<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/NCT01704820</url>
  </required_header>
  <id_info>
    <org_study_id>Retro-View</org_study_id>
    <nct_id>NCT01704820</nct_id>
  </id_info>
  <brief_title>Right Sided Colon Polyp Miss Rate: Impact Of Retroflexion In The Right Colon</brief_title>
  <official_title>RIGHT SIDED COLON POLYP MISS RATE: IMPACT OF RETROFLEXION IN THE RIGHT COLON</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colonoscopy is the gold standard screening test for colorectal cancer. Removal of&#xD;
      pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over&#xD;
      50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon&#xD;
      cancers, it provides only limited protection from cancer in the proximal (right side) colon.&#xD;
      Our goal is to determine if additional pre-cancerous colon polyps can be identified by&#xD;
      looking at the right side of the colon in retroflexion. During retroflexion the tip of the&#xD;
      colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If&#xD;
      additional polyps can be identified in this manner colonoscopy will become a more efficient&#xD;
      method of screening for colon cancer.&#xD;
&#xD;
      In order to evaluate how effective right colon retroflexion is at detecting polyps in the&#xD;
      proximal colon we plan on performing a randomized, controlled trial. Patients undergoing&#xD;
      screening or follow up colonoscopy will be invited to participate in the study. Those&#xD;
      patients who agree to participate will be randomized into one of two groups once the&#xD;
      colonoscope is fully inserted. Group one will have the right side of their colon examined for&#xD;
      polyps with the endoscope looking forward (traditional form of examination) followed by&#xD;
      repeat examination of the right side of the colon with the colonosocpe in retroflexion&#xD;
      (looking backwards). Polyps seen during each section of the exam will be removed and manner&#xD;
      in which the polyps were found/ removed will be recorded. Following the two exams of the&#xD;
      right side of the colon the colonoscopy will be completed in the usual manner. The duration&#xD;
      of each portion of colonoscopy will be recorded. After the procedure is completed the&#xD;
      physician performing the colonoscopy will rate difficulty of the procedure and confidence&#xD;
      with quality of the examination. Pathology results for each polyp will be recorded once&#xD;
      available. There will be no study related follow up after the pathology results are recorded.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">September 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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).</measure>
    <time_frame>2 weeks</time_frame>
    <description>The primary objective of our study is to determine whether the diagnostic yield for pre-malignant polyps is increased by retroflexion of the colonoscope during withdrawal from the proximal colon when compared to the diagnostic yield of a second examination of the proximal colon with the colonoscope in forward view.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the success rate of retroflexion in the proximal colon.</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluate the percent of patients in whom retroflexion can be performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify risk factors for missing polyps on first examination of right colon</measure>
    <time_frame>1 day</time_frame>
    <description>We will perform a multivariable analysis in order to identify patient and procedure related factors which are associated with missed polyps.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.</measure>
    <time_frame>1 day</time_frame>
    <description>Access whether duration of exam is different in the retroflexion vs. forward view arms of the study. By timing all portions of the exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate endoscopist comfort with performing retroflexion in the proximal colon.</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluate endoscopist comfort with performing retroflexion in the proximal colon using a 5 point Likert scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1020</enrollment>
  <condition>Colon Polyps</condition>
  <condition>Colon Cancer Screening</condition>
  <arm_group>
    <arm_group_label>Retroflexion arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Retroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Forward view arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Retroflexion in the right colon</intervention_name>
    <arm_group_label>Retroflexion arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients &gt;18 years of age undergoing colonoscopy for colorectal cancer screening or&#xD;
             routine polyp surveillance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Failure to intubate the cecum during colonoscope insertion&#xD;
&#xD;
               -  Prior right colon resection&#xD;
&#xD;
               -  Known polyposis syndrome or polyposis identified at colonoscopy&#xD;
&#xD;
               -  Inflammatory bowel disease&#xD;
&#xD;
               -  Preparation of the colon is judged fair or poor using Boston Bowel Preparation&#xD;
                  Scale.&#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_contact>
    <last_name>Vladimir M Kushnir, MD</last_name>
    <phone>3144548201</phone>
    <email>vkushnir@wustl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Washington University in St Louis</name>
      <address>
        <city>St Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vladimir M Kushnir, MD</last_name>
      <phone>314-454-8201</phone>
      <email>vkushnir@wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Early Dayna, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukie</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Young (Danny) Oh, MD</last_name>
      <phone>414-955-6836</phone>
      <email>yoh@mcw.edu</email>
    </contact>
    <investigator>
      <last_name>Young (Danny) Oh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.</citation>
    <PMID>21679946</PMID>
  </reference>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>May 29, 2013</last_update_submitted>
  <last_update_submitted_qc>May 29, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 31, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colon Polyps</keyword>
  <keyword>Colon Cancer screening</keyword>
  <keyword>Colonoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
    <mesh_term>Polyps</mesh_term>
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 1, 2015</submitted>
    <returned>June 16, 2015</returned>
  </pending_results>
  <!-- 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/NCT01704820
org study id: Retro-View
nct id: NCT01704820
lead sponsor: 
collaborator: 
has dmc: Yes
Colonoscopy is the gold standard screening test for colorectal cancer. Removal of
      pre-malignant colon polyps during colonoscopy reduces colorectal cancer mortality by over
      50%. However, while colonoscopy is highly effective at preventing distal (left sided) colon
      cancers, it provides only limited protection from cancer in the proximal (right side) colon.
