<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/NCT03802006</url>
  </required_header>
  <id_info>
    <org_study_id>L-2018-346</org_study_id>
    <nct_id>NCT03802006</nct_id>
  </id_info>
  <brief_title>Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy</brief_title>
  <official_title>Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators assess the gastric contents by ultrasonography in fasted patients with previous&#xD;
      subtotal gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators evaluate the gastric contents by ultrasonography in fasted patients with&#xD;
      previous subtotal gastrectomy, quantitatively and qualitatively. The frequency of&#xD;
      visualization fully will be also analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">December 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2020</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>Incidence of full cross section image</measure>
    <time_frame>Before the induction of anesthesia</time_frame>
    <description>The gastric remnant body is assessed by ultrasound and the incidence of cross sectional image visualized fully is evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type of gastric content assessed by gastric ultrasound</measure>
    <time_frame>Before the induction of anesthesia</time_frame>
    <description>The type of gastric content is assessed by gastric ultrasound; solid, fluid, empty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cross section area of stomach body assessed by gastric ultrasound</measure>
    <time_frame>Before the induction of anesthesia</time_frame>
    <description>Cross section area is assessed by gastric ultrasound in the supine and right lateral positions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of full stomach</measure>
    <time_frame>Before the induction of anesthesia</time_frame>
    <description>It is determined if the contents is solid or the amount of fluid is large.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Gastroparesis</condition>
  <arm_group>
    <arm_group_label>fasted patient with previous gastrectomy</arm_group_label>
    <description>The fasted patient with previous subtotal gastrectomy except exclusion criteria are included</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound assessment of gastric content</intervention_name>
    <description>Ultrasound assessment of gastric body is performed</description>
    <arm_group_label>fasted patient with previous gastrectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will conduct a study targeting the patients with previous subtotal gastectomy among the&#xD;
        patients fasted for an operation under general, spinal or MAC anesthesia, except people&#xD;
        with other anatomical abnormality or mass of stomach except gastrectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The preoperative fasted patients with previous subtotal gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other anatomical abnormality or mass of stomach except gastrectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tea Kyong Kim, M.D.,Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tea Kyong Kim, M.D.,Ph. D.</last_name>
    <phone>82-2-870-2519</phone>
    <email>ktkktk@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tae Kyong Kim, MD</last_name>
      <phone>82-2-2072-2467</phone>
      <email>ktkktk@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03802006
org study id: L-2018-346
nct id: NCT03802006
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Investigators assess the gastric contents by ultrasonography in fasted patients with previous
      subtotal gastrectomy.
Investigators evaluate the gastric contents by ultrasonography in fasted patients with
      previous subtotal gastrectomy, quantitatively and qualitatively. The frequency of
      visualization fully will be also analyzed.
observational model: Cohort
time perspective: Prospective
measure: Incidence of full cross section image
time frame: Before the induction of anesthesia
description: The gastric remnant body is assessed by ultrasound and the incidence of cross sectional image visualized fully is evaluated
measure: Type of gastric content assessed by gastric ultrasound
time frame: Before the induction of anesthesia
description: The type of gastric content is assessed by gastric ultrasound; solid, fluid, empty
measure: Cross section area of stomach body assessed by gastric ultrasound
time frame: Before the induction of anesthesia
description: Cross section area is assessed by gastric ultrasound in the supine and right lateral positions
measure: Incidence of full stomach
time frame: Before the induction of anesthesia
description: It is determined if the contents is solid or the amount of fluid is large.
arm group label: fasted patient with previous gastrectomy
description: The fasted patient with previous subtotal gastrectomy except exclusion criteria are included
intervention type: Diagnostic Test
intervention name: Ultrasound assessment of gastric content
description: Ultrasound assessment of gastric body is performed
arm group label: fasted patient with previous gastrectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Tea Kyong Kim, M.D.,Ph. D.
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Tea Kyong Kim, M.D.,Ph. D.
phone: 82-2-870-2519
email: ktkktk@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Gastroparesis