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Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease (CO2-IBD)

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ClinicalTrials.gov Identifier: NCT03282786
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Other: carbon dioxide insufflation during colonoscopy Not Applicable

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease
Actual Study Start Date : September 3, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Active Comparator: CD patient with CO2 insufflation
The investigators aim to include 76 Crohn's disease (CD) patients undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.
Other: carbon dioxide insufflation during colonoscopy
Use of Carbon dioxide instead of air insufflation

No Intervention: CD patient with air insufflation
The investigators aim to include 76 Crohn's disease patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.
Active Comparator: UC patient with CO2 insufflation
The investigators aim to include 76 ulcerative colitis patients (UC) undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.
Other: carbon dioxide insufflation during colonoscopy
Use of Carbon dioxide instead of air insufflation

No Intervention: UC patient with air insufflation
The investigators aim to include 76 ulcerative colitis patients undergoing colonoscopy in whom air insufflation during endoscopy should be used.



Primary Outcome Measures :
  1. 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 ]
    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).


Secondary Outcome Measures :
  1. 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 ]
    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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with inflammatory bowel disease
  • Indication for colonoscopy
  • Age 18-80 years
  • signed consent form

Exclusion Criteria:

  • Consent form not signed
  • Age < 18 or above 80 yrs
  • Pregnancy or Breast-Feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282786


Contacts
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Contact: Frank Lenze, MD 0049-251-8358103 frank.lenze@uni-muenster.de
Contact: Arne Bokemeyer, MD 0049-251-8347661 arne.bokemeyer@ukmuenster.de

Locations
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Germany
Unversity Clinic Muenster Recruiting
Muenster, NRW, Germany, 48149
Contact: Frank Lenze, MD, PhD    00492518458103    frank.lenze@ukmuenster.de   
Sponsors and Collaborators
University Hospital Muenster
Investigators
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Principal Investigator: Frank Lenze, MD Department of Medicine B, University Hospital Muenster

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Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT03282786     History of Changes
Other Study ID Numbers: 2017-191-f-S
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Muenster:
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Carbon Dioxide (CO2)
Colonoscopy
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis