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Position Changes During Colonoscope Withdrawal and Polyp Detection

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ClinicalTrials.gov Identifier: NCT01395173
Recruitment Status : Completed
First Posted : July 15, 2011
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Colonic Polyp Procedure: Position change Procedure: Standard

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Position Changes During Colonoscope Withdrawal to Increase Polyp Detection: a Prospective Randomized Trial
Study Start Date : July 2011
Primary Completion Date : July 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonic Polyps
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Control
Subject will undergo standard colonoscopy.
Procedure: Standard
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. Polyp detection rate [ Time Frame: 6 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395173


Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 2K5
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jennifer Telford, MD, FRCPC University of British Columbia
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01395173     History of Changes
Other Study ID Numbers: H11-00087
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014

Keywords provided by University of British Columbia:
detection

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps