Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: carbon dioxide insufflation during colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: CD patient with CO2 insufflation<br>The investigators aim to include 76 Crohn's disease (CD) patients undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used. | Other: carbon dioxide insufflation during colonoscopy<br>* Use of Carbon dioxide instead of air insufflation<br>|
| No Intervention: CD patient with air insufflation<br>The investigators aim to include 76 Crohn's disease patients undergoing colonoscopy in whom air insufflation during endoscopy should be used. | |
| Active Comparator: UC patient with CO2 insufflation<br>The investigators aim to include 76 ulcerative colitis patients (UC) undergoing colonoscopy in whom CO2 insufflation during endoscopy should be used. | Other: carbon dioxide insufflation during colonoscopy<br>* Use of Carbon dioxide instead of air insufflation<br>|
| No Intervention: UC patient with air insufflation<br>The investigators aim to include 76 ulcerative colitis patients undergoing colonoscopy in whom air insufflation during endoscopy should be used. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of colonoscopy related abdominal pain 1 hour after examination assessed by a visual analogue pain scale in patients with inflammatory bowel disease | For pain assessment a visual analogue scale will be used. For the primary outcome measure, the investigators will compare the difference in pain level 1 hour after colonoscopy (comparison of carbon dioxide to air insufflation). | Pain level assessment 1 hour after colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | For pain assessment a visual analogue scale will be used. For the secondary outcome measure, the investigators will compare the differences in pain level 3 hours, 6 hours and 24 hours after colonoscopy (comparison of carbon dioxide to air insufflation). | Pain level assessment 3 hours, 6 hours and 24 hours colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, Carbon Dioxide (CO2), Colonoscopy