Clinical trial NCT02135601: The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate
Official title: The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate: a Multicenter, Randomized, Single Blind, Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoma
Pain
Keywords: colonoscopy
water
adenoma
pain
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 3303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility 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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: up to one year
Secondary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: up to one year
measure: Cecal intubation success rate
timeFrame: up to one year
measure: Cecum intubation time
timeFrame: up to one year
measure: Quality of Bowel Preparation
timeFrame: up to one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chaoyang Hospital
state: Beijing
city: Guangzhou
country: China
facility: General Hospital of Guangzhou Military Command
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical college
state: Hubei
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
city: Urumqi
country: China
facility: First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
Study officials:
affiliation: Air Force Military Medical University, China
name: Yanglin Pan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sepulveda Ambulatory Care Center, VAGLAHS
name: Felix W. Leung, M.D.
role: PRINCIPAL_INVESTIGATOR
References: