Warm Water Versus Room Temperature 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. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials. The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice. The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not 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 will be also assessed.

Official Title
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Warm Water Versus Room Temperature Water Immersion Colonoscopy - a Prospective, Randomized, Double-blind, Single-center Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Warm Water Immersion Colonoscopy
* Procedure: Cool 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Warm Water Immersion Colonoscopy<br>Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | Procedure: Warm Water Immersion Colonoscopy<br>* Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.<br>|
| Active Comparator: Cool Water Immersion Colonoscopy<br>Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal. | Procedure: Cool Water Immersion Colonoscopy<br>* Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room 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 |  | 3 months | 
| Cecal Intubation Time | = time between introduction of the colonoscope into the anus and reaching the cecum. | 1-30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Comfort During Insertion Phase of the Colonoscopy |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, warm water immersion, cool water immersion