<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/NCT02978664</url>
  </required_header>
  <id_info>
    <org_study_id>DalinHsieh201401</org_study_id>
    <nct_id>NCT02978664</nct_id>
  </id_info>
  <brief_title>The Impact of Distraction on Adenoma Detection Rate</brief_title>
  <official_title>The Impact of Distraction on Adenoma Detection Rate in Patients Undergoing Colonoscopy With Air Insufflation, Water Immersion and Water Exchange</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalin Tzu Chi General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dalin Tzu Chi General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will review video-recordings of three randomized, controlled trials&#xD;
      (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water&#xD;
      exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi&#xD;
      Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will review video-recordings of three randomized controlled trials&#xD;
      (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water&#xD;
      exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be&#xD;
      obtained from the local Institutional Review Board (IRB) to review, analyze and report&#xD;
      de-identified findings.&#xD;
&#xD;
      Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies.&#xD;
      Recordings will be selected for review if they are complete examinations; include clear&#xD;
      identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at&#xD;
      the cecum; available in the appropriate format for video editing; and contain no patient or&#xD;
      endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection&#xD;
      will be excluded from analysis. The included video recordings will be edited to remove the&#xD;
      insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer&#xD;
      uninvolved in the performance of the colonoscopies will be in charge of evaluating the&#xD;
      selected videos, using the criteria described by Yung et al&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>adenoma detection rate</measure>
    <time_frame>one week after colonoscopy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distraction score</measure>
    <time_frame>Immediate after video reviewing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Withdrawal technique as specified by Lee RH (citation 1)</measure>
    <time_frame>immediate after video reviewing</time_frame>
    <description>adequacy of distention (0-5), fold examination (0-5) and cleaning (0-5) for each colonic segment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel preparation score</measure>
    <time_frame>immediate after video reviewing</time_frame>
    <description>Boston bowel preparation score</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Adenoma</condition>
  <arm_group>
    <arm_group_label>Air insufflation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Air insufflation will be used throughout whole procedure of colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>water immersion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>water exchange</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Water will be infused and removed during insertion phase of colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Air insufflation</intervention_name>
    <description>Air insufflation during colonoscopy including insertion phase</description>
    <arm_group_label>Air insufflation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>water immersion</intervention_name>
    <description>Water will infused during insertion phase and removed during withdrawal phase of colonoscopy.</description>
    <arm_group_label>water immersion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Water exchange</intervention_name>
    <description>Water will infused and removed during insertion phase of colonoscopy</description>
    <arm_group_label>water exchange</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  if they are complete examinations; include clear identification of the appendiceal&#xD;
             orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the&#xD;
             appropriate format for video editing; and contain no patient or endoscopist&#xD;
             identifiers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with incomplete recordings and a history of bowel resection will be excluded&#xD;
             from analysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Hsi Hsieh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalin Tzu Chi General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Buddhist Dalin Tzu Chi General Hospital</name>
      <address>
        <city>Chia-Yi</city>
        <zip>622</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Lee RH, Tang RS, Muthusamy VR, Ho SB, Shah NK, Wetzel L, Bain AS, Mackintosh EE, Paek AM, Crissien AM, Saraf LJ, Kalmaz DM, Savides TJ. Quality of colonoscopy withdrawal technique and variability in adenoma detection rates (with videos). Gastrointest Endosc. 2011 Jul;74(1):128-34. doi: 10.1016/j.gie.2011.03.003. Epub 2011 Apr 30.</citation>
    <PMID>21531410</PMID>
  </reference>
  <reference>
    <citation>Leung FW. Water exchange may be superior to water immersion for colonoscopy. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1012-4. doi: 10.1016/j.cgh.2011.09.007. Epub 2011 Sep 22. No abstract available.</citation>
    <PMID>21946120</PMID>
  </reference>
  <reference>
    <citation>Yung VY, Yen AW, Leung JW, Mann SK, Wilson MD, Leung FW. Validation of a novel method for analyzing video recordings of the withdrawal phase of air insufflation and water exchange colonoscopy - documentation of distractions from focused mucosal inspection. J Interv Gastroenterol. 2014 Jan;4(1):8-12.</citation>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <keyword>water exchange</keyword>
  <keyword>adenoma detection rate</keyword>
  <keyword>distraction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT02978664
org study id: DalinHsieh201401
nct id: NCT02978664
lead sponsor: 
has dmc: No
The investigators will review video-recordings of three randomized, controlled trials
      (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water
      exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi
      Hospital.
The investigators will review video-recordings of three randomized controlled trials
      (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water
      exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be
      obtained from the local Institutional Review Board (IRB) to review, analyze and report
      de-identified findings.

      Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies.
      Recordings will be selected for review if they are complete examinations; include clear
      identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at
      the cecum; available in the appropriate format for video editing; and contain no patient or
      endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection
      will be excluded from analysis. The included video recordings will be edited to remove the
      insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer
      uninvolved in the performance of the colonoscopies will be in charge of evaluating the
      selected videos, using the criteria described by Yung et al
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: adenoma detection rate
time frame: one week after colonoscopy
measure: Distraction score
time frame: Immediate after video reviewing
measure: Withdrawal technique as specified by Lee RH (citation 1)
time frame: immediate after video reviewing
description: adequacy of distention (0-5), fold examination (0-5) and cleaning (0-5) for each colonic segment
measure: Bowel preparation score
time frame: immediate after video reviewing
description: Boston bowel preparation score
arm group label: Air insufflation
arm group type: Active Comparator
description: Air insufflation will be used throughout whole procedure of colonoscopy
arm group label: water immersion
arm group type: Active Comparator
description: Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy
arm group label: water exchange
arm group type: Active Comparator
description: Water will be infused and removed during insertion phase of colonoscopy
intervention type: Procedure
intervention name: Air insufflation
description: Air insufflation during colonoscopy including insertion phase
arm group label: Air insufflation
intervention type: Procedure
intervention name: water immersion
description: Water will infused during insertion phase and removed during withdrawal phase of colonoscopy.
arm group label: water immersion
intervention type: Procedure
intervention name: Water exchange
description: Water will infused and removed during insertion phase of colonoscopy
arm group label: water exchange
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yu-Hsi Hsieh, MD
role: Principal Investigator
affiliation: Dalin Tzu Chi General Hospital
facility: 
country: Taiwan
citation: Lee RH, Tang RS, Muthusamy VR, Ho SB, Shah NK, Wetzel L, Bain AS, Mackintosh EE, Paek AM, Crissien AM, Saraf LJ, Kalmaz DM, Savides TJ. Quality of colonoscopy withdrawal technique and variability in adenoma detection rates (with videos). Gastrointest Endosc. 2011 Jul;74(1):128-34. doi: 10.1016/j.gie.2011.03.003. Epub 2011 Apr 30.
PMID: 21531410
citation: Leung FW. Water exchange may be superior to water immersion for colonoscopy. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1012-4. doi: 10.1016/j.cgh.2011.09.007. Epub 2011 Sep 22. No abstract available.
PMID: 21946120
citation: Yung VY, Yen AW, Leung JW, Mann SK, Wilson MD, Leung FW. Validation of a novel method for analyzing video recordings of the withdrawal phase of air insufflation and water exchange colonoscopy - documentation of distractions from focused mucosal inspection. J Interv Gastroenterol. 2014 Jan;4(1):8-12.
responsible party type: Sponsor
mesh term: Adenoma