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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01395173
Other study ID # H11-00087
Secondary ID
Status Completed
Phase N/A
First received July 13, 2011
Last updated September 29, 2014
Start date July 2011
Est. completion date December 2013

Study information

Verified date September 2014
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 776
Est. completion date December 2013
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Position change
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.
Standard
Subjects will undergo standard colonoscopy without position changes during scope withdrawal.

Locations

Country Name City State
Canada St. Paul's Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Polyp detection rate 6 minutes No
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