Position Changes During Colonoscope Withdrawal and Polyp Detection
1 other identifier
interventional
776
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
July 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 30, 2014
September 1, 2014
1 year
July 13, 2011
September 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Polyp detection rate
6 minutes
Study Arms (2)
Control
PLACEBO COMPARATORSubject will undergo standard colonoscopy.
Position change
ACTIVE COMPARATORSubject will under go standard colonoscopy, but also with position changes during colonoscope withdrawal.
Interventions
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.
Subjects will undergo standard colonoscopy without position changes during scope withdrawal.
Eligibility Criteria
You may qualify if:
- Outpatients undergoing colonoscopy
- Age 40 or greater
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Paul's Hospital
Vancouver, British Columbia, V6Z 2K5, Canada
Related Publications (1)
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.
PMID: 24629419DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Telford, MD, FRCPC
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2011
First Posted
July 15, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2012
Study Completion
December 1, 2013
Last Updated
September 30, 2014
Record last verified: 2014-09