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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
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Air Force Military Medical University, China

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.


Condition or disease Intervention/treatment Phase
Adenoma Pain Other: Water colonoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Air colonoscopy
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Water colonoscopy
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.




Primary Outcome Measures :
  1. Adenoma detection rate [ Time Frame: up to one year ]
    The proportion of participants with at least one adenoma in each group


Secondary Outcome Measures :
  1. Pain Scores on the Visual Analog Scale [ Time Frame: up to one year ]
    0 = no pain, to 10 = most severe pain

  2. Cecal intubation success rate [ Time Frame: up to one year ]
    Insertion of a colonoscope to the cecum

  3. Cecum intubation time [ Time Frame: up to one year ]
    Total time of colonoscope intubation from anus to cecum

  4. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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China, Beijing
Chaoyang Hospital
Beijing, Beijing, China, 100020
China, Guangdong
General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, China, 510010
China, Hubei
Union Hospital of Tongji Medical college
Wuhan, Hubei, China, 430022
China, Shaanxi
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032
China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200000
China, Xinjiang
First Teaching Hospital of Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
Sponsors and Collaborators
Air Force Military Medical University, China
Investigators
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Principal Investigator: Yanglin Pan, M.D. Air Force Military Medical University, China
Principal Investigator: Felix W. Leung, M.D. Sepulveda Ambulatory Care Center, VAGLAHS
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Responsible Party: Yanglin Pan, Associated professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT02135601    
Other Study ID Numbers: 20140408-7
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: August 2015
Keywords provided by Yanglin Pan, Air Force Military Medical University, China:
colonoscopy
water
adenoma
pain
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms