<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/NCT02264249</url>
  </required_header>
  <id_info>
    <org_study_id>FLA 14-086</org_study_id>
    <nct_id>NCT02264249</nct_id>
  </id_info>
  <brief_title>Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation</brief_title>
  <official_title>Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine residual gastric volume and residual gastric pH in&#xD;
      patients undergoing combined EGD and colonoscopy comparing the standard single dose prep with&#xD;
      the split dose bowel preparation and same day bowel preparations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ASGE and ACG have developed standards for high-quality colonoscopy and ADR. Bowel&#xD;
      cleansing must be optimal to enhance polyp detection and several studies have demonstrated&#xD;
      the advantage of split dose or same day preparation as opposed to ingesting the preparation&#xD;
      the day before. It is recommended that patients undergo split dosing of the bowel preparation&#xD;
      or even same day bowel preparation for optimal cleansing. This is critical for high quality&#xD;
      colonoscopy.&#xD;
&#xD;
      One of the risks associated with colonoscopy is pulmonary aspiration. Part of this risk may&#xD;
      be related to retained gastric volume and gastric pH at the time of the endoscopic&#xD;
      procedures. Aspiration pneumonia may be related to the acidity where more acidic aspirate may&#xD;
      cause more severe respiratory compromise. In a recent article, Huffman supported the safety&#xD;
      of split dose bowel preparation (4L bowel preparation) for outpatients undergoing&#xD;
      colonoscopy. In this study it was/found that residual gastric volume in split dose&#xD;
      preparations was higher than patients undergoing EGD alone but was not different from than in&#xD;
      patients receiving bowel preparation the evening before. Early morning bowel preps for&#xD;
      patients undergoing upper and lower endoscopies was not evaluated in this study. To our&#xD;
      knowledge, the relationship of residual gastric volume in same day bowel preps has not been&#xD;
      evaluated and has not been compared with the split dose bowel preps. A formal evaluation of&#xD;
      difference in gastric acidity has not been evaluated in patients undergoing bowel prep for&#xD;
      colonoscopy.&#xD;
&#xD;
      The study has a prospective observational design. The patients who have been already&#xD;
      scheduled for a combined esophagogastroduodenoscopy and colonoscopy for their specific&#xD;
      indications will be asked to be a part of this study. No additional intervention will be done&#xD;
      other than the procedure they were already scheduled for. No specific interventions will be&#xD;
      assigned to the subjects of the study. Outcomes will be assessed in pre-defined groups based&#xD;
      on the bowel preparation taken by the patient.&#xD;
&#xD;
      The fluid is going to be collected in a suction container without solidifier material. Once&#xD;
      the endoscopist enters the stomach all fluid will be suctioned which is part of the customary&#xD;
      process of endoscopy. Once all fluid is aspirated, the container will be removed to empty the&#xD;
      fluid into a measuring canister while the endoscopic procedure is continued and a container&#xD;
      with solidifier material is instead connected to suction. The pH will be measured on the&#xD;
      gastric fluid that was aspirated using a calibrated catheter pH device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Residual Gastric Volumes of Different Bowel Preparation Regimens</measure>
    <time_frame>1 day</time_frame>
    <description>The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pH of Gastric Fluid of Different Bowel Preparation Regimens</measure>
    <time_frame>1 day</time_frame>
    <description>The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Complications (Decrease in Oxygen Saturation)</measure>
    <time_frame>1 day</time_frame>
    <description>The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">449</enrollment>
  <condition>Esophagogastroduodenoscopy</condition>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Split dose colonoscopy preparation</arm_group_label>
    <description>Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evening before colonoscopy preparation</arm_group_label>
    <description>Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Same day prep colonoscopy preparation</arm_group_label>
    <description>Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Esophagogastroduodenoscopy and colonoscopy split dose prep</intervention_name>
    <description>Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive the Split dose colonoscopy prep&#xD;
split dose colonoscopy preparation- ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)</description>
    <arm_group_label>Split dose colonoscopy preparation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep</intervention_name>
    <description>Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Evening before (4L, 2L or miralax bowel preparation)</description>
    <arm_group_label>Evening before colonoscopy preparation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation</intervention_name>
    <description>Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Same day prep (4L volume or 2L volume or Miralax bowel preparation)</description>
    <arm_group_label>Same day prep colonoscopy preparation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients (ages 18 and over) scheduled for elective non-emergency outpatient combined&#xD;
        Esophagogastroduodenoscopy and colonoscopy procedures at Cleveland Clinic Florida.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (ages 18 and over) scheduled for elective non-emergency outpatient&#xD;
             combined Esophagogastroduodenoscopy and colonoscopy procedures at CCF. No additional&#xD;
             intervention will be done other than the procedure they were scheduled for.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Upper GI or lower GI bleeding at the time of procedure&#xD;
&#xD;
          2. Large amounts of vomiting reported before the procedure (with bowel preparation)&#xD;
&#xD;
          3. Hospital inpatients&#xD;
&#xD;
          4. History of abdominal surgery&#xD;
&#xD;
          5. History of gastroparesis or other documented GI transit disorder (ex. Colonic inertia)&#xD;
&#xD;
          6. Pregnancy Patients with diabetes mellitus taking Metoclopramide without proven&#xD;
             gastroparesis by formal testing will not be excluded.&#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>Alison Schneider, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <results_first_submitted>July 25, 2016</results_first_submitted>
  <results_first_submitted_qc>July 25, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 9, 2016</results_first_posted>
  <last_update_submitted>April 17, 2017</last_update_submitted>
  <last_update_submitted_qc>April 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Alison Schneider</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Split Dose Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
