<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/NCT03041532</url>
  </required_header>
  <id_info>
    <org_study_id>CEIC 62/16</org_study_id>
    <nct_id>NCT03041532</nct_id>
  </id_info>
  <brief_title>Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme</brief_title>
  <official_title>Impact of Proximal Colon Retroflexion in Colorectal Cancer Screening Programme: Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital del Río Hortega</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital del Río Hortega</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>
      Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the&#xD;
      Western world. The decrease in incidence and mortality by CRC in the population undergoing&#xD;
      screening has been observed. Colonoscopy is the recommended method for detecting tumors in&#xD;
      early stages, as well as identifying and resecting adenomatous polyps, which are the&#xD;
      precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence&#xD;
      and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does&#xD;
      not prevent right colon lesions in the same way as the left colon lesions, with most of the&#xD;
      interval cancers located in the right colon. Studies published so far show an increase in the&#xD;
      adenomas detection rate (ADT) in the right colon in the second visualization of this segment&#xD;
      and an increase between 2 and 10% if this second examination is performed with the proximal&#xD;
      retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our&#xD;
      study is to evaluate the ADT in the right colon by means of a second visualization by&#xD;
      performing proximal retroflexion or second frontal visualization at random in the CCR&#xD;
      screening population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</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>Proximal retroflexion improve adenoma detection rate in colorectal cancer screening</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Second look for right colon improve adenoma detection rate</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of retroflexion related adverse events</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of retroflexion proximal adverse events with a pediatric colonoscopy</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-procedure factors</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To analyze pre-procedure factors that may influence the prevalence of precursor lesions in the colon: age, sex, race, alcohol, smoking habit and the value of SOH, in which more detailed explorations should be performed using proximal retroflexion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">692</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Adenoma Detection Rate</condition>
  <arm_group>
    <arm_group_label>proximal retroflexion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>frontal view of right colon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Procedure: The endoscopy explore right colon with frontal view and frontal view</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Proximal retroflexion</intervention_name>
    <description>The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization</description>
    <arm_group_label>proximal retroflexion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Frontal view</intervention_name>
    <description>The investigator explore twice right colon with frontal viewing</description>
    <arm_group_label>frontal view of right colon</arm_group_label>
    <arm_group_label>proximal retroflexion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects participating in the Colorectal cancer Screening program with faecal&#xD;
             immunological test &gt; 100ng / ml.&#xD;
&#xD;
          -  Ages between 50-69 years.&#xD;
&#xD;
          -  Adequate preparation according to the Boston scale: in right colon (score&gt; 2 in this&#xD;
             section)&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to give informed consent.&#xD;
&#xD;
          -  Subjects with elevated colorectal cancer risk due to family history or inherited&#xD;
             diseases of polyposis or inflammatory bowel disease&#xD;
&#xD;
          -  Symptomatic subjects.&#xD;
&#xD;
          -  Diverticulitis, inflammatory bowel disease or colonic stenosis during the exploration&#xD;
&#xD;
          -  Inadequate preparation according to Boston cleanliness scale (score ≤ 2 in right&#xD;
             colon)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mª Henar Núñez Rodriguez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital del Rio Hortega Valladolid, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <zip>47012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 16, 2020</last_update_submitted>
  <last_update_submitted_qc>February 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital del Río Hortega</investigator_affiliation>
    <investigator_full_name>Mª Henar Núñez Rodriguez</investigator_full_name>
    <investigator_title>Principal Investigator: Dra Mª Henar Núñez Rodriguez</investigator_title>
  </responsible_party>
  <keyword>retroflexion proximal</keyword>
  <keyword>colorectal cancer screening programme</keyword>
  <keyword>adenoma detection rate</keyword>
  <keyword>right colon</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <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/NCT03041532
org study id: CEIC 62/16
nct id: NCT03041532
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer (CRC) is the most common tumor and the second leading cause of death in the
      Western world. The decrease in incidence and mortality by CRC in the population undergoing
      screening has been observed. Colonoscopy is the recommended method for detecting tumors in
      early stages, as well as identifying and resecting adenomatous polyps, which are the
      precursor lesions of most CRCs. Colonoscopy should be of high quality to decrease incidence
      and mortality by CRC and avoid interval cancer. The literature shows that colonoscopy does
      not prevent right colon lesions in the same way as the left colon lesions, with most of the
      interval cancers located in the right colon. Studies published so far show an increase in the
      adenomas detection rate (ADT) in the right colon in the second visualization of this segment
      and an increase between 2 and 10% if this second examination is performed with the proximal
      retroflexion maneuver.Retroflexion is a safe maneuver in expert endoscopists. The aim of our
      study is to evaluate the ADT in the right colon by means of a second visualization by
      performing proximal retroflexion or second frontal visualization at random in the CCR
      screening population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Proximal retroflexion improve adenoma detection rate in colorectal cancer screening
time frame: through study completion, an average of 1 year
description: Determine whether to perform retroflexion proximal improves adenoma detection rate in the right colon versus forward vision in population screening colorectal cancer with medium risk with immune blood test positive stool
measure: Second look for right colon improve adenoma detection rate
time frame: through study completion, an average of 1 year
description: Determine if a second look: retroflexion proximal or forward view improve adenoma detection rate
measure: Rate of retroflexion related adverse events
time frame: through study completion, an average of 1 year
measure: Rate of retroflexion proximal adverse events with a pediatric colonoscopy
time frame: through study completion, an average of 1 year
measure: Pre-procedure factors
time frame: through study completion, an average of 1 year
description: To analyze pre-procedure factors that may influence the prevalence of precursor lesions in the colon: age, sex, race, alcohol, smoking habit and the value of SOH, in which more detailed explorations should be performed using proximal retroflexion
arm group label: proximal retroflexion
arm group type: Experimental
description: Procedure: The endoscopy explore right colon with frontal view and a second look with proximal retroflexion
arm group label: frontal view of right colon
arm group type: Active Comparator
description: Procedure: The endoscopy explore right colon with frontal view and frontal view
intervention type: Procedure
intervention name: Proximal retroflexion
description: The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization
arm group label: proximal retroflexion
intervention type: Procedure
intervention name: Frontal view
description: The investigator explore twice right colon with frontal viewing
arm group label: frontal view of right colon
arm group label: proximal retroflexion
criteria: 
gender: All
minimum age: 50 Years
maximum age: 69 Years
healthy volunteers: No
last name: Mª Henar Núñez Rodriguez
role: Principal Investigator
affiliation: Hospital del Rio Hortega Valladolid, Spain
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital del Río Hortega
investigator full name: Mª Henar Núñez Rodriguez
investigator title: Principal Investigator: Dra Mª Henar Núñez Rodriguez
mesh term: Colorectal Neoplasms
mesh term: Adenoma