- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01802008
Comparison of Adenoma Detection Miss Rates at Colonoscopy Associated With Different Withdrawal Times
April 28, 2015 updated by: Subhas Banerjee, Stanford University
Comparison of Adenoma Detection and Miss Rates at Colonoscopy Associated With a Six-minute Withdrawal Time vs a Three-minute Withdrawal Time
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eligible patients will be randomized to colonoscopy with either a 6-minute withdrawal time or a 3-minute withdrawal time.
Patients will then undergo colonoscopy.
All colonoscopies will be performed by a GI attending (standard of care).
The colonoscopy is typically performed under conscious sedation using medications such as fentanyl and midazolam for comfort (standard of care).
Occasional patients undergo colonoscopy under general anesthesia.
For all patients, advancement of the colonoscope to the cecum will be followed by segmental withdrawal of the colonoscope in each of 3 segments of the examined colon (right side of colon, transverse colon and left side of colon).
Following examination of each individual segment, the colonoscope will be readvanced to the proximal end of the segment and a 2 minute withdrawal will be re-performed.
For those randomized to the 6-minute withdrawal each segment will be examined over 2 minutes, followed by a "second look" over each segment over 2 minutes by the same endoscopist.
For those randomized to the 3-minute withdrawal time, advancement to the cecum will also 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.
All patients will therefore undergo a second look colonoscopy with a 6-minute withdrawal time ('de-facto' standard of care).
Polyp/adenoma detection and miss rates will then be calculated and compared between the two groups.
Study Type
Interventional
Enrollment (Actual)
200
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
-
-
California
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Palo Alto, California, United States, 94305
- Stanford University
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Palo Alto, California, United States, 94304
- Veterans Administration Hospital (Palo Alto)
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-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18
- Already scheduled for colonoscopy
Exclusion Criteria:
- Age < 18
- Pregnant women
- Mentally disabled
- Decisionally challenged
- Cancer subjects
- Healthy volunteers
- Prisoners
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 3-minute withdrawal time
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 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.
|
Active Comparator: 6-minute withdrawal time
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polyp/Adenoma Detection Rate
Time Frame: This will be calculated up to one week after data collection.
|
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
Time Frame: Polyp/adenoma miss rate will be calculated up to one week after data collection.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Subhas Banerjee, M.D., Stanford University
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.
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
September 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
February 27, 2013
First Submitted That Met QC Criteria
February 28, 2013
First Posted (Estimate)
March 1, 2013
Study Record Updates
Last Update Posted (Estimate)
April 30, 2015
Last Update Submitted That Met QC Criteria
April 28, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-25203
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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