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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Fourth Military Medical University

Current Primary Outcome: Adenoma detection rate [ Time Frame: up to one year ]

The proportion of participants with at least one adenoma in each group


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Fourth Military Medical University

Dates:
Date Received: May 8, 2014
Date Started: April 2014
Date Completion:
Last Updated: November 8, 2015
Last Verified: August 2015