Ignite Creation Date:
2024-05-05 @ 10:54 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01211132
Status:
UNKNOWN
Last Update Posted:
2010-09-29
First Post:
2010-09-28
Brief Title:
Cap Assisted Colonoscopy for the Detection of Colon Polyps
Sponsor:
American Society for Gastrointestinal Endoscopy
Organization:
Kansas City Veteran Affairs Medical Center
Study Overview
Official Title:
Prospective Randomized Controlled Study of Cap Assisted Colonoscopy for the Detection of Colon Polyps
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 p004 Also the cecal intubation time was shorter with the cap 115 min vs 14 min p0008 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 p004 In an earlier study by Tada et al 22 use of a transparent cap improved the detection rate of lesions per patient 086 vs 058 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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None