<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/NCT03254030</url>
  </required_header>
  <id_info>
    <org_study_id>RD16/117</org_study_id>
    <nct_id>NCT03254030</nct_id>
  </id_info>
  <brief_title>Does Inspection of Colonic Mucosa During Insertion Improve Adenoma Detection?</brief_title>
  <acronym>INWARD</acronym>
  <official_title>Does Careful Inspection of Colonic Mucosa During Insertion and Withdrawal During Bowel Scope Improve Rate of Adenoma Detection?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London North West Healthcare NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>London North West Healthcare NHS Trust</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>
      This is a prospective randomised controlled trial to assess an intervention of inspection&#xD;
      during both phases of colonoscopic examination ( insertion and withdrawal) improve adenoma&#xD;
      detection rate when compared to inspection only during withdrawal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Successful implementation of colorectal screening programmes and improvement in colonoscopic&#xD;
      technology have resulted in significant decrease in colorectal cancer incidence and&#xD;
      mortality. Effectiveness of colonoscopy largely depends on detection and removal of adenomas&#xD;
      before they become cancerous. Despite the vast improvement in colonoscopy training and&#xD;
      technology, it remains as an imperfect tool. It has been reported that the adenoma miss rate&#xD;
      during colonoscopy varies between 6-27% in clinical practice. Adenoma Detection Rate (ADR) is&#xD;
      a surrogate marker of efficient colonoscopy. Researchers continue to explore various methods&#xD;
      and technologies to improve adenoma detection such as frequent position changes, routine use&#xD;
      of antispasmodics and devices to improve the mucosal visibility (third eye retro view scope,&#xD;
      Transparent cap, Endocuff).&#xD;
&#xD;
      However, all the techniques are focused on the withdrawal stage of the examination. Colonic&#xD;
      examination is traditionally performed with rapid passage of colonoscope to the caecum and a&#xD;
      careful examination of mucosa is carried out during the withdrawal phase. Polyps are removed&#xD;
      during the withdrawal phase. It is well known from expert opinion that some polyps are&#xD;
      detected during the insertion phase rather than withdrawal phase especially in sigmoid and&#xD;
      transverse colon. This could be due to different anatomical configuration of colon during&#xD;
      insertion and withdrawal.&#xD;
&#xD;
      During insertion phase colonic mucosa is stretched and the folds are splayed due to the&#xD;
      formation of loops and angulation hence affects the visualised area of the mucosa ahead of&#xD;
      the colonoscope. During withdrawal, the colon is shortened and the adjacent folds are brought&#xD;
      closer to each other. On withdrawal colon is much straighter. Therefore, it may expose&#xD;
      different portions of colonic mucosal surface on insertion and withdrawal.&#xD;
&#xD;
      Flexible sigmoidoscopy Bowel cancer screening programme (Bowel Scope) has been successfully&#xD;
      implemented since May 2013. Initial reports suggest ADR within Bowel Scope screening varies&#xD;
      considerably.&#xD;
&#xD;
      Therefore, we propose a simple technique to improve ADR in Bowel Scope Screening.&#xD;
&#xD;
      RATIONALE FOR CURRENT STUDY&#xD;
&#xD;
      Recent report suggests that ADR within Bowel Scope screening (BSS) varies considerably. We&#xD;
      propose a small technical alteration to improve ADR in BSS. A recent prospective trial&#xD;
      highlighted that if polypectomy was performed only during Withdrawal Phase (WP) when compared&#xD;
      to performing careful inspection and polypectomy during Inspection Phase (IP) plus WP, polyps&#xD;
      could be missed in about 7% of patients. We hypothesised that careful inspection and&#xD;
      polypectomy during both phases would be complementary and it would increase ADR by complete&#xD;
      visualisation of recto sigmoid mucosa during Bowel Scope.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 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>
    <intervention_model_description>Participants are randomised to undergo the flexible sigmoidoscopy screening examination either for control or intervention group. Control group is to undergo inspection of colonic mucosa only during withdrawal phase of the examination. Intervention group will undergo the examination during which the colonic mucosa will be inspected during inspection and withdrawal phase.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>8 months</time_frame>
    <description>Number of participants with at least one adenoma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>8 months</time_frame>
    <description>Number of patients with at least one polyp</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of adenoma per patient</measure>
    <time_frame>8 months</time_frame>
    <description>Number of adenomas divided by the number of patients in that group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>8 months</time_frame>
    <description>Time taken to complete the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Advanced adenoma detection rate</measure>
    <time_frame>8 months</time_frame>
    <description>Number of patients with adenoma larger than 10mm and or consists of villous histology or high grade dysplasia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">490</enrollment>
  <condition>Adenoma Colon</condition>
  <condition>Serrated Adenoma</condition>
  <arm_group>
    <arm_group_label>Inspection on withdrawal</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants colonic mucosa will be examined only during withdrawal phase of the examination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inspection on insertion and withdrawal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants colonic mucosa will be examined during insertion and withdrawal phase of the examination</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Colonic inspection</intervention_name>
    <description>Participants who are randomised to undergo the intervention will have the colonic mucosa examined during inspection and withdrawal phase of examination</description>
    <arm_group_label>Inspection on insertion and withdrawal</arm_group_label>
    <arm_group_label>Inspection on withdrawal</arm_group_label>
    <other_name>Inspection of colonic mucosa during insertion and withdrawal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who are referred for a bowel scope screening procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients lacking capacity to give informed consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Age less than 55 years&#xD;
&#xD;
          -  Uncorrectable coagulopathy&#xD;
&#xD;
          -  Patients who are not fit for flexible sigmoidoscopy&#xD;
&#xD;
          -  Incomplete procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajaratnam Rameshshanker, MBBS,MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>London North West Healthcare NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NorthWest London Hospitals - NOrthwick park hospital</name>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adenoma</keyword>
  <keyword>Sessile serrated adenoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</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/NCT03254030
org study id: RD16/117
nct id: NCT03254030
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective randomised controlled trial to assess an intervention of inspection
      during both phases of colonoscopic examination ( insertion and withdrawal) improve adenoma
      detection rate when compared to inspection only during withdrawal.
Successful implementation of colorectal screening programmes and improvement in colonoscopic
      technology have resulted in significant decrease in colorectal cancer incidence and
      mortality. Effectiveness of colonoscopy largely depends on detection and removal of adenomas
      before they become cancerous. Despite the vast improvement in colonoscopy training and
      technology, it remains as an imperfect tool. It has been reported that the adenoma miss rate
      during colonoscopy varies between 6-27% in clinical practice. Adenoma Detection Rate (ADR) is
      a surrogate marker of efficient colonoscopy. Researchers continue to explore various methods
      and technologies to improve adenoma detection such as frequent position changes, routine use
      of antispasmodics and devices to improve the mucosal visibility (third eye retro view scope,
      Transparent cap, Endocuff).