        <group group_id="P2">
          <title>Evening Before Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
        <group group_id="P3">
          <title>Same Day Prep Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="187"/>
                <participants group_id="P3" count="241"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="187"/>
                <participants group_id="P3" count="241"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Split Dose Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
        <group group_id="B2">
          <title>Evening Before Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
        <group group_id="B3">
          <title>Same Day Prep Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
        <group group_id="B4">
          <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="21"/>
            <count group_id="B2" value="187"/>
            <count group_id="B3" value="241"/>
            <count group_id="B4" value="449"/>
          </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="53" spread="13"/>
                    <measurement group_id="B2" value="56" spread="11"/>
                    <measurement group_id="B3" value="56" spread="12"/>
                    <measurement group_id="B4" value="56" spread="11.5"/>
                  </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="11"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="131"/>
                    <measurement group_id="B4" value="258"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="110"/>
                    <measurement group_id="B4" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="160"/>
                    <measurement group_id="B4" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="187"/>
                    <measurement group_id="B3" value="241"/>
                    <measurement group_id="B4" value="449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Mellitus</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Constipation</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PPI/H2 Blocker</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="117"/>
                    <measurement group_id="B4" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Drugs affecting GI motility</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="98"/>
                    <measurement group_id="B4" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Volume of preparation: 4L</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="155"/>
                    <measurement group_id="B4" value="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Last ingestion of solids (hours)</title>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.5" spread="8.7"/>
                    <measurement group_id="B2" value="37.3" spread="9.8"/>
                    <measurement group_id="B3" value="39.4" spread="9.6"/>
                    <measurement group_id="B4" value="38.4" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Last ingestion of clear liquids (hours)</title>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.4" spread="1.9"/>
                    <measurement group_id="B2" value="10.3" spread="4.6"/>
                    <measurement group_id="B3" value="5.8" spread="2.4"/>
                    <measurement group_id="B4" value="7.7" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Residual Gastric Volumes of Different Bowel Preparation Regimens</title>
        <description>The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Split Dose Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
          <group group_id="O2">
            <title>Evening Before Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
          <group group_id="O3">
            <title>Same Day Prep Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Gastric Volumes of Different Bowel Preparation Regimens</title>
          <description>The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.</description>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="187"/>
                <count group_id="O3" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="22"/>
                    <measurement group_id="O2" value="16" spread="16"/>
                    <measurement group_id="O3" value="18" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>pH of Gastric Fluid of Different Bowel Preparation Regimens</title>
        <description>The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Split Dose Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
          <group group_id="O2">
            <title>Evening Before Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
          <group group_id="O3">
            <title>Same Day Prep Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
        </group_list>
        <measure>
          <title>pH of Gastric Fluid of Different Bowel Preparation Regimens</title>
          <description>The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.</description>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="187"/>
                <count group_id="O3" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.5"/>
                    <measurement group_id="O2" value="2.5" spread="1.4"/>
                    <measurement group_id="O3" value="2.5" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Complications (Decrease in Oxygen Saturation)</title>
        <description>The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Split Dose Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
          <group group_id="O2">
            <title>Evening Before Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
          <group group_id="O3">
            <title>Same Day Prep Colonoscopy Preparation</title>
            <description>Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Complications (Decrease in Oxygen Saturation)</title>
          <description>The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="187"/>
                <count group_id="O3" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Split Dose Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
        <group group_id="E2">
          <title>Evening Before Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
        <group group_id="E3">
          <title>Same Day Prep Colonoscopy Preparation</title>
          <description>Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)&#xD;
Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="187"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>The patients were not randomized to the two groups. Endoscopists were not blinded to the fact that patients were in the study but were unaware of the preparation type.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Alison Schneider</name_or_title>
      <organization>Cleveland Clinic Florida</organization>
      <phone>954-659-5646</phone>
      <email>schneia2@ccf.org</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/NCT02264249
org study id: FLA 14-086
nct id: NCT02264249
lead sponsor: 
has dmc: No
The purpose of this study is to determine residual gastric volume and residual gastric pH in
      patients undergoing combined EGD and colonoscopy comparing the standard single dose prep with
      the split dose bowel preparation and same day bowel preparations.
