<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/NCT03242369</url>
  </required_header>
  <id_info>
    <org_study_id>108/11-29/2017</org_study_id>
    <nct_id>NCT03242369</nct_id>
  </id_info>
  <brief_title>Comparison of the Effectiveness of Bowel Preparations Before Colonoscopy</brief_title>
  <official_title>Comparison of the Effectiveness of Bowel Preparations in Bowel Cleansing Before Colonoscopy - Prospective, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Military University Hospital, Prague</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masaryk University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Military University Hospital, Prague</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Polyethylene glycol is the gold standard of bowel preparation for colonoscopy. The most&#xD;
      important disadvantage is high volume of this preparation. Sulphate based solution (SBS), low&#xD;
      volume PEG + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could&#xD;
      be suitable substitution of polyethylene glycol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be unicenter, randomized and single blind. It focuses on studying the&#xD;
      effectiveness of four preparations for bowel cleansing before colonoscopy. Polyethylenglycol&#xD;
      (PEG) will be compared as a gold standard of bowel cleansing with low volume preparations:&#xD;
      Sulfate-based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium&#xD;
      citric-acid and sodium picosulfate. The effectiveness will be rated according to a quality of&#xD;
      bowel preparation (Boston Bowel Preparation Scale) and detection of a colorectal neoplasia.&#xD;
      The aim of this project is to compare the effectiveness of each four preparations.&#xD;
&#xD;
      Primary endpoint: To compare a quality of bowel preparation. Secondary endpoint: To compare a&#xD;
      detection of colorectal neoplasia in those preparations.&#xD;
&#xD;
      Main hypothesis: PEG as a gold standard of bowel cleansing preparation is not worse than the&#xD;
      other compared preparations.&#xD;
&#xD;
      Secondary hypothesis: PEG is not worse in detection of colorectal neoplasia than the other&#xD;
      compared preparations.&#xD;
&#xD;
      Methods: There will be 400 patients included in the project with all indications for&#xD;
      colonoscopy (age ≥ 18 years, no upper age limit) except the exclusion criteria. The patients&#xD;
      will be offered to participate in the study at the Endoscopy unit when arranging the&#xD;
      examination. In case of agreement they will sign informed consent and they will be educated&#xD;
      about the correct process of bowel preparation. They also get all the instructions in printed&#xD;
      version and questionnaire of preparation tolerability. The advantages for the patients in&#xD;
      study will be earlier date of colonoscopy. On the day of colonoscopy, the patients will&#xD;
      submit the questionnaire and undergo standard colonoscopy examination.&#xD;
&#xD;
      The quality of a bowel cleansing will be evaluated by the experienced endoscopists who will&#xD;
      be blinded about a type of bowel preparation. The effectiveness will be assessed by the&#xD;
      degree of bowel cleansing (Boston Bowel Preparation Scale) and ADR, aADR and number of&#xD;
      cancers diagnosed. The GE unit staff will record all results in the on-line study database.&#xD;
      Results will be statistically evaluated in Institute of Biostatistics and Analyses, Masaryk&#xD;
      University, IBA MU).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">March 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of bowel cleansing according to Boston Bowel Preparation Scale (BBPS)</measure>
    <time_frame>1 day</time_frame>
    <description>0-Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared&#xD;
1-Portion of mucosa of the colon segment seen, but other areas of the segment are not well seen due to staining, residual stool, and/or opaque liquid&#xD;
2-Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa colon segment is seen well&#xD;
3-Entire mucosa of colon segment seen well, with no residual staining, small fragment of stool or opaque liquid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Detection of colorectal neoplasia</measure>
    <time_frame>1 day</time_frame>
    <description>In each colonoscopy the number of colorectal neoplasia will be rated.&#xD;
Colorectal neoplasia is defined by these two types of lession:&#xD;
advanced adenoma - 1cm size or greater or with villous component or with high grade dysplasia&#xD;
carcinoma</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>PEG group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 patients undergoing colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SBS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 patients undergoing colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG 2L + ascorbic acid group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 patients undergoing colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PICO group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 patients undergoing colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colonoscopy</intervention_name>
