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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Screening; Colon Adenomatous Polyp
• Intervention / Treatment: Other: Low lighting; Other: Ambient lighting

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 Type: Interventional
• Enrollment (Actual): 1109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Advocate Health Care

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 18, 2020
• First Posted (Actual): June 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Eye Diseases; Adenoma; Adenomatous Polyps; Asthenopia
• Other Study ID Numbers: 6665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No