<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/NCT02985944</url>
  </required_header>
  <id_info>
    <org_study_id>W-time</org_study_id>
    <nct_id>NCT02985944</nct_id>
  </id_info>
  <brief_title>Withdrawal Time and Use of Wide-angle Endoscope to Increase the Adenoma Detection Rate of Screening Colonoscopy</brief_title>
  <official_title>Effect of a Longer Withdrawal Time or of the Use of a Wide-angle Endoscope on the Adenoma Detection Rate of Screening Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ASST Rhodense</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ASST Rhodense</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy&#xD;
      withdrawal time &gt;6min has been suggested to increase the ADR since it allows for thorough&#xD;
      evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy&#xD;
      system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle&#xD;
      view. In the present study the authors evaluate the impact of WT on ADR for High Definition&#xD;
      Standard Endoscopes with just a single imager to the FUSE endoscope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Colonoscopy outcome is strictly related to the adenoma detection rate. An&#xD;
      endoscopy withdrawal time &gt;6min has been suggested to increase the adenoma detection rate&#xD;
      since it allows for accurate evaluation of the several hidden areas of the colon. The FUSE&#xD;
      endoscope has been demonstrated also to reduce the rate of missed lesions due to its wide&#xD;
      angle view.&#xD;
&#xD;
      Aim of the study to evaluate the impact on the adenoma detection rate either of the use of a&#xD;
      FUSE endoscope or of interventions directed at optimizing withdrawal time.&#xD;
&#xD;
      to assess the impact of different factors in influencing the withdrawal time&#xD;
&#xD;
      Methods A prospective non-randomized observational single-center study involving consecutive&#xD;
      outpatients, aged 18-85 yr, undergoing colonoscopy with different indications. Previous&#xD;
      abdominal colon resection, obstruction, inadequate preparation and incomplete examination&#xD;
      were exclusion criteria.&#xD;
&#xD;
      In a 3-month period 4 expert endoscopists will performed 500 colonoscopies either with&#xD;
      standard endoscope or with FUSE without a dedicated withdrawal time protocol. Colonoscopy&#xD;
      withdrawal times will be measured without the endoscopists' knowledge of being monitored.&#xD;
&#xD;
      During a subsequent 3-month period the same endoscopists will perform further 500&#xD;
      colonoscopies with standard and FUSE scopes using dedicated inspection techniques and a&#xD;
      minimum 6-minute withdrawal time. In this second phase withdrawal times will be again&#xD;
      measured, but endoscopists will be aware of being monitored.&#xD;
&#xD;
      The following parameters will be recorded:&#xD;
&#xD;
        -  Demographic and general characteristics&#xD;
&#xD;
        -  Indications to colonoscopy&#xD;
&#xD;
        -  Colonoscopy findings&#xD;
&#xD;
        -  Quality of preparation: Boston scale&#xD;
&#xD;
        -  Time to reach the coecum&#xD;
&#xD;
        -  Withdrawal time The adenoma detection rate and the mean adenomas per patients will be&#xD;
           calculated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>Up to 10 days from the end of endoscopy</time_frame>
    <description>The rate of patient with at least one adenoma detected at colonoscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Factors affecting the withdrawal time</measure>
    <time_frame>Up to 10 days from the end of endoscopy</time_frame>
    <description>Analysis of the factors (quality of preparation, indications for colonoscopy) likely to influence the withdrawal time</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>ColoRectal Cancer</condition>
  <condition>Colon Polyp</condition>
  <arm_group>
    <arm_group_label>Standard scope-short time</arm_group_label>
    <description>Standard colonoscopy with unmonitored withdrawal time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FUSE scope-short time</arm_group_label>
    <description>Wide-angle colonoscopy with unmonitored withdrawal time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard scope-long time</arm_group_label>
    <description>Standard colonoscopy with monitored withdrawal time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FUSE scope-long time</arm_group_label>
    <description>Wide-angle colonoscopy with monitored withdrawal time</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colonoscopy</intervention_name>
    <description>Colonoscopy performed in adult consecutive patients for different indications</description>
    <arm_group_label>FUSE scope-long time</arm_group_label>
    <arm_group_label>FUSE scope-short time</arm_group_label>
    <arm_group_label>Standard scope-long time</arm_group_label>
    <arm_group_label>Standard scope-short time</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult outpatients undergoing colonoscopy for different indications&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for colonoscopy, age 18-85&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous abdominal colon resection, colon obstruction, inadequate preparation and&#xD;
             incomplete examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>gianpiero manes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ASST Rhodense</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ASST Rhodense</name>
      <address>
        <city>Garbagnate Milanese</city>
        <state>Lombardia</state>
        <zip>20020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>January 17, 2021</last_update_submitted>
  <last_update_submitted_qc>January 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>ASST Rhodense</investigator_affiliation>
    <investigator_full_name>gianpiero manes</investigator_full_name>
    <investigator_title>Head of th Gastroenterology Unit</investigator_title>
  </responsible_party>
  <keyword>colorectal cancer</keyword>
  <keyword>Colon polyp</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Adenoma detection rate</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>
    <mesh_term>Colonic Polyps</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02985944
org study id: W-time
nct id: NCT02985944
lead sponsor: 
has dmc: Yes
Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy
      withdrawal time >6min has been suggested to increase the ADR since it allows for thorough
      evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy
      system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle
      view. In the present study the authors evaluate the impact of WT on ADR for High Definition
      Standard Endoscopes with just a single imager to the FUSE endoscope.
Introduction Colonoscopy outcome is strictly related to the adenoma detection rate. An
      endoscopy withdrawal time >6min has been suggested to increase the adenoma detection rate
      since it allows for accurate evaluation of the several hidden areas of the colon. The FUSE
      endoscope has been demonstrated also to reduce the rate of missed lesions due to its wide
      angle view.

