Cap-assisted Water Immersion Versus Water Immersion Colonoscopy

Study Overview
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Brief Summary
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Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. Cap attached to the colonoscope tip may improve insertion and shorten cecal intubation time. The investigators would like to assess whether combination of cap-fitted colonoscopy and water immersion insertion is feasible and safe method of diagnostic colonoscopy. The primary endpoint is cecal intubation time and the investigators suppose that the use of cap is able to shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy are assessed.

Official Title
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Cap-assisted Water Immersion Versus Water Immersion Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial

Conditions
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Colonoscopy

Intervention / Treatment
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* Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope
* Procedure: water immersion colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: outpatient diagnostic colonoscopy bowel prep with macrogolum initial 2 mg of midazolam i.v. signed informed consent form Exclusion Criteria: planned therapeutic intervention colorectal surgery in history known inflammatory bowel disease or colorectal cancer refusal of 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: cap-assisted water immersion colonoscopy<br>Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | Device: soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope<br>* Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.<br>|
| Active Comparator: water immersion colonoscopy<br>Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | Procedure: water immersion colonoscopy<br>* Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecal Intubation Time | The primary endpoint (cecal intubation time) was defined as a time between introduction of the colonoscope into the anus and reaching the cecum. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comfort During Insertion Phase of the Colonoscopy |  | 3 months | 
| Success Rate of Minimal Sedation Colonoscopy | A successful minimal sedation colonoscopy was defined as reaching the cecum without switching to another insertion method and without additional sedation beyond the initial 2 mg of midazolam. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, cap-assisted colonoscopy, water immersion colonoscopy