<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/NCT03298945</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 15-346</org_study_id>
    <nct_id>NCT03298945</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens</brief_title>
  <official_title>Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      From the patients' perspective, the most formidable part of the colonoscopy experience is the&#xD;
      process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to&#xD;
      incompletion of scheduled colonoscopies which in turn undermines the effectiveness of&#xD;
      colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel&#xD;
      preparation in the VA is of larger volume and less palatable than another commonly used bowel&#xD;
      preparation regimen. The investigators propose to compare these two commonly used bowel&#xD;
      preparations with respect to the overall completion rate of scheduled colonoscopies in a&#xD;
      real-world VA practice setting. The results of the study can be immediately applied to&#xD;
      maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anticipated Impacts on Veterans Health Care: by identifying a colonoscopy bowel preparation&#xD;
      regimen which is the most effective in real-world VA practice and can be immediately&#xD;
      implemented on a VA-wide scale, the proposed study will maximize the effectiveness of&#xD;
      colonoscopy in reducing colorectal cancer (CRC) risk among Veterans, increase Veteran&#xD;
      satisfaction, and reduce VA healthcare cost. Background: CRC is a leading cause of&#xD;
      cancer-related death among Veterans. Colonoscopy can effectively reduce CRC incidence and&#xD;
      mortality. However, non-adherence to screening colonoscopy substantially undermines this&#xD;
      benefit. Existing evidence indicates that a disagreeable bowel preparation is a leading&#xD;
      barrier to completing a colonoscopy from the patients' perspective. The taste and the volume&#xD;
      of the bowel preparation determine patient tolerability and compliance to the preparation&#xD;
      instructions, which in turn affects the incompletion (e.g., cancellation/no-show/reschedule)&#xD;
      rate of scheduled colonoscopies as well as the effectiveness of the completed colonoscopies&#xD;
      and patient satisfaction. The two most commonly used preparations currently in the US are the&#xD;
      split-dose 4L polyethylene glycol (PEG) and the split-dose 2L MiraLAX/Gatorade preparations.&#xD;
      While a high-volume regimen may in theory be more effective than a lower volume one, it may&#xD;
      be associated with lower tolerability and adherence in real-world practice. Three small&#xD;
      trials have compared these two preparations. However, data from these explanatory trials&#xD;
      cannot inform policy decisions because they were conducted under artificial conditions,&#xD;
      restricted among narrow patient populations, and most importantly not designed to capture the&#xD;
      full impact of bowel preparation on the completion rate or effectiveness of colonoscopy. To&#xD;
      address this critical knowledge gap, the investigators are proposing a pragmatic trial to&#xD;
      determine the optimal split-dose bowel preparation in the general Veteran population.&#xD;
      Objectives: to compare the real-world effectiveness of the two most commonly used split-dose&#xD;
      colonoscopy bowel preparation regimens in the US (i.e., 4L PEG and 2L MiraLAX/Gatorade) with&#xD;
      respect to the completion rate of scheduled colonoscopies, adenoma detection rate and&#xD;
      secondarily preparation quality, cancellation/no-show rate and patient-oriented outcomes&#xD;
      (e.g., willingness to repeat the preparation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>Phase 4</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>Parallel groups</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>colonoscopy completion rate</measure>
    <time_frame>This outcome is determined within 1 month after colonoscopy</time_frame>
    <description>The completion rate of scheduled colonoscopy will be defined as the proportion of patients who show up for their scheduled colonoscopy and have endoscopist-rated &quot;adequate&quot; bowel preparation quality, among those scheduled for a colonoscopy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Population level adenoma detection rate (ADR)</measure>
    <time_frame>within 1 month of colonoscopy</time_frame>
    <description>the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cancellation or no-show in each bowel prep arm</measure>
    <time_frame>within 1 month after colonoscopy</time_frame>
    <description>The proportion of patients who cancel or no-show in each group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate bowel prep quality</measure>
