<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/NCT04456790</url>
  </required_header>
  <id_info>
    <org_study_id>PHT/2019/32</org_study_id>
    <nct_id>NCT04456790</nct_id>
  </id_info>
  <brief_title>Plenvu 1 - Questionnaire Study Exploring Patients Preference in Bowel Preparation Timings for Morning Colonoscopy</brief_title>
  <official_title>Plenvu 1 - Questionnaire Study Exploring Patients Preference in Bowel Preparation Timings for Morning Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Portsmouth Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Portsmouth Hospitals 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>
      Questionnaire study exploring patients preference in bowel preparation timings for morning&#xD;
      colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is often difficult to achieve optimal bowel cleansing for patients having morning&#xD;
      colonoscopies. One possible cause of this is the timing of the bowel preparation prior to the&#xD;
      procedure. A clean bowel will allow for a clear view of its inner lining which is important&#xD;
      for both accurate diagnosis and treatment. Abnormal changes may be tiny, so even the smallest&#xD;
      amount of faeces could potentially disguise polyps and cancers.&#xD;
&#xD;
      Additionally, poor bowel cleansing can lead to the procedure being cancelled and repeated on&#xD;
      another occasion at a later date, adding to the burden on current resources. Poor bowel&#xD;
      preparation has also been shown to be a factor in more difficult and longer procedures,&#xD;
      increased patient discomfort, and a higher risk of complications.&#xD;
&#xD;
      This is more of an issue for patients having a colonoscopy in the morning. One cause of this&#xD;
      could be the timing of bowel preparation. Studies have shown that having a smaller window of&#xD;
      time between finishing bowel preparation and having a colonoscopy results in a much cleaner&#xD;
      bowel. The investigators are therefore considering the times patients are required to take&#xD;
      their bowel preparation in order to improve the bowel cleansing outcome for a morning&#xD;
      colonoscopy.&#xD;
&#xD;
      Previous studies have indicated that a split dose (one evening dose and one early morning&#xD;
      dose) improves bowel cleansing compared to all doses taken the day prior to colonoscopy.&#xD;
      However, there has been no research to assess the efficacy of early morning bowel preparation&#xD;
      and its acceptability to patients. This information may lead to future studies and in order&#xD;
      to ensure the success of this further research it is important to understand any potential&#xD;
      barriers from patients to new timing regimens.&#xD;
&#xD;
      Therefore, such information as highest education level, employment status, age and experience&#xD;
      of previous bowel preparation for colonoscopy for the patient population is captured.&#xD;
&#xD;
      Results from previous studies looking at potential barriers have shown that such issues as&#xD;
      having a simplified colonoscopy instruction sheet improved bowel preparation and lowered&#xD;
      cancellation rates and that patients with a history of colonoscopy are less likely to follow&#xD;
      bowel preparation instructions and therefore achieve adequate bowel cleansing.&#xD;
&#xD;
      A total of 300 participants will be approached; 150 participants who have previously had&#xD;
      bowel preparation for colonoscopy and 150 participants who have not, and are attending for a&#xD;
      flexi sigmoidoscopy and therefore may have to go on to have a colonoscopy.&#xD;
&#xD;
      These groups will be further split to half attending in the morning and half attending in the&#xD;
      afternoon, thus achieving a cross section of this patient group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2020</start_date>
  <completion_date type="Actual">January 14, 2021</completion_date>
  <primary_completion_date type="Actual">January 14, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient preferences questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Patients to rate their preference for timings from 1st to third choice.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient preferences questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>To establish the reasons for expressed preferences for bowel preparation timings</description>
  </secondary_outcome>
  <enrollment type="Actual">304</enrollment>
  <condition>Bowel Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients attending the endoscopy unit for a flexible sigmoidoscopy or colonoscopy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Attending the endoscopy suite at Portsmouth Hospitals NHS Trust for colonoscopy or&#xD;
             flexi-sigmoidoscopy procedures&#xD;
&#xD;
               -  Aged 18 years and above&#xD;
&#xD;
               -  Participant is willing and able to give informed consent for participation in the&#xD;
                  study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Aged under 18 years&#xD;
&#xD;
               -  Unable to complete the questionnaire unsupervised&#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>Joanne Sr Dash</last_name>
    <role>Principal Investigator</role>
    <affiliation>Portsmouth NHS Hosptials Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Portsmouth Hospitals NHS Trust</name>
      <address>
        <city>Portsmouth</city>
        <state>Wessex</state>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>February 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 11, 2021</last_update_submitted>
  <last_update_submitted_qc>March 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</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>Intestinal Diseases</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/NCT04456790
org study id: PHT/2019/32
nct id: NCT04456790
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Questionnaire study exploring patients preference in bowel preparation timings for morning
      colonoscopy.
It is often difficult to achieve optimal bowel cleansing for patients having morning
      colonoscopies. One possible cause of this is the timing of the bowel preparation prior to the
      procedure. A clean bowel will allow for a clear view of its inner lining which is important
      for both accurate diagnosis and treatment. Abnormal changes may be tiny, so even the smallest
      amount of faeces could potentially disguise polyps and cancers.

      Additionally, poor bowel cleansing can lead to the procedure being cancelled and repeated on
      another occasion at a later date, adding to the burden on current resources. Poor bowel
      preparation has also been shown to be a factor in more difficult and longer procedures,
      increased patient discomfort, and a higher risk of complications.

      This is more of an issue for patients having a colonoscopy in the morning. One cause of this
      could be the timing of bowel preparation. Studies have shown that having a smaller window of
      time between finishing bowel preparation and having a colonoscopy results in a much cleaner
      bowel. The investigators are therefore considering the times patients are required to take
      their bowel preparation in order to improve the bowel cleansing outcome for a morning
      colonoscopy.

      Previous studies have indicated that a split dose (one evening dose and one early morning
      dose) improves bowel cleansing compared to all doses taken the day prior to colonoscopy.
      However, there has been no research to assess the efficacy of early morning bowel preparation
      and its acceptability to patients. This information may lead to future studies and in order
      to ensure the success of this further research it is important to understand any potential
      barriers from patients to new timing regimens.

      Therefore, such information as highest education level, employment status, age and experience
      of previous bowel preparation for colonoscopy for the patient population is captured.

      Results from previous studies looking at potential barriers have shown that such issues as
      having a simplified colonoscopy instruction sheet improved bowel preparation and lowered
      cancellation rates and that patients with a history of colonoscopy are less likely to follow
      bowel preparation instructions and therefore achieve adequate bowel cleansing.

      A total of 300 participants will be approached; 150 participants who have previously had
      bowel preparation for colonoscopy and 150 participants who have not, and are attending for a
      flexi sigmoidoscopy and therefore may have to go on to have a colonoscopy.

      These groups will be further split to half attending in the morning and half attending in the
      afternoon, thus achieving a cross section of this patient group.
observational model: Other
time perspective: Prospective
measure: Patient preferences questionnaire
time frame: 3 months
description: Patients to rate their preference for timings from 1st to third choice.
measure: Patient preferences questionnaire
time frame: 3 months
description: To establish the reasons for expressed preferences for bowel preparation timings
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joanne Sr Dash
role: Principal Investigator
affiliation: Portsmouth NHS Hosptials Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Intestinal Diseases
sharing ipd: No