<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/NCT03282786</url>
  </required_header>
  <id_info>
    <org_study_id>2017-191-f-S</org_study_id>
    <nct_id>NCT03282786</nct_id>
  </id_info>
  <brief_title>Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease</brief_title>
  <acronym>CO2-IBD</acronym>
  <official_title>Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Muenster</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>
      Patients with inflammatory bowel disease (IBD) frequently undergo endoscopic examination and&#xD;
      may suffer from diagnostic procedures. Independent from IBD patients, colonoscopy is usually&#xD;
      performed using air insufflation, however recent data indicates a superior role of carbon&#xD;
      dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower degree of&#xD;
      patient's discomfort. The role of CO2 as an insufflation gas for colonoscopy in IBD patients&#xD;
      remains undetermined, wherefore this study aims to address this issue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with inflammatory bowel disease (IBD) suffer from a chronic inflammatory course of&#xD;
      disease. To stage the course of disease endoscopic procedures including colonoscopy may be&#xD;
      required and especially IBD patients with their inflamed gut may suffer from repetitive&#xD;
      endoscopic examinations including colonoscopy. Independent from IBD patients, colonoscopy is&#xD;
      usually performed using air insufflation, however recent data indicates a superior role of&#xD;
      carbon dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower&#xD;
      degree of patient's discomfort which has been mainly demonstrated in groups of patients&#xD;
      undergoing cancer surveillance colonoscopies and who do not suffer from IBD. Therefore the&#xD;
      role of CO2 as an insufflation gas for colonoscopy in IBD patients remains undetermined and&#xD;
      this study aims to address this issue. For pain assessment a visual analogue scale will be&#xD;
      used. As the primary outcome measure, the investigators will compare the differences in pain&#xD;
      level 1h after colonoscopy (comparison of carbon dioxide to air insufflation). For the&#xD;
      secondary outcome measure the investigators will compare the differences in pain level 3h, 6h&#xD;
      and 24h after colonoscopy (comparison of carbon dioxide to air insufflation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 3, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</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 (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of colonoscopy related abdominal pain 1 hour after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease</measure>
    <time_frame>Pain level assessment 1 hour after colonoscopy</time_frame>
    <description>For pain assessment a visual analogue scale will be used. For the primary outcome measure, the investigators will compare the difference in pain level 1 hour after colonoscopy (comparison of carbon dioxide to air insufflation).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of colonoscopy related abdominal pain 3 hours, 6 hours and 24 hours after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease</measure>
    <time_frame>Pain level assessment 3 hours, 6 hours and 24 hours colonoscopy</time_frame>
    <description>For pain assessment a visual analogue scale will be used. For the secondary outcome measure, the investigators will compare the differences in pain level 3 hours, 6 hours and 24 hours after colonoscopy (comparison of carbon dioxide to air insufflation).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">304</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>CD patient with CO2 insufflation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The investigators aim to include 76 Crohn's disease (CD) patients undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CD patient with air insufflation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The investigators aim to include 76 Crohn's disease patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UC patient with CO2 insufflation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The investigators aim to include 76 ulcerative colitis patients (UC) undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UC patient with air insufflation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The investigators aim to include 76 ulcerative colitis patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>carbon dioxide insufflation during colonoscopy</intervention_name>
    <description>Use of Carbon dioxide instead of air insufflation</description>
    <arm_group_label>CD patient with CO2 insufflation</arm_group_label>
    <arm_group_label>UC patient with CO2 insufflation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with inflammatory bowel disease&#xD;
&#xD;
          -  Indication for colonoscopy&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
          -  signed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Consent form not signed&#xD;
&#xD;
          -  Age &lt; 18 or above 80 yrs&#xD;
&#xD;
          -  Pregnancy or Breast-Feeding&#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>Frank Lenze, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medicine B, University Hospital Muenster</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Frank Lenze, MD</last_name>
    <phone>0049-251-8358103</phone>
    <email>frank.lenze@uni-muenster.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arne Bokemeyer, MD</last_name>
    <phone>0049-251-8347661</phone>
    <email>arne.bokemeyer@ukmuenster.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Unversity Clinic Muenster</name>
      <address>
        <city>Muenster</city>
        <state>NRW</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank Lenze, MD, PhD</last_name>
      <phone>00492518458103</phone>
      <email>frank.lenze@uni-muenster.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammatory Bowel Disease</keyword>
  <keyword>Crohn's Disease</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <keyword>Carbon Dioxide (CO2)</keyword>
  <keyword>Colonoscopy</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>Undecided</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/NCT03282786
org study id: 2017-191-f-S
nct id: NCT03282786
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with inflammatory bowel disease (IBD) frequently undergo endoscopic examination and
      may suffer from diagnostic procedures. Independent from IBD patients, colonoscopy is usually
      performed using air insufflation, however recent data indicates a superior role of carbon
      dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower degree of
      patient's discomfort. The role of CO2 as an insufflation gas for colonoscopy in IBD patients
      remains undetermined, wherefore this study aims to address this issue.