    <description>100 patients undergoing colonoscopy will be prepared with split dose (2+2l) PEG. 2 liters will be drunk during 2 hours in the evening the day before colonoscopy, the second 2l during 2 hours in the day of colonoscopy finishing the dose 4- 6 hours before colonoscopy.</description>
    <arm_group_label>PEG group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colonoscopy</intervention_name>
    <description>100 patients undergoing colonoscopy will by prepared with split dose of SS. The first bottle of SS with water (total volume 0,5l) will be drunk in the evening the day before colonoscopy during 1 hour, than another 1liter of clear fluid will be drunk. The same procedure will be repeated with the second bottle of SS finishing at least 3 hours before colonoscop</description>
    <arm_group_label>SBS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colonoscopy</intervention_name>
    <description>100 patients undergoing colonoscopy will be prepared with split dose of PEG (1+1L) with ascorbic acid. The first 1l of solution will be drunk in the evening the day before colonoscopy, the second 1l of solution in the day of colonoscopy finishing 4-6 hours before the examination. Another 1l of clear fluid should be drunk during the cleansing process.</description>
    <arm_group_label>PEG 2L + ascorbic acid group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>colonoscopy</intervention_name>
    <description>100 patients undergoing colonoscopy will be prepared with split dose (150ml +150ml) of solution of magnesium acid and sodium picosulfate. The first dose will be drunk in the evening the day before colonoscopy, then at least 1l of another clear fluid will be drunk within a few hours, the second dose will be drunk in the day of examination finishing 4-6hours before colonoscopy and then another at least 750ml clear fluid.</description>
    <arm_group_label>PICO group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Individuls ≥ 18 years old undergoing colonoscopy for all indications except exclusion&#xD;
        criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active idiopathic bowel disease&#xD;
&#xD;
          -  Chronic renal insufficiency&#xD;
&#xD;
          -  Serious internal comorbidity&#xD;
&#xD;
          -  Planned therapeutic colonoscopy&#xD;
&#xD;
          -  No informed consent signed (with the study and/or with the colonoscopy)&#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>Stepan Suchanek, MD., PhD.</last_name>
    <role>Study Director</role>
    <affiliation>Military Univesity Hosital Prague</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stepan Suchanek, MD., PhD.</last_name>
    <phone>973208367</phone>
    <phone_ext>00420</phone_ext>
    <email>stepan.suchanek@uvn.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Klara Kmochova, MD.,</last_name>
    <phone>973203076</phone>
    <phone_ext>00420</phone_ext>
    <email>klara.kmochova@uvn.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Military University Hospital</name>
      <address>
        <city>Prague</city>
        <zip>16902</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stepan Suchanek, MD., Ph.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>January 31, 2018</last_update_submitted>
  <last_update_submitted_qc>January 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Military University Hospital, Prague</investigator_affiliation>
    <investigator_full_name>Stepan Suchanek, MD., Ph.D.</investigator_full_name>
    <investigator_title>Head of Department of Gastrointestinal Endoscopy</investigator_title>
  </responsible_party>
  <keyword>colorectal neoplasia</keyword>
  <keyword>colonoscopy</keyword>
  <keyword>quality of bowel cleansing</keyword>
  <keyword>bowel preparation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT03242369
org study id: 108/11-29/2017
nct id: NCT03242369
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Polyethylene glycol is the gold standard of bowel preparation for colonoscopy. The most
      important disadvantage is high volume of this preparation. Sulphate based solution (SBS), low
      volume PEG + ascorbic acid and solution of magnesium citric acid and sodium picosulfate could
      be suitable substitution of polyethylene glycol.
This study will be unicenter, randomized and single blind. It focuses on studying the
      effectiveness of four preparations for bowel cleansing before colonoscopy. Polyethylenglycol
      (PEG) will be compared as a gold standard of bowel cleansing with low volume preparations:
      Sulfate-based solution (SBS), low volume PEG + ascorbic acid and solution of magnesium
      citric-acid and sodium picosulfate. The effectiveness will be rated according to a quality of
      bowel preparation (Boston Bowel Preparation Scale) and detection of a colorectal neoplasia.
      The aim of this project is to compare the effectiveness of each four preparations.

