<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/NCT03259841</url>
  </required_header>
  <id_info>
    <org_study_id>2017-8-4</org_study_id>
    <nct_id>NCT03259841</nct_id>
  </id_info>
  <brief_title>Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy</brief_title>
  <official_title>Ultrasound Assessment of Gastric Contents in Fasted Patient Undergoing Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SMG-SNU Boramae Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SMG-SNU Boramae Medical Center</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 undergoing&#xD;
      cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators evaluate the gastric volume through cross sectional area and amount of clear&#xD;
      fluid using Perlas grade by ultrasound in the supine and right lateral position of fasted&#xD;
      patients undergoing cholecystectomy. Full stomach is regarded if solid gastric contents are&#xD;
      detected or clear fluid is more than 1.5 ml/kg. The frequency of full stomach will be&#xD;
      analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">February 8, 2019</completion_date>
  <primary_completion_date type="Actual">February 8, 2019</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 stomach</measure>
    <time_frame>Before the induction of anesthesia</time_frame>
    <description>The incidence of full stomach is assessed by using ultrasonography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cross sectional area of the stomach</measure>
    <time_frame>Before the induction of anesthesia</time_frame>
    <description>The cross sectional area of the stomach is assessed by using ultrasonography in the supine and right lateral positions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of stomach</measure>
    <time_frame>Before the induction of anesthesia</time_frame>
    <description>The volume of stomach is assessed using the following formula; volume of stomach (mL) = 27.0 + 14.6 x cross-sectional area (right lateral position) - 1.28 x age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of gastric contents</measure>
    <time_frame>Before the induction of anesthesia</time_frame>
    <description>The type of gastric contents is assessed using ultrasonography.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Fasted patients for cholecyctectomy</arm_group_label>
    <description>The fasted patients for cholecyctectomy except exclusion criteria are included</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound assessment of gastric contet</intervention_name>
    <description>Ultrasound assessment of gastric content is performed in fasted patient undergoing cholecystectomy.</description>
    <arm_group_label>Fasted patients for cholecyctectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for cholecystectomy are included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for cholecystectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of gastric anatomic abnormality or pathology&#xD;
&#xD;
          -  A previous surgery of esophagus or stomach&#xD;
&#xD;
          -  Current pregnancy&#xD;
&#xD;
          -  Who could not lie in the right lateral decubitus (RLD) position&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Young Hwang, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>SMG-SNU Boramae Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul Metropolitan Government Seoul National University Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>156-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>May 19, 2019</last_update_submitted>
  <last_update_submitted_qc>May 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SMG-SNU Boramae Medical Center</investigator_affiliation>
    <investigator_full_name>Jin-Young Hwang</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03259841
org study id: 2017-8-4
nct id: NCT03259841
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 undergoing
      cholecystectomy.
Investigators evaluate the gastric volume through cross sectional area and amount of clear
      fluid using Perlas grade by ultrasound in the supine and right lateral position of fasted
      patients undergoing cholecystectomy. Full stomach is regarded if solid gastric contents are
      detected or clear fluid is more than 1.5 ml/kg. The frequency of full stomach will be
      analyzed.
observational model: Cohort
time perspective: Prospective
measure: Incidence of full stomach
time frame: Before the induction of anesthesia
description: The incidence of full stomach is assessed by using ultrasonography.
measure: Cross sectional area of the stomach
time frame: Before the induction of anesthesia
description: The cross sectional area of the stomach is assessed by using ultrasonography in the supine and right lateral positions.
measure: Volume of stomach
time frame: Before the induction of anesthesia
description: The volume of stomach is assessed using the following formula; volume of stomach (mL) = 27.0 + 14.6 x cross-sectional area (right lateral position) - 1.28 x age.
measure: Type of gastric contents
time frame: Before the induction of anesthesia
description: The type of gastric contents is assessed using ultrasonography.
arm group label: Fasted patients for cholecyctectomy
description: The fasted patients for cholecyctectomy except exclusion criteria are included
intervention type: Other
intervention name: Ultrasound assessment of gastric contet
description: Ultrasound assessment of gastric content is performed in fasted patient undergoing cholecystectomy.
arm group label: Fasted patients for cholecyctectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Jin-Young Hwang, M.D., Ph.D.
role: Principal Investigator
affiliation: SMG-SNU Boramae Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: SMG-SNU Boramae Medical Center
investigator full name: Jin-Young Hwang
investigator title: associate professor
mesh term: Gastroparesis
sharing ipd: No