<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/NCT03270046</url>
  </required_header>
  <id_info>
    <org_study_id>Si307/2014</org_study_id>
    <nct_id>NCT03270046</nct_id>
  </id_info>
  <brief_title>The Effects of An Addition of Water Enema to PEG for Colon Preparation</brief_title>
  <official_title>The Effects of An Addition of Water Enema to PEG for Colon Preparation: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</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>
      The purpose of this study is to compare the preparation quality by using Ottawa Bowel&#xD;
      Preparation Scale between the standard PEG preparation and the addition of water enema in&#xD;
      participants scheduled for CRC screening&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background : Good bowel preparation improves the rate of polyp detection and the time of&#xD;
      caecal intubation during colorectal cancer (CRC) screening.&#xD;
&#xD;
      Suboptimal bowel preparation can results in adenoma miss rate up to 42% (95% CI, 35-49) and&#xD;
      advanced adenoma miss rate up to 27% (95% CI, 17-41) The European Society of Gastrointestinal&#xD;
      Endoscopy (ESGE) Guideline recommends a split regimen of 4L of polyethylene glycol (PEG)&#xD;
      solution (or a same-day regimen in the case of afternoon colonoscopy) for a routine bowel&#xD;
      preparation and the delay between the last dose of bowel preparation and colonoscopy should&#xD;
      be minimized and no longer than 4 hours.&#xD;
&#xD;
      The investigators hypothesize that the addition of water enema to the standard PEG bowel&#xD;
      preparation could provide the better quality of bowel preparation and then result in&#xD;
      improvement in the rate of adenoma detection among participants scheduled for CRC screening&#xD;
      with preparation to procedure interval &gt; 8 hr.&#xD;
&#xD;
      The purpose of this study is to compare the preparation quality using Ottawa Bowel&#xD;
      Preparation Scale between the standard PEG preparation and the addition of water enema in&#xD;
      participants scheduled for CRC screening. The secondary aim is to compare the effect of the&#xD;
      standard PEG bowel preparation and the addition of water enema in terms of adenoma detection&#xD;
      rate, the completeness of the examination, total and withdrawal time, safety and adverse&#xD;
      events among those scheduled for CRC screening.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>
    <intervention_model_description>In this study, participants will be randomised 1:1 to water enema group or no water enema group using blocked randomization with random block sizes.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bowel preparation quality using Ottawa Bowel Preparation Scale</measure>
    <time_frame>1 days</time_frame>
    <description>Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate</measure>
    <time_frame>1 days</time_frame>
    <description>Evaluate the adenoma detection rate compare between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluate the completeness of examination compare between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluate total and withdrawal times of colonoscopy procedures compare between two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events</measure>
    <time_frame>3 days</time_frame>
    <description>Evaluate the safety and efficacy of procedures compare between two groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Adenoma, Bile Duct</condition>
  <arm_group>
    <arm_group_label>No enema group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy without water enema.&#xD;
Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication. The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale for evaluation of side effect, complication during PEG ingestion, enema and colonoscopy, and participant satisfactory.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Water enema group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy and enema with sterile water until stool was clear or patient felt discomfort but not exceed 3 liter, before colonoscopy.&#xD;
Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication.The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Water enema</intervention_name>
    <description>Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.</description>
    <arm_group_label>No enema group</arm_group_label>
    <arm_group_label>Water enema group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for CRC screening&#xD;
&#xD;
          -  Bowel preparation using 3 liters of PEG solution&#xD;
&#xD;
          -  Colonoscopy performed at 8-16 hours after bowel preparation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of a failed bowel preparation&#xD;
&#xD;
          -  Previous colonic surgery&#xD;
&#xD;
          -  Uncontrolled underlying disease&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Somchai Leelakusolvong, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mahidol University</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>May 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Somchai Leelakusolvong</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Bowel preparation</keyword>
  <keyword>CRC screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Adenoma, Bile Duct</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/NCT03270046
org study id: Si307/2014
nct id: NCT03270046
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the preparation quality by using Ottawa Bowel
      Preparation Scale between the standard PEG preparation and the addition of water enema in
      participants scheduled for CRC screening
Background : Good bowel preparation improves the rate of polyp detection and the time of
      caecal intubation during colorectal cancer (CRC) screening.

