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

Not Applicable

• Conditions: Inflammatory Bowel Diseases
• Interventions: Other: carbon dioxide insufflation during colonoscopy

• Registration Number: NCT03282786
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-09-03
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-14
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-16
• Primary Completion: 2021-08-01
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CD patient with CO2 insufflation	carbon dioxide insufflation during colonoscopy	The investigators aim to include 76 Crohn's disease (CD) patients undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.
UC patient with CO2 insufflation	carbon dioxide insufflation during colonoscopy	The investigators aim to include 76 ulcerative colitis patients (UC) undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used.

Primary Outcome Measures

Name	Time	Method
Comparison of colonoscopy related abdominal pain 1 hour after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease	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

Name	Time	Method
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	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).

Trial Locations

Locations (1)

Unversity Clinic Muenster; 🇩🇪 Muenster, NRW, Germany