Ignite Creation Date:
2024-05-05 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 9:39 AM
Study NCT ID:
NCT00577083
Status:
COMPLETED
Last Update Posted:
2018-12-10
First Post:
2007-12-11
Brief Title:
Cap-fitted Colonoscopy a Randomized Tandem Colonoscopy Study of Adenoma Miss Rates
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Cap-fitted Colonoscopy a Randomized Tandem Colonoscopy Study of Adenoma Miss Rates
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
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 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 15 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 13 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
Detailed Description:
Patient will undergo tandem colonoscopy on the same day using propofol sedation Patients will undergo one colonoscopy without the cap and a second colonoscopy with the cap on We will endeavor to keep the total examination time equal between the groups and approximately six minutes The order in which patients receive the two colonoscopies ie cap or without cap first will be randomized Any polyps detected during the first colonoscopy will be removed during that procedure During the withdrawal phase the 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 The stopwatch will also be stopped for suctioning fluid or washing debris from the colon surface Any polyp detected and removed during the first colonoscopy will be counted as the detection for that procedure During the second colonoscopy all polyps will also be removed when detected Any polyp identified and removed during the second procedure will be counted as a miss for the first procedure All polyps will be sent separately for pathologic evaluation The time required to remove and retrieve polyps with and without the cap on will be measured using a stopwatch as a secondary end point The primary end point will be the miss rate for colonoscopy with the cap and colonoscopy without the cap
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