Carbon Dioxide Insufflation Colonoscopy in IBD Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Carbon Dioxide Insufflation Colonoscopy in Inflammatory Bowel Disease Patients

Conditions
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Colonoscopy, Carbon Dioxide, Inflammatory Bowel Disease

Intervention / Treatment
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* Procedure: Carbon dioxide insufflation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbon dioxide insufflation colonoscopy (CO2)<br>Carbon dioxide during both insertion and withdrawal phase of the colonoscopy. | Procedure: Carbon dioxide insufflation<br>* Carbon dioxide insufflation during diagnostic colonoscopy<br>|
| No Intervention: Air insufflation colonoscopy (AI)<br>Air insufflation during both insertion and withdrawal phase of the colonoscopy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloating score 1 hour after the colonoscopy | Bloating severity on continuous scale 0-10 (0 = none, 10 = worst) 1 hour after colonoscopy | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, carbon dioxide, inflammatory bowel disease