Adenoma, Pain
Conditions
Keywords
colonoscopy, water, adenoma, pain
Brief summary
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.
Interventions
OTHERWater colonoscopy
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.
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | up to one year | The proportion of participants with at least one adenoma in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on the Visual Analog Scale | up to one year | 0 = no pain, to 10 = most severe pain |
| Cecal intubation success rate | up to one year | Insertion of a colonoscope to the cecum |
| Cecum intubation time | up to one year | Total time of colonoscope intubation from anus to cecum |
| Quality of Bowel Preparation | up to one year | 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. |
Countries
China
Outcome results
None listed