<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/NCT04441242</url>
  </required_header>
  <id_info>
    <org_study_id>6665</org_study_id>
    <nct_id>NCT04441242</nct_id>
  </id_info>
  <brief_title>Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue</brief_title>
  <official_title>Use of Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advocate Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advocate Health Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A retrospective and prospective study to determine if the use of ambient lighting during&#xD;
      screening colonoscopy is well tolerated and if ambient lighting will help physicians maintain&#xD;
      adenoma detection rates while decreasing symptoms of eye strain as the day progresses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a a single-center study at an independent community-based teaching hospital&#xD;
      comparing adenoma detection rate in screening colonoscopies performed in low lighting with&#xD;
      those performed with ambient lighting (75-150 lux). All cases included in the study involved&#xD;
      adult patients undergoing screening colonoscopy with a participating gastroenterologist.&#xD;
      Diagnostic colonoscopies, history of colon resection, colorectal cancer, and cases performed&#xD;
      in children, pregnant women, and prisoners were excluded from analysis. Cases involving&#xD;
      gastroenterology fellows were also excluded. Retrospective data was collected over a six&#xD;
      month period from January 2017 to June 2017, followed by a prospective arm the during the&#xD;
      same calendar months the subsequent year (January 2018 to June 2018).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 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>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in adenoma detection rate</measure>
    <time_frame>6 months</time_frame>
    <description>Adenoma detection rate, comparing change from first case of the day to the last. Ranges from 0-99%, with greater increases ADR being more favorable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Eye strain score</measure>
    <time_frame>6 months</time_frame>
    <description>Eye strain score, as calculated from survey responses completed by physicians. Ranges from 0 - 60, with lower scores indicating less severe symptoms (therefore, lower scores are more favorable).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate (overall)</measure>
    <time_frame>Participants each assessed on one day during 6 month study period</time_frame>
    <description>Overall adenoma detection rate. Ranges from 0% to 100%. Higher ADR is more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate (first case vs last case of the day)</measure>
    <time_frame>Participants each assessed on one day during 6 month study period</time_frame>
    <description>Adenoma detection rate, comparing first case of the day to the last. Ranges from from -99 to 99%, with greater numbers (increases) being more favorable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction by staff</measure>
    <time_frame>6 months</time_frame>
    <description>Satisfaction by staff involved in endoscopy, based on survey responses</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1109</enrollment>
  <condition>Colorectal Cancer Screening</condition>
  <condition>Colon Adenomatous Polyp</condition>
  <arm_group>
    <arm_group_label>Retrospective: Low lighting during screening colonoscopy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Screening colonoscopies performed with low lighting conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective: Ambient lighting during screening colonoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Screening colonoscopies performed with ambient lighting conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ambient lighting</intervention_name>
    <description>Use of ambient lighting (75-150 lux) in endoscopy room.</description>
    <arm_group_label>Prospective: Ambient lighting during screening colonoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low lighting</intervention_name>
    <description>Use of low lighting (&lt;75 lux) in endoscopy room.</description>
    <arm_group_label>Retrospective: Low lighting during screening colonoscopy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults undergoing screening colonoscopy&#xD;
&#xD;
          -  Procedure performed by a participating gastroenterologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any diagnostic colonoscopies&#xD;
&#xD;
          -  History of colon resection&#xD;
&#xD;
          -  History of colorectal cancer&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Cases involving trainees, including gastroenterology fellows&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Advocate Lutheran General Hospital</name>
      <address>
        <city>Park Ridge</city>
        <state>Illinois</state>
        <zip>60068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546.</citation>
    <PMID>17700327</PMID>
  </results_reference>
  <results_reference>
    <citation>Almadi MA, Sewitch M, Barkun AN, Martel M, Joseph L. Adenoma detection rates decline with increasing procedural hours in an endoscopist's workload. Can J Gastroenterol Hepatol. 2015 Aug-Sep;29(6):304-8. doi: 10.1155/2015/789038. Epub 2015 May 21.</citation>
    <PMID>25996612</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</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>Adenoma</mesh_term>
    <mesh_term>Adenomatous Polyps</mesh_term>
    <mesh_term>Asthenopia</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/NCT04441242
org study id: 6665
nct id: NCT04441242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A retrospective and prospective study to determine if the use of ambient lighting during
      screening colonoscopy is well tolerated and if ambient lighting will help physicians maintain
      adenoma detection rates while decreasing symptoms of eye strain as the day progresses.
This study is a a single-center study at an independent community-based teaching hospital
      comparing adenoma detection rate in screening colonoscopies performed in low lighting with
      those performed with ambient lighting (75-150 lux). All cases included in the study involved
      adult patients undergoing screening colonoscopy with a participating gastroenterologist.
      Diagnostic colonoscopies, history of colon resection, colorectal cancer, and cases performed
      in children, pregnant women, and prisoners were excluded from analysis. Cases involving
      gastroenterology fellows were also excluded. Retrospective data was collected over a six
      month period from January 2017 to June 2017, followed by a prospective arm the during the
      same calendar months the subsequent year (January 2018 to June 2018).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in adenoma detection rate
time frame: 6 months
description: Adenoma detection rate, comparing change from first case of the day to the last. Ranges from 0-99%, with greater increases ADR being more favorable.
measure: Eye strain score
time frame: 6 months
description: Eye strain score, as calculated from survey responses completed by physicians. Ranges from 0 - 60, with lower scores indicating less severe symptoms (therefore, lower scores are more favorable).
measure: Adenoma detection rate (overall)
time frame: Participants each assessed on one day during 6 month study period
description: Overall adenoma detection rate. Ranges from 0% to 100%. Higher ADR is more favorable.
measure: Adenoma detection rate (first case vs last case of the day)
time frame: Participants each assessed on one day during 6 month study period
description: Adenoma detection rate, comparing first case of the day to the last. Ranges from from -99 to 99%, with greater numbers (increases) being more favorable.
measure: Satisfaction by staff
time frame: 6 months
description: Satisfaction by staff involved in endoscopy, based on survey responses
arm group label: Retrospective: Low lighting during screening colonoscopy
arm group type: Placebo Comparator
description: Screening colonoscopies performed with low lighting conditions.
arm group label: Prospective: Ambient lighting during screening colonoscopy
arm group type: Active Comparator
description: Screening colonoscopies performed with ambient lighting conditions.
intervention type: Other
intervention name: Ambient lighting
description: Use of ambient lighting (75-150 lux) in endoscopy room.
arm group label: Prospective: Ambient lighting during screening colonoscopy
intervention type: Other
intervention name: Low lighting
description: Use of low lighting (<75 lux) in endoscopy room.
arm group label: Retrospective: Low lighting during screening colonoscopy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546.
PMID: 17700327
citation: Almadi MA, Sewitch M, Barkun AN, Martel M, Joseph L. Adenoma detection rates decline with increasing procedural hours in an endoscopist's workload. Can J Gastroenterol Hepatol. 2015 Aug-Sep;29(6):304-8. doi: 10.1155/2015/789038. Epub 2015 May 21.
PMID: 25996612
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Adenomatous Polyps
mesh term: Asthenopia
sharing ipd: No