      However, all the techniques are focused on the withdrawal stage of the examination. Colonic
      examination is traditionally performed with rapid passage of colonoscope to the caecum and a
      careful examination of mucosa is carried out during the withdrawal phase. Polyps are removed
      during the withdrawal phase. It is well known from expert opinion that some polyps are
      detected during the insertion phase rather than withdrawal phase especially in sigmoid and
      transverse colon. This could be due to different anatomical configuration of colon during
      insertion and withdrawal.

      During insertion phase colonic mucosa is stretched and the folds are splayed due to the
      formation of loops and angulation hence affects the visualised area of the mucosa ahead of
      the colonoscope. During withdrawal, the colon is shortened and the adjacent folds are brought
      closer to each other. On withdrawal colon is much straighter. Therefore, it may expose
      different portions of colonic mucosal surface on insertion and withdrawal.

      Flexible sigmoidoscopy Bowel cancer screening programme (Bowel Scope) has been successfully
      implemented since May 2013. Initial reports suggest ADR within Bowel Scope screening varies
      considerably.

      Therefore, we propose a simple technique to improve ADR in Bowel Scope Screening.

      RATIONALE FOR CURRENT STUDY

      Recent report suggests that ADR within Bowel Scope screening (BSS) varies considerably. We
      propose a small technical alteration to improve ADR in BSS. A recent prospective trial
      highlighted that if polypectomy was performed only during Withdrawal Phase (WP) when compared
      to performing careful inspection and polypectomy during Inspection Phase (IP) plus WP, polyps
      could be missed in about 7% of patients. We hypothesised that careful inspection and
      polypectomy during both phases would be complementary and it would increase ADR by complete
      visualisation of recto sigmoid mucosa during Bowel Scope.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomised to undergo the flexible sigmoidoscopy screening examination either for control or intervention group. Control group is to undergo inspection of colonic mucosa only during withdrawal phase of the examination. Intervention group will undergo the examination during which the colonic mucosa will be inspected during inspection and withdrawal phase.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Adenoma detection rate
time frame: 8 months
description: Number of participants with at least one adenoma
measure: Polyp detection rate
time frame: 8 months
description: Number of patients with at least one polyp
measure: Mean number of adenoma per patient
time frame: 8 months
description: Number of adenomas divided by the number of patients in that group
measure: Total procedure time
time frame: 8 months
description: Time taken to complete the procedure
measure: Advanced adenoma detection rate
time frame: 8 months
description: Number of patients with adenoma larger than 10mm and or consists of villous histology or high grade dysplasia
arm group label: Inspection on withdrawal
arm group type: Placebo Comparator
description: Participants colonic mucosa will be examined only during withdrawal phase of the examination.
arm group label: Inspection on insertion and withdrawal
arm group type: Active Comparator
description: Participants colonic mucosa will be examined during insertion and withdrawal phase of the examination
intervention type: Other
intervention name: Colonic inspection
description: Participants who are randomised to undergo the intervention will have the colonic mucosa examined during inspection and withdrawal phase of examination
arm group label: Inspection on insertion and withdrawal
arm group label: Inspection on withdrawal
other name: Inspection of colonic mucosa during insertion and withdrawal
criteria: 
gender: All
minimum age: 55 Years
maximum age: 79 Years
healthy volunteers: No
last name: Rajaratnam Rameshshanker, MBBS,MRCP
role: Principal Investigator
affiliation: London North West Healthcare NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Adenoma
sharing ipd: No