<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/NCT03260426</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00048403</org_study_id>
    <nct_id>NCT03260426</nct_id>
  </id_info>
  <brief_title>Trial of Low Residue Diet Versus Clear Liquids Following Elective Colorectal Surgery</brief_title>
  <official_title>Prospective Randomized Controlled Trial Investigating Commencement of Low Residue Diet Versus Clear Liquids on Postoperative Zero Following Elective Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective randomized controlled trial investigating commencement of low residue diet versus&#xD;
      clear liquids on postoperative zero following elective colorectal surgery, with regards to&#xD;
      patient tolerability, incidence of nausea and/or vomiting, and postoperative length of&#xD;
      hospitalization stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Offering patients, a low residue diet on the first postoperative day (POD1) after colorectal&#xD;
      surgery is safe and improves surgical outcomes and postoperative hospital stay. Early use of&#xD;
      low solid is superior to clear liquid diet after elective colorectal surgery.&#xD;
&#xD;
      The purpose of this study is to prospectively evaluate whether providing a patient a solid&#xD;
      diet from postoperative day zero is superior to clear liquids. The primary endpoint measured&#xD;
      will be patient tolerability, as evidenced by absence of vomiting. The secondary endpoints&#xD;
      measured will be duration of supplemental intravenous hydration needed, length of hospital&#xD;
      stay and postoperative complications, and intestinal rate measured by Abstats.&#xD;
&#xD;
      Abstats™ consists of a disposable plastic device embedded with a microphone that adheres to&#xD;
      the abdominal wall and connects to a computer measuring acoustic event rates. The monitor&#xD;
      will be placed on the patient's abdomen 30 minutes prior to surgery in the preoperative&#xD;
      holding area to obtain baseline intestinal rate. The monitor will be removed prior to surgery&#xD;
      and replaced by the surgical team in the operating room and maintained until postoperative&#xD;
      day 3. Daily intestinal rate will be calculated as mean and median acoustic events per&#xD;
      minute. The raw data will be analyzed by an investigator blinded to the clinical data.&#xD;
      Intestinal rates of patients offered immediate solid feeds will be compared with those&#xD;
      offered clear feeds. In addition, patients not tolerating or consuming early solid meal will&#xD;
      be compared with those who do to identify whether Abstat™ can be an early predictor of diet&#xD;
      intolerance in patients undergoing colorectal surgery.&#xD;
&#xD;
      Patients will be assigned into one of two groups:&#xD;
&#xD;
      Group I - Clear liquids on postoperative day zero immediately upon return to the floor and&#xD;
      subsequent days' advancement of enteral diet to regular diet is as per discretion of the&#xD;
      attending physician.&#xD;
&#xD;
      Group II - Regular diet from postoperative day zero immediately upon return to floor and&#xD;
      onwards.&#xD;
&#xD;
      Three questionnaires assessing quality of life are to be completed by the patient, during&#xD;
      his/her hospital stay. On postoperative day one, a self-administered questionnaire is to be&#xD;
      completed by the patient. Please see appendix A for the questionnaire details. The same&#xD;
      questionnaire is administered on postoperative day two and again on the last day of&#xD;
      hospitalization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Experienced Emesis on Post Operative Day 2</measure>
    <time_frame>POD 2</time_frame>
    <description>Patient tolerability, as evidenced by development of vomiting on postoperative day two.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).</measure>
    <time_frame>POD 0</time_frame>
    <description>Tolerability of regular diet will be determined by the patients ability to eat more than 50% of a solid meal on post operative day zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiemetic Usage</measure>
    <time_frame>30 days</time_frame>
    <description>If antiemetics were used in</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Stay</measure>
    <time_frame>30 days</time_frame>
    <description>Length of postoperative stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Ileus</measure>
    <time_frame>30 days</time_frame>
    <description>Development of post-operative ileus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>POD 1 and POD 2 and Discharge</time_frame>
    <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Pain score evaluated POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea Score</measure>
    <time_frame>POD 1 and POD 2 and Discharge</time_frame>
    <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Nausea Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bloating Score</measure>
    <time_frame>POD 1 and POD 2 and Discharge</time_frame>
    <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Bloating Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Nausea/Vomiting</condition>
  <arm_group>
    <arm_group_label>Clear Liquid Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular Solid Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Clear Liquids</intervention_name>
    <description>Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.</description>
    <arm_group_label>Clear Liquid Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Regular Solid</intervention_name>
    <description>Regular diet from postoperative day zero immediately upon return to floor and onwards</description>
    <arm_group_label>Regular Solid Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Abstats</intervention_name>
    <description>Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
    <arm_group_label>Clear Liquid Diet</arm_group_label>
    <arm_group_label>Regular Solid Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to freely give written informed consent to participate in the study and have&#xD;
             signed the Informed Consent Form;&#xD;
&#xD;
          2. Males or females, &gt;18 years of age inclusive at the time of study screening;&#xD;
&#xD;
          3. American Society of Anesthesiologists (ASA) Class I-III;&#xD;
&#xD;
          4. Colorectal surgery (open and/or robotic/laparoscopic);&#xD;
&#xD;
