Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue

Study Overview
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Brief Summary
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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
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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).

Official Title
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Use of Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue: a Pilot Study

Conditions
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Colon Adenomatous Polyp, Colorectal Cancer Screening

Intervention / Treatment
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* Other: Ambient lighting
* Other: Low lighting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults undergoing screening colonoscopy Procedure performed by a participating gastroenterologist Exclusion Criteria: Any diagnostic colonoscopies History of colon resection History of colorectal cancer Children Pregnant women Prisoners Cases involving trainees, including gastroenterology fellows

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Retrospective: Low lighting during screening colonoscopy<br>Screening colonoscopies performed with low lighting conditions. | Other: Low lighting<br>* Use of low lighting (<75 lux) in endoscopy room.<br>|
| Active Comparator: Prospective: Ambient lighting during screening colonoscopy<br>Screening colonoscopies performed with ambient lighting conditions. | Other: Ambient lighting<br>* Use of ambient lighting (75-150 lux) in endoscopy room.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ADR being more favorable. | 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate (overall) | Overall adenoma detection rate. Ranges from 0% to 100%. Higher ADR is more favorable. | 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. | Participants each assessed on one day during 6 month study period | 
| Satisfaction by staff | Satisfaction by staff involved in endoscopy, based on survey responses | 6 months |