<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/NCT03765216</url>
  </required_header>
  <id_info>
    <org_study_id>2018SDU-QILU-09</org_study_id>
    <nct_id>NCT03765216</nct_id>
  </id_info>
  <brief_title>Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study</brief_title>
  <official_title>Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong 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>
      About 30% of patients were reported to suffer inadequate bowel preparation. So, it is&#xD;
      desirable to prescribe personalized regimen according to patient's personal characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole&#xD;
      colon. Inadequate bowel preparation is the predominant threaten to the efficacy of&#xD;
      colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel&#xD;
      preparation. In order to improve adequate bowel preparation rate, it is desirable to&#xD;
      prescribe personalized regimen according to patient characteristics. We intend to improve&#xD;
      adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are&#xD;
      many predictive factors of inadequate bowel preparation such as obesity, constipation,&#xD;
      abdominal surgery and so on. By recognizing these risk factors of the patients , we can&#xD;
      prescribe the patients with higher dose of bowel cleansing regimen to improve bowel&#xD;
      preparation quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">March 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2019</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>Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequate bowel preparation rates</measure>
    <time_frame>2 months</time_frame>
    <description>Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>2 months</time_frame>
    <description>Polyp detection rates between 2 groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Bowel Preparation</condition>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Group A: standard group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: tailored group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage).&#xD;
Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2L Polyethylene Glycol (PEG)</intervention_name>
    <description>Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen</description>
    <arm_group_label>Group A: standard group</arm_group_label>
    <arm_group_label>Group B: tailored group</arm_group_label>
    <other_name>Standard</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4L Polyethylene Glycol (PEG)</intervention_name>
    <description>High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen</description>
    <arm_group_label>Group B: tailored group</arm_group_label>
    <other_name>High dose</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged 18 or older&#xD;
&#xD;
          -  patients undergoing colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with a history of colorectal surgery&#xD;
&#xD;
          -  patients with severe colonic stricture or obstructing tumor&#xD;
&#xD;
          -  patients with dysphagia&#xD;
&#xD;
          -  patients with compromised swallowing reflex or mental status&#xD;
&#xD;
          -  patients with significant gastroparesis or gastric outlet obstruction&#xD;
&#xD;
          -  patients with known or suspected bowel obstruction or perforation&#xD;
&#xD;
          -  patients with severe chronic renal failure (creatinine clearance&lt;30 ml/min)&#xD;
&#xD;
          -  patients with severe chronic renal failure (creatinine clearance&lt;30 ml/min)&#xD;
&#xD;
          -  patients with uncontrolled hypertension (systolic blood pressure&gt;170 mm Hg, diastolic&#xD;
             blood pressure&gt;100 mm Hg)&#xD;
&#xD;
          -  patients with inflammatory bowel disease or megacolon&#xD;
&#xD;
          -  patients with dehydration&#xD;
&#xD;
          -  patients with dehydration&#xD;
&#xD;
          -  patients with pregnancy or lactation&#xD;
&#xD;
          -  patients hemodynamically unstable&#xD;
&#xD;
          -  patients unable to give informed consent&#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_official>
    <last_name>Li Yanqing, PhD,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Qilu Hospital, Shandong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Li Yanqing, PhD,MD</last_name>
    <phone>86-531-82169236</phone>
    <email>liyanqing@sdu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Gastroenterology, Qilu Hospital, Shandong University</name>
      <address>
        <city>Ji'nan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Yanqing Li</investigator_full_name>
    <investigator_title>Vice President of Qilu Hospital</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The individual participant data of this trial will be shared when necessary</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/NCT03765216
org study id: 2018SDU-QILU-09
nct id: NCT03765216
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
About 30% of patients were reported to suffer inadequate bowel preparation. So, it is
      desirable to prescribe personalized regimen according to patient's personal characteristics.
Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole
      colon. Inadequate bowel preparation is the predominant threaten to the efficacy of
      colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel
      preparation. In order to improve adequate bowel preparation rate, it is desirable to
      prescribe personalized regimen according to patient characteristics. We intend to improve
      adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are
      many predictive factors of inadequate bowel preparation such as obesity, constipation,
      abdominal surgery and so on. By recognizing these risk factors of the patients , we can
      prescribe the patients with higher dose of bowel cleansing regimen to improve bowel
      preparation quality.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.
primary purpose: Prevention
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Adequate bowel preparation rates
time frame: 2 months
description: Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)
measure: Polyp detection rate
time frame: 2 months
description: Polyp detection rates between 2 groups
arm group label: Group A: standard group
arm group type: Active Comparator
description: Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.
arm group label: Group B: tailored group
arm group type: Experimental
description: Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage).
Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.
intervention type: Drug
intervention name: 2L Polyethylene Glycol (PEG)
description: Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen
arm group label: Group A: standard group
arm group label: Group B: tailored group
other name: Standard
intervention type: Drug
intervention name: 4L Polyethylene Glycol (PEG)
description: High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen
arm group label: Group B: tailored group
other name: High dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Li Yanqing, PhD,MD
role: Principal Investigator
affiliation: Qilu Hospital, Shandong University
last name: Li Yanqing, PhD,MD
phone: 86-531-82169236
email: liyanqing@sdu.edu.cn
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Yanqing Li
investigator title: Vice President of Qilu Hospital
sharing ipd: Undecided
ipd description: The individual participant data of this trial will be shared when necessary