Colon PolypNCT04749303
Impact of Screen Size on Colorectal Adenoma Detection
A study testing Large Screen in people with Colon Polyp and Colon Adenoma, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Polyp, Colon Adenoma, Colorectal Neoplasms
- What is being tested?
- Large Screen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2020to 31 Aug 2021
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or above
- Referred to the endoscopy unit for diagnostic or surveillance colonoscopy
Who cannot join
- Familial history of Familial adenomatous polyposis or Hereditary non-polyposis colorectal cancer
- Known history of inflammatory bowel disease
- Emergency endoscopy of any nature (such as for gastrointestinal bleeding, assessment of large bowel investigation and colonic decompression)
- Patients with colostomy
- Previously incomplete colonoscopy (not including insufficient preparation)
- Patients with known palliative colorectal malignant disease Patients with coagulopathies Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Tony WC Mak, MD, FRCS, 26321495, tonymak@surgery.cuhk.edu.hk
Kaori Futaba, FRCS, 35051495, kfutaba@surgery.cuhk.edu.hk
About this study
Official title: Impact of Screen Size on Colorectal Adenoma Detection Rate: a Single Centre Randomised Controlled Trial
The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate.
Read the detailed description
Colorectal cancer is the 3rd most common cancer in the world. Recently in Hong Kong it has surpassed lung cancer to be the most common cancer. Hence it is essential not only to have up-to-date surgical and oncological treatment but also a need an effective preventative strategy.
In the past few decades, removal of pre-malignant colonic lesions such as adenomas have been shown to prevent development of colorectal cancers. Colonoscopy is currently the only technique which can perform both detection and treatment during the same procedure. However, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon. Most ICs are suspected to arise from missed colon lesions during colonoscopy. Factors concerning missed colonic lesions are multifactorial such as adequate bowel preparation, skill level of endoscopists, the number of endoscopy staff in the room as "eyes" to help with polyp detection and withdrawal time.
Following a pilot study in our endoscopy unit, we believe the size of the screen projecting the endoscopic image may have a positive influence on adenoma detection. Therefore, we feel that a well-designed and adequately powered randomised controlled trial may help to confirm this.
- Conditions
- Colon Polyp, Colon Adenoma, Colorectal Neoplasms
- Being tested
- Large Screen
- Keywords
- Colonoscopy, Adenoma Detection Rate, Colorectal cancer screening, Screen size
- Medical subject headings
- Colonic Polyps, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large ScreenProcedure or surgery
Also called Standard Screen
Large screen size is 4x larger than standard screen, we hope that the colonoscopies carried out with large screens will confer to better lesion detection
| Study group | Role | What they receive |
|---|---|---|
| Large screen | Active comparator | This is a high definition screen which gives a 76cm height and 67cm width (area: 5092cm2) endoscopic image. Receives: Procedure: Large Screen |
| Standard screen | No intervention | This is a high definition screen which gives a 37.5cm height and 32.5cm width (area: 1218.75cm2) endoscopic image. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
ADR is defined as the proportion of an endoscopist's screening colonoscopies in which one or more adenomas have been detected in patients
Measured: 12 months
Secondary outcomes (6)
Mean number of adenomas detected per colonoscopy
Mean number of adenomas detected per colonoscopy found in each arm
Measured: 12 months
Mean number of sessile serrated polyps
Mean number of sessile serrated polyps found in each arm
Measured: 12 months
Caecal intubation rate
percentage of caecal intubation rate in each arm
Measured: 12 months
Bowel cleansing level
According to the Boston bowel preparation scale (0=worst bowel preparation to 9= best bowel preparation). Comparison of each arm.
Measured: 12 months
Procedure Time
Both intubation and withdrawal time will be recorded. Comparison of each arm.
Measured: 12 months
Severe adverse events
SAEs of both arms for comparisons
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Jul 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Large screen vs standard screen
- Masking
- None (open label)
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Wing Chung Mak, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749303
- Sponsor's protocol ID
- 2020.327
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Screen Size on Colorectal Adenoma Detection Rate: a Single Centre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04749303
- Acronym / sponsor ID
- 2020.327
- Conditions
- Colon Polyp, Colon Adenoma, Colorectal Neoplasms
- Keywords
- Colonoscopy, Adenoma Detection Rate, Colorectal cancer screening, Screen size
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 11 Feb 2021 (actual)
- 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.
The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate.
Detailed description
Colorectal cancer is the 3rd most common cancer in the world. Recently in Hong Kong it has surpassed lung cancer to be the most common cancer. Hence it is essential not only to have up-to-date surgical and oncological treatment but also a need an effective preventative strategy.
In the past few decades, removal of pre-malignant colonic lesions such as adenomas have been shown to prevent development of colorectal cancers. Colonoscopy is currently the only technique which can perform both detection and treatment during the same procedure. However, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon. Most ICs are suspected to arise from missed colon lesions during colonoscopy. Factors concerning missed colonic lesions are multifactorial such as adequate bowel preparation, skill level of endoscopists, the number of endoscopy staff in the room as "eyes" to help with polyp detection and withdrawal time.
Following a pilot study in our endoscopy unit, we believe the size of the screen projecting the endoscopic image may have a positive influence on adenoma detection. Therefore, we feel that a well-designed and adequately powered randomised controlled trial may help to confirm this.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Large screen vs standard screen
| Arm | Type | Receives |
|---|---|---|
| Large screen | Active comparator | Procedure: Large ScreenThis is a high definition screen which gives a 76cm height and 67cm width (area: 5092cm2) endoscopic image. |
| Standard screen | No intervention | –This is a high definition screen which gives a 37.5cm height and 32.5cm width (area: 1218.75cm2) endoscopic image. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years or above
- Referred to the endoscopy unit for diagnostic or surveillance colonoscopy
Key exclusion criteria (6 listed)
- Familial history of Familial adenomatous polyposis or Hereditary non-polyposis colorectal cancer
- Known history of inflammatory bowel disease
- Emergency endoscopy of any nature (such as for gastrointestinal bleeding, assessment of large bowel investigation and colonic decompression)
- Patients with colostomy
- Previously incomplete colonoscopy (not including insufficient preparation)
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 |
|---|---|---|
| Large ScreenAlso: Standard ScreenLarge screen size is 4x larger than standard screen, we hope that the colonoscopies carried out with large screens will confer to better lesion detection | Procedure or surgery | Large screen |
Primary outcome
Adenoma Detection Rate (ADR)
Time frame: 12 months
ADR is defined as the proportion of an endoscopist's screening colonoscopies in which one or more adenomas have been detected in patients
6 secondary outcomes
Mean number of adenomas detected per colonoscopy
Time frame: 12 months
Mean number of sessile serrated polyps
Time frame: 12 months
Caecal intubation rate
Time frame: 12 months
Bowel cleansing level
Time frame: 12 months
Procedure Time
Time frame: 12 months
Severe adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Large Screen in people with Colon Polyp and Colon 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (ADR) (time frame: 12 months). 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 11 Feb 2021.