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Completed

NCT Number: NCT02135601

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

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.

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Key information

Conditions

Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chaoyang Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water colonoscopy

Other

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 outcomes

  1. Adenoma detection rate

    Time frame: up to one year

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 12, 2014
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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