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

Not Applicable

Completed

• Conditions: Adenoma; Pain
• Interventions: Other: Water colonoscopy

• Registration Number: NCT02135601
• Lead Sponsor: Air Force Military Medical University, China

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 available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-08
• Study First Posted: 2014-05-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-11-08
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3303

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water colonoscopy	Water colonoscopy	Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	up to one year	The proportion of participants with at least one adenoma in each group

Secondary Outcome Measures

Name	Time	Method
Cecal intubation success rate	up to one year	Insertion of a colonoscope to the cecum
Cecum intubation time	up to one year	Total time of colonoscope intubation from anus to cecum
Pain Scores on the Visual Analog Scale	up to one year	0 = no pain, to 10 = most severe pain
Quality of Bowel Preparation	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.

Trial Locations

Locations (6)

General Hospital of Guangzhou Military Command; 🇨🇳 Guangzhou, Guangdong, China

Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China

Union Hospital of Tongji Medical college; 🇨🇳 Wuhan, Hubei, China

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China

First Teaching Hospital of Xinjiang Medical University; 🇨🇳 Urumqi, Xinjiang, China

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China