ColonoscopyNCT02759081
Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy
A study testing cap-assisted water exchange and water exchange in people with Colonoscopy and Intubation Time, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Intubation Time, Cap-assisted Colonoscopy
- What is being tested?
- cap-assisted water exchange and water exchange
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Dec 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
- Patients undergoing fully sedated colonoscopy performed by the investigators
Who cannot join
- obstructive lesions of the colon
- massive ascites
- history of partial colectomy
- provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Trial Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy
This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.
- Conditions
- Colonoscopy, Intubation Time, Cap-assisted Colonoscopy
- Being tested
- cap-assisted water exchange, water exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cap-assisted water exchangeDevice
a transparent cap was mounted to the tip of colonoscopy when water exchange was performed.
water exchangeProcedure or surgery
water was infused and suctioned at the same time during insertion of colonoscope
| Study group | Role | What they receive |
|---|---|---|
| water exchange | Active comparator | The air was turned off at the beginning of colonoscopy. Water was infused and suctioned at the same time during insertion. The air was turned on when the colonoscope reached the cecum. Receives: Procedure: water exchange |
| cap-assisted water exchange | Experimental | Cap was mounted to the tip of the colonoscope when water exchange was performed. Receives: Device: cap-assisted water exchange; Procedure: water exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
cecal intubation time
Measured: when the colonoscope reaches the cecum, an average of 14 minutes
Secondary outcomes (2)
Dose of propofol
Measured: The end of colonoscopy, an average of 14 minutes
adenoma detection rate
when histology analysis of the removed polyps are available
Measured: One week after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hsi hsieh, Dalin Tzu Chi General Hospital
- Investigators
- Yu-Hsi Hsieh, MD, Principal investigator, Dalin Tzu Chi Hospital. Tzu Chi medication Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759081
- Sponsor's protocol ID
- Hsieh-2016-01
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Leung 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 22898423Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
PubMed 21997547Kondo S, Yamaji Y, Watabe H, Yamada A, Sugimoto T, Ohta M, Ogura K, Okamoto M, Yoshida H, Kawabe T, Omata M. A randomized controlled trial evaluating the usefulness of a transparent hood attached to the tip of the colonoscope. Am J Gastroenterol. 2007 Jan;102(1):75-81. doi: 10.1111/j.1572-0241.2006.00897.x. Epub 2006 Nov 13.
PubMed 17100978Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.
PubMed 19098847
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy
- ClinicalTrials.gov ID
- NCT02759081
- Acronym / sponsor ID
- Hsieh-2016-01
- Conditions
- Colonoscopy, Intubation Time, Cap-assisted Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- First posted
- 3 May 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.
This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water exchange | Active comparator | Procedure: water exchangeThe air was turned off at the beginning of colonoscopy. Water was infused and suctioned at the same time during insertion. The air was turned on when the colonoscope reached the cecum. |
| cap-assisted water exchange | Experimental | Device: cap-assisted water exchange, Procedure: water exchangeCap was mounted to the tip of the colonoscope when water exchange was performed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing fully sedated colonoscopy performed by the investigators
Key exclusion criteria (4 listed)
- obstructive lesions of the colon
- massive ascites
- history of partial colectomy
- 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 |
|---|---|---|
| cap-assisted water exchangea transparent cap was mounted to the tip of colonoscopy when water exchange was performed. | Device | cap-assisted water exchange |
| water exchangewater was infused and suctioned at the same time during insertion of colonoscope | Procedure or surgery | cap-assisted water exchange, water exchange |
Primary outcome
cecal intubation time
Time frame: when the colonoscope reaches the cecum, an average of 14 minutes
2 secondary outcomes
Dose of propofol
Time frame: The end of colonoscopy, an average of 14 minutes
adenoma detection rate
Time frame: One week after colonoscopy
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 3 May 2016.
- 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 21997547Rastogi A, Bansal A, Rao DS, Gupta N, Wani SB, Shipe T, Gaddam S, Singh V, Sharma P. Higher adenoma detection rates with cap-assisted colonoscopy: a randomised controlled trial. Gut. 2012 Mar;61(3):402-8. doi: 10.1136/gutjnl-2011-300187. Epub 2011 Oct 13.
- Background: PubMed 17100978Kondo S, Yamaji Y, Watabe H, Yamada A, Sugimoto T, Ohta M, Ogura K, Okamoto M, Yoshida H, Kawabe T, Omata M. A randomized controlled trial evaluating the usefulness of a transparent hood attached to the tip of the colonoscope. Am J Gastroenterol. 2007 Jan;102(1):75-81. doi: 10.1111/j.1572-0241.2006.00897.x. Epub 2006 Nov 13.
- Background: PubMed 19098847Lee YT, Lai LH, Hui AJ, Wong VW, Ching JY, Wong GL, Wu JC, Chan HL, Leung WK, Lau JY, Sung JJ, Chan FK. Efficacy of cap-assisted colonoscopy in comparison with regular colonoscopy: a randomized controlled trial. Am J Gastroenterol. 2009 Jan;104(1):41-6. doi: 10.1038/ajg.2008.56.
- Individual participant dataSharing planned: No
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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 Hospital. Tzu Chi medication Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cap-assisted water exchange and water exchange in people with Colonoscopy and Intubation Time, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
cecal intubation time (time frame: when the colonoscope reaches the cecum, an average of 14 minutes). 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 NCT02759081, which also lists 4 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 3 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.