Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

Study Overview
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Brief Summary
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Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.

Official Title
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Water-aided Colonoscopy in Patients With Inflammatory Bowel Disease - a Single-center, Single-blinded Randomized Trial

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Procedure: Water immersion
* Procedure: Air insufflation insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: known diagnosis of inflammatory bowel disease planned diagnostic outpatient colonoscopy signed informed consent willingness to undergo unsedated colonoscopy Exclusion Criteria: ulcerative proctitis bowel resection longer than ileocecal resection requirement for sedation

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water immersion colonoscopy<br>Water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | Procedure: Water immersion<br>* Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.<br>|
| Active Comparator: Air insufflation colonoscopy<br>Standard room air insufflation during both colonoscope insertion and withdrawal. | Procedure: Air insufflation insertion<br> <br> * Other names: Room air insufflation during colonoscope insertion.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of unsedated colonoscopy | Successful unsedated colonoscopy is defined as reaching the cecum by using given insertion technique without administering sedation. | at the end of each colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discomfort during colonoscopy | Discomfort level using visual continuous scale 0-10 (0 = no pain, 10 = worst pain). | at the end of each colonoscopy | 
| Cecal intubation time | Cecal intubation time is defined as time between colonoscope introduction into the anus and reaching the cecum. | while reaching the cecum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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water, colonoscopy, Crohn´s disease, ulcerative colitis