Patients with inflammatory bowel disease (IBD) suffer from a chronic inflammatory course of
      disease. To stage the course of disease endoscopic procedures including colonoscopy may be
      required and especially IBD patients with their inflamed gut may suffer from repetitive
      endoscopic examinations including colonoscopy. Independent from IBD patients, colonoscopy is
      usually performed using air insufflation, however recent data indicates a superior role of
      carbon dioxide (CO2) as an insufflation gas during colonoscopy. Using CO2 leads to a lower
      degree of patient's discomfort which has been mainly demonstrated in groups of patients
      undergoing cancer surveillance colonoscopies and who do not suffer from IBD. Therefore the
      role of CO2 as an insufflation gas for colonoscopy in IBD patients remains undetermined and
      this study aims to address this issue. For pain assessment a visual analogue scale will be
      used. As the primary outcome measure, the investigators will compare the differences in pain
      level 1h after colonoscopy (comparison of carbon dioxide to air insufflation). For the
      secondary outcome measure the investigators will compare the differences in pain level 3h, 6h
      and 24h after colonoscopy (comparison of carbon dioxide to air insufflation).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Investigator)
measure: Comparison of colonoscopy related abdominal pain 1 hour after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease
time frame: Pain level assessment 1 hour after colonoscopy
description: For pain assessment a visual analogue scale will be used. For the primary outcome measure, the investigators will compare the difference in pain level 1 hour after colonoscopy (comparison of carbon dioxide to air insufflation).
measure: Comparison of colonoscopy related abdominal pain 3 hours, 6 hours and 24 hours after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease
time frame: Pain level assessment 3 hours, 6 hours and 24 hours colonoscopy
description: For pain assessment a visual analogue scale will be used. For the secondary outcome measure, the investigators will compare the differences in pain level 3 hours, 6 hours and 24 hours after colonoscopy (comparison of carbon dioxide to air insufflation).
arm group label: CD patient with CO2 insufflation
arm group type: Active Comparator
description: The investigators aim to include 76 Crohn's disease (CD) patients undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.
arm group label: CD patient with air insufflation
arm group type: No Intervention
description: The investigators aim to include 76 Crohn's disease patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.
arm group label: UC patient with CO2 insufflation
arm group type: Active Comparator
description: The investigators aim to include 76 ulcerative colitis patients (UC) undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.
arm group label: UC patient with air insufflation
arm group type: No Intervention
description: The investigators aim to include 76 ulcerative colitis patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.
intervention type: Other
intervention name: carbon dioxide insufflation during colonoscopy
description: Use of Carbon dioxide instead of air insufflation
arm group label: CD patient with CO2 insufflation
arm group label: UC patient with CO2 insufflation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Frank Lenze, MD
role: Principal Investigator
affiliation: Department of Medicine B, University Hospital Muenster
last name: Frank Lenze, MD
phone: 0049-251-8358103
email: frank.lenze@uni-muenster.de
last name: Arne Bokemeyer, MD
phone: 0049-251-8347661
email: arne.bokemeyer@ukmuenster.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
sharing ipd: Undecided