    <time_frame>within 1 month after the colonoscopy</time_frame>
    <description>this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy</measure>
    <time_frame>within 1 month after colonoscopy</time_frame>
    <description>patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy</description>
  </other_outcome>
  <other_outcome>
    <measure>hyponatremia</measure>
    <time_frame>within 6 months after colonoscopy</time_frame>
    <description>Hyponatremia</description>
  </other_outcome>
  <other_outcome>
    <measure>renal failure</measure>
    <time_frame>within 6 months of colonoscopy</time_frame>
    <description>renal failure documented in CPRS</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2261</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Golytely</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4-L split-dose Golytely bowel prep</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Miralax-Gatorade prep</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2-L split-dose Miralax-Gatorade bowel prep</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miralax-Gatorade Prep</intervention_name>
    <description>2-L split-dose Miralax-Gatorade bowel prep for colonoscopy</description>
    <arm_group_label>Miralax-Gatorade prep</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Golytely</intervention_name>
    <description>4-L split dose Golytely is the current standard prep at the VA</description>
    <arm_group_label>Golytely</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 18 years of age, and&#xD;
&#xD;
          -  being scheduled for outpatient elective screening, surveillance or diagnostic&#xD;
             colonoscopies, and&#xD;
&#xD;
          -  the provider ordering the colonoscopy giving permission to enroll the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are &lt;18 years&#xD;
&#xD;
          -  undergoing inpatient colonoscopy&#xD;
&#xD;
          -  those with contra-indications to receiving the standard 4L PEG-ELS colonoscopy bowel&#xD;
             preparation (e.g., allergy to PEG) will be excluded&#xD;
&#xD;
               -  The investigators are excluding inpatient colonoscopies because they account for&#xD;
                  a very small fraction of the total colonoscopies performed.&#xD;
&#xD;
               -  Also, inpatient colonoscopies are often performed for urgent reasons such that&#xD;
                  rapid bowel preparation procedures are followed.&#xD;
&#xD;
          -  In addition, because the objective of inpatient colonoscopy is often not to look for&#xD;
             small polyps, the threshold for &quot;adequate&quot; bowel preparation quality might be&#xD;
             different from that for outpatient procedures.&#xD;
&#xD;
          -  In addition, for patients undergoing more than 1 colonoscopy during the study period,&#xD;
             only their first colonoscopy will be included in the primary analysis.&#xD;
&#xD;
          -  Patients who are undergoing a repeat colonoscopy for to a recent inadequate&#xD;
             colonoscopy examination with poor bowel preparation will be excluded.&#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>Yu-Xiao Yang, MD MSCE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-4551</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Patel D, Yang YX, Trivedi C, Kavani H, Xie D, Medvedeva E, Lewis J, Khan N. Incidence, Duration, and Management of Anemia: A Nationwide Comparison Between IBD and Non-IBD Populations. Inflamm Bowel Dis. 2020 May 12;26(6):934-940. doi: 10.1093/ibd/izz206.</citation>
    <PMID>31560755</PMID>
  </results_reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colonoscopy</keyword>
  <keyword>colorectal cancer</keyword>
  <keyword>bowel preparation regimen</keyword>
  <keyword>pragmatic trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyethylene glycol 3350</mesh_term>
  </intervention_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/NCT03298945
org study id: IIR 15-346
nct id: NCT03298945
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
From the patients' perspective, the most formidable part of the colonoscopy experience is the
      process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to
      incompletion of scheduled colonoscopies which in turn undermines the effectiveness of
      colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel
      preparation in the VA is of larger volume and less palatable than another commonly used bowel
      preparation regimen. The investigators propose to compare these two commonly used bowel
      preparations with respect to the overall completion rate of scheduled colonoscopies in a
      real-world VA practice setting. The results of the study can be immediately applied to
      maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.
