<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/NCT03011788</url>
  </required_header>
  <id_info>
    <org_study_id>AN0011</org_study_id>
    <nct_id>NCT03011788</nct_id>
  </id_info>
  <brief_title>Polyethylene Glycol Cleansing in Patients at High Risk for Poor Bowel Preparation</brief_title>
  <official_title>A Randomized Study of Single vs Two-Day Polyethylene Glycol Cleansing in Patients at High Risk for Poor Bowel Preparation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Connecticut Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Connecticut Healthcare System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized trial is to compare the proportion of patients achieving an&#xD;
      adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation&#xD;
      regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2&#xD;
      consecutive days in a population identified as high risk for an inadequate bowel preparation.&#xD;
&#xD;
      2. Research Design: This study is a single-center prospective randomized study at the West&#xD;
      Haven VAMC.&#xD;
&#xD;
      3. Methodology:&#xD;
&#xD;
        1. Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation&#xD;
           Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left,&#xD;
           transverse, and right).&#xD;
&#xD;
        2. Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated&#xD;
           polyp/adenoma detection rate, patient tolerability of preparation using the validated&#xD;
           Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related to&#xD;
           bowel preparation&#xD;
&#xD;
      Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high&#xD;
      risk for poor bowel preparation,&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Group 1: One day of split-dose Golytely 4L (2 liters the evening before procedure, 2 liters&#xD;
      the morning of procedure) Group 2: Two days of split-dose Golytely 4L (beginning 2 days&#xD;
      before the procedure with 2 liters in the evening, 2 liters the morning of the day before the&#xD;
      procedure, 2 liters the evening before the procedure, 2 liters the morning of the procedure)&#xD;
      Patients will be instructed to ingest each of the 2-liter aliquots of Golytely over 2 hours.&#xD;
&#xD;
      Diet: Both groups will be instructed to ingest a low-residue diet beginning 2 days before the&#xD;
      procedure, (attachment 2) the last low-residual meal at 4 pm on day prior to procedure, with&#xD;
      no food on the day of the procedure. Clear liquid diet after 4 pm on day prior to procedure&#xD;
      and clear liquids on the day of procedure up-to 4 hours prior to the procedure.&#xD;
&#xD;
      Education: Both groups will receive face to face, pre-procedure education 1 week prior to&#xD;
      their procedure. Patient who cannot come for face-to-face education will not be included in&#xD;
      the study.&#xD;
&#xD;
      Reminders: Both groups will receive a telephone call 2 days prior to their procedure to&#xD;
      remind them of their procedure and to remind them to take the laxative preparation as&#xD;
      prescribed.&#xD;
&#xD;
      Compliance: Patient will receive an educational handout about bowel preparation and&#xD;
      colonoscopy. This practice is standard for all patients receiving colonoscopy at our&#xD;
      institute. All Patients will get a copy of low residual diet and be asked to complete diet&#xD;
      intake handout for 2 days prior to procedure. Patients will be requested to bring their&#xD;
      unused Golytely prep medications to evaluate compliance.&#xD;
&#xD;
      Tolerability: The tolerability of the bowel preparation will be assessed using the validated&#xD;
      Mayo clinic bowel prep tolerability questionnaire. (Attachment 3) On the day of the&#xD;
      procedure, a member of the research team will review the patient's diet for the previous 2&#xD;
      days, the proportion of bowel prep solution ingested, and complications potentially related&#xD;
      to the preparation (described above); the patient will also complete the Mayo tolerability&#xD;
      questionnaire. Orthostatic vital signs will be checked prior to colonoscopy. Patient will&#xD;
      undergo colonoscopy by an endoscopist following our standard protocols at WHVA MC. The bowel&#xD;
      preparation will be scored using the BBPS and all polyps identified will be recorded and&#xD;
      removed in the standard fashion.&#xD;
&#xD;
      Following discharge, patients will receive a telephone call within 2 days to document any&#xD;
      post-procedure complications, including emergency room visits or hospitalizations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Screening</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Boston Bowel Preparation Scale (BBPS)</measure>
    <time_frame>Day 1</time_frame>
    <description>Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>Day 1</time_frame>
    <description>Adenoma detection rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire</measure>
    <time_frame>Day 1</time_frame>
    <description>patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Single day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single day Golytely purge 4L purge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 day colon purge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two days of Golytely purge 8L purge</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Golytely Oral Solution</intervention_name>
    <description>Bowel purge prior to,colonoscopy</description>
    <arm_group_label>2 day colon purge</arm_group_label>
    <arm_group_label>Single day</arm_group_label>
    <other_name>Bowel purge</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Risk factors that increase likelihood of poor bowel prep&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior colon resection&#xD;
&#xD;
          -  Women of child bearing age&#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_contact>
    <last_name>Anil Nagar, MD</last_name>
    <phone>2039325711</phone>
    <phone_ext>2830</phone_ext>
    <email>anil.nagar@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>West Have VAMC</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>anil nagar, MD</last_name>
      <phone>203-932-5711</phone>
      <phone_ext>2830</phone_ext>
      <email>anil.nagar@va.gov</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>December 2, 2019</last_update_submitted>
  <last_update_submitted_qc>December 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VA Connecticut Healthcare System</investigator_affiliation>
    <investigator_full_name>Anil Nagar</investigator_full_name>
    <investigator_title>Director Of Endoscopy, Associate professor Internal Medicine</investigator_title>
  </responsible_party>
  <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/NCT03011788
org study id: AN0011
nct id: NCT03011788
lead sponsor: 
has dmc: Yes
The aim of this randomized trial is to compare the proportion of patients achieving an
      adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation
      regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2
      consecutive days in a population identified as high risk for an inadequate bowel preparation.

