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

Primary Purpose

Adenoma, Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Water colonoscopy
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Adenoma focused on measuring colonoscopy, water, adenoma, pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chaoyang Hospital
  • General Hospital of Guangzhou Military Command
  • Union Hospital of Tongji Medical college
  • Xijing Hospital of Digestive Diseases
  • Renji Hospital
  • First Teaching Hospital of Xinjiang Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Air colonoscopy

Water colonoscopy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Scores on the Visual Analog Scale
0 = no pain, to 10 = most severe pain
Cecal intubation success rate
Insertion of a colonoscope to the cecum
Cecum intubation time
Total time of colonoscope intubation from anus to cecum
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.

Full Information

First Posted
May 8, 2014
Last Updated
November 8, 2015
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02135601
Brief Title
The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate
Official Title
The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate: a Multicenter, Randomized, Single Blind, Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Pain
Keywords
colonoscopy, water, adenoma, pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Air colonoscopy
Arm Type
No Intervention
Arm Description
Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion.
Arm Title
Water colonoscopy
Arm Type
Other
Arm Description
Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope.
Intervention Type
Other
Intervention Name(s)
Water colonoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adenoma detection rate
Description
The proportion of participants with at least one adenoma in each group
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Description
0 = no pain, to 10 = most severe pain
Time Frame
up to one year
Title
Cecal intubation success rate
Description
Insertion of a colonoscope to the cecum
Time Frame
up to one year
Title
Cecum intubation time
Description
Total time of colonoscope intubation from anus to cecum
Time Frame
up to one year
Title
Quality of Bowel Preparation
Description
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.
Time Frame
up to one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, M.D.
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felix W. Leung, M.D.
Organizational Affiliation
Sepulveda Ambulatory Care Center, VAGLAHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
General Hospital of Guangzhou Military Command
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Facility Name
Union Hospital of Tongji Medical college
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
First Teaching Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China

12. IPD Sharing Statement

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

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