      Primary endpoint: To compare a quality of bowel preparation. Secondary endpoint: To compare a
      detection of colorectal neoplasia in those preparations.

      Main hypothesis: PEG as a gold standard of bowel cleansing preparation is not worse than the
      other compared preparations.

      Secondary hypothesis: PEG is not worse in detection of colorectal neoplasia than the other
      compared preparations.

      Methods: There will be 400 patients included in the project with all indications for
      colonoscopy (age ≥ 18 years, no upper age limit) except the exclusion criteria. The patients
      will be offered to participate in the study at the Endoscopy unit when arranging the
      examination. In case of agreement they will sign informed consent and they will be educated
      about the correct process of bowel preparation. They also get all the instructions in printed
      version and questionnaire of preparation tolerability. The advantages for the patients in
      study will be earlier date of colonoscopy. On the day of colonoscopy, the patients will
      submit the questionnaire and undergo standard colonoscopy examination.

      The quality of a bowel cleansing will be evaluated by the experienced endoscopists who will
      be blinded about a type of bowel preparation. The effectiveness will be assessed by the
      degree of bowel cleansing (Boston Bowel Preparation Scale) and ADR, aADR and number of
      cancers diagnosed. The GE unit staff will record all results in the on-line study database.
      Results will be statistically evaluated in Institute of Biostatistics and Analyses, Masaryk
      University, IBA MU).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Quality of bowel cleansing according to Boston Bowel Preparation Scale (BBPS)
time frame: 1 day
description: 0-Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared
1-Portion of mucosa of the colon segment seen, but other areas of the segment are not well seen due to staining, residual stool, and/or opaque liquid
2-Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa colon segment is seen well
3-Entire mucosa of colon segment seen well, with no residual staining, small fragment of stool or opaque liquid
measure: Detection of colorectal neoplasia
time frame: 1 day
description: In each colonoscopy the number of colorectal neoplasia will be rated.
Colorectal neoplasia is defined by these two types of lession:
advanced adenoma - 1cm size or greater or with villous component or with high grade dysplasia
carcinoma
arm group label: PEG group
arm group type: Experimental
description: 100 patients undergoing colonoscopy.
arm group label: SBS group
arm group type: Experimental
description: 100 patients undergoing colonoscopy
arm group label: PEG 2L + ascorbic acid group
arm group type: Experimental
description: 100 patients undergoing colonoscopy.
arm group label: PICO group
arm group type: Experimental
description: 100 patients undergoing colonoscopy.
intervention type: Procedure
intervention name: colonoscopy
description: 100 patients undergoing colonoscopy will be prepared with split dose (2+2l) PEG. 2 liters will be drunk during 2 hours in the evening the day before colonoscopy, the second 2l during 2 hours in the day of colonoscopy finishing the dose 4- 6 hours before colonoscopy.
arm group label: PEG group
intervention type: Procedure
intervention name: colonoscopy
description: 100 patients undergoing colonoscopy will by prepared with split dose of SS. The first bottle of SS with water (total volume 0,5l) will be drunk in the evening the day before colonoscopy during 1 hour, than another 1liter of clear fluid will be drunk. The same procedure will be repeated with the second bottle of SS finishing at least 3 hours before colonoscop
arm group label: SBS group
intervention type: Procedure
intervention name: colonoscopy
description: 100 patients undergoing colonoscopy will be prepared with split dose of PEG (1+1L) with ascorbic acid. The first 1l of solution will be drunk in the evening the day before colonoscopy, the second 1l of solution in the day of colonoscopy finishing 4-6 hours before the examination. Another 1l of clear fluid should be drunk during the cleansing process.
arm group label: PEG 2L + ascorbic acid group
intervention type: Procedure
intervention name: colonoscopy
description: 100 patients undergoing colonoscopy will be prepared with split dose (150ml +150ml) of solution of magnesium acid and sodium picosulfate. The first dose will be drunk in the evening the day before colonoscopy, then at least 1l of another clear fluid will be drunk within a few hours, the second dose will be drunk in the day of examination finishing 4-6hours before colonoscopy and then another at least 750ml clear fluid.
arm group label: PICO group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stepan Suchanek, MD., PhD.
role: Study Director
affiliation: Military Univesity Hosital Prague
last name: Stepan Suchanek, MD., PhD.
phone: 973208367
phone ext: 00420
email: stepan.suchanek@uvn.cz
last name: Klara Kmochova, MD.,
phone: 973203076
phone ext: 00420
email: klara.kmochova@uvn.cz
facility: 
status: Recruiting
contact: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Military University Hospital, Prague
investigator full name: Stepan Suchanek, MD., Ph.D.
investigator title: Head of Department of Gastrointestinal Endoscopy
mesh term: Colorectal Neoplasms