Clinical trial NCT04441242: Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue
Official title: Use of Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Colon Adenomatous Polyp
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 1109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in adenoma detection rate
timeFrame: 6 months
measure: Eye strain score
timeFrame: 6 months
Secondary outcomes:
measure: Adenoma detection rate (overall)
timeFrame: Participants each assessed on one day during 6 month study period
measure: Adenoma detection rate (first case vs last case of the day)
timeFrame: Participants each assessed on one day during 6 month study period
measure: Satisfaction by staff
timeFrame: 6 months
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
Study officials:
References:
citation: 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.
citation: Almadi 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.