<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/NCT03776916</url>
  </required_header>
  <id_info>
    <org_study_id>307-simethicone</org_study_id>
    <nct_id>NCT03776916</nct_id>
  </id_info>
  <brief_title>Application of Simethicone in Esophagogastroscopy</brief_title>
  <official_title>Optimization of Simethicone Administration Strategy Before Esophagogastroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Affiliated Hospital to Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Affiliated Hospital to Academy of Military Medical Sciences</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>
      This is a randomized controlled trial to comparing the different simethicone administration&#xD;
      strategies for esophagogastroscopy. Recent studies have indicated that the administration of&#xD;
      simethicone before endoscopic examination could shorten the procedure time and improve the&#xD;
      diagnostic rate of the gastric mucosal lesions. But the time interval between simethicone&#xD;
      administration and the examination has not been fully determined. This study will test&#xD;
      whether the time of taking simethicone before endoscopy could influence the performance of&#xD;
      the procedure in a randomized controlled trial. The results may benefit the current clinical&#xD;
      practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Esophagogastroscopy can enable the direct examination of the esophageal and gastric mucosal&#xD;
      lesions, which has been widely applied in clinical practice. However, during the examination,&#xD;
      too much water, foam or residues in the stomach will not only increase the procedure time and&#xD;
      the misdiagnosis rate, but also decrease the patients' tolerance, for more efforts should be&#xD;
      made to deal with the excessive water, foam or residues in order to obtain a clear view of&#xD;
      the mucosa. Simethicone is also called poly-dimethylsiloxane, which can be used to remove the&#xD;
      foam and water. Although simethicone has been routinely administrated before the&#xD;
      esophagogastroscopy, the optimal strategy of administrating simethicone has not been clearly&#xD;
      investigated, especially the time to administrate simethicone. Intaking simethicone too early&#xD;
      will result in too excessive water in the stomach, while if the patients take it too late it&#xD;
      doesn't take effects. Thus, this is a study to determine whether selecting different&#xD;
      simethicone administration strategies could improve the performance of the&#xD;
      esophagogastroscopy and minimize the patients' dissatisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure time</measure>
    <time_frame>4 months</time_frame>
    <description>The time of examining the whole stomach was recorded, and the time for biopsy was not included.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients' satisfaction</measure>
    <time_frame>4 months</time_frame>
    <description>A 10-point scale was used to evaluate the patients' satisfaction (0 worst, 10 best). All the symptoms such as abdominal pain, distension and the like were all recorded.&#xD;
It is anticipated that the use of simethicone will significantly improve patients' satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">311</enrollment>
  <condition>Gastric Disease</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Simethicone administration 20-30 min before the procedure:&#xD;
Patients intake simethicone solution 20-30 min before the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Simethicone administration 31-60 min before the procedure:&#xD;
Patients intake simethicone solution 31-60 min before the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Simethicone administration &gt;60 min before the procedure; Patients intake simethicone solution &gt;60 min before the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simethicone administration 20-30 min before the procedure</intervention_name>
    <description>Patients intake simethicone 20-30 min before the procedure</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simethicone administration 31-60 min before the procedure</intervention_name>
    <description>Patients intake simethicone administration 31-60 min before the procedure.</description>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simethicone administration &gt; 60 min before the procedure</intervention_name>
    <description>Patients intake simethicone administration &gt; 60 min before the procedure.</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Above 18 years old patients&#xD;
&#xD;
          -  Who agree to participate in the study&#xD;
&#xD;
          -  Patients with the indications for gastroduodenoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors&#xD;
             (PPI) or antibiotics in the last 3 weeks.&#xD;
&#xD;
          -  Severe uncontrolled coagulopathy&#xD;
&#xD;
          -  Prior history of gastric surgery.&#xD;
&#xD;
          -  Pregnancy and lactation&#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>Yan Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>PLA General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Sajid MS, Rehman S, Chedgy F, Singh KK. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone +/- N-acetylcysteine. Transl Gastroenterol Hepatol. 2018 May 19;3:29. doi: 10.21037/tgh.2018.05.02. eCollection 2018.</citation>
    <PMID>29971260</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>September 18, 2019</last_update_submitted>
  <last_update_submitted_qc>September 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 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>Stomach Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simethicone</mesh_term>
  </intervention_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/NCT03776916
org study id: 307-simethicone
nct id: NCT03776916
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial to comparing the different simethicone administration
      strategies for esophagogastroscopy. Recent studies have indicated that the administration of
      simethicone before endoscopic examination could shorten the procedure time and improve the
      diagnostic rate of the gastric mucosal lesions. But the time interval between simethicone
      administration and the examination has not been fully determined. This study will test
      whether the time of taking simethicone before endoscopy could influence the performance of
      the procedure in a randomized controlled trial. The results may benefit the current clinical
      practice.
Esophagogastroscopy can enable the direct examination of the esophageal and gastric mucosal
      lesions, which has been widely applied in clinical practice. However, during the examination,
      too much water, foam or residues in the stomach will not only increase the procedure time and
      the misdiagnosis rate, but also decrease the patients' tolerance, for more efforts should be
      made to deal with the excessive water, foam or residues in order to obtain a clear view of
      the mucosa. Simethicone is also called poly-dimethylsiloxane, which can be used to remove the
      foam and water. Although simethicone has been routinely administrated before the
      esophagogastroscopy, the optimal strategy of administrating simethicone has not been clearly
      investigated, especially the time to administrate simethicone. Intaking simethicone too early
      will result in too excessive water in the stomach, while if the patients take it too late it
      doesn't take effects. Thus, this is a study to determine whether selecting different
      simethicone administration strategies could improve the performance of the
      esophagogastroscopy and minimize the patients' dissatisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Procedure time
time frame: 4 months
description: The time of examining the whole stomach was recorded, and the time for biopsy was not included.
measure: Patients' satisfaction
time frame: 4 months
description: A 10-point scale was used to evaluate the patients' satisfaction (0 worst, 10 best). All the symptoms such as abdominal pain, distension and the like were all recorded.
It is anticipated that the use of simethicone will significantly improve patients' satisfaction.
arm group label: Group 1
arm group type: Experimental
description: Simethicone administration 20-30 min before the procedure:
Patients intake simethicone solution 20-30 min before the procedure.
arm group label: Group 2
arm group type: Experimental
description: Simethicone administration 31-60 min before the procedure:
Patients intake simethicone solution 31-60 min before the procedure.
arm group label: Group 3
arm group type: Experimental
description: Simethicone administration >60 min before the procedure; Patients intake simethicone solution >60 min before the procedure.
intervention type: Other
intervention name: Simethicone administration 20-30 min before the procedure
description: Patients intake simethicone 20-30 min before the procedure
arm group label: Group 1
intervention type: Other
intervention name: Simethicone administration 31-60 min before the procedure
description: Patients intake simethicone administration 31-60 min before the procedure.
arm group label: Group 2
intervention type: Other
intervention name: Simethicone administration > 60 min before the procedure
description: Patients intake simethicone administration > 60 min before the procedure.
arm group label: Group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yan Liu
role: Principal Investigator
affiliation: PLA General Hospital
facility: 
country: China
citation: Sajid MS, Rehman S, Chedgy F, Singh KK. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone +/- N-acetylcysteine. Transl Gastroenterol Hepatol. 2018 May 19;3:29. doi: 10.21037/tgh.2018.05.02. eCollection 2018.
PMID: 29971260
responsible party type: Sponsor
mesh term: Stomach Diseases
mesh term: Simethicone