          5. Elective Surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mentally incompetent or unable or unwilling to provide informed consent or comply with&#xD;
             study procedures.&#xD;
&#xD;
          2. Children &lt;18 years of age.&#xD;
&#xD;
          3. Pre-operative clinical diagnosis of intestinal obstruction.&#xD;
&#xD;
          4. Pre-existing known upper gastrointestinal disorders including hiatus hernia,&#xD;
             gastroesophageal reflux disease, peptic ulcer disease.&#xD;
&#xD;
          5. Pre-existing oropharyngeal disorders such as stomatitis, altered taste sensations.&#xD;
&#xD;
          6. Colorectal surgery with concomitant resectional surgery of the stomach or proximal&#xD;
             jejunum (small bowel).&#xD;
&#xD;
          7. Pregnant patients.&#xD;
&#xD;
          8. Bedbound or moribund patients.&#xD;
&#xD;
          9. Pre-existing history of clinical depression.&#xD;
&#xD;
         10. Epidural analgesia.&#xD;
&#xD;
         11. Surgical procedures completed after 4pm&#xD;
&#xD;
         12. Patients taking narcotics prior to elective colorectal surgery&#xD;
&#xD;
        Exclusion Criteria After randomization:&#xD;
&#xD;
          1. Postoperative diagnosis of intra-abdominal sepsis, including anastomotic leaks.&#xD;
&#xD;
          2. Postoperative complications requiring early reoperation within the same hospital stay.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Phillip Fleshner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lau C, Phillips E, Bresee C, Fleshner P. Early use of low residue diet is superior to clear liquid diet after elective colorectal surgery: a randomized controlled trial. Ann Surg. 2014 Oct;260(4):641-7; discussion 647-9. doi: 10.1097/SLA.0000000000000929.</citation>
    <PMID>25203881</PMID>
  </reference>
  <reference>
    <citation>Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.</citation>
    <PMID>25091837</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <results_first_submitted>October 30, 2019</results_first_submitted>
  <results_first_submitted_qc>January 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 31, 2020</results_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Phillip Fleshner MD</investigator_full_name>
    <investigator_title>Clinical Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Tolerability diet after surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03260426/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Clear Liquid Diet</title>
          <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
        </group>
        <group group_id="P2">
          <title>Regular Solid Diet</title>
          <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Clear Liquid Diet</title>
          <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
        </group>
        <group group_id="B2">
          <title>Regular Solid Diet</title>
          <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.5" spread="50"/>
                    <measurement group_id="B2" value="45.5" spread="50"/>
                    <measurement group_id="B3" value="46.5" spread="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.6" spread="4.3"/>
                    <measurement group_id="B2" value="22.7" spread="4.9"/>
                    <measurement group_id="B3" value="23.1" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior abdominal surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Site of surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Small bowel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subtotal/left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pelvis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>IBD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ostomy Use</title>
          <population>Out of the 100 patients total of 49 patients received an ostomy. at the time of surgery.&#xD;
46 patient received and ileostomy and 3 patients received a colostomy.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ileostomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Colostomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No ostomy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anastomosis</title>
          <description>Out of the 100 patients who were enrolled and had surgery only 71 patients had an anastomosis formed. That is why the total is 71 patient. 35 in clear liquid group and 36 in regular diet group had an anastomosis formed.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Anastomosis formed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Anastomosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Experienced Emesis on Post Operative Day 2</title>
        <description>Patient tolerability, as evidenced by development of vomiting on postoperative day two.</description>
        <time_frame>POD 2</time_frame>
        <population>All participants undergoing surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Clear Liquid Diet</title>
            <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
          <group group_id="O2">
            <title>Regular Solid Diet</title>
            <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Emesis on Post Operative Day 2</title>
          <description>Patient tolerability, as evidenced by development of vomiting on postoperative day two.</description>
          <population>All participants undergoing surgery</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).</title>
        <description>Tolerability of regular diet will be determined by the patients ability to eat more than 50% of a solid meal on post operative day zero.</description>
        <time_frame>POD 0</time_frame>
        <population>All participants undergoing surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Clear Liquid Diet</title>
            <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
          <group group_id="O2">
            <title>Regular Solid Diet</title>
            <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).</title>
          <description>Tolerability of regular diet will be determined by the patients ability to eat more than 50% of a solid meal on post operative day zero.</description>
          <population>All participants undergoing surgery</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antiemetic Usage</title>
        <description>If antiemetics were used in</description>
        <time_frame>30 days</time_frame>
        <population>All participants undergoing surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Clear Liquid Diet</title>
