<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/NCT02250196</url>
  </required_header>
  <id_info>
    <org_study_id>Korea University Prep</org_study_id>
    <nct_id>NCT02250196</nct_id>
  </id_info>
  <brief_title>A Randomized Prospective Trial Comparing Low-volume Bowel Preparation Methods</brief_title>
  <official_title>A Randomized, Prospective Tiral on Efficacy and Tolerability of Low-volume Bowel Preparation Methods for Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korea University Anam Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colonoscopy is a common screening method to detect polyps and CRC. With the early detection&#xD;
      of CRC through screening colonoscopy, patients could have better therapeutic effects and&#xD;
      outcomes. In population screening programs, an increase in completed colonoscopies is related&#xD;
      to a decrease in mortality from CRC. However, the miss rate for detecting colorectal&#xD;
      neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel&#xD;
      preparation results in the relatively low rate of detection of polyps and CRC, because poor&#xD;
      preparation interferes with successful colon mucosa examination during a colonoscopy.&#xD;
&#xD;
      Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4&#xD;
      liter polyethylene glycol. However, studies comparing the superiority between low-volume&#xD;
      bowel preparations are rare, and results are controversial. This study aimed to compare the&#xD;
      bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium&#xD;
      citrate and polyethylene glycol with ascorbic acid.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Study design: endoscopist-blinded, prospective, randomized controlled trial&#xD;
&#xD;
        2. Subjects&#xD;
&#xD;
             1. Entry criteria: Male or female patients, aged between18 and 80 years undergoing&#xD;
                elective outpatient colonoscopy were eligible for the study.&#xD;
&#xD;
             2. Exclusion criteria:&#xD;
&#xD;
           patients who had chronic kidney disease, severe heart failure(New York Heart Association&#xD;
           [NYHA] class III or IV), uncontrolled hypertension (systolic pressure ≥170 mm Hg,&#xD;
           diastolic pressure ≥100 mm Hg), severe constipation, any bowel resection, significant&#xD;
           gastroparesis, or suspected bowel obstruction or perforation.&#xD;
&#xD;
        3. Sampling design: Consecutive recruitment of consenting patients&#xD;
&#xD;
        4. Variables Predictor&#xD;
&#xD;
             1. group 1 (SPMC 2) received one sachet of SPMC at 7 p.m the evening before&#xD;
                colonoscopy and another sachet of SPMC at 5 hours before procedure&#xD;
&#xD;
             2. group 2 (PEG-Asc) received 1 L solution of PEG-Asc at 7 p.m the evening before&#xD;
                colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;&#xD;
&#xD;
        5. Primary Outcome: Quality of bowel preparation (Boston Bowel Preparation Scale, Aronchick&#xD;
           scale, bubble score)&#xD;
&#xD;
        6. Secondary Outcome: Tolerability, palatability&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 3</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>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the quality of the bowel preparation using Preparation Scale</measure>
    <time_frame>20 minutes</time_frame>
    <description>Preparation Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Completeness of the bowel preparation</measure>
    <time_frame>30 minutes before the colonoscopy</time_frame>
    <description>Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the patient's tolerability</measure>
    <time_frame>30 minutes before the colonoscopy</time_frame>
    <description>Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = &quot;none&quot;, 2 = &quot;mild&quot;, 3 = &quot;moderate&quot;, 4 = &quot;severe&quot;, and 5 = &quot;very severe&quot;.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Colon Adenoma</condition>
  <arm_group>
    <arm_group_label>PEG-Asc</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group 1 (PEG-Asc, N=100) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPMC 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>group 2 (SPMC 2, N=100) received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG-Asc</intervention_name>
    <description>received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure</description>
    <arm_group_label>PEG-Asc</arm_group_label>
    <other_name>Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPMC 2</intervention_name>
    <description>received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure</description>
    <arm_group_label>SPMC 2</arm_group_label>
    <other_name>Picolight(Pharmbio korea, Seoul, Korea)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients, aged between18 and 80 years undergoing elective outpatient&#xD;
             colonoscopy were eligible for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who had chronic kidney disease, severe heart failure(New York Heart&#xD;
             Association [NYHA] class III or IV), uncontrolled hypertension (systolic pressure ≥170&#xD;
             mm Hg, diastolic pressure ≥100 mm Hg), severe constipation, any bowel resection,&#xD;
             significant gastroparesis, or suspected bowel obstruction or perforation.&#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>Eun Sun Kim, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>In Kyung Yoo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <state>Anamdong 5-ga, Seongbuk-gu</state>
        <zip>136-705</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University Anam Hospital</investigator_affiliation>
    <investigator_full_name>In-Kyung Yoo</investigator_full_name>
    <investigator_title>fellow</investigator_title>
  </responsible_party>
  <keyword>Bowel preparation</keyword>
  <keyword>Polyethylene glycol with ascorbic acid</keyword>
  <keyword>Sodium picosulfate with magnesium citrate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_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/NCT02250196
org study id: Korea University Prep
nct id: NCT02250196
lead sponsor: 
has dmc: Yes
Colonoscopy is a common screening method to detect polyps and CRC. With the early detection
      of CRC through screening colonoscopy, patients could have better therapeutic effects and
      outcomes. In population screening programs, an increase in completed colonoscopies is related
      to a decrease in mortality from CRC. However, the miss rate for detecting colorectal
      neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel
      preparation results in the relatively low rate of detection of polyps and CRC, because poor
      preparation interferes with successful colon mucosa examination during a colonoscopy.

      Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4
      liter polyethylene glycol. However, studies comparing the superiority between low-volume
      bowel preparations are rare, and results are controversial. This study aimed to compare the
      bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium
      citrate and polyethylene glycol with ascorbic acid.
1. Study design: endoscopist-blinded, prospective, randomized controlled trial

        2. Subjects

             1. Entry criteria: Male or female patients, aged between18 and 80 years undergoing
                elective outpatient colonoscopy were eligible for the study.

             2. Exclusion criteria:

           patients who had chronic kidney disease, severe heart failure(New York Heart Association
           [NYHA] class III or IV), uncontrolled hypertension (systolic pressure ≥170 mm Hg,
           diastolic pressure ≥100 mm Hg), severe constipation, any bowel resection, significant
           gastroparesis, or suspected bowel obstruction or perforation.

        3. Sampling design: Consecutive recruitment of consenting patients

        4. Variables Predictor

             1. group 1 (SPMC 2) received one sachet of SPMC at 7 p.m the evening before
                colonoscopy and another sachet of SPMC at 5 hours before procedure

             2. group 2 (PEG-Asc) received 1 L solution of PEG-Asc at 7 p.m the evening before
                colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;

        5. Primary Outcome: Quality of bowel preparation (Boston Bowel Preparation Scale, Aronchick
           scale, bubble score)

        6. Secondary Outcome: Tolerability, palatability
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: the quality of the bowel preparation using Preparation Scale
time frame: 20 minutes
description: Preparation Scale
measure: Completeness of the bowel preparation
time frame: 30 minutes before the colonoscopy
description: Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.
measure: the patient's tolerability
time frame: 30 minutes before the colonoscopy
description: Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe".
arm group label: PEG-Asc
arm group type: Active Comparator
description: group 1 (PEG-Asc, N=100) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure
arm group label: SPMC 2
arm group type: Active Comparator
description: group 2 (SPMC 2, N=100) received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure
intervention type: Drug
intervention name: PEG-Asc
description: received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure
arm group label: PEG-Asc
other name: Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea
intervention type: Drug
intervention name: SPMC 2
description: received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure
arm group label: SPMC 2
other name: Picolight(Pharmbio korea, Seoul, Korea)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Eun Sun Kim, PhD
role: Study Director
affiliation: Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
last name: In Kyung Yoo, MD
role: Principal Investigator
affiliation: Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Korea University Anam Hospital
investigator full name: In-Kyung Yoo
investigator title: fellow
mesh term: Adenoma