
- American Society of Anesthesiologists physical status classification > 3 and age < 18.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202
Gregory Mehaffey, MD, 501-686-7616, grmehaffey@uams.edu
About this study
Official title: An Analysis of the Impact of the Enhanced Recovery After Surgery System for Colorectal Surgery at the University of Arkansas for Medical Sciences
This is an observational study to look at the impact of the Enhanced Recovery After Surgery system for colorectal surgery (Group 1) in shortening hospital length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day readmission when compared to patients who had colorectal surgery performed at UAMS prior to the implementation of the Enhanced Recovery After Surgery system (Group 2).
This is a retrospective study using de-identified records and therefore will not require subject enrollment and is NOT Human Subjects Research.
Read the detailed description
The Enhanced Recovery After Surgery system for perioperative care of patients undergoing major abdominal surgery, particularly colorectal surgery, was formed in Europe by a surgeon named Henrik Kehlet in 1994. Dr. Kehlet observed that his patients undergoing colorectal surgery were hospitalized postoperatively for extended periods of time due to prolonged return of the normal intestinal physiology and of other bodily functions. Dr. Kehlet formulated a system of perioperative care that focused on preserving and promoting faster return of normal physiologic function of the human body following surgery.
The Enhanced Recovery After Surgery system has been implemented in the United States for nearly a decade now, primarily at major academic institutions. Numerous publications exist that report the dramatic positive impacts of this program on reducing postoperative hospital length of stay, reducing 30-day hospital readmissions, and improving patient satisfaction.
The University of Arkansas for Medical Sciences implemented several components of the Enhanced Recovery After Surgery system for colorectal surgery in June 2015. This is an observational study to look at the impact that program (Group 1) in shortening hospital length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day readmission when compared to patients who had colorectal surgery performed at University of Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After Surgery system (Group 2).
- Being tested
- Enhanced Recovery protocol
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery protocolOther
The Enhanced Recovery protocol focuses on many areas or perioperative care, including non-narcotic pain management, optimization of fluid balance throughout the perioperative course, early eating, ambulation, early removal of drains postoperatively, and preoperative patient education.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery | Those subjects who had major colorectal surgery at the University of Arkansas for Medical Sciences after Enhanced Recovery After Surgery implementation, between the dates of June 1, 2015 to November 30, 2016 Receives: Other: Enhanced Recovery protocol | |
| pre-Enhanced Recovery | Those subjects who had major colorectal surgery at the University of Arkansas for Medical Sciences prior to Enhanced Recovery After Surgery implementation between the dates of January 1, 2014 to December 31, 2014 Receives: Other: Enhanced Recovery protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
To compare the hospital length of stay following major colorectal surgery at the University of Arkansas for Medical Sciences for patients who had their perioperative care guided by the principles of the Enhanced Recovery After Surgery system to those that had major colorectal surgery at University of Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After Surgery system.
Measured: 30 days from the conclusion of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColoRectal Cancer and Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greg Mehaffey, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997293
- Sponsor's protocol ID
- 206240
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2016
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of the Impact of the Enhanced Recovery After Surgery System for Colorectal Surgery at the University of Arkansas for Medical Sciences
- ClinicalTrials.gov ID
- NCT02997293
- Acronym / sponsor ID
- 206240
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- 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.
This is an observational study to look at the impact of the Enhanced Recovery After Surgery system for colorectal surgery (Group 1) in shortening hospital length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day readmission when compared to patients who had colorectal surgery performed at UAMS prior to the implementation of the Enhanced Recovery After Surgery system (Group 2).
This is a retrospective study using de-identified records and therefore will not require subject enrollment and is NOT Human Subjects Research.
Detailed description
The Enhanced Recovery After Surgery system for perioperative care of patients undergoing major abdominal surgery, particularly colorectal surgery, was formed in Europe by a surgeon named Henrik Kehlet in 1994. Dr. Kehlet observed that his patients undergoing colorectal surgery were hospitalized postoperatively for extended periods of time due to prolonged return of the normal intestinal physiology and of other bodily functions. Dr. Kehlet formulated a system of perioperative care that focused on preserving and promoting faster return of normal physiologic function of the human body following surgery.
The Enhanced Recovery After Surgery system has been implemented in the United States for nearly a decade now, primarily at major academic institutions. Numerous publications exist that report the dramatic positive impacts of this program on reducing postoperative hospital length of stay, reducing 30-day hospital readmissions, and improving patient satisfaction.
The University of Arkansas for Medical Sciences implemented several components of the Enhanced Recovery After Surgery system for colorectal surgery in June 2015. This is an observational study to look at the impact that program (Group 1) in shortening hospital length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day readmission when compared to patients who had colorectal surgery performed at University of Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After Surgery system (Group 2).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery | – | Other: Enhanced Recovery protocolThose subjects who had major colorectal surgery at the University of Arkansas for Medical Sciences after Enhanced Recovery After Surgery implementation, between the dates of June 1, 2015 to November 30, 2016 |
| pre-Enhanced Recovery | – | Other: Enhanced Recovery protocolThose subjects who had major colorectal surgery at the University of Arkansas for Medical Sciences prior to Enhanced Recovery After Surgery implementation between the dates of January 1, 2014 to December 31, 2014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All men and women 18 years and older who underwent major colorectal surgery at the University of Arkansas for Medical Sciences between January 1, 2014 to December 31, 2014 and June 1, 2015 to November 30, 2016, and were American Society of Anesthesiologist physical status classification 1-3 at the time of surgery.
Key inclusion criteria (1 listed)
- All men and women 18 years and older who underwent major colorectal surgery at University of Arkansas for Medical Sciences between January 1, 2014 to December 31, 2014 and June 1, 2015 to November 30, 2016, and were American Society of Anesthesiologist physical status classification 1-3 at the time of surgery.
Key exclusion criteria (1 listed)
- American Society of Anesthesiologists physical status classification > 3 and age < 18.
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 |
|---|---|---|
| Enhanced Recovery protocolThe Enhanced Recovery protocol focuses on many areas or perioperative care, including non-narcotic pain management, optimization of fluid balance throughout the perioperative course, early eating, ambulation, early removal of drains postoperatively, and preoperative patient education. | Other | Enhanced Recovery, pre-Enhanced Recovery |
Primary outcome
Hospital length of stay
Time frame: 30 days from the conclusion of the surgical procedure
To compare the hospital length of stay following major colorectal surgery at the University of Arkansas for Medical Sciences for patients who had their perioperative care guided by the principles of the Enhanced Recovery After Surgery system to those that had major colorectal surgery at University of Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After Surgery system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Greg Mehaffey, MD principal investigator
University of Arkansas
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 Cancer and Inflammatory Bowel Disease, run by University of Arkansas 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 1 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg Mehaffey, MD (5016867616, grmehaffey@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: 30 days from the conclusion of the surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.