Warm Water and Unsedated Colonoscopy

Study Overview
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Brief Summary
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Unsedated or slightly sedated colonoscopy has fast recovery time, less cost and lower or no incidence of drug-related side effects. May be slightly painful or discomforting for the patient. Based on numerous recent reports, the investigators designed this randomized controlled trial hypothesizing that the use of warm water irrigation versus air insufflation during the insertion phase of colonoscopy might increase the global tolerability of the examination and the proportion of patients undergoing complete colonoscopy without sedation or with a low dose of sedatives.

Official Title
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Warm Water Colonoscopy: a Novel Method for Unsedated Colonoscopy

Conditions
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Gastrointestinal Diseases, Digestive System Diseases

Intervention / Treatment
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* Other: air insufflation
* Other: warm water irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 Years to 85 Years adult patients willing to undergo colonoscopy without routine initial sedation Exclusion Criteria: refuse to initiate colonoscopy without routine sedation inadequate bowel preparation incapacity to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: warm water irrigation<br>warm water irrigation during insertion phase of colonoscopy | Other: warm water irrigation<br>* warm water irrigation during insertion phase colonoscopy<br>|
| Experimental: air insufflation<br>air insufflation during insertion phase of colonoscopy | Other: air insufflation<br>* air insufflation during insertion phase colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients undergoing complete unsedated or slightly sedated colonoscopy | number of patients undergoing complete unsedated conoloscopy with a pain score (as per used scale) ≤2, or patients with no more than that score AND ≤2 mg Midazolam E.V. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of pain and tolerability scores | Numeric rating scale, Verbal Descriptor Scale and Faces Pain Scale (0= no pain, 10 worst possible pain.) Hicks CL et al. Pain 2001;93:173-183. Bieri D. et al. Pain. 1990;41(2):138-50. | 1 hour | 
| percentage of caecum intubation |  | 1 hour | 
| time to reach caecum |  | 1 hour | 
| Adenoma detection rate | Proportion of patients with at least one adenoma of any size | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, warm water method, hydrocolonoscopy, unsedated colonoscopy