<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/NCT03817788</url>
  </required_header>
  <id_info>
    <org_study_id>130022</org_study_id>
    <nct_id>NCT03817788</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy</brief_title>
  <official_title>Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong Yang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xu Hong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jilin University</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>
      This study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of&#xD;
      colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2019</start_date>
  <completion_date type="Actual">April 12, 2020</completion_date>
  <primary_completion_date type="Actual">April 2, 2020</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cleansing quality</measure>
    <time_frame>during the procedure of colonoscopy</time_frame>
    <description>The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the duration of the procedure</measure>
    <time_frame>during the procedure of colonoscopy</time_frame>
    <description>time to cecal intubation and withdrawal time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient tolerance</measure>
    <time_frame>before the procedure of colonoscopy</time_frame>
    <description>patient tolerance about oral laxatives.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the degree of difficulty of the procedure</measure>
    <time_frame>at the end of the procedure of colonoscopy</time_frame>
    <description>6-point scale: extremely easy, easy, fairly easy, fairly difficult, difficult, extremely difficult</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>polyps or other endoscopic lesions</measure>
    <time_frame>at the end of the procedure of colonoscopy</time_frame>
    <description>For polyps or other endoscopic lesions, a histopathologic diagnosis was systematically obtained and recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient pain</measure>
    <time_frame>at the end of the procedure of colonoscopy</time_frame>
    <description>(visual analog scale, 0-10).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">586</enrollment>
  <condition>Polyethylene Glycol</condition>
  <condition>Sodium Phosphate</condition>
  <arm_group>
    <arm_group_label>polyethylene glycol group (group P)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sodium phosphate group (group S)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>polyethylene glycol</intervention_name>
    <description>All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For polyethylene glycol group (group P): the day before colonoscopy, 750 mL (1 box) of polyethylene glycol solution should be drunk 2 hours after dinner; the other 1500 ml (2 boxes) of polyethylene glycol solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same juniar clinician, and related indicators were recorded.</description>
    <arm_group_label>polyethylene glycol group (group P)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sodium phosphate</intervention_name>
    <description>All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For sodium phosphate group (group S), 750 mL (1 box) of sodium phosphate solution should be drunk 2 hours after dinner; and the other 750 mL (1 box) of sodium phosphate solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same clinician, and related indicators were recorded.</description>
    <arm_group_label>sodium phosphate group (group S)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients meet the following criteria: 1) age 18-60 years; 2) BMI 18.9-28; 3) Heart,&#xD;
             lung, liver, and kidney function can tolerate colonoscopy; 4) Patients and their&#xD;
             families are able to understand and be willing to participate in this clinical study&#xD;
             and to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) colorectal surgery history (except appendectomy); 2) patients with intestinal&#xD;
             obstruction, incomplete obstruction, intestinal hemorrhage; 3) patients with renal&#xD;
             insufficiency; 4) patients with hirschsprung disease; 5) patients with inflammatory&#xD;
             bowel disease during active period, which affects intestinal observation; 6) patients&#xD;
             who are bedridden and lose the moving ability ; 7) have a history of severe mental&#xD;
             illness; 8) pregnant or lactating women; 9) patients with other clinical conditions&#xD;
             considered by some researchers should not participate in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>the First Hospital of Jilin University</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 15, 2020</last_update_submitted>
  <last_update_submitted_qc>April 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Jilin University</investigator_affiliation>
    <investigator_full_name>Dong Yang</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers.</ipd_description>
  </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/NCT03817788
org study id: 130022
nct id: NCT03817788
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of
      colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Cleansing quality
time frame: during the procedure of colonoscopy
description: The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.
measure: the duration of the procedure
time frame: during the procedure of colonoscopy
description: time to cecal intubation and withdrawal time
measure: patient tolerance
time frame: before the procedure of colonoscopy
description: patient tolerance about oral laxatives.
measure: the degree of difficulty of the procedure
time frame: at the end of the procedure of colonoscopy
description: 6-point scale: extremely easy, easy, fairly easy, fairly difficult, difficult, extremely difficult
measure: polyps or other endoscopic lesions
time frame: at the end of the procedure of colonoscopy
description: For polyps or other endoscopic lesions, a histopathologic diagnosis was systematically obtained and recorded
measure: patient pain
time frame: at the end of the procedure of colonoscopy
description: (visual analog scale, 0-10).
arm group label: polyethylene glycol group (group P)
arm group type: Active Comparator
description: For all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy
arm group label: sodium phosphate group (group S)
arm group type: Experimental
description: For all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy
intervention type: Drug
intervention name: polyethylene glycol
description: All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For polyethylene glycol group (group P): the day before colonoscopy, 750 mL (1 box) of polyethylene glycol solution should be drunk 2 hours after dinner; the other 1500 ml (2 boxes) of polyethylene glycol solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same juniar clinician, and related indicators were recorded.
arm group label: polyethylene glycol group (group P)
intervention type: Drug
intervention name: sodium phosphate
description: All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For sodium phosphate group (group S), 750 mL (1 box) of sodium phosphate solution should be drunk 2 hours after dinner; and the other 750 mL (1 box) of sodium phosphate solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same clinician, and related indicators were recorded.
arm group label: sodium phosphate group (group S)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Jilin University
investigator full name: Dong Yang
investigator title: Doctor
sharing ipd: No
ipd description: There is no plan to make individual participant data (IPD) available to other researchers.