Carbon Dioxide Insufflation Colonoscopy in IBD Patients
Primary Purpose
Colonoscopy, Carbon Dioxide, Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Carbon dioxide insufflation
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonoscopy focused on measuring colonoscopy, carbon dioxide, inflammatory bowel disease
Eligibility Criteria
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)
Sites / Locations
- Digestive Diseases Center - Vitkovice Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Carbon dioxide insufflation colonoscopy (CO2)
Air insufflation colonoscopy (AI)
Arm Description
Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.
Air insufflation during both insertion and withdrawal phase of the colonoscopy.
Outcomes
Primary Outcome Measures
Bloating score 1 hour after the colonoscopy
Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02563132
Brief Title
Carbon Dioxide Insufflation Colonoscopy in IBD Patients
Official Title
Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vitkovice Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Carbon Dioxide, Inflammatory Bowel Disease
Keywords
colonoscopy, carbon dioxide, inflammatory bowel disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carbon dioxide insufflation colonoscopy (CO2)
Arm Type
Experimental
Arm Description
Carbon dioxide during both insertion and withdrawal phase of the colonoscopy.
Arm Title
Air insufflation colonoscopy (AI)
Arm Type
No Intervention
Arm Description
Air insufflation during both insertion and withdrawal phase of the colonoscopy.
Intervention Type
Procedure
Intervention Name(s)
Carbon dioxide insufflation
Intervention Description
Carbon dioxide insufflation during diagnostic colonoscopy
Primary Outcome Measure Information:
Title
Bloating score 1 hour after the colonoscopy
Description
Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Digestive Diseases Center - Vitkovice Hospital
City
Ostrava
ZIP/Postal Code
703 84
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
Carbon Dioxide Insufflation Colonoscopy in IBD Patients
We'll reach out to this number within 24 hrs