Adenoma Detection Rate With Position Change at Colonoscopy
Primary Purpose
Polyps
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Polyps focused on measuring position change, adenoma, colonoscopy
Eligibility Criteria
Inclusion Criteria: Patients referred ot colonoscopy, age between 50 - 70 years Exclusion Criteria: Patients with colorectal cancer, previous colonic surgery, active colitis and musculoskeletal problems Patients may also be excluded after the first insertion, if painful, routine care will proceed
Sites / Locations
- North West London NHS Trust
Outcomes
Primary Outcome Measures
adenoma detection rate for position 1 compared to position 2
Secondary Outcome Measures
percentage of adenomas detected in all the participants for each position
Full Information
NCT ID
NCT00234650
First Posted
October 5, 2005
Last Updated
April 1, 2009
Sponsor
London North West Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00234650
Brief Title
Adenoma Detection Rate With Position Change at Colonoscopy
Official Title
Evaluation of the Effect of Position Change During the Withdrawal Phase of Colonoscopy on Adenoma Detection Rate
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
London North West Healthcare NHS Trust
4. Oversight
5. Study Description
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).
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 8.6% to 15.9%. 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 2)or vice versa.
May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV). No further patient data collection involved.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyps
Keywords
position change, adenoma, colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Primary Outcome Measure Information:
Title
adenoma detection rate for position 1 compared to position 2
Secondary Outcome Measure Information:
Title
percentage of adenomas detected in all the participants for each position
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients referred ot colonoscopy, age between 50 - 70 years
Exclusion Criteria:
Patients with colorectal cancer, previous colonic surgery, active colitis and musculoskeletal problems Patients may also be excluded after the first insertion, if painful, routine care will proceed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Saunders, MD
Organizational Affiliation
St Mark's Hospital, North West London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
North West London NHS Trust
City
London
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20950801
Citation
East JE, Bassett P, Arebi N, Thomas-Gibson S, Guenther T, Saunders BP. Dynamic patient position changes during colonoscope withdrawal increase adenoma detection: a randomized, crossover trial. Gastrointest Endosc. 2011 Mar;73(3):456-63. doi: 10.1016/j.gie.2010.07.046. Epub 2010 Oct 15.
Results Reference
derived
Learn more about this trial
Adenoma Detection Rate With Position Change at Colonoscopy
We'll reach out to this number within 24 hrs