<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/NCT04497935</url>
  </required_header>
  <id_info>
    <org_study_id>PLNV012018</org_study_id>
    <nct_id>NCT04497935</nct_id>
  </id_info>
  <brief_title>Comparison of Two Preparations for the Study of the Colon Through Colonoscopy</brief_title>
  <official_title>Comparative, Prospective and Randomized Study of Two Preparations for the Study of the Colon Through Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital da Senhora da Oliveira</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital da Senhora da Oliveira</source>
  <brief_summary>
    <textblock>
      Compare the quality of bowel preparation between two groups of patients, who will undergo two&#xD;
      different preparations: 1. Moviprep + diet; 2. Plenvu + diet&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The quality of bowel preparation is essential for the success of a colonoscopy, reducing&#xD;
      colonoscopy duration, and increasing the rate of cecal intubation and of polyp detection.&#xD;
      There are several types of preparations available on the market and, irrespective of the&#xD;
      choice, the split-dose regimen should be followed. A reduced volume preparation makes the&#xD;
      process easier and more tolerable, increasing adhesion. Regarding the diet to be applied&#xD;
      before the examination, there are no advantages to a liquid diet compared to a low fiber&#xD;
      diet, and there is no evidence on the duration of the diet. In addition, a restrictive diet&#xD;
      has an impact on satisfaction and also on adherence to treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of bowel preparation between the two groups of patients</measure>
    <time_frame>Patients were instructed to report any possible adverse events for up to 1 month after the procedure.</time_frame>
    <description>The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of &gt;6 with no individual segment scoring &lt;2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Degree of satisfaction with the two bowel preparation</measure>
    <time_frame>Patients were instructed to report any possible adverse events for up to 1 month after the procedure.</time_frame>
    <description>The level of patient satisfaction with the 2 bowel preparation regimens was also assessed through a comparative analysis of the patient satisfaction questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of bowel preparation in patients who had a morning or afternoon colonoscopy and those who received written, oral and additional telephone re-education on the day before the colonoscopy versus written and oral information only.</measure>
    <time_frame>Patients were instructed to report any possible adverse events for up to 1 month after the procedure.</time_frame>
    <description>The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of &gt;6 with no individual segment scoring &lt;2.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">613</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Colon Polyp</condition>
  <condition>Colon Adenoma</condition>
  <condition>Colon Rectal Cancer</condition>
  <arm_group>
    <arm_group_label>1LPEG</arm_group_label>
    <description>Patients receiving 1LPEG who had a colonoscopy in the morning were advised to follow a day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, they prepared the Dose 1 sachet in 500 mL of water and consumed it over a period of 30 minutes, followed by 500 mL of clear liquids. The second dose was then taken at 11:00 pm by mixing the two Dose 2 sachets in a single glass of 500 mL of water and consuming them over 30 minutes, followed by 500 mL of clear liquids. If the colonoscopy was scheduled for the afternoon, the same dosing instructions were given, but the first dose was taken at 7:00 am on the day of the procedure, and the second dose began at 10:00 am.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2LPEG</arm_group_label>
    <description>Patients receiving 2LPEG who had a colonoscopy in the morning were asked to follow a similar day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, the first 1L dose was consumed over a 1-hour period, followed by the second dose at 11:00 pm. For 2LPEG patients with procedures in the afternoon, they took Dose 1 at 7:00 am and Dose 2 at 10:00 am. Any patient receiving 2LPEG was also told to consume 1L of clear liquids during the preparation procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PLENVU</intervention_name>
    <description>Bowel preparation for a colonoscopy</description>
    <arm_group_label>1LPEG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MoviPrep</intervention_name>
    <description>Bowel preparation for a colonoscopy</description>
    <arm_group_label>2LPEG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients aged &gt; 18 years and indicated for a colonoscopy requiring bowel preparation in&#xD;
        the Gastroenterology Service of the Hospital of Senhora da Oliveira - Guimarães.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients aged &gt; 18 years and indicated for examination requiring bowel preparation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patients with gastroparesis or gastric obstruction.&#xD;
