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

NCT02135601 | Completed DMC

• 1 other identifier: 20140408-7
• Study Type: interventional
• Target: 3,303
• Locations: 1 country
• Sites: 6

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

Keywords

colonoscopy; water; adenoma; pain

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

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

  up to one year

Secondary Outcomes (4)

• Pain Scores on the Visual Analog Scale

  up to one year

• Cecal intubation success rate

  up to one year

• Cecum intubation time

  up to one year

• Quality of Bowel Preparation

  up to one year

Study Arms (2)

Air colonoscopy

NO INTERVENTION

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

Water colonoscopy

OTHER

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

Other: Water colonoscopy

Interventions

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.

Water colonoscopy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80 patients with intact colon and rectum

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (6)

Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

Location

General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510010, China

Location

Union Hospital of Tongji Medical college

Wuhan, Hubei, 430022, China

Location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Renji Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

MeSH Terms

Conditions

Adenoma; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Yanglin Pan, M.D.

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

• Felix W. Leung, M.D.

  Sepulveda Ambulatory Care Center, VAGLAHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 12, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-08

Locations

CN (6)