Impact of the Enhanced Recovery After Surgery System for Colorectal Surgery

Sponsor
University of Arkansas (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02997293
Collaborator
(none)
200
1
69
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Enhanced Recovery protocol

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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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.

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

Outcome Measures

Primary Outcome Measures

  1. Hospital length of stay [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • American Society of Anesthesiologists physical status classification > 3 and age < 18.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72202

Sponsors and Collaborators

  • University of Arkansas

Investigators

  • Principal Investigator: Greg Mehaffey, MD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT02997293
Other Study ID Numbers:
  • 206240
First Posted:
Dec 20, 2016
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022