Impact of the Enhanced Recovery After Surgery System for Colorectal Surgery

ColoRectal Cancer and Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02997293
• Other study ID #: 206240
• Status: Active, not recruiting
• Start date: March 1, 2017
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2023
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ColoRectal Cancer and Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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