AdenomaNCT02737514
Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
A study testing Air insufflation, water immersion and water exchange in people with Adenoma, run by Dalin Tzu Chi General Hospital at 2 sites in 2 countries.
Trial summary
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Adenoma
- What is being tested?
- Air insufflation, water immersion and water exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2015to Feb 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing colonoscopy performed by the participating endoscopists
Who cannot join
- obstructive lesions of the colon known before colonoscopy
- massive ascites
- past history of partial colectomy
- refusal to provide written informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Sepulveda Ambulatory Care Center, Veterans Affairs Greater
North Hills, California
About this study
Official title: A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon
Read the detailed description
All of the procedures will be recorded and stored as digital files.
- Conditions
- Adenoma
- Being tested
- Air insufflation, water immersion, water exchange
- Keywords
- adenoma detection rate, colonoscopy, water exchange
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air insufflationProcedure or surgery
Insufflation during colonoscopy including insertion phase
water immersionProcedure or surgery
Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
water exchangeProcedure or surgery
Water will infused and removed during insertion phase of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| air insufflation | Active comparator | Air insufflation will be used throughout whole procedure of colonoscopy Receives: Procedure: Air insufflation |
| water immersion | Active comparator | Water will be infused during the insertion phase and removed during withdrawal phase of colonoscopy Receives: Procedure: water immersion |
| water exchange | Active comparator | Water will be infused and removed during insertion phase of colonoscopy Receives: Procedure: water exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate in the right colon
Measured: one week
Secondary outcomes (3)
overall adenoma detection rate
Measured: one week
post-procedure discomfort
pain or distention on a 0 to 10 VAS scale
Measured: 1 day after colonoscopy
30 days complication rate
incidence of bleeding, perforation and unexpected admission
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Hsi Hsieh, MD, Principal investigator, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737514
- Sponsor's protocol ID
- DalinHsieh201402
- Status last verified
- May 2020
- First submitted
- 25 Aug 2015
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.
PubMed 15300577Stock C, Pulte D, Haug U, Brenner H. Subsite-specific colorectal cancer risk in the colorectal endoscopy era. Gastrointest Endosc. 2012 Mar;75(3):621-30. doi: 10.1016/j.gie.2011.10.025.
PubMed 22341107Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
PubMed 22898423Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
PubMed 20883846Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
PubMed 21633535
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy
- ClinicalTrials.gov ID
- NCT02737514
- Acronym / sponsor ID
- DalinHsieh201402
- Conditions
- Adenoma
- Keywords
- adenoma detection rate, colonoscopy, water exchange
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 14 Apr 2016 (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.
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon
Detailed description
All of the procedures will be recorded and stored as digital files.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| air insufflation | Active comparator | Procedure: Air insufflationAir insufflation will be used throughout whole procedure of colonoscopy |
| water immersion | Active comparator | Procedure: water immersionWater will be infused during the insertion phase and removed during withdrawal phase of colonoscopy |
| water exchange | Active comparator | Procedure: water exchangeWater will be infused and removed during insertion phase of colonoscopy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing colonoscopy performed by the participating endoscopists
Key exclusion criteria (4 listed)
- obstructive lesions of the colon known before colonoscopy
- massive ascites
- past history of partial colectomy
- refusal to provide written informed consent
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 |
|---|---|---|
| Air insufflationInsufflation during colonoscopy including insertion phase | Procedure or surgery | air insufflation |
| water immersionWater will infused during insertion phase and removed during withdrawal phase of colonoscopy | Procedure or surgery | water immersion |
| water exchangeWater will infused and removed during insertion phase of colonoscopy | Procedure or surgery | water exchange |
Primary outcome
adenoma detection rate in the right colon
Time frame: one week
3 secondary outcomes
overall adenoma detection rate
Time frame: one week
post-procedure discomfort
Time frame: 1 day after colonoscopy
30 days complication rate
Time frame: 30 days
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 29 May 2020.
- Background: PubMed 15300577Bressler B, Paszat LF, Vinden C, Li C, He J, Rabeneck L. Colonoscopic miss rates for right-sided colon cancer: a population-based analysis. Gastroenterology. 2004 Aug;127(2):452-6. doi: 10.1053/j.gastro.2004.05.032.
- Background: PubMed 22341107Stock C, Pulte D, Haug U, Brenner H. Subsite-specific colorectal cancer risk in the colorectal endoscopy era. Gastrointest Endosc. 2012 Mar;75(3):621-30. doi: 10.1016/j.gie.2011.10.025.
- Background: PubMed 22898423Leung FW, Amato A, Ell C, Friedland S, Harker JO, Hsieh YH, Leung JW, Mann SK, Paggi S, Pohl J, Radaelli F, Ramirez FC, Siao-Salera R, Terruzzi V. Water-aided colonoscopy: a systematic review. Gastrointest Endosc. 2012 Sep;76(3):657-66. doi: 10.1016/j.gie.2012.04.467.
- Background: PubMed 20883846Radaelli F, Paggi S, Amato A, Terruzzi V. Warm water infusion versus air insufflation for unsedated colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2010 Oct;72(4):701-9. doi: 10.1016/j.gie.2010.06.025.
- Background: PubMed 21633535Hsieh YH, Lin HJ, Tseng KC. Limited water infusion decreases pain during minimally sedated colonoscopy. World J Gastroenterol. 2011 May 7;17(17):2236-40. doi: 10.3748/wjg.v17.i17.2236.
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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.
Yu-Hsi Hsieh, MD principal investigator
Dalin Tzu Chi General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air insufflation, water immersion and water exchange in people with Adenoma, run by Dalin Tzu Chi General Hospital at 2 sites in 2 countries.
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 4 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 29 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Taiwan. 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 in the right colon (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02737514, which also lists 5 linked publications.
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 29 May 2020.