Ignite Creation Date:
2024-05-05 @ 9:40 PM
Last Modification Date:
2024-10-26 @ 10:07 AM
Study NCT ID:
NCT00930462
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2009-06-26
Brief Title:
Evaluation of the Use of Cap in Improving the Performance of Colonoscopy
Sponsor:
Royal Prince Alfred Hospital Sydney Australia
Organization:
Royal Prince Alfred Hospital Sydney Australia
Study Overview
Official Title:
A Prospective Randomised Controlled Trial Comparing Cap-Assisted Colonoscopy Versus Standard Colonoscopy
Status:
COMPLETED
Status Verified Date:
2009-06
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:
The aim of this study is to compare the colonoscopy success rate cecal time and polyp detection rate between cap-fitted colonoscopy and conventional colonoscopy
Detailed Description:
Colonoscopic examination has been used in clinical practice for approximately 40 years Despite the fact that colonoscopy is widely available and is performed by many experienced colonoscopists there are concerns about the quality of colonoscopy as measured by several technical endpoints such as rate of failed caecal intubation and polyp miss rate A large population-based study revealed 131 of colonoscopies failed to reach the cecum In addition one large review of back-to-back colonoscopies showed polyp miss rates of 24 for adenoma
One potentially promising technique is cap-assisted colonoscopy A transparent cap or hood is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy Several randomized trials from Japan have mixed results regarding improved cecal intubation times and polyp detection rates A recent large study from Hong Kong showed improved time to cecum but a reduced polyp detection rate To date there is no large randomized study using the cap in a western population in whom the colorectal cancer CRC incidence is known to be higher We plan to conduct a randomized controlled trial to investigate the usefulness of cap-assisted colonoscopy in a Western population
One potentially promising technique is cap-assisted colonoscopy A transparent cap or hood is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy Several randomized trials from Japan have mixed results regarding improved cecal intubation times and polyp detection rates A recent large study from Hong Kong showed improved time to cecum but a reduced polyp detection rate To date there is no large randomized study using the cap in a western population in whom the colorectal cancer CRC incidence is known to be higher We plan to conduct a randomized controlled trial to investigate the usefulness of cap-assisted colonoscopy in a Western population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| X07-0107 | None | None | None |