      Aim of the study to evaluate the impact on the adenoma detection rate either of the use of a
      FUSE endoscope or of interventions directed at optimizing withdrawal time.

      to assess the impact of different factors in influencing the withdrawal time

      Methods A prospective non-randomized observational single-center study involving consecutive
      outpatients, aged 18-85 yr, undergoing colonoscopy with different indications. Previous
      abdominal colon resection, obstruction, inadequate preparation and incomplete examination
      were exclusion criteria.

      In a 3-month period 4 expert endoscopists will performed 500 colonoscopies either with
      standard endoscope or with FUSE without a dedicated withdrawal time protocol. Colonoscopy
      withdrawal times will be measured without the endoscopists' knowledge of being monitored.

      During a subsequent 3-month period the same endoscopists will perform further 500
      colonoscopies with standard and FUSE scopes using dedicated inspection techniques and a
      minimum 6-minute withdrawal time. In this second phase withdrawal times will be again
      measured, but endoscopists will be aware of being monitored.

      The following parameters will be recorded:

        -  Demographic and general characteristics

        -  Indications to colonoscopy

        -  Colonoscopy findings

        -  Quality of preparation: Boston scale

        -  Time to reach the coecum

        -  Withdrawal time The adenoma detection rate and the mean adenomas per patients will be
           calculated.
observational model: Cohort
time perspective: Prospective
measure: Adenoma detection rate
time frame: Up to 10 days from the end of endoscopy
description: The rate of patient with at least one adenoma detected at colonoscopy
measure: Factors affecting the withdrawal time
time frame: Up to 10 days from the end of endoscopy
description: Analysis of the factors (quality of preparation, indications for colonoscopy) likely to influence the withdrawal time
arm group label: Standard scope-short time
description: Standard colonoscopy with unmonitored withdrawal time
arm group label: FUSE scope-short time
description: Wide-angle colonoscopy with unmonitored withdrawal time
arm group label: Standard scope-long time
description: Standard colonoscopy with monitored withdrawal time
arm group label: FUSE scope-long time
description: Wide-angle colonoscopy with monitored withdrawal time
intervention type: Procedure
intervention name: Colonoscopy
description: Colonoscopy performed in adult consecutive patients for different indications
arm group label: FUSE scope-long time
arm group label: FUSE scope-short time
arm group label: Standard scope-long time
arm group label: Standard scope-short time
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: gianpiero manes, MD
role: Principal Investigator
affiliation: ASST Rhodense
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: ASST Rhodense
investigator full name: gianpiero manes
investigator title: Head of th Gastroenterology Unit
mesh term: Colorectal Neoplasms
mesh term: Adenoma
mesh term: Colonic Polyps
sharing ipd: No