The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate
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|ClinicalTrials.gov Identifier: NCT02135601|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : November 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Adenoma Pain||Other: Water colonoscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3303 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate: a Multicenter, Randomized, Single Blind, Control Trial|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
No Intervention: Air colonoscopy
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.
Other: Water 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.
- Adenoma detection rate [ Time Frame: up to one year ]The proportion of participants with at least one adenoma in each group
- Pain Scores on the Visual Analog Scale [ Time Frame: up to one year ]0 = no pain, to 10 = most severe pain
- Cecal intubation success rate [ Time Frame: up to one year ]Insertion of a colonoscope to the cecum
- Cecum intubation time [ Time Frame: up to one year ]Total time of colonoscope intubation from anus to cecum
- Quality of Bowel Preparation [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135601
|Beijing, Beijing, China, 100020|
|General Hospital of Guangzhou Military Command|
|Guangzhou, Guangdong, China, 510010|
|Union Hospital of Tongji Medical college|
|Wuhan, Hubei, China, 430022|
|Xijing Hospital of Digestive Diseases|
|Xi'an, Shaanxi, China, 710032|
|Shanghai, Shanghai, China, 200000|
|First Teaching Hospital of Xinjiang Medical University|
|Urumqi, Xinjiang, China, 830054|
|Principal Investigator:||Yanglin Pan, M.D.||Air Force Military Medical University, China|
|Principal Investigator:||Felix W. Leung, M.D.||Sepulveda Ambulatory Care Center, VAGLAHS|