Colorectal Cancer ScreeningNCT04441242
Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue
A study testing Ambient lighting and Low lighting in people with Colorectal Cancer Screening and Colon Adenomatous Polyp, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
A retrospective and prospective study to determine if the use of ambient lighting during screening colonoscopy is well tolerated and if ambient lighting will help physicians maintain adenoma detection rates while decreasing symptoms of eye strain as the day progresses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Screening, Colon Adenomatous Polyp
- What is being tested?
- Ambient lighting and Low lighting
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,109 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Jun 2018
- 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
- Adults undergoing screening colonoscopy
- Procedure performed by a participating gastroenterologist
Who cannot join
- Any diagnostic colonoscopies
- History of colon resection
- History of colorectal cancer
- Children
- Pregnant women
- Prisoners
- Cases involving trainees, including gastroenterology fellows
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
Official title: Use of Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue: a Pilot Study
A retrospective and prospective study to determine if the use of ambient lighting during screening colonoscopy is well tolerated and if ambient lighting will help physicians maintain adenoma detection rates while decreasing symptoms of eye strain as the day progresses.
Read the detailed description
This study is a a single-center study at an independent community-based teaching hospital comparing adenoma detection rate in screening colonoscopies performed in low lighting with those performed with ambient lighting (75-150 lux). All cases included in the study involved adult patients undergoing screening colonoscopy with a participating gastroenterologist. Diagnostic colonoscopies, history of colon resection, colorectal cancer, and cases performed in children, pregnant women, and prisoners were excluded from analysis. Cases involving gastroenterology fellows were also excluded. Retrospective data was collected over a six month period from January 2017 to June 2017, followed by a prospective arm the during the same calendar months the subsequent year (January 2018 to June 2018).
- Being tested
- Ambient lighting, Low lighting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambient lightingOther
Use of ambient lighting (75-150 lux) in endoscopy room.
Low lightingOther
Use of low lighting (<75 lux) in endoscopy room.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective: Low lighting during screening colonoscopy | Placebo comparator | Screening colonoscopies performed with low lighting conditions. Receives: Other: Low lighting |
| Prospective: Ambient lighting during screening colonoscopy | Active comparator | Screening colonoscopies performed with ambient lighting conditions. Receives: Other: Ambient lighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adenoma detection rate
Adenoma detection rate, comparing change from first case of the day to the last. Ranges from 0-99%, with greater increases adenoma detection rate (ADR) being more favorable.
Measured: 6 months
Eye strain score
Eye strain score, as calculated from survey responses completed by physicians. Ranges from 0 - 60, with lower scores indicating less severe symptoms (therefore, lower scores are more favorable).
Measured: 6 months
Secondary outcomes (3)
Adenoma detection rate (overall)
Overall adenoma detection rate. Ranges from 0% to 100%. Higher ADR is more favorable.
Measured: Participants each assessed on one day during 6 month study period
Adenoma detection rate (first case vs last case of the day)
Adenoma detection rate, comparing first case of the day to the last. Ranges from from -99 to 99%, with greater numbers (increases) being more favorable.
Measured: Participants each assessed on one day during 6 month study period
Satisfaction by staff
Satisfaction by staff involved in endoscopy, based on survey responses
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jan 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441242
- Sponsor's protocol ID
- 6665
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546.
PubMed 17700327Almadi MA, Sewitch M, Barkun AN, Martel M, Joseph L. Adenoma detection rates decline with increasing procedural hours in an endoscopist's workload. Can J Gastroenterol Hepatol. 2015 Aug-Sep;29(6):304-8. doi: 10.1155/2015/789038. Epub 2015 May 21.
PubMed 25996612
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue: a Pilot Study
- ClinicalTrials.gov ID
- NCT04441242
- Acronym / sponsor ID
- 6665
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,109 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Jun 2020 (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.
A retrospective and prospective study to determine if the use of ambient lighting during screening colonoscopy is well tolerated and if ambient lighting will help physicians maintain adenoma detection rates while decreasing symptoms of eye strain as the day progresses.
Detailed description
This study is a a single-center study at an independent community-based teaching hospital comparing adenoma detection rate in screening colonoscopies performed in low lighting with those performed with ambient lighting (75-150 lux). All cases included in the study involved adult patients undergoing screening colonoscopy with a participating gastroenterologist. Diagnostic colonoscopies, history of colon resection, colorectal cancer, and cases performed in children, pregnant women, and prisoners were excluded from analysis. Cases involving gastroenterology fellows were also excluded. Retrospective data was collected over a six month period from January 2017 to June 2017, followed by a prospective arm the during the same calendar months the subsequent year (January 2018 to June 2018).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective: Low lighting during screening colonoscopy | Placebo comparator | Other: Low lightingScreening colonoscopies performed with low lighting conditions. |
| Prospective: Ambient lighting during screening colonoscopy | Active comparator | Other: Ambient lightingScreening colonoscopies performed with ambient lighting conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults undergoing screening colonoscopy
- Procedure performed by a participating gastroenterologist
Key exclusion criteria (7 listed)
- Any diagnostic colonoscopies
- History of colon resection
- History of colorectal cancer
- Children
- Pregnant women
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 |
|---|---|---|
| Ambient lightingUse of ambient lighting (75-150 lux) in endoscopy room. | Other | Prospective: Ambient lighting during screening colonoscopy |
| Low lightingUse of low lighting (<75 lux) in endoscopy room. | Other | Retrospective: Low lighting during screening colonoscopy |
Primary outcome
Change in adenoma detection rate
Time frame: 6 months
Adenoma detection rate, comparing change from first case of the day to the last. Ranges from 0-99%, with greater increases adenoma detection rate (ADR) being more favorable.
Eye strain score
Time frame: 6 months
Eye strain score, as calculated from survey responses completed by physicians. Ranges from 0 - 60, with lower scores indicating less severe symptoms (therefore, lower scores are more favorable).
3 secondary outcomes
Adenoma detection rate (overall)
Time frame: Participants each assessed on one day during 6 month study period
Adenoma detection rate (first case vs last case of the day)
Time frame: Participants each assessed on one day during 6 month study period
Satisfaction by staff
Time frame: 6 months
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 4 Oct 2024.
- Results publication: PubMed 17700327Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546.
- Results publication: PubMed 25996612Almadi MA, Sewitch M, Barkun AN, Martel M, Joseph L. Adenoma detection rates decline with increasing procedural hours in an endoscopist's workload. Can J Gastroenterol Hepatol. 2015 Aug-Sep;29(6):304-8. doi: 10.1155/2015/789038. Epub 2015 May 21.
- 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.
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 Ambient lighting and Low lighting in people with Colorectal Cancer Screening and Colon Adenomatous Polyp, run by Wake Forest University Health Sciences at 1 site in United States.
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 7 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 4 Oct 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Change in adenoma detection rate (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04441242, which also lists 2 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 4 Oct 2024.