AdenomaNCT02135601
The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate
A study testing Water colonoscopy in people with Adenoma and Pain, run by Air Force Military Medical University, China at 6 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Water colonoscopy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,303 participants
- Where
- 6 sitesChina
- Study dates
- Apr 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-80 patients with intact colon and rectum
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Chaoyang Hospital
Beijing, Beijing Municipality, 100020
General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
Renji Hospital
Shanghai, Shanghai Municipality, 200000
First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Union Hospital of Tongji Medical college
Wuhan, Hubei, 430022
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, 710032
About this study
Official title: 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.
- Being tested
- Water colonoscopy
- Keywords
- colonoscopy, water, adenoma, pain
- Medical subject headings
- Adenoma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water colonoscopyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Water colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The proportion of participants with at least one adenoma in each group
Measured: up to one year
Secondary outcomes (4)
Pain Scores on the Visual Analog Scale
0 = no pain, to 10 = most severe pain
Measured: up to one year
Cecal intubation success rate
Insertion of a colonoscope to the cecum
Measured: up to one year
Cecum intubation time
Total time of colonoscope intubation from anus to cecum
Measured: 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.
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
- Investigators
- Yanglin Pan, M.D., Principal investigator, Air Force Military Medical University, ChinaFelix W. Leung, M.D., Principal investigator, Sepulveda Ambulatory Care Center, VAGLAHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135601
- Sponsor's protocol ID
- 20140408-7
- Status last verified
- Aug 2015
- First submitted
- 8 May 2014
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Water-exchanged Colonoscopy on Adenoma Detection Rate: a Multicenter, Randomized, Single Blind, Control Trial
- ClinicalTrials.gov ID
- NCT02135601
- Acronym / sponsor ID
- 20140408-7
- Keywords
- colonoscopy, water, adenoma, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,303 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air colonoscopy | No intervention | –Colonoscopy will be performed without medications and with judicious air insufflation during colonoscope insertion. |
| Water colonoscopy | Other | Other: Water colonoscopyColonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 18-80 patients with intact colon and rectum
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water colonoscopyColonoscopy 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. | Other | Water colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: up to one year
The proportion of participants with at least one adenoma in each group
4 secondary outcomes
Pain Scores on the Visual Analog Scale
Time frame: up to one year
Cecal intubation success rate
Time frame: up to one year
Cecum intubation time
Time frame: up to one year
Quality of Bowel Preparation
Time frame: up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanglin Pan, M.D. principal investigator
Air Force Military Medical University, China
Felix W. Leung, M.D. principal investigator
Sepulveda Ambulatory Care Center, VAGLAHS
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water colonoscopy in people with Adenoma and Pain, run by Air Force Military Medical University, China at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.