<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/NCT03763266</url>
  </required_header>
  <id_info>
    <org_study_id>2017308</org_study_id>
    <nct_id>NCT03763266</nct_id>
  </id_info>
  <brief_title>Low Residue Diet During 3 Days vs 1 Day Prior Colonoscopy</brief_title>
  <official_title>Low Residue Diet 3 Days Versus 1 Day as Preparation for Colonoscopy: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Parc Taulí, Sabadell</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Parc Taulí, Sabadell</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>
      Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy&#xD;
      quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel&#xD;
      preparation.&#xD;
&#xD;
      The role of diet in preparing for colonoscopy is not fully established. Currently there is&#xD;
      not enough evidence available to choice between 3 days of low residue diet versus 1 day.&#xD;
&#xD;
      The research hypothesis is that the low residue diet offers a non-inferior bowel preparation&#xD;
      and an improved tolerance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2019</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bowel preparation</measure>
    <time_frame>During the colonoscopy</time_frame>
    <description>Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diet tolerance</measure>
    <time_frame>It is reported before entering the endoscopy room. Regarding the 3 or 1 days on low fiber diet depending on which study group is the participant.</time_frame>
    <description>Using Likert scale. From 1 to 5, lower is better tolerance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preparation tolerance</measure>
    <time_frame>It is reported before entering the endoscopy room. Regarding the 3 or 1 day on bowel preparation depending on which study group is the participant.</time_frame>
    <description>Using Likert scale. From 1 to 5, lower is better tolerance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>up to 2 weeks after colonoscopy depending on pathology department workload.</time_frame>
    <description>Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopic diagnosis</measure>
    <time_frame>It is assessed during the colonoscopy and will be reported the same day.</time_frame>
    <description>Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cecum intubation rate</measure>
    <time_frame>It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done</time_frame>
    <description>Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation time</measure>
    <time_frame>it is assessed from the start of the colonoscopy until cecum is reached (1 day)</time_frame>
    <description>time lapse from the start of the exploration until cecum is reached.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Withdrawal time</measure>
    <time_frame>it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)</time_frame>
    <description>Time lapse between cecum withdrawal the end of the exploration.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">858</enrollment>
  <condition>Colonoscopy</condition>
  <condition>Colon Adenoma</condition>
  <condition>Colorectal Neoplasms</condition>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Colon Disease</condition>
  <arm_group>
    <arm_group_label>1 day low residue diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 days low residue diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients are instructed to complete a low residue diet three days prior the colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1 day low residue diet</intervention_name>
    <description>Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.</description>
    <arm_group_label>1 day low residue diet</arm_group_label>
    <other_name>low fiber diet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3 day low residue diet</intervention_name>
    <description>Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.</description>
    <arm_group_label>3 days low residue diet</arm_group_label>
    <other_name>low fiber diet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants in the colorectal cancer screening program that give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for colonoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Martínez, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Corporació Sanitaria Parc Taulí</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salvador Machlab, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Corporació Sanitaria Parc Taulí</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rafel Campo, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Corporació Sanitaria Parc Taulí</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Parc Taulí</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Parc Taulí, Sabadell</investigator_affiliation>
    <investigator_full_name>Salvador Machlab</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>bowel preparation</keyword>
  <keyword>low residue diet</keyword>
  <keyword>colonoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Colonic Diseases</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/NCT03763266
org study id: 2017308
nct id: NCT03763266
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy
      quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel
      preparation.

      The role of diet in preparing for colonoscopy is not fully established. Currently there is
      not enough evidence available to choice between 3 days of low residue diet versus 1 day.

      The research hypothesis is that the low residue diet offers a non-inferior bowel preparation
      and an improved tolerance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Bowel preparation
time frame: During the colonoscopy
description: Measured with the Boston Bowel Preparation Scale from 0 until 9. 9 represents an excellent preparation.
measure: Diet tolerance
time frame: It is reported before entering the endoscopy room. Regarding the 3 or 1 days on low fiber diet depending on which study group is the participant.
description: Using Likert scale. From 1 to 5, lower is better tolerance.
measure: Preparation tolerance
time frame: It is reported before entering the endoscopy room. Regarding the 3 or 1 day on bowel preparation depending on which study group is the participant.
description: Using Likert scale. From 1 to 5, lower is better tolerance.
measure: Adenoma detection rate
time frame: up to 2 weeks after colonoscopy depending on pathology department workload.
description: Proportion of colonoscopies with detection of colorectal cancer or adenoma excluding distal hyperplastic
measure: Endoscopic diagnosis
time frame: It is assessed during the colonoscopy and will be reported the same day.
description: Final endoscopic diagnosis. For example; normal, diverticulosis, polyps, colorectal cancer, etc.
measure: Cecum intubation rate
time frame: It will be calculated through study completion, approximately 1 year, for all the study period using all participants having the colonoscopy done
description: Cecum intubation will be assessed during each colonoscopy if the endoscope reaches the cecum.
measure: Intubation time
time frame: it is assessed from the start of the colonoscopy until cecum is reached (1 day)
description: time lapse from the start of the exploration until cecum is reached.
measure: Withdrawal time
time frame: it is assessed from at the beginning of the withdrawal of the colonoscope until the colonoscopy is finished. (procedure)
description: Time lapse between cecum withdrawal the end of the exploration.
arm group label: 1 day low residue diet
arm group type: Experimental
description: Patients are instructed to complete a low residue diet exclusively one day prior the colonoscopy.
arm group label: 3 days low residue diet
arm group type: Active Comparator
description: Patients are instructed to complete a low residue diet three days prior the colonoscopy.
intervention type: Other
intervention name: 1 day low residue diet
description: Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.
arm group label: 1 day low residue diet
other name: low fiber diet
intervention type: Other
intervention name: 3 day low residue diet
description: Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.
arm group label: 3 days low residue diet
other name: low fiber diet
criteria: 
gender: All
minimum age: 50 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eva Martínez, PhD
role: Study Director
affiliation: Corporació Sanitaria Parc Taulí
last name: Salvador Machlab, MD
role: Principal Investigator
affiliation: Corporació Sanitaria Parc Taulí
last name: Rafel Campo, PhD
role: Study Director
affiliation: Corporació Sanitaria Parc Taulí
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Parc Taulí, Sabadell
investigator full name: Salvador Machlab
investigator title: Principal Investigator
mesh term: Adenoma
mesh term: Colorectal Neoplasms
mesh term: Inflammatory Bowel Diseases
mesh term: Colonic Diseases