Comparison of Adenoma Detection Miss Rates at Colonoscopy Associated With Different Withdrawal Times
1 other identifier
interventional
200
1 country
2
Brief Summary
The objective of this study is to determine the optimal withdrawal time for colonoscopy. A 6-minute withdrawal time is currently the standard of care but has only been evaluated in an observational fashion. The investigators believe that this should be validated in a standardized fashion. If the benefits of a 6 minute withdrawal are proven in this study (ie a low polyp/adenoma miss rate and a high polyp/adenoma detection rate), then this will support widespread adoption of a 6 minute withdrawal as the standard of care. This in turn may decrease the occurence of 'interval colon cancers', which are early colon cancers arising in subjects despite their having undergone colonoscopy. Our hypothesis is that the polyp/adenoma detection rate will be unacceptably low and the polyp/adenoma miss rate will be unacceptably high in the 3-minute withdrawal group when compared to the 6-minute withdrawal group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 27, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedApril 30, 2015
April 1, 2015
11 months
February 27, 2013
April 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Polyp/Adenoma Detection Rate
Polyp/adenoma detection rate will be calculated for each segment of the tandem colonoscopy- this will be calculated as the number of polyps/adenomas that are discovered and resected for each segment of the tandem colonoscopy.
This will be calculated up to one week after data collection.
Polyp/adenoma Miss Rate
Polyp/adenoma miss rate will be calculated for each segment of the tandem colonoscopy- this will be calculated as the number of polyps/adenomas that are discovered and resected on the tandem portion of each segment of the colonoscopy, divided by the total number of polyps/adenomas that are discovered/resected.
Polyp/adenoma miss rate will be calculated up to one week after data collection.
Study Arms (2)
3-minute withdrawal time
ACTIVE COMPARATORFor subjects randomized to the 3-minute withdrawal time, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 1 minute, followed by a "second look" over each segment over 2 minutes by the same endoscopist.
6-minute withdrawal time
ACTIVE COMPARATORFor subjects randomized to the 6-minute withdrawal, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 2 minutes, followed by a "second look" over each segment over 2 minutes by the same endoscopist.
Interventions
For subjects randomized to the 3-minute withdrawal time, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 1 minute, followed by a "second look" over each segment over 2 minutes by the same endoscopist.
For subjects randomized to the 6-minute withdrawal, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 2 minutes, followed by a "second look" over each segment over 2 minutes by the same endoscopist.
Eligibility Criteria
You may qualify if:
- Age \> 18
- Already scheduled for colonoscopy
You may not qualify if:
- Age \< 18
- Pregnant women
- Mentally disabled
- Decisionally challenged
- Cancer subjects
- Healthy volunteers
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Veterans Administration Hospital (Palo Alto)
Palo Alto, California, 94304, United States
Stanford University
Palo Alto, California, 94305, United States
Related Publications (1)
Kumar S, Thosani N, Ladabaum U, Friedland S, Chen AM, Kochar R, Banerjee S. Adenoma miss rates associated with a 3-minute versus 6-minute colonoscopy withdrawal time: a prospective, randomized trial. Gastrointest Endosc. 2017 Jun;85(6):1273-1280. doi: 10.1016/j.gie.2016.11.030. Epub 2016 Dec 6.
PMID: 27931951DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Subhas Banerjee, M.D.
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 27, 2013
First Posted
March 1, 2013
Study Start
September 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
April 30, 2015
Record last verified: 2015-04