            <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
          <group group_id="O2">
            <title>Regular Solid Diet</title>
            <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Antiemetic Usage</title>
          <description>If antiemetics were used in</description>
          <population>All participants undergoing surgery</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Stay</title>
        <description>Length of postoperative stay</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Clear Liquid Diet</title>
            <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
          <group group_id="O2">
            <title>Regular Solid Diet</title>
            <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Stay</title>
          <description>Length of postoperative stay</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="3.5"/>
                    <measurement group_id="O2" value="2.5" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Ileus</title>
        <description>Development of post-operative ileus</description>
        <time_frame>30 days</time_frame>
        <population>All participants undergoing surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Clear Liquid Diet</title>
            <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
          <group group_id="O2">
            <title>Regular Solid Diet</title>
            <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Ileus</title>
          <description>Development of post-operative ileus</description>
          <population>All participants undergoing surgery</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score</title>
        <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Pain score evaluated POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
        <time_frame>POD 1 and POD 2 and Discharge</time_frame>
        <population>All participants undergoing surgery</population>
        <group_list>
          <group group_id="O1">
            <title>Clear Liquid Diet</title>
            <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
          <group group_id="O2">
            <title>Regular Solid Diet</title>
            <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score</title>
          <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Pain score evaluated POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
          <population>All participants undergoing surgery</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POD 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="3" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nausea Score</title>
        <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Nausea Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
        <time_frame>POD 1 and POD 2 and Discharge</time_frame>
        <population>All participants undergoing surgery.</population>
        <group_list>
          <group group_id="O1">
            <title>Clear Liquid Diet</title>
            <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
          <group group_id="O2">
            <title>Regular Solid Diet</title>
            <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Nausea Score</title>
          <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Nausea Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
          <population>All participants undergoing surgery.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POD 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bloating Score</title>
        <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Bloating Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
        <time_frame>POD 1 and POD 2 and Discharge</time_frame>
        <population>All participants undergoing surgery.</population>
        <group_list>
          <group group_id="O1">
            <title>Clear Liquid Diet</title>
            <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
          <group group_id="O2">
            <title>Regular Solid Diet</title>
            <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
          </group>
        </group_list>
        <measure>
          <title>Bloating Score</title>
          <description>Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.&#xD;
Bloating Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.</description>
          <population>All participants undergoing surgery.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POD 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Clear Liquid Diet</title>
          <description>Clear liquids on postoperative day zero and intestinal rate measured by Abstats&#xD;
Clear Liquids: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
        </group>
        <group group_id="E2">
          <title>Regular Solid Diet</title>
          <description>Regular diet from postoperative day zero and intestinal rate measured by Abstats&#xD;
Regular Solid: Regular diet from postoperative day zero immediately upon return to floor and onwards&#xD;
Abstats: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Post-operative Ileus</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Phillip Fleshner, MD</name_or_title>
      <organization>Cedars Sinai Medical Center</organization>
      <phone>310-289-9224</phone>
      <email>pfleshner@aol.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03260426
org study id: Pro00048403
nct id: NCT03260426
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Prospective randomized controlled trial investigating commencement of low residue diet versus
      clear liquids on postoperative zero following elective colorectal surgery, with regards to
      patient tolerability, incidence of nausea and/or vomiting, and postoperative length of
      hospitalization stay.
Offering patients, a low residue diet on the first postoperative day (POD1) after colorectal
      surgery is safe and improves surgical outcomes and postoperative hospital stay. Early use of
      low solid is superior to clear liquid diet after elective colorectal surgery.

      The purpose of this study is to prospectively evaluate whether providing a patient a solid
      diet from postoperative day zero is superior to clear liquids. The primary endpoint measured
      will be patient tolerability, as evidenced by absence of vomiting. The secondary endpoints
      measured will be duration of supplemental intravenous hydration needed, length of hospital
      stay and postoperative complications, and intestinal rate measured by Abstats.