      Suboptimal bowel preparation can results in adenoma miss rate up to 42% (95% CI, 35-49) and
      advanced adenoma miss rate up to 27% (95% CI, 17-41) The European Society of Gastrointestinal
      Endoscopy (ESGE) Guideline recommends a split regimen of 4L of polyethylene glycol (PEG)
      solution (or a same-day regimen in the case of afternoon colonoscopy) for a routine bowel
      preparation and the delay between the last dose of bowel preparation and colonoscopy should
      be minimized and no longer than 4 hours.

      The investigators hypothesize that the addition of water enema to the standard PEG bowel
      preparation could provide the better quality of bowel preparation and then result in
      improvement in the rate of adenoma detection among participants scheduled for CRC screening
      with preparation to procedure interval > 8 hr.

      The purpose of this study is to compare the preparation quality using Ottawa Bowel
      Preparation Scale between the standard PEG preparation and the addition of water enema in
      participants scheduled for CRC screening. The secondary aim is to compare the effect of the
      standard PEG bowel preparation and the addition of water enema in terms of adenoma detection
      rate, the completeness of the examination, total and withdrawal time, safety and adverse
      events among those scheduled for CRC screening.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, participants will be randomised 1:1 to water enema group or no water enema group using blocked randomization with random block sizes.
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Bowel preparation quality using Ottawa Bowel Preparation Scale
time frame: 1 days
description: Evaluate Ottawa Bowel Preparation Scale by 2 endoscopists using video record
measure: The effect of addition of water enema in standard PEG bowel preparation in terms of adenoma detection rate
time frame: 1 days
description: Evaluate the adenoma detection rate compare between two groups
measure: The effect of addition of water enema in the standard PEG bowel preparation in terms of the completeness of the examination
time frame: 1 day
description: Evaluate the completeness of examination compare between two groups
measure: The effect of addition of water enema in the standard PEG bowel preparation in terms of total and withdrawal times
time frame: 1 day
description: Evaluate total and withdrawal times of colonoscopy procedures compare between two groups
measure: The effect of addition of water enema in the standard PEG bowel preparation in terms of safety and adverse events
time frame: 3 days
description: Evaluate the safety and efficacy of procedures compare between two groups
arm group label: No enema group
arm group type: Placebo Comparator
description: Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy without water enema.
Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication. The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale for evaluation of side effect, complication during PEG ingestion, enema and colonoscopy, and participant satisfactory.
arm group label: Water enema group
arm group type: Active Comparator
description: Consecutive participants will be randomly assigned to take a preparation regimen of 3 liter of PEG 8-16 hr. before colonoscopy and enema with sterile water until stool was clear or patient felt discomfort but not exceed 3 liter, before colonoscopy.
Before the procedure, investigators record baseline parameters. Colonoscopies underwent by experienced endoscopists and by GI fellows. During the colonoscopy, the investigators recorded video, cecal intubation and withdraw time, amount and position of polyps, rate of complete examination and complication.The video was sent to other 2 endoscopists who did not known which participant was enema to evaluate the quality of bowel cleansing by using Ottawa bowel preparation scale and Likert scale.
intervention type: Procedure
intervention name: Water enema
description: Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.
arm group label: No enema group
arm group label: Water enema group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Somchai Leelakusolvong, M.D.
role: Principal Investigator
affiliation: Mahidol University
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Somchai Leelakusolvong
investigator title: Associate professor
mesh term: Adenoma
mesh term: Adenoma, Bile Duct
sharing ipd: No