View Clinical Trial (Medical Research Study)
Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps
| City: |
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Kansas City |
| State: |
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Missouri |
| Zip Code: |
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64128 |
| Conditions: |
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Adenoma - Colon Polyps - Colon Cancer |
| Purpose: |
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This simple technique of attaching a transparent cap to the tip of the colonoscope has been
evaluated in Japan for improving the detection of polyps and cecal intubation but has not
been formally evaluated in the US and other western countries. In one study (19), the polyp
detection rate was higher with the transparent cap compared to no cap (49% vs. 39%, p=0.04).
Also, the cecal intubation time was shorter with the cap (11.5 min vs 14 min, p=0.008). In a
recently published study, a variation of the cap called the transparent retractable
extension device was used (21). Overall, the number of adenomas detected were significantly
higher with the device compared to without it (205 vs. 150, p=0.04). In an earlier study by
Tada et al (22), use of a transparent cap improved the detection rate of lesions per patient
(0.86 vs. 0.58) but did not increase the cecal intubation time. Finally, Lee et al (20) used
cap assisted colonoscopy in patients with difficult colonoscopy procedure (defined as
failure to pass through sigmoid colon after 20 minutes or failure to reach cecum). Using
the cap, cecal intubation was achieved in 94% of patients and this proved to be an effective
rescue method for failed or difficult colonoscopy. The major appeal of this technique is
that it is inexpensive, very practical, and easy to use. Furthermore it is safe and there
are no reported complications from this. If found to be effective in increasing the polyp
yield it has the potential to being incorporated by busy gastroenterologists in their day to
day clinical practice. These features and the preliminary data from Japan merit the
evaluation of this promising technique in the US.
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| Study Summary: |
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The investigators hypothesize that adenoma detection rate will be higher using cap assisted
colonoscopy compared to standard colonoscopy. Also, cap assisted colonoscopy will be safe
and cecal intubation rate will be similar compared to standard colonoscopy.
Specific Aim 1 - To compare the prevalence of adenomas detected by standard colonoscopy and
cap assisted colonoscopy.
Specific Aim 2 - To compare the number of adenomas detected per subject by standard
colonoscopy and cap assisted colonoscopy.
Specific aim 3 - To compare the cecal intubation rate, insertion time, withdrawal time and
complications of standard colonoscopy and cap assisted colonoscopy.
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| Criteria: |
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Inclusion Criteria:
- Referral for screening and/or surveillance colonoscopy and the ability to provide
informed consent.
Exclusion Criteria:
- prior surgical resection of any portion of colon,
- prior history of colon cancer,
- history of inflammatory bowel disease,
- use of anti-platelet agents or anticoagulants that precludes removal of polyps during
the procedure,
- poor general condition or any other reason to avoid prolonged procedure time
- inability to give informed consent,
- inadequate bowel preparation.
- history of polyposis syndrome or HNPCC,
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| NCT ID: |
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NCT01211132 |
| Primary Contact: |
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Principal Investigator
Amit Rastogi, MD
Veterans Affairs Medical Center, Kansas City, MO
Deepthi S Rao, MBBS
Phone: 816-861-4700 ext. 56428
Email: Deepthi.Rao@va.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Kansas City, Missouri 64128
United States
Deepthi S Rao, MBBS
Phone: 816-861-4700
Email: Deepthi.Rao@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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