N/A
N=100
Cap-fitted Colonoscopy: a Randomized, Tandem Colonoscopy Study of Adenoma Miss Rates
Polyps
Bottom Line
View on ClinicalTrials.gov: NCT00577083 ↗Enrolled (actual)
100
Serious AEs
—
Results posted
Feb 2016
Primary outcome: Primary: Number of Adenomas — 83; 89; 28; 44 First Colonoscopy number of adenomas
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cap-fitted colonoscopy (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adenomas |
83; 89; 28; 44 | — |
| SECONDARY Time for Examination Will be Measured With a Stopwatch, and the Stopwatch Will be Stopped at Any Time a Polyp is Located and Restarted When the Polyp Has Been Removed and Retrieved. |
3.1; 3.2; 7.0; 7.0; 18.1; 20.5 | — |
Summary
This is a test in which a thin, black, flexible tube with a lighting system on the end is passed through the anus, into the rectum, in order to examine the large bowel or intestine, also called the colon. Colonoscopy is a very good test for examining the colon for polyps (warty growths that can turn into cancer), but it is not perfect. In fact, about 30% of polyps that are under 5 mm (about 1/5 of an inch) in size are missed during colonoscopy because they are hiding behind folds and bends in the colon. This research study is being done to determine if performing colonoscopy with a cap on the tip of the colonoscope will reduce the miss rate for polyps. A cap is a clear plastic hood that fits on the tip of the colonoscope and sticks out about 1/3 of an inch. During colonoscopy, the cap can be pressed against a fold or ridge in order to flatten it, so that the lining on the other side can be more easily seen. This may reduce the miss rate for colon polyps.
Eligibility Criteria
Inclusion Criteria
- 50 years of age or older, undergoing scheduled colonoscopy and able to give informed consent.
Exclusion Criteria
- Previous surgical resection of the colon or rectum
- American Society of Anesthesiology class III or higher
- Inflammatory bowel disease
- Current use of anticoagulants.
Data sourced from ClinicalTrials.gov (NCT00577083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.