<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/NCT03306030</url>
  </required_header>
  <id_info>
    <org_study_id>KY20172055-2</org_study_id>
    <nct_id>NCT03306030</nct_id>
  </id_info>
  <brief_title>Comparison of Two Methods for Bowel Preparation in Patients With Constipation</brief_title>
  <official_title>Comparison of Two Split-dose Regimes for Bowel Preparation in Patients With Constipation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Constipation is a common high risk factor for inadequate bowel preparation. The bowel&#xD;
      cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated&#xD;
      patients. The investigator hypothesized that compared with the standard preparation regime,&#xD;
      the split-dose with three times of 4L PEG may be superior in BP quality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">November 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2018</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</measure>
    <time_frame>1 year</time_frame>
    <description>Adequacy of bowel preparation quality was defined as a total score ≥6 and each segmental score ≥2. The total scores included 3 scores of colonic regions: the right side, the transverse section, and the left side, which ranged from 0 to 9 (0= very poor, 9=excellent). For the unreached colon in incomplete colonoscopy, the segmental BBPS was scored as 0. The total and segmental scores were judged through videos by investigators who were familiar with the criteria and blinded to group allocation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse event rate</measure>
    <time_frame>1 year</time_frame>
  </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>Polyps detection rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Split group</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>
  <arm_group>
    <arm_group_label>Three times group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three times-dose of 4l PEG was used before and on the day of colonoscop of 4l PEG was used before and on the day of colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Split dose of 4L PEG</intervention_name>
    <description>All patients were given oral instruction for bowel preparation on the day of appointment and re-instruction through phone call on two days before scheduled colonoscopy. They were instructed to have a regular lunch and take only clear liquid or low-residual food for the dinner on the day before colonoscopy. The participants began to drink the first 2 L of PEG at 7:00-9 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 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Three times dose of 4L PEG</intervention_name>
    <description>The same as mentioned above. The participants began to drink the first 1.5 L of PEG at 2:00 PM and the second 1.5L of PEG at 8:00PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients take the remaining 1.0 L 4-6 hours before colonoscopy.</description>
    <arm_group_label>Three times group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18-80 with constipation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of colorectal surgery BMI&gt;30 Suspected colonic stricture or bowel obstruction&#xD;
             Use of purgatives within 3 days Pregnancy or lactation Unable to give informed consent&#xD;
             Haemodynamically unstable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hui Jia</last_name>
    <phone>+862984771536</phone>
    <email>jiahuifmmu@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Endoscopic center, Xijing Hospital of Digestive Diseases</name>
      <address>
        <city>Xi'an</city>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Jia, MD</last_name>
      <phone>+862984771536</phone>
      <email>jiahuifmmu@163.com</email>
    </contact>
    <investigator>
      <last_name>Yanglin Pan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>November 24, 2017</last_update_submitted>
  <last_update_submitted_qc>November 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 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>
  <keyword>split-does</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</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/NCT03306030
org study id: KY20172055-2
nct id: NCT03306030
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Constipation is a common high risk factor for inadequate bowel preparation. The bowel
      cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated
      patients. The investigator hypothesized that compared with the standard preparation regime,
      the split-dose with three times of 4L PEG may be superior in BP quality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Rate of adequate bowel preparation
time frame: 1 year
description: Adequacy of bowel preparation quality was defined as a total score ≥6 and each segmental score ≥2. The total scores included 3 scores of colonic regions: the right side, the transverse section, and the left side, which ranged from 0 to 9 (0= very poor, 9=excellent). For the unreached colon in incomplete colonoscopy, the segmental BBPS was scored as 0. The total and segmental scores were judged through videos by investigators who were familiar with the criteria and blinded to group allocation.
measure: Adverse event rate
time frame: 1 year
measure: Cecal intubation rate
time frame: 1 year
measure: Cecal intubation time
time frame: 1 year
measure: Withdrawal time
time frame: 1 year
measure: Polyps detection rate
time frame: 1 year
arm group label: Split group
arm group type: Active Comparator
description: Split-dose of 4l PEG was used before and on the day of colonoscopy
arm group label: Three times group
arm group type: Experimental
description: Three times-dose of 4l PEG was used before and on the day of colonoscop of 4l PEG was used before and on the day of colonoscopy
intervention type: Drug
intervention name: Split dose of 4L PEG
description: All patients were given oral instruction for bowel preparation on the day of appointment and re-instruction through phone call on two days before scheduled colonoscopy. They were instructed to have a regular lunch and take only clear liquid or low-residual food for the dinner on the day before colonoscopy. The participants began to drink the first 2 L of PEG at 7:00-9 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 group
intervention type: Drug
intervention name: Three times dose of 4L PEG
description: The same as mentioned above. The participants began to drink the first 1.5 L of PEG at 2:00 PM and the second 1.5L of PEG at 8:00PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients take the remaining 1.0 L 4-6 hours before colonoscopy.
arm group label: Three times group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hui Jia
phone: +862984771536
email: jiahuifmmu@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Yanglin Pan
investigator title: Associated professor
mesh term: Constipation
sharing ipd: No