Back to resultsPosition Changes During Colonoscope Withdrawal and Polyp Detection
Primary Purpose
Colonic Polyp
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Position change
Standard
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonic Polyp focused on measuring detection
Eligibility Criteria
Inclusion Criteria:
- Outpatients undergoing colonoscopy
- Age 40 or greater
Exclusion Criteria:
- Inpatient colonoscopy
- Unable to provide informed consent
- Unable to complete colonoscopy to cecum
- Previous bowel resection, inflammatory bowel disease, polyposis syndrome
- Musculoskeletal disorder or other mobility issue limiting effective patient position changes
- Inadequate bowel preparation
Sites / Locations
- St. Paul's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Position change
Arm Description
Subject will undergo standard colonoscopy.
Subject will under go standard colonoscopy, but also with position changes during colonoscope withdrawal.
Outcomes
Primary Outcome Measures
Polyp detection rate
Secondary Outcome Measures
Full Information
NCT ID
NCT01395173
First Posted
July 13, 2011
Last Updated
September 29, 2014
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01395173
Brief Title
Position Changes During Colonoscope Withdrawal and Polyp Detection
Official Title
Position Changes During Colonoscope Withdrawal to Increase Polyp Detection: a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether position changes during colonoscope withdrawal affects polyp detection rate. We hypothesize that positions change during scope withdrawal will increase polyp detection rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyp
Keywords
detection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
776 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subject will undergo standard colonoscopy.
Arm Title
Position change
Arm Type
Active Comparator
Arm Description
Subject will under go standard colonoscopy, but also with position changes during colonoscope withdrawal.
Intervention Type
Procedure
Intervention Name(s)
Position change
Intervention Description
Patients will be randomly assigned to two groups: Control group (those who will receive standard colonoscopy without position changes) and Position change group (those who will undergo position changes during colonoscope withdrawal during colonoscopy). Subjects in position change group will be asked to shift into three different positions during colonoscope withdrawal.
Intervention Type
Procedure
Intervention Name(s)
Standard
Intervention Description
Subjects will undergo standard colonoscopy without position changes during scope withdrawal.
Primary Outcome Measure Information:
Title
Polyp detection rate
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients undergoing colonoscopy
Age 40 or greater
Exclusion Criteria:
Inpatient colonoscopy
Unable to provide informed consent
Unable to complete colonoscopy to cecum
Previous bowel resection, inflammatory bowel disease, polyposis syndrome
Musculoskeletal disorder or other mobility issue limiting effective patient position changes
Inadequate bowel preparation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Telford, MD, FRCPC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
24629419
Citation
Ou G, Kim E, Lakzadeh P, Tong J, Enns R, Ramji A, Whittaker S, Ko HH, Bressler B, Halparin L, Lam E, Amar J, Telford J. A randomized controlled trial assessing the effect of prescribed patient position changes during colonoscope withdrawal on adenoma detection. Gastrointest Endosc. 2014 Aug;80(2):277-83. doi: 10.1016/j.gie.2014.01.032. Epub 2014 Mar 12.
Results Reference
derived
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Position Changes During Colonoscope Withdrawal and Polyp Detection
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