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

NCT ID: NCT02135601

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-07-31

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.

Conditions

Adenoma; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Air colonoscopy

Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Water colonoscopy

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

Group Type: OTHER

Water colonoscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

Associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanglin Pan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Felix W. Leung, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sepulveda Ambulatory Care Center, VAGLAHS

Locations

Chaoyang Hospital

Beijing, Beijing Municipality, China

General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, China

Union Hospital of Tongji Medical college

Wuhan, Hubei, China

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Renji Hospital

Shanghai, Shanghai Municipality, China

First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Countries

China

Other Identifiers

20140408-7

Identifier Type: -

Identifier Source: org_study_id