Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234650
Status:
COMPLETED
Last Update Posted:
2009-04-02
First Post:
2005-10-05
Brief Title:
Adenoma Detection Rate With Position Change at Colonoscopy
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
Evaluation of the Effect of Position Change During the Withdrawal Phase of Colonoscopy on Adenoma Detection Rate
Status:
COMPLETED
Status Verified Date:
2008-12
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 hypothesis to be tested is that position changes during the withdrawal phase of colonoscopy leads to a higher adenoma polyp detection rate because of better distension of the colon Since adenomas are precancerous lesions the enhanced adenoma detection will increase the success of colorectal cancer screening programmes This study will provide evidence for the value of position changes and encourage endoscopist to adopt position change as a routine in their practice
May 2007 protocol amendment to include additional prospective analysis using High Definition TV HDTV
May 2007 protocol amendment to include additional prospective analysis using High Definition TV HDTV
Detailed Description:
Colorectal cancer is the second commonest cause of cancer death In a majority of cases it is preceded by a precancerous lesion called an adenoma commonly known as polyp Detection and removal of adenomas at colonoscopy has been shown to reduce mortality from colorectal cancer The success of the impending colorectal cancer screening programme to reduce cancer mortality in an average-risk population depends on optimal adenoma detection at colonoscopy The detection of adenomas has been shown to vary between different endoscopist Some of the factors that have been reported to affect adenoma detection rates included the time spent viewing the adequacy of the bowel preparation and the time spent cleaning the colonic mucosa of excess fluid Careful examination of proximal side of flexures folds and valves by the endoscopist is equally important However even with careful examination adenoma detection rates have been shown to vary between endoscopist from 86 to 159 Previous experience and training may be contributed to this difference Some endoscopist adopt regular changes in position during the procedure to maximize distension of the colon Better luminal distension enhances mucosal views for detection of the smaller adenomas The validity of this approach has never been tested and we propose that this factor may contribute to the differences in adenoma detection rates
Patients will be randomised to either position 1 first then position 2 or vice versa and examined twice During one withdrawal the colon will be examined with the participant in the left lateral position only position 1 or with position changes position 2or vice versa
May 2007 protocol amendment to include additional prospective analysis using High Definition TV HDTV No further patient data collection involved
Patients will be randomised to either position 1 first then position 2 or vice versa and examined twice During one withdrawal the colon will be examined with the participant in the left lateral position only position 1 or with position changes position 2or vice versa
May 2007 protocol amendment to include additional prospective analysis using High Definition TV HDTV No further patient data collection involved
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