&#xD;
          -  Patients with psychiatric disorders&#xD;
&#xD;
          -  Severe renal impairment with CrCl &lt;30mL/min&#xD;
&#xD;
          -  Class III-IV Heart Failure&#xD;
&#xD;
          -  Dependence / use of laxatives&#xD;
&#xD;
          -  Chronic constipation (&lt;3 stools/week).&#xD;
&#xD;
          -  Uncontrolled hypertension (SBP &gt;170mmHg or DBP &gt;100mmHg)&#xD;
&#xD;
          -  Intestinal Obstruction&#xD;
&#xD;
          -  Colostomy from previous intestinal surgery&#xD;
&#xD;
          -  Severe ascites&#xD;
&#xD;
          -  Refusal of participation in the study&#xD;
&#xD;
          -  Patients unable to understand or respond to the satisfaction survey&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Senhora da Oliveira</name>
      <address>
        <city>Guimarães</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital da Senhora da Oliveira</investigator_affiliation>
    <investigator_full_name>Cátia Vanessa Meixedo Arieira</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Bowel preparation</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Laxative</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/NCT04497935
org study id: PLNV012018
nct id: NCT04497935
lead sponsor: 
Compare the quality of bowel preparation between two groups of patients, who will undergo two
      different preparations: 1. Moviprep + diet; 2. Plenvu + diet
The quality of bowel preparation is essential for the success of a colonoscopy, reducing
      colonoscopy duration, and increasing the rate of cecal intubation and of polyp detection.
      There are several types of preparations available on the market and, irrespective of the
      choice, the split-dose regimen should be followed. A reduced volume preparation makes the
      process easier and more tolerable, increasing adhesion. Regarding the diet to be applied
      before the examination, there are no advantages to a liquid diet compared to a low fiber
      diet, and there is no evidence on the duration of the diet. In addition, a restrictive diet
      has an impact on satisfaction and also on adherence to treatment.
observational model: Case-Control
time perspective: Prospective
measure: Quality of bowel preparation between the two groups of patients
time frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
description: The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of >6 with no individual segment scoring <2.
measure: Degree of satisfaction with the two bowel preparation
time frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
description: The level of patient satisfaction with the 2 bowel preparation regimens was also assessed through a comparative analysis of the patient satisfaction questionnaire
measure: Quality of bowel preparation in patients who had a morning or afternoon colonoscopy and those who received written, oral and additional telephone re-education on the day before the colonoscopy versus written and oral information only.
time frame: Patients were instructed to report any possible adverse events for up to 1 month after the procedure.
description: The colonoscopist assessed each of the 3 colon segments on the BBPS and assigned each a score of 0 to 3. Successful overall bowel preparation is defined as a BBPS score of >6 with no individual segment scoring <2.
arm group label: 1LPEG
description: Patients receiving 1LPEG who had a colonoscopy in the morning were advised to follow a day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, they prepared the Dose 1 sachet in 500 mL of water and consumed it over a period of 30 minutes, followed by 500 mL of clear liquids. The second dose was then taken at 11:00 pm by mixing the two Dose 2 sachets in a single glass of 500 mL of water and consuming them over 30 minutes, followed by 500 mL of clear liquids. If the colonoscopy was scheduled for the afternoon, the same dosing instructions were given, but the first dose was taken at 7:00 am on the day of the procedure, and the second dose began at 10:00 am.
arm group label: 2LPEG
description: Patients receiving 2LPEG who had a colonoscopy in the morning were asked to follow a similar day-before dosing regimen, where, at 7:00 pm the day before the colonoscopy, the first 1L dose was consumed over a 1-hour period, followed by the second dose at 11:00 pm. For 2LPEG patients with procedures in the afternoon, they took Dose 1 at 7:00 am and Dose 2 at 10:00 am. Any patient receiving 2LPEG was also told to consume 1L of clear liquids during the preparation procedure.
intervention type: Drug
intervention name: PLENVU
description: Bowel preparation for a colonoscopy
arm group label: 1LPEG
intervention type: Drug
intervention name: MoviPrep
description: Bowel preparation for a colonoscopy
arm group label: 2LPEG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Hospital da Senhora da Oliveira
investigator full name: Cátia Vanessa Meixedo Arieira
investigator title: Principal Investigator
mesh term: Adenoma