Colonoscopy Clinical Trial
Official title:
Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients
Verified date | May 2016 |
Source | Vitkovice Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Czech Republic: Ethics Committee |
Study type | Interventional |
Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) after the procedure. So far, it has not been studied in inflammatory bowel disease patients. The study was designed to evaluate discomfort after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - known diagnosis of Crohn´s disease and ulcerative colitis - indication for diagnostic colonoscopy - informed consent - unsedated or minimally sedated procedure (< 3 mg of midazolam) Exclusion Criteria: - planned incomplete or therapeutic procedure - deep sedation or general anesthesia - intestinal resection longer than ileocecal resection - isolated gastroduodenal or jejunal location of Crohn´s disease (L4) - ulcerative proctitis (E1) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Czech Republic | Digestive Diseases Center - Vitkovice Hospital | Ostrava |
Lead Sponsor | Collaborator |
---|---|
Vitkovice Hospital |
Czech Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bloating score 1 hour after the colonoscopy | Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy | 1 hour | No |
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