<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/NCT01675934</url>
  </required_header>
  <id_info>
    <org_study_id>PRO00017208</org_study_id>
    <nct_id>NCT01675934</nct_id>
  </id_info>
  <brief_title>Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes</brief_title>
  <official_title>Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical College of Wisconsin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in&#xD;
      the proximal colon compared to the distal colon. Possible reasons for this include bowel&#xD;
      preparation often being worse in the proximal colon as well as flat depressed lesions being&#xD;
      more common in the proximal colon.&#xD;
&#xD;
      Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the&#xD;
      proximal colon is not currently routinely performed due to concerns of perforation and&#xD;
      possibly because of the increased time required.&#xD;
&#xD;
      Proximal colon retroflexion has been shown to be safe and effective without any&#xD;
      complications, but data regarding ability to retroflex with certain types of colonoscopes is&#xD;
      limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric&#xD;
      colonoscopes. Studies have not been performed to comparatively evaluate the success rates of&#xD;
      standard adult and pediatric colonoscopes and whether either type of instrument confers a&#xD;
      greater polyp detection rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI has left institution&#xD;
  </why_stopped>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.</measure>
    <time_frame>After 50% and 100% of patient enrollment is complete.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate in forward and retroflexed views.</measure>
    <time_frame>After 50% and 100% of patient enrollment is complete.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for failure of retroflexion.</measure>
    <time_frame>After 50% and 100% of patient enrollment is complete.</time_frame>
    <description>This will be assessed as a yes/no variable. In addition, the specific reasons that the endoscopist could not retroflex the colonoscope in the right colon will assessed, such as the colonoscope not being able to be advanced to the cecum, small diameter of the right colon, too much resistance encountered when attempting retroflexion that the endoscopist does not feel comfortable with, etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Colonic Neoplasms</condition>
  <arm_group>
    <arm_group_label>Adult colonoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of the adult colonoscope.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pediatric colonoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of the pediatric colonoscope.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Retroflexion with the adult colonoscope.</intervention_name>
    <arm_group_label>Adult colonoscope</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Retroflexion with the pediatric colonoscope.</intervention_name>
    <arm_group_label>Pediatric colonoscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients over the age 18 undergoing screening or surveillance colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  History of ulcerative colitis or Crohn's disease&#xD;
&#xD;
          -  History of polyposis syndromes&#xD;
&#xD;
          -  History of colon resection&#xD;
&#xD;
          -  Colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain,&#xD;
             alternating bowel habits)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young Oh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Froedtert Surgery Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>January 6, 2016</last_update_submitted>
  <last_update_submitted_qc>January 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 2016</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>Colonic Neoplasms</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/NCT01675934
org study id: PRO00017208
nct id: NCT01675934
lead sponsor: 
has dmc: No
Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in
      the proximal colon compared to the distal colon. Possible reasons for this include bowel
      preparation often being worse in the proximal colon as well as flat depressed lesions being
      more common in the proximal colon.

      Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the
      proximal colon is not currently routinely performed due to concerns of perforation and
      possibly because of the increased time required.

      Proximal colon retroflexion has been shown to be safe and effective without any
      complications, but data regarding ability to retroflex with certain types of colonoscopes is
      limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric
      colonoscopes. Studies have not been performed to comparatively evaluate the success rates of
      standard adult and pediatric colonoscopes and whether either type of instrument confers a
      greater polyp detection rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.
time frame: After 50% and 100% of patient enrollment is complete.
measure: Adenoma detection rate in forward and retroflexed views.
time frame: After 50% and 100% of patient enrollment is complete.
measure: Reasons for failure of retroflexion.
time frame: After 50% and 100% of patient enrollment is complete.
description: This will be assessed as a yes/no variable. In addition, the specific reasons that the endoscopist could not retroflex the colonoscope in the right colon will assessed, such as the colonoscope not being able to be advanced to the cecum, small diameter of the right colon, too much resistance encountered when attempting retroflexion that the endoscopist does not feel comfortable with, etc.
arm group label: Adult colonoscope
arm group type: Active Comparator
description: Use of the adult colonoscope.
arm group label: Pediatric colonoscope
arm group type: Active Comparator
description: Use of the pediatric colonoscope.
intervention type: Procedure
intervention name: Retroflexion with the adult colonoscope.
arm group label: Adult colonoscope
intervention type: Procedure
intervention name: Retroflexion with the pediatric colonoscope.
arm group label: Pediatric colonoscope
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Young Oh, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
facility: 
country: United States
responsible party type: Sponsor
mesh term: Colonic Neoplasms