Anticipated Impacts on Veterans Health Care: by identifying a colonoscopy bowel preparation
      regimen which is the most effective in real-world VA practice and can be immediately
      implemented on a VA-wide scale, the proposed study will maximize the effectiveness of
      colonoscopy in reducing colorectal cancer (CRC) risk among Veterans, increase Veteran
      satisfaction, and reduce VA healthcare cost. Background: CRC is a leading cause of
      cancer-related death among Veterans. Colonoscopy can effectively reduce CRC incidence and
      mortality. However, non-adherence to screening colonoscopy substantially undermines this
      benefit. Existing evidence indicates that a disagreeable bowel preparation is a leading
      barrier to completing a colonoscopy from the patients' perspective. The taste and the volume
      of the bowel preparation determine patient tolerability and compliance to the preparation
      instructions, which in turn affects the incompletion (e.g., cancellation/no-show/reschedule)
      rate of scheduled colonoscopies as well as the effectiveness of the completed colonoscopies
      and patient satisfaction. The two most commonly used preparations currently in the US are the
      split-dose 4L polyethylene glycol (PEG) and the split-dose 2L MiraLAX/Gatorade preparations.
      While a high-volume regimen may in theory be more effective than a lower volume one, it may
      be associated with lower tolerability and adherence in real-world practice. Three small
      trials have compared these two preparations. However, data from these explanatory trials
      cannot inform policy decisions because they were conducted under artificial conditions,
      restricted among narrow patient populations, and most importantly not designed to capture the
      full impact of bowel preparation on the completion rate or effectiveness of colonoscopy. To
      address this critical knowledge gap, the investigators are proposing a pragmatic trial to
      determine the optimal split-dose bowel preparation in the general Veteran population.
      Objectives: to compare the real-world effectiveness of the two most commonly used split-dose
      colonoscopy bowel preparation regimens in the US (i.e., 4L PEG and 2L MiraLAX/Gatorade) with
      respect to the completion rate of scheduled colonoscopies, adenoma detection rate and
      secondarily preparation quality, cancellation/no-show rate and patient-oriented outcomes
      (e.g., willingness to repeat the preparation).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel groups
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: colonoscopy completion rate
time frame: This outcome is determined within 1 month after colonoscopy
description: The completion rate of scheduled colonoscopy will be defined as the proportion of patients who show up for their scheduled colonoscopy and have endoscopist-rated "adequate" bowel preparation quality, among those scheduled for a colonoscopy.
measure: Population level adenoma detection rate (ADR)
time frame: within 1 month of colonoscopy
description: the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.
measure: cancellation or no-show in each bowel prep arm
time frame: within 1 month after colonoscopy
description: The proportion of patients who cancel or no-show in each group.
measure: Adequate bowel prep quality
time frame: within 1 month after the colonoscopy
description: this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation
measure: patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy
time frame: within 1 month after colonoscopy
description: patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy
measure: hyponatremia
time frame: within 6 months after colonoscopy
description: Hyponatremia
measure: renal failure
time frame: within 6 months of colonoscopy
description: renal failure documented in CPRS
arm group label: Golytely
arm group type: Active Comparator
description: 4-L split-dose Golytely bowel prep
arm group label: Miralax-Gatorade prep
arm group type: Experimental
description: 2-L split-dose Miralax-Gatorade bowel prep
intervention type: Drug
intervention name: Miralax-Gatorade Prep
description: 2-L split-dose Miralax-Gatorade bowel prep for colonoscopy
arm group label: Miralax-Gatorade prep
intervention type: Drug
intervention name: Golytely
description: 4-L split dose Golytely is the current standard prep at the VA
arm group label: Golytely
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yu-Xiao Yang, MD MSCE
role: Principal Investigator
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
facility: 
country: United States
citation: Patel D, Yang YX, Trivedi C, Kavani H, Xie D, Medvedeva E, Lewis J, Khan N. Incidence, Duration, and Management of Anemia: A Nationwide Comparison Between IBD and Non-IBD Populations. Inflamm Bowel Dis. 2020 May 12;26(6):934-940. doi: 10.1093/ibd/izz206.
PMID: 31560755
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Polyethylene glycol 3350
sharing ipd: No