<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/NCT02208401</url>
  </required_header>
  <id_info>
    <org_study_id>STH17227</org_study_id>
    <nct_id>NCT02208401</nct_id>
  </id_info>
  <brief_title>Randomised Comparison of 2 Cold Snare Polypectomy Techniques</brief_title>
  <official_title>A Prospective Randomised Comparison of Cold Snare Polypectomy Versus Cold Snare Pseudosuction Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Different modalities are employed to remove small colonic polyps which potentially harbour a&#xD;
      cancer risk. But, they can all vary in their completeness of removal, safety and the&#xD;
      histological quality and the gold standard technique has yet to be defined. A novel suction&#xD;
      pseudopolyp technique has been described by Patullo et al and in their prospective study, 126&#xD;
      polyps measuring less than 10mm flat or sessile were removed by this method with 100%&#xD;
      complete endoscopic resection and without any immediate or delayed complications. The aim of&#xD;
      the investigators study is to compare this technique with the standard cold snare technique.&#xD;
      Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size&#xD;
      will be eligible and they will be randomised to the polypectomy technique. Patient&#xD;
      demographics and polyp characteristics will be recorded. The primary outcome measured will be&#xD;
      the macroscopic resection rate. The secondary outcome measures are abdominal pain,&#xD;
      tenderness, bleeding and fever.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 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>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete macroscopic polyp eradication rate</measure>
    <time_frame>At time of polypectomy intervention</time_frame>
    <description>The primary outcome for this study is the polypectomy completion rate. This will be assessed both macroscopically and histologically. The analysis for statistical difference between the 2 techniques and abdominal symptoms will be compared by the Chi2 test for categorical data.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">112</enrollment>
  <condition>Bowel Cancer</condition>
  <arm_group>
    <arm_group_label>conventional cold snare polypectomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional cold snare polypectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cold snare polypectomy with suction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cold snare polypectomy with suction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>conventional cold snare polypectomy</intervention_name>
    <description>conventional cold snare polypectomy</description>
    <arm_group_label>conventional cold snare polypectomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cold snare polypectomy with suction</intervention_name>
    <description>Cold snare polypectomy with suction</description>
    <arm_group_label>Cold snare polypectomy with suction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with small polyps 3-7 mm in size, flat or sessile found during&#xD;
             colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients are less than 18 years old&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Inadequate bowel preparation&#xD;
&#xD;
          -  On anticoagulants or clopidogrel&#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_official>
    <last_name>Shawinder Johal, MBChB, PhD, MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02208401
org study id: STH17227
nct id: NCT02208401
lead sponsor: 
has dmc: No
Different modalities are employed to remove small colonic polyps which potentially harbour a
      cancer risk. But, they can all vary in their completeness of removal, safety and the
      histological quality and the gold standard technique has yet to be defined. A novel suction
      pseudopolyp technique has been described by Patullo et al and in their prospective study, 126
      polyps measuring less than 10mm flat or sessile were removed by this method with 100%
      complete endoscopic resection and without any immediate or delayed complications. The aim of
      the investigators study is to compare this technique with the standard cold snare technique.
      Patients attending for a routine colonoscopy and found to have polyps measuring 37mm in size
      will be eligible and they will be randomised to the polypectomy technique. Patient
      demographics and polyp characteristics will be recorded. The primary outcome measured will be
      the macroscopic resection rate. The secondary outcome measures are abdominal pain,
      tenderness, bleeding and fever.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Complete macroscopic polyp eradication rate
time frame: At time of polypectomy intervention
description: The primary outcome for this study is the polypectomy completion rate. This will be assessed both macroscopically and histologically. The analysis for statistical difference between the 2 techniques and abdominal symptoms will be compared by the Chi2 test for categorical data.
arm group label: conventional cold snare polypectomy
arm group type: Active Comparator
description: conventional cold snare polypectomy
arm group label: Cold snare polypectomy with suction
arm group type: Experimental
description: Cold snare polypectomy with suction
intervention type: Procedure
intervention name: conventional cold snare polypectomy
description: conventional cold snare polypectomy
arm group label: conventional cold snare polypectomy
intervention type: Procedure
intervention name: Cold snare polypectomy with suction
description: Cold snare polypectomy with suction
arm group label: Cold snare polypectomy with suction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shawinder Johal, MBChB, PhD, MRCP
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor