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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Adenoma
• Intervention / Treatment: Other: Water colonoscopy

• Study Type: Interventional
• Enrollment (Actual): 3303
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Chaoyang Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510010
      • General Hospital of Guangzhou Military Command
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital of Tongji Medical college
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • RenJi Hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830054
      • First Teaching Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Air colonoscopy; Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Other: Water colonoscopy; Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	The proportion of participants with at least one adenoma in each group	up to one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores on the Visual Analog Scale	0 = no pain, to 10 = most severe pain	up to one year
Cecal intubation success rate	Insertion of a colonoscope to the cecum	up to one year
Cecum intubation time	Total time of colonoscope intubation from anus to cecum	up to one year
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Yanglin Pan, M.D., Air Force Military Medical University, China; Principal Investigator: Felix W. Leung, M.D., Sepulveda Ambulatory Care Center, VAGLAHS

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: May 8, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 8, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: pain; colonoscopy; adenoma; water
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 20140408-7