<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/NCT03830489</url>
  </required_header>
  <id_info>
    <org_study_id>Score-guided colon cleansing</org_study_id>
    <nct_id>NCT03830489</nct_id>
  </id_info>
  <brief_title>Impact of a Predictive Score of Bowel Preparation Quality in Clinical Practice</brief_title>
  <acronym>REPREP2</acronym>
  <official_title>Intensive High-volume Bowel Cleansing Regimen Versus Low-volume Bowel Regimen in Patients With a High Risk of Poor Colonic Cleansing Following a Validated Predictive Score</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario de Canarias</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario de Canarias</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center randomized controlled trial to compare the colon cleansing quality&#xD;
      determined by the Boston Bowel Preparation Scale achieved by two strategies in patients with&#xD;
      high risk of poor colon cleansing defined as those patients with a score&gt; 1.225 following a&#xD;
      predictive score previously published: one group will receive an intensified split-dose 4 L&#xD;
      polyethylene glycol solution (PEG) plus bisacodyl and 3 days of fiber-free diet and the other&#xD;
      group a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free&#xD;
      diet.&#xD;
&#xD;
      Patients with a score ≤ 1.225 will receive a split-dose 2 L PEG solution with ascorbic plus&#xD;
      bisacodyl and 1 day of fiber-free diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, single-blind phase IV study in which all outpatients&#xD;
      scheduled for a colonoscopy will be given a different bowel cleansing strategy (conventional&#xD;
      or intensified) according to a scoring system already validated in the investigator's center,&#xD;
      designed with variables independently associated with poor bowel cleansing, constipation,&#xD;
      abdominal/pelvic surgery, comorbidity and to be on antidepressant treatment. According to&#xD;
      this system, a score equal to or less than 1.225, predicts with a high confidence (negative&#xD;
      predictive value = 88%) a suitable cleansing quality with a standard preparation protocol.&#xD;
      Therefore, these subjects will be advised of a conventional preparation (low fiber diet the&#xD;
      day before the examination and low volume preparation consisting of 2 L of PEG with ascorbic&#xD;
      acid). Subjects with a score greater than 1.225 will be randomized to receive an intensive&#xD;
      bowel preparation (low fiber diet three days prior to colonoscopy and large bowel preparation&#xD;
      consisting of 4 L PEG with bisacodyl) or a conventional one (low fiber diet the day before&#xD;
      the examination and 2 L of PEG with ascorbic acid). The choice of low-volume preparation as a&#xD;
      control is supported by the absence of significant differences in quality of cleanliness in&#xD;
      patients with a score &gt; 1.225 among patients prepared with high or low volume and that low&#xD;
      volume preparation appears to improve tolerance and compliance.&#xD;
&#xD;
      A researcher will offer to participate in the study to all outpatients with a scheduled&#xD;
      colonoscopy, who meet all the inclusion criteria and none of the exclusion criteria. The&#xD;
      researchers will explain the purpose of the study and will ask to sign the informed consent.&#xD;
      They will give verbal and written information on the bowel preparation strategy. Thus,&#xD;
      according to the allocation group, participants must comply with a large volume cleansing&#xD;
      strategy or a conventional one. For patients with a low score (≤ 1.225) a conventional&#xD;
      preparation will be recommended.&#xD;
&#xD;
      Patients must complete a baseline questionnaire at the inclusion visit and another&#xD;
      questionnaire at the colonoscopy visit.&#xD;
&#xD;
      The hypothesis of the study is that in patients with a high risk of poor bowel preparation,&#xD;
      the large bowel based preparation strategy is superior to the conventional bowel preparation&#xD;
      in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel&#xD;
      Preparation Score).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">October 30, 2019</completion_date>
  <primary_completion_date type="Actual">October 21, 2019</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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Only the endoscopists in charge of rating the bowel cleansing during the colonoscopy will be masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Boston Bowel Preparation Scale</measure>
    <time_frame>8 months</time_frame>
    <description>This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of polyps detected in each arm</measure>
    <time_frame>8 months</time_frame>
    <description>Number of polyps in one arm/total of polyps detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance to bowel preparation</measure>
    <time_frame>8 months</time_frame>
    <description>It will be subjective and assessed by a visual analog scale (0 very bad, 10 excellent)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Cleansing Quality of the Colon</condition>
  <arm_group>
    <arm_group_label>Large volume based preparation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This strategy will consist of split dose 4 L polyethylene glycol plus 10 mg bisacodyl plus 3 days of fiber-free diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low volume based preparation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This strategy will consist of split dose 2 L polyethylene glycol plus Ascorbic acid plus 1 day of fiber-free diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>polyethylene glycol</intervention_name>
    <description>The experimental arm will take 4 L polyethylene glycol solution (PEG) in split dose plus bisacodyl and 3 days of fiber-free diet</description>
    <arm_group_label>Large volume based preparation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>polyethylene glycol plus ascorbic acid</intervention_name>
    <description>The control arm will take 2 L polyethylene glycol solution (PEG) plus ascorbic acid in split dose plus 1 day of fiber-free diet</description>
    <arm_group_label>Low volume based preparation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Outpatient colonoscopy&#xD;
&#xD;
          -  Willing to participate (informed consent signed).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intestinal perforation&#xD;
&#xD;
          -  Poorly controlled arterial hypertension (HTAS&gt; 180 HTAD&gt; 100)&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  NYHA III-IV&#xD;
&#xD;
          -  Acute hepatic failure&#xD;
&#xD;
          -  End-stage renal disease (creatinine &lt;15 ml / min dialysis or pre-dialysis)&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Known hypersensitivity reaction to drug components&#xD;
&#xD;
          -  Phenylketonuria or Glucose-6-phosphate dehydrogenase deficiency&#xD;
&#xD;
          -  Dementia with difficulty in intake of Preparation&#xD;
&#xD;
          -  Past history of poor bowel preparation colonic cleanliness&#xD;
&#xD;
          -  Inability to follow the instructions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Goretti Hernandez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario de Canarias</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology</name>
      <address>
        <city>La Laguna</city>
        <state>S/C De Tenerife</state>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Gimeno-Garcia AZ, Hernandez G, Aldea A, Nicolas-Perez D, Jimenez A, Carrillo M, Felipe V, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Moreno M, Ramos L, Quintero E. Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study. Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.</citation>
    <PMID>28291237</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <results_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>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cleansing quality score</keyword>
  <keyword>Colonoscopy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03830489
org study id: Score-guided colon cleansing
nct id: NCT03830489
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single center randomized controlled trial to compare the colon cleansing quality
      determined by the Boston Bowel Preparation Scale achieved by two strategies in patients with
      high risk of poor colon cleansing defined as those patients with a score> 1.225 following a
      predictive score previously published: one group will receive an intensified split-dose 4 L
      polyethylene glycol solution (PEG) plus bisacodyl and 3 days of fiber-free diet and the other
      group a split-dose 2 L PEG solution with ascorbic plus bisacodyl and 1 day of fiber-free
      diet.