The ASGE and ACG have developed standards for high-quality colonoscopy and ADR. Bowel
      cleansing must be optimal to enhance polyp detection and several studies have demonstrated
      the advantage of split dose or same day preparation as opposed to ingesting the preparation
      the day before. It is recommended that patients undergo split dosing of the bowel preparation
      or even same day bowel preparation for optimal cleansing. This is critical for high quality
      colonoscopy.

      One of the risks associated with colonoscopy is pulmonary aspiration. Part of this risk may
      be related to retained gastric volume and gastric pH at the time of the endoscopic
      procedures. Aspiration pneumonia may be related to the acidity where more acidic aspirate may
      cause more severe respiratory compromise. In a recent article, Huffman supported the safety
      of split dose bowel preparation (4L bowel preparation) for outpatients undergoing
      colonoscopy. In this study it was/found that residual gastric volume in split dose
      preparations was higher than patients undergoing EGD alone but was not different from than in
      patients receiving bowel preparation the evening before. Early morning bowel preps for
      patients undergoing upper and lower endoscopies was not evaluated in this study. To our
      knowledge, the relationship of residual gastric volume in same day bowel preps has not been
      evaluated and has not been compared with the split dose bowel preps. A formal evaluation of
      difference in gastric acidity has not been evaluated in patients undergoing bowel prep for
      colonoscopy.

      The study has a prospective observational design. The patients who have been already
      scheduled for a combined esophagogastroduodenoscopy and colonoscopy for their specific
      indications will be asked to be a part of this study. No additional intervention will be done
      other than the procedure they were already scheduled for. No specific interventions will be
      assigned to the subjects of the study. Outcomes will be assessed in pre-defined groups based
      on the bowel preparation taken by the patient.

      The fluid is going to be collected in a suction container without solidifier material. Once
      the endoscopist enters the stomach all fluid will be suctioned which is part of the customary
      process of endoscopy. Once all fluid is aspirated, the container will be removed to empty the
      fluid into a measuring canister while the endoscopic procedure is continued and a container
      with solidifier material is instead connected to suction. The pH will be measured on the
      gastric fluid that was aspirated using a calibrated catheter pH device.
observational model: Cohort
time perspective: Prospective
measure: Residual Gastric Volumes of Different Bowel Preparation Regimens
time frame: 1 day
description: The residual gastric volume for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.
measure: pH of Gastric Fluid of Different Bowel Preparation Regimens
time frame: 1 day
description: The pH of gastric fluid for the patients undergoing a combined esophagogastroduodenoscopy and colonoscopy will be measured and compared among the groups taking different bowel preparations.
measure: Procedure Complications (Decrease in Oxygen Saturation)
time frame: 1 day
description: The patients will be evaluated for complications namely decrease in oxygen saturation during the procedure (Esophagogastroduodenoscopy and colonoscopy) in three groups.
arm group label: Split dose colonoscopy preparation
description: Esophagogastroduodenoscopy and colonoscopy - split dose - ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)
arm group label: Evening before colonoscopy preparation
description: Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)
arm group label: Same day prep colonoscopy preparation
description: Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)
intervention type: Other
intervention name: Esophagogastroduodenoscopy and colonoscopy split dose prep
description: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive the Split dose colonoscopy prep
split dose colonoscopy preparation- ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)
arm group label: Split dose colonoscopy preparation
intervention type: Other
intervention name: Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep
description: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Evening before (4L, 2L or miralax bowel preparation)
arm group label: Evening before colonoscopy preparation
intervention type: Other
intervention name: Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation
description: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Same day prep (4L volume or 2L volume or Miralax bowel preparation)
arm group label: Same day prep colonoscopy preparation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alison Schneider, M.D.
role: Principal Investigator
affiliation: Cleveland Clinic Florida
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Alison Schneider
investigator title: Staff Physician
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The patients were not randomized to the two groups. Endoscopists were not blinded to the fact that patients were in the study but were unaware of the preparation type.
point of contact: 