<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/NCT01670253</url>
  </required_header>
  <id_info>
    <org_study_id>S-20120069</org_study_id>
    <nct_id>NCT01670253</nct_id>
  </id_info>
  <brief_title>Reduction of Starvation Time Prior to Gastroscopy</brief_title>
  <acronym>RETIME</acronym>
  <official_title>Randomized, Double-blind, Controlled, Parallel-group Study Reduction of Starvation Time Prior to Gastroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The primary objective is to investigate whether intake of approximately 200 ml of sugary&#xD;
      fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of&#xD;
      fasting period for patients without reducing the quality of the study.&#xD;
&#xD;
      Current standard for fasting and fluid intake before gastroscopy is completely fasting 6&#xD;
      hours before the study. Studies in patients in general anesthesia has been found that it does&#xD;
      not increase the risk of aspiration of stomach content during the operation by allowing the&#xD;
      patient to drink up to 2 hours prior to anesthesia induction. There are no studies that have&#xD;
      examined the quality gastroscopy using this fasting procedure. Some studies show that intake&#xD;
      of sugary liquids do not have significant effect on gastric emptying.&#xD;
&#xD;
      There are not deemed to be ethical problems with this study, as it seeks to show that a more&#xD;
      lenient standard procedure in endoscopy is as safe as the established. The study is&#xD;
      considered safe.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not enough facilities to study&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">December 11, 2014</completion_date>
  <primary_completion_date type="Actual">December 1, 2014</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>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of uncomplicated examinations</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 1 hour</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of discomfort for the patients according to the survey.</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 1 hour</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Habile Adult Patients Referred to the Elective Gastroscopy</condition>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>6 hours of total fast for all solid and liquid food / drinks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 hour fast from all solid foods and milk beverages&#xD;
2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)&#xD;
Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group 1</intervention_name>
    <description>6 hour fast from all solid foods and milk beverages&#xD;
2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)&#xD;
Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
          -  Sufficient knowledge of Danish to understand the written information&#xD;
&#xD;
          -  legally competent patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of pyloric stenosis (narrowing of the transition from stomach&#xD;
             to the duodenum)&#xD;
&#xD;
          -  Incapacitated patients&#xD;
&#xD;
          -  Patients with daily vomiting.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anton Bilenko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense University Hospital</affiliation>
  </overall_official>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Anton Bilenko, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Starvation</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/NCT01670253
org study id: S-20120069
nct id: NCT01670253
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to investigate whether intake of approximately 200 ml of sugary
      fluid 2 hours before the scheduled gastroscopy of the abdomen can reduce the discomfort of
      fasting period for patients without reducing the quality of the study.

      Current standard for fasting and fluid intake before gastroscopy is completely fasting 6
      hours before the study. Studies in patients in general anesthesia has been found that it does
      not increase the risk of aspiration of stomach content during the operation by allowing the
      patient to drink up to 2 hours prior to anesthesia induction. There are no studies that have
      examined the quality gastroscopy using this fasting procedure. Some studies show that intake
      of sugary liquids do not have significant effect on gastric emptying.

      There are not deemed to be ethical problems with this study, as it seeks to show that a more
      lenient standard procedure in endoscopy is as safe as the established. The study is
      considered safe.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Care Provider, Investigator)
measure: Number of uncomplicated examinations
time frame: participants will be followed for the duration of hospital stay, an expected average of 1 hour
measure: Reduction of discomfort for the patients according to the survey.
time frame: participants will be followed for the duration of hospital stay, an expected average of 1 hour
arm group label: Group 2
arm group type: No Intervention
description: 6 hours of total fast for all solid and liquid food / drinks
arm group label: Group 1
arm group type: Experimental
description: 6 hour fast from all solid foods and milk beverages
2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)
Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like.
intervention type: Behavioral
intervention name: Group 1
description: 6 hour fast from all solid foods and milk beverages
2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)
Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like.
arm group label: Group 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anton Bilenko, MD
role: Principal Investigator
affiliation: Odense University Hospital
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Anton Bilenko, MD
investigator title: MD
mesh term: Starvation