      Our goal is to determine if additional pre-cancerous colon polyps can be identified by
      looking at the right side of the colon in retroflexion. During retroflexion the tip of the
      colonoscope is turned 180 degrees; allowing the doctor to view the backs of colonic folds. If
      additional polyps can be identified in this manner colonoscopy will become a more efficient
      method of screening for colon cancer.

      In order to evaluate how effective right colon retroflexion is at detecting polyps in the
      proximal colon we plan on performing a randomized, controlled trial. Patients undergoing
      screening or follow up colonoscopy will be invited to participate in the study. Those
      patients who agree to participate will be randomized into one of two groups once the
      colonoscope is fully inserted. Group one will have the right side of their colon examined for
      polyps with the endoscope looking forward (traditional form of examination) followed by
      repeat examination of the right side of the colon with the colonosocpe in retroflexion
      (looking backwards). Polyps seen during each section of the exam will be removed and manner
      in which the polyps were found/ removed will be recorded. Following the two exams of the
      right side of the colon the colonoscopy will be completed in the usual manner. The duration
      of each portion of colonoscopy will be recorded. After the procedure is completed the
      physician performing the colonoscopy will rate difficulty of the procedure and confidence
      with quality of the examination. Pathology results for each polyp will be recorded once
      available. There will be no study related follow up after the pathology results are recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Per patient adenoma detection rate (average # adenomas detected/ patient in each arm of the study).
time frame: 2 weeks
description: The primary objective of our study is to determine whether the diagnostic yield for pre-malignant polyps is increased by retroflexion of the colonoscope during withdrawal from the proximal colon when compared to the diagnostic yield of a second examination of the proximal colon with the colonoscope in forward view.
measure: Evaluate the success rate of retroflexion in the proximal colon.
time frame: 1 day
description: Evaluate the percent of patients in whom retroflexion can be performed.
measure: Identify risk factors for missing polyps on first examination of right colon
time frame: 1 day
description: We will perform a multivariable analysis in order to identify patient and procedure related factors which are associated with missed polyps.
measure: Access whether duration of exam is different in the retroflexion vs. forward view arms of the study.
time frame: 1 day
description: Access whether duration of exam is different in the retroflexion vs. forward view arms of the study. By timing all portions of the exam.
measure: Evaluate endoscopist comfort with performing retroflexion in the proximal colon.
time frame: 1 day
description: Evaluate endoscopist comfort with performing retroflexion in the proximal colon using a 5 point Likert scale
arm group label: Retroflexion arm
arm group type: Experimental
description: Retroflexion arm: retroflexion in the cecum or proximal ascending colon and slow withdrawal to the hepatic flexure with removal of all visible colon polyps
arm group label: Forward view arm
arm group type: Placebo Comparator
description: Colonoscope is slowly withdrawn from the proximal colon to the hepatic flexure and all visible colon polyps are removed.
intervention type: Procedure
intervention name: Retroflexion in the right colon
arm group label: Retroflexion arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vladimir M Kushnir, MD
phone: 3144548201
email: vkushnir@wustl.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: United States
citation: Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.
PMID: 21679946
responsible party type: Sponsor
mesh term: Colonic Neoplasms
mesh term: Polyps
mesh term: Colonic Polyps
submitted: June 1, 2015
returned: June 16, 2015