<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/NCT02243930</url>
  </required_header>
  <id_info>
    <org_study_id>KOESURG-41580</org_study_id>
    <secondary_id>41580</secondary_id>
    <nct_id>NCT02243930</nct_id>
  </id_info>
  <brief_title>Cap-assisted Sigmoidoscopy - Influence on Pain, Duration and Rate of Success</brief_title>
  <official_title>Cap-assisted Sigmoidoscopy - Reduction in Pain, Reduction in Investigation Time and Increased Rate of Success, When Examined by the Less-experienced Endoscopist. A Prospective Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the attachment of a transparent hood (&quot;cap&quot;) on&#xD;
      the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce&#xD;
      investigation time, and increases the success rate of the sigmoidoscopy. The study focus on&#xD;
      the less-experienced endoscopist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators randomize study subject to sigmoidoscopy +/- the attachment of the cap.&#xD;
&#xD;
      Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its&#xD;
      intubation end-point (60cm from anus). The investigators also register the time spent to this&#xD;
      point and the rate of examinations not achieving this endpoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS recording of pain</measure>
    <time_frame>During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.</time_frame>
    <description>the registration is performed when the endoscopist has advanced the scope to the 60 cm mark.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time</measure>
    <time_frame>During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.</time_frame>
    <description>Recording of the time it takes from the introduction of the endoscopy through anus until it reaches 60 cm intubation mark.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>rate of success</measure>
    <time_frame>During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.</time_frame>
    <description>recording the rate of examinations that reached the intubation endpoint at 60cm from anus</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">193</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Cap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sigmoidoscopy with cap</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No cap</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sigmoidoscopy without cap</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Disposable distal attachment</intervention_name>
    <arm_group_label>Cap</arm_group_label>
    <other_name>&quot;cap&quot;</other_name>
    <other_name>Model No. D-201-14304 - Olympus</other_name>
    <other_name>Dimentions: Ø15,0mm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  planned to undergo sigmoidoscopy&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of iv medication for pain and/or anxiety immediately before the endoscopy&#xD;
&#xD;
          -  lack of indication for a full sigmoidoscopy (eg just need to investigate the rectum)&#xD;
&#xD;
          -  lack or improper administration of standard bowel preparation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magnus Ploug, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Koege Hospital, Surgical Department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Surgical department, endoscopy unit, Koege Hospital, Denmark</name>
      <address>
        <city>Koege</city>
        <state>Region Sjaelland</state>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>magnus Ploug</investigator_full_name>
    <investigator_title>MD, Junior Doctor</investigator_title>
  </responsible_party>
  <keyword>Sigmoidoscopy with or without cap</keyword>
  <keyword>Pain during sigmoidoscopy</keyword>
  <keyword>Sigmoidoscopy and time</keyword>
  <!-- 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/NCT02243930
org study id: KOESURG-41580
secondary id: 41580
nct id: NCT02243930
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate the attachment of a transparent hood ("cap") on
      the sigmoidoscope. The investigators hypothesis is that this will reduce pain, reduce
      investigation time, and increases the success rate of the sigmoidoscopy. The study focus on
      the less-experienced endoscopist.
The investigators randomize study subject to sigmoidoscopy +/- the attachment of the cap.

      Using a 100mm VAS scale the investigators record pain when the sigmoidoscopy reaches its
      intubation end-point (60cm from anus). The investigators also register the time spent to this
      point and the rate of examinations not achieving this endpoint.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: VAS recording of pain
time frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
description: the registration is performed when the endoscopist has advanced the scope to the 60 cm mark.
measure: Time
time frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
description: Recording of the time it takes from the introduction of the endoscopy through anus until it reaches 60 cm intubation mark.
measure: rate of success
time frame: During endoscopy. The subject is randomized immediately prior to the endoscopy. The outcome measures are all measured during examination.
description: recording the rate of examinations that reached the intubation endpoint at 60cm from anus
arm group label: Cap
arm group type: Experimental
description: Sigmoidoscopy with cap
arm group label: No cap
arm group type: No Intervention
description: Sigmoidoscopy without cap
intervention type: Device
intervention name: Disposable distal attachment
arm group label: Cap
other name: "cap"
other name: Model No. D-201-14304 - Olympus
other name: Dimentions: Ø15,0mm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Magnus Ploug, MD
role: Principal Investigator
affiliation: Koege Hospital, Surgical Department
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: magnus Ploug
investigator title: MD, Junior Doctor