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NCT02563132 Clinical Trial

Carbon Dioxide Insufflation Colonoscopy in IBD Patients

Colonoscopy Clinical Trial

Official title:
Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02563132
Other study ID # DDC VN 08
Secondary ID
Status Completed
Phase N/A
First received September 28, 2015
Last updated May 28, 2016
Start date October 2015
Est. completion date May 2016

Study information
Verified date May 2016
Source Vitkovice Hospital
Contact n/a
Is FDA regulated No
Health authority Czech Republic: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

Description:

Carbon dioxide insufflation during colonoscopy significantly reduces discomfort (pain, bloating and flatulence) during up to 24 hours after the procedure. So far, it has not been studied in inflammatory bowel disease patients who represent specific patient population indicated for colonoscopy. They are characterized by younger age, structural changes of the colon including intestinal resections and need for repeated and frequently difficult procedures.The study was designed to evaluate discomfort during 24 hours after the carbon dioxide insufflation colonoscopy in comparison to standard air insufflation colonoscopy.

Recruitment information / eligibility
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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• Carbon dioxide insufflation
Carbon dioxide insufflation during diagnostic colonoscopy

Locations
Country Name City State
Czech Republic Digestive Diseases Center - Vitkovice Hospital Ostrava

Sponsors (1)
Lead Sponsor Collaborator
Vitkovice Hospital

Country where clinical trial is conducted

Czech Republic, 

Outcome
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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