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

Colorectal Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441242
• Other study ID #: 6665
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2020
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1109
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenomatous Polyps
• Asthenopia
• Colon Adenomatous Polyp
• Colorectal Cancer Screening
• Fatigue

Intervention

Other:
• Ambient lighting
Use of ambient lighting (75-150 lux) in endoscopy room.
• Low lighting
Use of low lighting (<75 lux) in endoscopy room.

Locations

Country	Name	City	State
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Advocate Health Care

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2015 May 21. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Satisfaction by staff	Satisfaction by staff involved in endoscopy, based on survey responses	6 months