<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/NCT02998255</url>
  </required_header>
  <id_info>
    <org_study_id>KY20162097-5</org_study_id>
    <nct_id>NCT02998255</nct_id>
  </id_info>
  <brief_title>Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients Undergoing Colonoscopy</brief_title>
  <official_title>Effect of Single Dose of 2L PEG on Bowel Preparation in Average-risk Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Air Force Military Medical University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Air Force Military Medical University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines&#xD;
      recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the&#xD;
      high-volume PEG still results in lower compliance to the regime and increased cost.&#xD;
&#xD;
      Some high risk factors for inadequate BP have been identified, including old age,&#xD;
      constipation, diabetes, the use of narcotics and prior history of inadequate BP. For&#xD;
      average-risk patients without the high risk factors, the procedure of BP could be easier. In&#xD;
      the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk&#xD;
      patients achieved adequate BP. Here investigators hypothesized that compared with the&#xD;
      standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while&#xD;
      may be accompanied with better tolerability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)</measure>
    <time_frame>1 year</time_frame>
    <description>The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.The withdrawal procedure was recorded by vedios. The BBPS and segmental scores in each segment were judged by one endoscopist who was familiar with the criteria of BBPS and blinded to group allocation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>adverse events, such as vomiting, nausea, headache, abdominal pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cecal intubation rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cecal intubation time</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Withdrawal time</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness to repeat bowel preparation</measure>
    <time_frame>1 year</time_frame>
    <description>The number of patients have a willingness to undergo a repeated bowel preparation if needed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">940</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Single dose of 2L PEG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 L of PEG solution was used on the day of colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Split-dose of 4L PEG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Split-dose of 4l PEG was used before and on the day of colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single dose of 2L PEG</intervention_name>
    <description>Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.</description>
    <arm_group_label>Single dose of 2L PEG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Split dose of 4L PEG</intervention_name>
    <description>All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.</description>
    <arm_group_label>Split-dose of 4L PEG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing colonoscopy;&#xD;
&#xD;
          -  Patients with average risks for inadequate BP (Patients were identified average-risk&#xD;
             if they did not meet any factor of the following risk factors):&#xD;
&#xD;
               -  Constipation&#xD;
&#xD;
               -  Diabetes&#xD;
&#xD;
               -  Parkinson's disease&#xD;
&#xD;
               -  History of stroke or spine cord injure&#xD;
&#xD;
               -  Prior history of inadequate bowel preparation&#xD;
&#xD;
               -  BMI&gt;25&#xD;
&#xD;
               -  Use of tricyclic antidepressant or narcotics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of colorectal resection;&#xD;
&#xD;
          -  Suspected colonic stricture or perforation;&#xD;
&#xD;
          -  Incomplete or complete bowel obstruction;&#xD;
&#xD;
          -  Use of prokinetic agents or purgatives within 7 days;&#xD;
&#xD;
          -  Toxic colitis or megacolon;&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Unable to give informed consent;&#xD;
&#xD;
          -  Haemodynamically unstable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of gastroenterology, Qinghai Provincial People's Hospital</name>
      <address>
        <city>Xining</city>
        <state>Qinghai</state>
        <zip>810000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of gastroenterology, Shaanxi Second People's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoscopic center, Xijing Hospital of Digestive Diseases</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Air Force Military Medical University, China</investigator_affiliation>
    <investigator_full_name>Yanglin Pan</investigator_full_name>
    <investigator_title>Associated professor</investigator_title>
  </responsible_party>
  <keyword>PEG</keyword>
  <keyword>Bowel preparation</keyword>
  <keyword>Colonoscopy</keyword>
  <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/NCT02998255
org study id: KY20162097-5
nct id: NCT02998255
lead sponsor: 
has dmc: Yes
Adequate quality of bowel preparation(BP) is important for colonoscopy. Several guidelines
      recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the
      high-volume PEG still results in lower compliance to the regime and increased cost.

      Some high risk factors for inadequate BP have been identified, including old age,
      constipation, diabetes, the use of narcotics and prior history of inadequate BP. For
      average-risk patients without the high risk factors, the procedure of BP could be easier. In
      the previous study, with the use of single dose of 2L PEG, more than 90% of average-risk
      patients achieved adequate BP. Here investigators hypothesized that compared with the
      standard split dose of 4L PEG, single dose of 2L PEG may be not inferior in BP quality while
      may be accompanied with better tolerability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Rate of adequate bowel preparation(defined as a total BostonBowel Preparation Score ≥6 with each segmental BBPS≥2)
time frame: 1 year
description: The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9.The withdrawal procedure was recorded by vedios. The BBPS and segmental scores in each segment were judged by one endoscopist who was familiar with the criteria of BBPS and blinded to group allocation.
measure: Polyp detection rate
time frame: 1 year
measure: Rate of adverse events
time frame: 1 year
description: adverse events, such as vomiting, nausea, headache, abdominal pain
measure: Cecal intubation rate
time frame: 1 year
measure: Cecal intubation time
time frame: 1 year
measure: Withdrawal time
time frame: 1 year
measure: Willingness to repeat bowel preparation
time frame: 1 year
description: The number of patients have a willingness to undergo a repeated bowel preparation if needed
arm group label: Single dose of 2L PEG
arm group type: Experimental
description: 2 L of PEG solution was used on the day of colonoscopy.
arm group label: Split-dose of 4L PEG
arm group type: Active Comparator
description: Split-dose of 4l PEG was used before and on the day of colonoscopy
intervention type: Drug
intervention name: Single dose of 2L PEG
description: Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.
arm group label: Single dose of 2L PEG
intervention type: Drug
intervention name: Split dose of 4L PEG
description: All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
arm group label: Split-dose of 4L PEG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Yanglin Pan
investigator title: Associated professor
sharing ipd: No