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

Primary Purpose

Colorectal Cancer Screening, Colon Adenomatous Polyp

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambient lighting
Low lighting
Sponsored by
Advocate Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advocate Lutheran General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Retrospective: Low lighting during screening colonoscopy

Prospective: Ambient lighting during screening colonoscopy

Arm Description

Screening colonoscopies performed with low lighting conditions.

Screening colonoscopies performed with ambient lighting conditions.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Adenoma detection rate (overall)
Overall adenoma detection rate. Ranges from 0% to 100%. Higher ADR is more favorable.
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.
Satisfaction by staff
Satisfaction by staff involved in endoscopy, based on survey responses

Full Information

First Posted
June 2, 2020
Last Updated
June 18, 2020
Sponsor
Advocate Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT04441242
Brief Title
Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue
Official Title
Use of Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advocate Health Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening, Colon Adenomatous Polyp

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retrospective: Low lighting during screening colonoscopy
Arm Type
Placebo Comparator
Arm Description
Screening colonoscopies performed with low lighting conditions.
Arm Title
Prospective: Ambient lighting during screening colonoscopy
Arm Type
Active Comparator
Arm Description
Screening colonoscopies performed with ambient lighting conditions.
Intervention Type
Other
Intervention Name(s)
Ambient lighting
Intervention Description
Use of ambient lighting (75-150 lux) in endoscopy room.
Intervention Type
Other
Intervention Name(s)
Low lighting
Intervention Description
Use of low lighting (<75 lux) in endoscopy room.
Primary Outcome Measure Information:
Title
Change in adenoma detection rate
Description
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.
Time Frame
6 months
Title
Eye strain score
Description
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 Outcome Measure Information:
Title
Adenoma detection rate (overall)
Description
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
Title
Adenoma detection rate (first case vs last case of the day)
Description
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
Title
Satisfaction by staff
Description
Satisfaction by staff involved in endoscopy, based on survey responses
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17700327
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. doi: 10.1097/OPX.0b013e31812f7546.
Results Reference
result
PubMed Identifier
25996612
Citation
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.
Results Reference
result

Learn more about this trial

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

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