      2. Research Design: This study is a single-center prospective randomized study at the West
      Haven VAMC.

      3. Methodology:

        1. Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation
           Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left,
           transverse, and right).

        2. Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated
           polyp/adenoma detection rate, patient tolerability of preparation using the validated
           Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related to
           bowel preparation

      Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high
      risk for poor bowel preparation,
Group 1: One day of split-dose Golytely 4L (2 liters the evening before procedure, 2 liters
      the morning of procedure) Group 2: Two days of split-dose Golytely 4L (beginning 2 days
      before the procedure with 2 liters in the evening, 2 liters the morning of the day before the
      procedure, 2 liters the evening before the procedure, 2 liters the morning of the procedure)
      Patients will be instructed to ingest each of the 2-liter aliquots of Golytely over 2 hours.

      Diet: Both groups will be instructed to ingest a low-residue diet beginning 2 days before the
      procedure, (attachment 2) the last low-residual meal at 4 pm on day prior to procedure, with
      no food on the day of the procedure. Clear liquid diet after 4 pm on day prior to procedure
      and clear liquids on the day of procedure up-to 4 hours prior to the procedure.

      Education: Both groups will receive face to face, pre-procedure education 1 week prior to
      their procedure. Patient who cannot come for face-to-face education will not be included in
      the study.

      Reminders: Both groups will receive a telephone call 2 days prior to their procedure to
      remind them of their procedure and to remind them to take the laxative preparation as
      prescribed.

      Compliance: Patient will receive an educational handout about bowel preparation and
      colonoscopy. This practice is standard for all patients receiving colonoscopy at our
      institute. All Patients will get a copy of low residual diet and be asked to complete diet
      intake handout for 2 days prior to procedure. Patients will be requested to bring their
      unused Golytely prep medications to evaluate compliance.

      Tolerability: The tolerability of the bowel preparation will be assessed using the validated
      Mayo clinic bowel prep tolerability questionnaire. (Attachment 3) On the day of the
      procedure, a member of the research team will review the patient's diet for the previous 2
      days, the proportion of bowel prep solution ingested, and complications potentially related
      to the preparation (described above); the patient will also complete the Mayo tolerability
      questionnaire. Orthostatic vital signs will be checked prior to colonoscopy. Patient will
      undergo colonoscopy by an endoscopist following our standard protocols at WHVA MC. The bowel
      preparation will be scored using the BBPS and all polyps identified will be recorded and
      removed in the standard fashion.

      Following discharge, patients will receive a telephone call within 2 days to document any
      post-procedure complications, including emergency room visits or hospitalizations.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Investigator)
measure: Boston Bowel Preparation Scale (BBPS)
time frame: Day 1
description: Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments
measure: Adenoma detection rate
time frame: Day 1
description: Adenoma detection rates
measure: patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire
time frame: Day 1
description: patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire
arm group label: Single day
arm group type: Active Comparator
description: Single day Golytely purge 4L purge
arm group label: 2 day colon purge
arm group type: Active Comparator
description: Two days of Golytely purge 8L purge
intervention type: Drug
intervention name: Golytely Oral Solution
description: Bowel purge prior to,colonoscopy
arm group label: 2 day colon purge
arm group label: Single day
other name: Bowel purge
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anil Nagar, MD
phone: 2039325711
phone ext: 2830
email: anil.nagar@va.gov
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: VA Connecticut Healthcare System
investigator full name: Anil Nagar
investigator title: Director Of Endoscopy, Associate professor Internal Medicine
sharing ipd: No