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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135601
• Other study ID #: 20140408-7
• Status: Completed
• Phase: N/A
• First received: May 8, 2014
• Last updated: November 8, 2015
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3303
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pain

Intervention

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.

Locations

Country	Name	City	State
China	Chaoyang Hospital	Beijing	Beijing
China	General Hospital of Guangzhou Military Command	Guangzhou	Guangdong
China	Renji Hospital	Shanghai	Shanghai
China	First Teaching Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Union Hospital of Tongji Medical college	Wuhan	Hubei
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	The proportion of participants with at least one adenoma in each group	up to one year
Secondary	Pain Scores on the Visual Analog Scale	0 = no pain, to 10 = most severe pain	up to one year
Secondary	Cecal intubation success rate	Insertion of a colonoscope to the cecum	up to one year
Secondary	Cecum intubation time	Total time of colonoscope intubation from anus to cecum	up to one year
Secondary	Quality of Bowel Preparation	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.	up to one year