<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/NCT03753425</url>
  </required_header>
  <id_info>
    <org_study_id>P/2016/310</org_study_id>
    <nct_id>NCT03753425</nct_id>
  </id_info>
  <brief_title>National Multicentric Observatory of Low Bowel Preparations in Patients With IBD</brief_title>
  <acronym>CLEAN</acronym>
  <official_title>Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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>
      National multicentric observatory of low bowel preparations in patients with IBD&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective french multicentre observational study, during one month: from March 6th to April&#xD;
      6th 2017, under the auspice of the IBD group of the Société Française d'Endoscopie Digestive-&#xD;
      SFED. All French gastroenterologists in charge of IBD patients in public or private endoscopy&#xD;
      centers were reached out through various professional and scientific associations to&#xD;
      participate in the study via e-mail, web sites, and national congresses. Investigators were&#xD;
      asked to prescribe the bowel preparation independently from the study, as per their usual&#xD;
      habits. The achievement of low residue diet, the split and the timing of the preparation were&#xD;
      left free to the investigator according to local protocols.&#xD;
&#xD;
      Data recording The physicians participating in the study completed data on an online&#xD;
      questionnaire via an internet-based tool (CleanWeb software, hosted by Besançon university&#xD;
      hospital research center) or through a questionnaire sheet. The questionnaire included a&#xD;
      medical record and a self-reported patient questionnaire. The medical record included&#xD;
      physicians and centers characteristics, patient's demographics, disease characteristics,&#xD;
      modality of bowel preparation (diet, split dose, type of bowel preparation, delay before&#xD;
      colonoscopy), and colonoscopy findings and outcomes. Patients self-administered&#xD;
      questionnaires assessed preparation tolerability by symptoms and satisfaction recording.&#xD;
&#xD;
      Clinical endpoints The efficacy of the preparation was evaluated by the Boston's score&#xD;
      (efficacy was defined as a Boston's score was ≥ 7 without any segment &lt;2)23, the rate of&#xD;
      caecal or anastomosis intubation and the necessity or not to repeat the colonoscopy.&#xD;
&#xD;
      The tolerance was evaluated by the quantity of preparation actually absorbed by the patient,&#xD;
      (quantity of active preparation and quantity of clear liquid), patients and investigators&#xD;
      visual analogue scale evaluation of tolerance (VAS), a self-administered validated&#xD;
      bowel-preparation tolerability questionnaire 24 and by the patients' wish to take the same&#xD;
      preparation for the next colonoscopy.&#xD;
&#xD;
      Safety data: adverse events were collected per preparation and per endoscopic procedure, at&#xD;
      24 hours and 30 days later. A special focus was made on aphtoid lesions as they were&#xD;
      previously reported as adverse preparation-induced mucosal lesions possibly associated with&#xD;
      some solutions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2017</start_date>
  <completion_date type="Actual">June 3, 2017</completion_date>
  <primary_completion_date type="Actual">June 3, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Boston Score</measure>
    <time_frame>30 days</time_frame>
    <description>According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tolerance: visual analogue scale</measure>
    <time_frame>30 days</time_frame>
    <description>visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events per procedure</measure>
    <time_frame>30 days</time_frame>
    <description>fever, bowel perforation, bleeding, inhalation, hospitalisation, disease flare</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">278</enrollment>
  <condition>Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>PEG4L, four liters polyethylene glycol</arm_group_label>
    <description>PEG4L, four liters polyethylene glycol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG2L, two liters polyethylene glycol with ascorbic acid</arm_group_label>
    <description>PEG2L, two liters polyethylene glycol with ascorbic acid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pico, sodium picosulfate</arm_group_label>
    <description>Pico, sodium picosulfate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NaP, sodium phosphate</arm_group_label>
    <description>NaP, sodium phosphate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MPS, sodium, magnesium and potassium sulphates</arm_group_label>
    <description>MPS, sodium, magnesium and potassium sulphates</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Low volume bowel preparation in inflammatory bowel diseases</intervention_name>
    <description>Low volume bowel preparation in inflammatory bowel diseases</description>
    <arm_group_label>MPS, sodium, magnesium and potassium sulphates</arm_group_label>
    <other_name>Preparation in inflammatory bowel diseases given to patients before a coloscopy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an indication of colonoscopy independent from the study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 18-75 years,&#xD;
&#xD;
          -  symptoms of IBD for at least 3 month,&#xD;
&#xD;
          -  inidcation of colonoscopy independent from the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congestive heart failure,&#xD;
&#xD;
          -  severe renal failure,&#xD;
&#xD;
          -  gastro intestinal symptomatic obstruction or occlusive bowel stenosis (a non-occlusive&#xD;
             stenosis was not an exclusion criterion),&#xD;
&#xD;
          -  severe acute colitis,&#xD;
&#xD;
          -  severe dehydration or electrolyte disturbances,&#xD;
&#xD;
          -  patient's refusal to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hosptalier Universitaire</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 19, 2017</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammatory bowel disease</keyword>
  <keyword>colonoscopy</keyword>
  <keyword>bowel preparations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03753425
org study id: P/2016/310
nct id: NCT03753425
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
National multicentric observatory of low bowel preparations in patients with IBD
Prospective french multicentre observational study, during one month: from March 6th to April
      6th 2017, under the auspice of the IBD group of the Société Française d'Endoscopie Digestive-
      SFED. All French gastroenterologists in charge of IBD patients in public or private endoscopy
      centers were reached out through various professional and scientific associations to
      participate in the study via e-mail, web sites, and national congresses. Investigators were
      asked to prescribe the bowel preparation independently from the study, as per their usual
      habits. The achievement of low residue diet, the split and the timing of the preparation were
      left free to the investigator according to local protocols.

