Comparison of Adenoma Detection Miss Rates at Colonoscopy Associated With Different Withdrawal Times
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | August 2012 |
| End Date: | August 2013 |
| Contact: | Subhas Banerjee, MD |
| Email: | subhas.banerjee@stanford.edu |
| Phone: | (650) 736-5555 |
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.
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.
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.
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.
Inclusion Criteria:
- Age > 18
- Already scheduled for colonoscopy
Exclusion Criteria:
- Age < 18
- Pregnant women
- Mentally disabled
- Decisionally challenged
- Cancer subjects
- Healthy volunteers
- Prisoners
We found this trial at
2
sites
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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