- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01395173
Position Changes During Colonoscope Withdrawal and Polyp Detection
September 29, 2014 updated by: University of British Columbia
Position Changes During Colonoscope Withdrawal to Increase Polyp Detection: a Prospective Randomized Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
776
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 2K5
- St. Paul's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Subject will undergo standard colonoscopy.
|
Subjects will undergo standard colonoscopy without position changes during scope withdrawal.
|
|
Active Comparator: Position change
Subject will under go standard colonoscopy, but also with position changes during colonoscope withdrawal.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Polyp detection rate
Time Frame: 6 minutes
|
6 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Telford, MD, FRCPC, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 13, 2011
First Submitted That Met QC Criteria
July 14, 2011
First Posted (Estimate)
July 15, 2011
Study Record Updates
Last Update Posted (Estimate)
September 30, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H11-00087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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