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

October 2, 2024 updated by: Wake Forest University Health Sciences

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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).
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants each assessed on one day during 6 month study period
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.
Participants each assessed on one day during 6 month study period
Satisfaction by staff
Time Frame: 6 months
Satisfaction by staff involved in endoscopy, based on survey responses
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

October 4, 2024

Last Update Submitted That Met QC Criteria

October 2, 2024

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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