      Patients with a score ≤ 1.225 will receive a split-dose 2 L PEG solution with ascorbic plus
      bisacodyl and 1 day of fiber-free diet.
This is a prospective, randomized, single-blind phase IV study in which all outpatients
      scheduled for a colonoscopy will be given a different bowel cleansing strategy (conventional
      or intensified) according to a scoring system already validated in the investigator's center,
      designed with variables independently associated with poor bowel cleansing, constipation,
      abdominal/pelvic surgery, comorbidity and to be on antidepressant treatment. According to
      this system, a score equal to or less than 1.225, predicts with a high confidence (negative
      predictive value = 88%) a suitable cleansing quality with a standard preparation protocol.
      Therefore, these subjects will be advised of a conventional preparation (low fiber diet the
      day before the examination and low volume preparation consisting of 2 L of PEG with ascorbic
      acid). Subjects with a score greater than 1.225 will be randomized to receive an intensive
      bowel preparation (low fiber diet three days prior to colonoscopy and large bowel preparation
      consisting of 4 L PEG with bisacodyl) or a conventional one (low fiber diet the day before
      the examination and 2 L of PEG with ascorbic acid). The choice of low-volume preparation as a
      control is supported by the absence of significant differences in quality of cleanliness in
      patients with a score > 1.225 among patients prepared with high or low volume and that low
      volume preparation appears to improve tolerance and compliance.

      A researcher will offer to participate in the study to all outpatients with a scheduled
      colonoscopy, who meet all the inclusion criteria and none of the exclusion criteria. The
      researchers will explain the purpose of the study and will ask to sign the informed consent.
      They will give verbal and written information on the bowel preparation strategy. Thus,
      according to the allocation group, participants must comply with a large volume cleansing
      strategy or a conventional one. For patients with a low score (≤ 1.225) a conventional
      preparation will be recommended.

      Patients must complete a baseline questionnaire at the inclusion visit and another
      questionnaire at the colonoscopy visit.

      The hypothesis of the study is that in patients with a high risk of poor bowel preparation,
      the large bowel based preparation strategy is superior to the conventional bowel preparation
      in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel
      Preparation Score).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
masking description: Only the endoscopists in charge of rating the bowel cleansing during the colonoscopy will be masked
measure: Boston Bowel Preparation Scale
time frame: 8 months
description: This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points
measure: Proportion of polyps detected in each arm
time frame: 8 months
description: Number of polyps in one arm/total of polyps detected
measure: Tolerance to bowel preparation
time frame: 8 months
description: It will be subjective and assessed by a visual analog scale (0 very bad, 10 excellent)
arm group label: Large volume based preparation
arm group type: Experimental
description: This strategy will consist of split dose 4 L polyethylene glycol plus 10 mg bisacodyl plus 3 days of fiber-free diet.
arm group label: Low volume based preparation
arm group type: Active Comparator
description: This strategy will consist of split dose 2 L polyethylene glycol plus Ascorbic acid plus 1 day of fiber-free diet
intervention type: Drug
intervention name: polyethylene glycol
description: The experimental arm will take 4 L polyethylene glycol solution (PEG) in split dose plus bisacodyl and 3 days of fiber-free diet
arm group label: Large volume based preparation
intervention type: Drug
intervention name: polyethylene glycol plus ascorbic acid
description: The control arm will take 2 L polyethylene glycol solution (PEG) plus ascorbic acid in split dose plus 1 day of fiber-free diet
arm group label: Low volume based preparation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Goretti Hernandez, MD
role: Principal Investigator
affiliation: Hospital Universitario de Canarias
facility: 
country: Spain
citation: Gimeno-Garcia AZ, Hernandez G, Aldea A, Nicolas-Perez D, Jimenez A, Carrillo M, Felipe V, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Moreno M, Ramos L, Quintero E. Comparison of Two Intensive Bowel Cleansing Regimens in Patients With Previous Poor Bowel Preparation: A Randomized Controlled Study. Am J Gastroenterol. 2017 Jun;112(6):951-958. doi: 10.1038/ajg.2017.53. Epub 2017 Mar 14.
PMID: 28291237
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
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: 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
responsible party type: Sponsor
mesh term: Ascorbic Acid