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

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

Tracking Information

• First Submitted Date: September 5, 2017
• First Posted Date: September 14, 2017
• Last Update Posted Date: September 14, 2017
• Actual Study Start Date: September 3, 2017
• Estimated Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2017)

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).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 13, 2017)

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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease
• Official Title: Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease
• 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.
• 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).
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Diagnostic
• Condition: Inflammatory Bowel Diseases

Intervention

Other: carbon dioxide insufflation during colonoscopy

Use of Carbon dioxide instead of air insufflation

Study Arms

• 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.
  Intervention: Other: carbon dioxide insufflation during colonoscopy
• 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.
  Intervention: Other: carbon dioxide insufflation during colonoscopy
• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 13, 2017): 304
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2020
• Estimated Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03282786
• Other Study ID Numbers: 2017-191-f-S
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: University Hospital Muenster
• Study Sponsor: University Hospital Muenster
• Collaborators: Not Provided

Investigators

• Principal Investigator: Frank Lenze, MD; Department of Medicine B, University Hospital Muenster

• PRS Account: University Hospital Muenster
• Verification Date: August 2017