Clinical trial NCT03282786: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Carbon Dioxide (CO2)
Colonoscopy
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Comparison of colonoscopy related abdominal pain 1 hour after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease
timeFrame: Pain level assessment 1 hour after colonoscopy
Secondary outcomes:
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
timeFrame: Pain level assessment 3 hours, 6 hours and 24 hours colonoscopy
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Unversity Clinic Muenster
state: NRW
Study officials:
affiliation: Department of Medicine B, University Hospital Muenster
name: Frank Lenze, MD
role: PRINCIPAL_INVESTIGATOR
References: