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CompletedNCT04441242Updated Oct 4, 2024

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

An interventional study of Ambient lighting and Low lighting in Colorectal Cancer Screening and Colon Adenomatous Polyp, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Jan 2017, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
1,109
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Colorectal Cancer Screening
  • Colon Adenomatous Polyp
03

In context

Adenomatous Polyps

66 studies on the registry are indexed under Adenomatous Polyps; 8 are open to participants now.

This study's enrollment of 1,109 is above the median of 216 across 47 interventional studies indexed under Adenomatous Polyps.

Browse Adenomatous Polyps studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.

Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults undergoing screening colonoscopy
  • Procedure performed by a participating gastroenterologist

Exclusion criteria

Exclusion Criteria:

  • Any diagnostic colonoscopies
  • History of colon resection
  • History of colorectal cancer
  • Children
  • Pregnant women
  • Prisoners
  • Cases involving trainees, including gastroenterology fellows
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,109 participants (actual)

Study arms

  • Placebo comparator
    Retrospective: Low lighting during screening colonoscopy

    Screening colonoscopies performed with low lighting conditions.

    Other: Low lighting

  • Active comparator
    Prospective: Ambient lighting during screening colonoscopy

    Screening colonoscopies performed with ambient lighting conditions.

    Other: Ambient lighting

Interventions

  • OtherAmbient lighting

    Use of ambient lighting (75-150 lux) in endoscopy room.

  • OtherLow lighting

    Use of low lighting (\<75 lux) in endoscopy room.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

  2. 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).

    Time frame: 6 months

Secondary outcomes

  1. Adenoma detection rate (overall)

    Overall adenoma detection rate. Ranges from 0% to 100%. Higher ADR is more favorable.

    Time frame: Participants each assessed on one day during 6 month study period

  2. 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.

    Time frame: Participants each assessed on one day during 6 month study period

  3. Satisfaction by staff

    Satisfaction by staff involved in endoscopy, based on survey responses

    Time frame: 6 months

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Study locations

1 site
  • Advocate Lutheran General Hospital
    Park Ridge, Illinois 60068, United States
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References and documents

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 17700327 ↗
  • 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. PubMed 25996612 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04441242
Responsible party
Sponsor
First posted
Jun 22, 2020
Start date
Jan 1, 2017
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Oct 4, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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