NCT02997293

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress81%
Mar 2017Jul 2028

First Submitted

Initial submission to the registry

December 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
11.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

11.3 years

First QC Date

December 12, 2016

Last Update Submit

August 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days from the conclusion of the surgical procedure

Study Arms (2)

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

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

Other: Enhanced Recovery protocol

Interventions

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.

Enhanced Recoverypre-Enhanced Recovery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • American Society of Anesthesiologists physical status classification \> 3 and age \< 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72202, United States

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGastroenteritis

Study Officials

  • Greg Mehaffey, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg Mehaffey, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 20, 2016

Study Start

March 1, 2017

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations