The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate

Study Overview
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Brief Summary
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Water exchange method has been shown to reduce medication requirement and pain experienced during colonoscopy. It may increase the adenoma detection rate (ADR). Water exchange provides salvage cleansing and the refractive index of water (n equals about 1.3) is larger than that of air, which creates optical distortion that likely contributes to objects appearing larger underwater, making smaller lesions easier to visualize and it may help draw attention to those smaller lesions during withdraw. These principles facilitate to the higher adenoma detection rate. There is a large number of literature on the adenoma detection rate during water exchange colonoscopy, but most studies have been conducted in only one centre, simple-size, and under sedation patients, the influence of adenoma detection rate under unsedation patients was unclear. The aim of this study is to compare the ADR of colonoscopy by using the water exchange method versus the conventional air method in unsedation patients in multiple centers in China.

Official Title
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The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate: a Multicenter, Randomized, Single Blind, Control Trial

Conditions
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Adenoma, Pain

Intervention / Treatment
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* Other: Water colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 patients with intact colon and rectum Exclusion Criteria: prior finding of severe colorectal stricture; solid fetus contained in the last stool before colonoscopy no bowel preparation or cleansed by enema/lavage without the requirement of reaching cecum known colorectal polyps or polyposis syndrome without complete removal previously pregnant women hemodynamically unstable patients who cannot give informed consent

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Air colonoscopy<br>Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion. | |
| Other: Water colonoscopy<br>Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. | Other: Water colonoscopy<br>* Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | The proportion of participants with at least one adenoma in each group | up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores on the Visual Analog Scale | 0 = no pain, to 10 = most severe pain | up to one year | 
| Cecal intubation success rate | Insertion of a colonoscope to the cecum | up to one year | 
| Cecum intubation time | Total time of colonoscope intubation from anus to cecum | up to one year | 
| Quality of Bowel Preparation | BBPS：cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small frag- ments of stool, or opaque liquid. | up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, water, adenoma, pain