      Data recording The physicians participating in the study completed data on an online
      questionnaire via an internet-based tool (CleanWeb software, hosted by Besançon university
      hospital research center) or through a questionnaire sheet. The questionnaire included a
      medical record and a self-reported patient questionnaire. The medical record included
      physicians and centers characteristics, patient's demographics, disease characteristics,
      modality of bowel preparation (diet, split dose, type of bowel preparation, delay before
      colonoscopy), and colonoscopy findings and outcomes. Patients self-administered
      questionnaires assessed preparation tolerability by symptoms and satisfaction recording.

      Clinical endpoints The efficacy of the preparation was evaluated by the Boston's score
      (efficacy was defined as a Boston's score was ≥ 7 without any segment <2)23, the rate of
      caecal or anastomosis intubation and the necessity or not to repeat the colonoscopy.

      The tolerance was evaluated by the quantity of preparation actually absorbed by the patient,
      (quantity of active preparation and quantity of clear liquid), patients and investigators
      visual analogue scale evaluation of tolerance (VAS), a self-administered validated
      bowel-preparation tolerability questionnaire 24 and by the patients' wish to take the same
      preparation for the next colonoscopy.

      Safety data: adverse events were collected per preparation and per endoscopic procedure, at
      24 hours and 30 days later. A special focus was made on aphtoid lesions as they were
      previously reported as adverse preparation-induced mucosal lesions possibly associated with
      some solutions.
observational model: Cohort
time perspective: Prospective
measure: Boston Score
time frame: 30 days
description: According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination
measure: tolerance: visual analogue scale
time frame: 30 days
description: visual analogue scale
measure: adverse events per procedure
time frame: 30 days
description: fever, bowel perforation, bleeding, inhalation, hospitalisation, disease flare
arm group label: PEG4L, four liters polyethylene glycol
description: PEG4L, four liters polyethylene glycol
arm group label: PEG2L, two liters polyethylene glycol with ascorbic acid
description: PEG2L, two liters polyethylene glycol with ascorbic acid
arm group label: Pico, sodium picosulfate
description: Pico, sodium picosulfate
arm group label: NaP, sodium phosphate
description: NaP, sodium phosphate
arm group label: MPS, sodium, magnesium and potassium sulphates
description: MPS, sodium, magnesium and potassium sulphates
intervention type: Procedure
intervention name: Low volume bowel preparation in inflammatory bowel diseases
description: Low volume bowel preparation in inflammatory bowel diseases
arm group label: MPS, sodium, magnesium and potassium sulphates
other name: Preparation in inflammatory bowel diseases given to patients before a coloscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: No