<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02997293</url>
  </required_header>
  <id_info>
    <org_study_id>206240</org_study_id>
    <nct_id>NCT02997293</nct_id>
  </id_info>
  <brief_title>Impact of the Enhanced Recovery After Surgery System for Colorectal Surgery</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arkansas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arkansas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study to look at the impact of the Enhanced Recovery After Surgery&#xD;
      system for colorectal surgery (Group 1) in shortening hospital length of stay, reducing&#xD;
      postoperative narcotic consumption, lowering Visual Analog Scale scores, decreasing the&#xD;
      incidence of postoperative nausea and vomiting, and reducing 30-day readmission when compared&#xD;
      to patients who had colorectal surgery performed at UAMS prior to the implementation of the&#xD;
      Enhanced Recovery After Surgery system (Group 2).&#xD;
&#xD;
      This is a retrospective study using de-identified records and therefore will not require&#xD;
      subject enrollment and is NOT Human Subjects Research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Enhanced Recovery After Surgery system for perioperative care of patients undergoing&#xD;
      major abdominal surgery, particularly colorectal surgery, was formed in Europe by a surgeon&#xD;
      named Henrik Kehlet in 1994. Dr. Kehlet observed that his patients undergoing colorectal&#xD;
      surgery were hospitalized postoperatively for extended periods of time due to prolonged&#xD;
      return of the normal intestinal physiology and of other bodily functions. Dr. Kehlet&#xD;
      formulated a system of perioperative care that focused on preserving and promoting faster&#xD;
      return of normal physiologic function of the human body following surgery.&#xD;
&#xD;
      The Enhanced Recovery After Surgery system has been implemented in the United States for&#xD;
      nearly a decade now, primarily at major academic institutions. Numerous publications exist&#xD;
      that report the dramatic positive impacts of this program on reducing postoperative hospital&#xD;
      length of stay, reducing 30-day hospital readmissions, and improving patient satisfaction.&#xD;
&#xD;
      The University of Arkansas for Medical Sciences implemented several components of the&#xD;
      Enhanced Recovery After Surgery system for colorectal surgery in June 2015. This is an&#xD;
      observational study to look at the impact that program (Group 1) in shortening hospital&#xD;
      length of stay, reducing postoperative narcotic consumption, lowering Visual Analog Scale&#xD;
      scores, decreasing the incidence of postoperative nausea and vomiting, and reducing 30-day&#xD;
      readmission when compared to patients who had colorectal surgery performed at University of&#xD;
      Arkansas for Medical Sciences prior to the implementation of the Enhanced Recovery After&#xD;
      Surgery system (Group 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>30 days from the conclusion of the surgical procedure</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>ColoRectal Cancer and Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>Enhanced Recovery</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pre-Enhanced Recovery</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Recovery protocol</intervention_name>
    <description>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.</description>
    <arm_group_label>Enhanced Recovery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All men and women 18 years and older who underwent major colorectal surgery at the&#xD;
        University of Arkansas for Medical Sciences between January 1, 2014 to December 31, 2014&#xD;
        and June 1, 2015 to November 30, 2016, and were American Society of Anesthesiologist&#xD;
        physical status classification 1-3 at the time of surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All men and women 18 years and older who underwent major colorectal surgery at&#xD;
             University of Arkansas for Medical Sciences between January 1, 2014 to December 31,&#xD;
             2014 and June 1, 2015 to November 30, 2016, and were American Society of&#xD;
             Anesthesiologist physical status classification 1-3 at the time of surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status classification &gt; 3 and age &lt; 18.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Greg Mehaffey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arkansas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>January 13, 2023</last_update_submitted>
  <last_update_submitted_qc>January 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02997293
org study id: 206240
nct id: NCT02997293
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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).
observational model: Cohort
time perspective: Retrospective
measure: Hospital length of stay
time frame: 30 days from the conclusion of the surgical procedure
description: 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.
arm group label: Enhanced Recovery
description: 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
arm group label: pre-Enhanced Recovery
description: 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
intervention type: Other
intervention name: Enhanced Recovery protocol
description: 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.
arm group label: Enhanced Recovery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Greg Mehaffey, MD
role: Principal Investigator
affiliation: University of Arkansas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases
sharing ipd: No