<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/NCT04434625</url>
  </required_header>
  <id_info>
    <org_study_id>KY20200614-3</org_study_id>
    <nct_id>NCT04434625</nct_id>
  </id_info>
  <brief_title>The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors</brief_title>
  <official_title>The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors: a Multicenter, Randomized Controlled Study</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>
      The rate of adequate bowel preparation is one of important quality indicators of colonoscopy.&#xD;
      Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with&#xD;
      inadequate bowel preparation were identified before the procedure, enhanced strategy could be&#xD;
      offered to achieve better bowel cleaning. Currently, there were three predicting models of&#xD;
      inadequate bowel preparation established based on patient-related factors. So far, none of&#xD;
      predictive models have been tested in other than their validation cohort populations, and no&#xD;
      study has attempted to apply a different regimen to patients presenting with risk factors for&#xD;
      inadequate colon cleanliness. In previous studies, we established a prediction model based on&#xD;
      procedure-related factors, which has better accuracy and can better predict the quality of&#xD;
      bowel preparation.&#xD;
&#xD;
      The aim of this study is to compare the quality of bowel preparation by using a predictive&#xD;
      model based on procedure-related factors versus the criterion group in unsedation patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 14, 2020</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequate bowel preparation</measure>
    <time_frame>6 months</time_frame>
    <description>Defined by each segmental BBPS≥2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>6 months</time_frame>
    <description>The proportion of participants with at least one adenoma in each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall complication related to bowel preparation</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">900</enrollment>
  <condition>Colonoscopy</condition>
  <condition>Bowel Preparation</condition>
  <condition>Predictive Model</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Colonoscopy was performed in the control group directly.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>model-based interference group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score&lt;3 in IM group colonoscopy directly.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polyethylene glycol</intervention_name>
    <description>Before colonoscopy, patient-related and procedure-related parameters were collected by one investigator in each center. In MI group, a procedure-based score, used for predicting inadequate bowel preparation, was calculated for each patients. Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score&lt;3 in IM group and those in the control group underwent colonoscopy directly</description>
    <arm_group_label>model-based interference group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18~75 years&#xD;
&#xD;
          -  Patients undergoing morning colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  colon resection;&#xD;
&#xD;
          -  suspected bowel obstruction;&#xD;
&#xD;
          -  moderate or severe complications related to drinking the 1st or 2rd dose of PEG&#xD;
&#xD;
          -  hemodynamically unstable;&#xD;
&#xD;
          -  lactating or pregnant women;&#xD;
&#xD;
          -  no need to reach the ileocecal segment&#xD;
&#xD;
          -  unwilling to provided informed content.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanglin Pan, M.D</last_name>
    <role>Study Chair</role>
    <affiliation>Air Force Military Medical University, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology, Hongai Hospital</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <zip>361000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Holistic Integrative Medicine, Shenzhen Hospital of Southern Medical University</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Gastroenterology, Huaihe Hospital of Henan University</name>
      <address>
        <city>Kaifeng</city>
        <state>Henan</state>
        <zip>475000</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>710005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endoscopic center, Xijing Hospital of Digestive Diseases</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.</citation>
    <PMID>22239959</PMID>
  </reference>
  <reference>
    <citation>Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.</citation>
    <PMID>25600879</PMID>
  </reference>
  <reference>
    <citation>Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.</citation>
    <PMID>28282690</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</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>factors</keyword>
  <keyword>bowel preparation</keyword>
  <keyword>colonoscopy</keyword>
  <!-- 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/NCT04434625
org study id: KY20200614-3
nct id: NCT04434625
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The rate of adequate bowel preparation is one of important quality indicators of colonoscopy.
      Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with
      inadequate bowel preparation were identified before the procedure, enhanced strategy could be
      offered to achieve better bowel cleaning. Currently, there were three predicting models of
      inadequate bowel preparation established based on patient-related factors. So far, none of
      predictive models have been tested in other than their validation cohort populations, and no
      study has attempted to apply a different regimen to patients presenting with risk factors for
      inadequate colon cleanliness. In previous studies, we established a prediction model based on
      procedure-related factors, which has better accuracy and can better predict the quality of
      bowel preparation.

      The aim of this study is to compare the quality of bowel preparation by using a predictive
      model based on procedure-related factors versus the criterion group in unsedation patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Adequate bowel preparation
time frame: 6 months
description: Defined by each segmental BBPS≥2
measure: Adenoma detection rate
time frame: 6 months
description: The proportion of participants with at least one adenoma in each group
measure: Overall complication related to bowel preparation
time frame: 6 months
arm group label: control group
arm group type: No Intervention
description: Colonoscopy was performed in the control group directly.
arm group label: model-based interference group
arm group type: Experimental
description: Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group colonoscopy directly.
intervention type: Drug
intervention name: Polyethylene glycol
description: Before colonoscopy, patient-related and procedure-related parameters were collected by one investigator in each center. In MI group, a procedure-based score, used for predicting inadequate bowel preparation, was calculated for each patients. Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group and those in the control group underwent colonoscopy directly
arm group label: model-based interference group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yanglin Pan, M.D
role: Study Chair
affiliation: Air Force Military Medical University, China
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
citation: Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
PMID: 22239959
citation: Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.
PMID: 25600879
citation: Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
PMID: 28282690
responsible party type: Principal Investigator
investigator affiliation: Air Force Military Medical University, China
investigator full name: Yanglin Pan
investigator title: Associated professor