      Abstats™ consists of a disposable plastic device embedded with a microphone that adheres to
      the abdominal wall and connects to a computer measuring acoustic event rates. The monitor
      will be placed on the patient's abdomen 30 minutes prior to surgery in the preoperative
      holding area to obtain baseline intestinal rate. The monitor will be removed prior to surgery
      and replaced by the surgical team in the operating room and maintained until postoperative
      day 3. Daily intestinal rate will be calculated as mean and median acoustic events per
      minute. The raw data will be analyzed by an investigator blinded to the clinical data.
      Intestinal rates of patients offered immediate solid feeds will be compared with those
      offered clear feeds. In addition, patients not tolerating or consuming early solid meal will
      be compared with those who do to identify whether Abstat™ can be an early predictor of diet
      intolerance in patients undergoing colorectal surgery.

      Patients will be assigned into one of two groups:

      Group I - Clear liquids on postoperative day zero immediately upon return to the floor and
      subsequent days' advancement of enteral diet to regular diet is as per discretion of the
      attending physician.

      Group II - Regular diet from postoperative day zero immediately upon return to floor and
      onwards.

      Three questionnaires assessing quality of life are to be completed by the patient, during
      his/her hospital stay. On postoperative day one, a self-administered questionnaire is to be
      completed by the patient. Please see appendix A for the questionnaire details. The same
      questionnaire is administered on postoperative day two and again on the last day of
      hospitalization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants Who Experienced Emesis on Post Operative Day 2
time frame: POD 2
description: Patient tolerability, as evidenced by development of vomiting on postoperative day two.
measure: Number of Participants Able to Tolerate a Regular Diet as Compared to a Clear Liquid Diet on Post Operative Day 0 (POD 0).
time frame: POD 0
description: Tolerability of regular diet will be determined by the patients ability to eat more than 50% of a solid meal on post operative day zero.
measure: Antiemetic Usage
time frame: 30 days
description: If antiemetics were used in
measure: Hospital Stay
time frame: 30 days
description: Length of postoperative stay
measure: Post-operative Ileus
time frame: 30 days
description: Development of post-operative ileus
measure: Pain Score
time frame: POD 1 and POD 2 and Discharge
description: Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.
Pain score evaluated POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.
measure: Nausea Score
time frame: POD 1 and POD 2 and Discharge
description: Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.
Nausea Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.
measure: Bloating Score
time frame: POD 1 and POD 2 and Discharge
description: Instrument title: Quality of Life Assessment Visual Analogue scale.Higher scores mean a worse outcome.
Bloating Score on POD 1 and POD 2 and Discharge by using a self reported quality of life measure at regular intervals using a visual analog scale (0-10). A higher score means worse outcome and lower score means better outcome.
arm group label: Clear Liquid Diet
arm group type: Experimental
description: Clear liquids on postoperative day zero and intestinal rate measured by Abstats
arm group label: Regular Solid Diet
arm group type: Experimental
description: Regular diet from postoperative day zero and intestinal rate measured by Abstats
intervention type: Dietary Supplement
intervention name: Clear Liquids
description: Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
arm group label: Clear Liquid Diet
intervention type: Dietary Supplement
intervention name: Regular Solid
description: Regular diet from postoperative day zero immediately upon return to floor and onwards
arm group label: Regular Solid Diet
intervention type: Device
intervention name: Abstats
description: Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
arm group label: Clear Liquid Diet
arm group label: Regular Solid Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Phillip Fleshner, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
citation: Lau C, Phillips E, Bresee C, Fleshner P. Early use of low residue diet is superior to clear liquid diet after elective colorectal surgery: a randomized controlled trial. Ann Surg. 2014 Oct;260(4):641-7; discussion 647-9. doi: 10.1097/SLA.0000000000000929.
PMID: 25203881
citation: Spiegel BM, Kaneshiro M, Russell MM, Lin A, Patel A, Tashjian VC, Zegarski V, Singh D, Cohen SE, Reid MW, Whitman CB, Talley J, Martinez BM, Kaiser W. Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J Gastrointest Surg. 2014 Oct;18(10):1795-803. doi: 10.1007/s11605-014-2597-y. Epub 2014 Aug 5.
PMID: 25091837
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Phillip Fleshner MD
investigator title: Clinical Professor of Surgery
mesh term: Vomiting
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 