xml: <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/NCT06000241</url>
    </required_header>
    <id_info>
      <org_study_id>JS-3388</org_study_id>
      <nct_id>NCT06000241</nct_id>
    </id_info>
    <brief_title>Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation for Colonoscopy Under Anesthesia</brief_title>
    <official_title>Comparison of Same Morning vs Previous Evening Dosing Regimen for Assessment of Quality of Bowel Preparation Under Anesthesia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        220 patients are allocated randomly to the morning group (am group) or the afternoon group&#xD;
        (pm group) and assessed by quality of bowel preparation and residual volume gastric residue.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>ottawa score</measure>
      <time_frame>a day</time_frame>
      <description>Two nurses observe cleaning of three parts of colon and give a score for each.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>gastric residual volume</measure>
      <time_frame>30 minutes</time_frame>
      <description>Gastric contents are suctioned and measured.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>colonic residual volume</measure>
      <time_frame>30 minutes</time_frame>
      <description>Colonic fluids are suctioned and measured.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>reflux</measure>
      <time_frame>60mins</time_frame>
      <description>incidence of reflux during both the EGD and colonoscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>adenoma detection rate</measure>
      <time_frame>a day</time_frame>
      <description>percentages of patients screened with colonic adenoma in total patients</description>
    </secondary_outcome>
    <enrollment type="Actual">220</enrollment>
    <condition>Bowel Preparation</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Participants have a cluster of elective EGD and colonoscopy under anesthesia.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients are able to follow the instructions of bowel preparation and have good ability of&#xD;
          walking at least an hour.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Clinical diagnosis of obstruction of bowel and sever renal and heart disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Peking Union Medical Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000241
  org study id: JS-3388
  nct id: NCT06000241
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  220 patients are allocated randomly to the morning group (am group) or the afternoon group
        (pm group) and assessed by quality of bowel preparation and residual volume gastric residue.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: ottawa score
  time frame: a day
  description: Two nurses observe cleaning of three parts of colon and give a score for each.
  measure: gastric residual volume
  time frame: 30 minutes
  description: Gastric contents are suctioned and measured.
  measure: colonic residual volume
  time frame: 30 minutes
  description: Colonic fluids are suctioned and measured.
  measure: reflux
  time frame: 60mins
  description: incidence of reflux during both the EGD and colonoscopy
  measure: adenoma detection rate
  time frame: a day
  description: percentages of patients screened with colonic adenoma in total patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  facility: 
  country: China
  responsible party type: Sponsor