Colonic AdenomaNCT01989650
The Effect of Taking Break During Colonoscopy Session on Adenoma Detection, a Prospective, Randomized Control Study
A study testing Break and No break in people with Colonic Adenoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Recent research has suggested that endoscopist fatigue may significantly affect the polyp detection rate. There have been no studies on interventions that may reduce endoscopist fatigue and therefore improve colonoscopy performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Adenoma
- What is being tested?
- Break and No break
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,379 participants
- Where
- 1 siteHong Kong
- Study dates
- Feb 2012to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who underwent colonoscopies in the afternoon session at the endoscopy unit in AHNH were eligible for inclusion in this study.
Who cannot join
- Emergency inpatient colonoscopy
- Patient with history of colorectal cancer , FAP or IBD
Trial locations and contacts
1 site in 1 country.
About this study
Recent research has suggested that endoscopist fatigue may significantly affect the polyp detection rate. There have been no studies on interventions that may reduce endoscopist fatigue and therefore improve colonoscopy performance.
We want to determine whether a break in the middle of colonoscopy session would maintain a more stable adenoma detection rate
Read the detailed description
In recent years, there has been a dramatic increase in the volume of endoscopic procedures performed in most endoscopy centers. With the growing awareness of colorectal cancer screening, there is increasing demand for colonoscopy which has increased the workload of endoscopists in every healthcare system. There are studies showing that physician fatigue impairs quality of care and performance in other medical specialties such as anesthesia and surgery. Colonoscopy by nature is repetitive and frequently prolonged which can promote distractibility and fatigability. Studies from western countries have showed that afternoon colonoscopies are associated with lower adenoma detection rate (ADR) compared with the morning colonoscopies and physician fatigue has been hypothesized as a potential contributor. Previous studies also showed that the polyp detection rate decreases hour-by-hour throughout the day and the colonoscopy completion rate appears to decline with successive procedures due to endoscopist fatigue. The most recent study using the queue position as a surrogate marker for endoscopist fatigue had showed that both the later colonoscopy start time and increasing number of preceding endoscopic procedures are associated with decreasing polyp detection rate. It is not surprising that endoscopist fatigue may contribute to a significant decline in the effectiveness of colonoscopy and yet it is probably not realistic to reduce the number of colonoscopy procedures per session given the heavy clinical demand. There have been no studies on any intervention that may improve the performance of colonoscopy. It would be reasonable to postulate that taking a break half way through the colonoscopy session may alleviate endoscopist fatigue and hence improve the polyp detection rate. This study aims to evaluate the effect of introducing a break in the middle of a colonoscopy session on the quality of colonoscopy performance.
- Conditions
- Colonic Adenoma
- Being tested
- Break, No break
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreakOther
A break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total
No breakOther
No break will be provided
| Study group | Role | What they receive |
|---|---|---|
| Break | Active comparator | A break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total Receives: Other: Break; Other: No break |
| No break | No intervention | No break will be provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Measured: 2 years
Secondary outcomes (6)
Colonoscopy insertion time
Measured: 2 years
Cecal intubation rate
Measured: 2 years
Patient satisfaction score
A questionnaire will be used to asses patient's satisfaction level
Measured: 2 years
Complication rate
Measured: 2 years
Withdrawal time
Measured: 2 years
Patient pain score
A questionnaire will be used to asses patient's level of pain
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic AdenomaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aric Josun Hui, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989650
- Sponsor's protocol ID
- Break
- Status last verified
- Feb 2015
- First submitted
- 7 Nov 2013
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Taking Break During Colonoscopy Session on Adenoma Detection, a Prospective, Randomized Control Study
- ClinicalTrials.gov ID
- NCT01989650
- Acronym / sponsor ID
- Break
- Conditions
- Colonic Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,379 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Nov 2013 (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.
Recent research has suggested that endoscopist fatigue may significantly affect the polyp detection rate. There have been no studies on interventions that may reduce endoscopist fatigue and therefore improve colonoscopy performance.
We want to determine whether a break in the middle of colonoscopy session would maintain a more stable adenoma detection rate
Detailed description
In recent years, there has been a dramatic increase in the volume of endoscopic procedures performed in most endoscopy centers. With the growing awareness of colorectal cancer screening, there is increasing demand for colonoscopy which has increased the workload of endoscopists in every healthcare system. There are studies showing that physician fatigue impairs quality of care and performance in other medical specialties such as anesthesia and surgery. Colonoscopy by nature is repetitive and frequently prolonged which can promote distractibility and fatigability. Studies from western countries have showed that afternoon colonoscopies are associated with lower adenoma detection rate (ADR) compared with the morning colonoscopies and physician fatigue has been hypothesized as a potential contributor. Previous studies also showed that the polyp detection rate decreases hour-by-hour throughout the day and the colonoscopy completion rate appears to decline with successive procedures due to endoscopist fatigue. The most recent study using the queue position as a surrogate marker for endoscopist fatigue had showed that both the later colonoscopy start time and increasing number of preceding endoscopic procedures are associated with decreasing polyp detection rate. It is not surprising that endoscopist fatigue may contribute to a significant decline in the effectiveness of colonoscopy and yet it is probably not realistic to reduce the number of colonoscopy procedures per session given the heavy clinical demand. There have been no studies on any intervention that may improve the performance of colonoscopy. It would be reasonable to postulate that taking a break half way through the colonoscopy session may alleviate endoscopist fatigue and hence improve the polyp detection rate. This study aims to evaluate the effect of introducing a break in the middle of a colonoscopy session on the quality of colonoscopy performance.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Break | Active comparator | Other: Break, Other: No breakA break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total |
| No break | No intervention | –No break will be provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who underwent colonoscopies in the afternoon session at the endoscopy unit in AHNH were eligible for inclusion in this study.
Key exclusion criteria (2 listed)
- Emergency inpatient colonoscopy
- Patient with history of colorectal cancer , FAP or IBD
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 |
|---|---|---|
| BreakA break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total | Other | Break |
| No breakNo break will be provided | Other | Break |
Primary outcome
Adenoma detection rate
Time frame: 2 years
6 secondary outcomes
Colonoscopy insertion time
Time frame: 2 years
Cecal intubation rate
Time frame: 2 years
Patient satisfaction score
Time frame: 2 years
Complication rate
Time frame: 2 years
Withdrawal time
Time frame: 2 years
Patient pain score
Time frame: 2 years
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 16 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Break and No break in people with Colonic Adenoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 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 16 Feb 2015. 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 Hong Kong. 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: 2 years). 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 16 Feb 2015.