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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

Tracking Information
First Submitted Date  ICMJE May 8, 2014
First Posted Date  ICMJE May 12, 2014
Last Update Posted Date November 10, 2015
Study Start Date  ICMJE April 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
Adenoma detection rate [ Time Frame: up to one year ]
The proportion of participants with at least one adenoma in each group
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Condition  ICMJE
  • Adenoma
  • Pain
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Water colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2015)
3303
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
3300
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135601
Other Study ID Numbers  ICMJE 20140408-7
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanglin Pan, Air Force Military Medical University, China
Study Sponsor  ICMJE Air Force Military Medical University, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanglin Pan, M.D. Air Force Military Medical University, China
Principal Investigator: Felix W. Leung, M.D. Sepulveda Ambulatory Care Center, VAGLAHS
PRS Account Air Force Military Medical University, China
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP