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Completed

NCT Number: NCT04441242

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

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.

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Key information

Conditions

Colorectal Cancer Screening Colon Adenomatous Polyp

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambient lighting

Other

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

Low lighting

Other

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

Primary outcomes

  1. Change in adenoma detection rate

    Time frame: 6 months

    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.

  2. Eye strain score

    Time frame: 6 months

    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).

Secondary outcomes

  1. Adenoma detection rate (overall)

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

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

  2. Adenoma detection rate (first case vs last case of the day)

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

    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.

  3. Satisfaction by staff

    Time frame: 6 months

    Satisfaction by staff involved in endoscopy, based on survey responses

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2020
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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