Position Changes During Colonoscope Withdrawal and Polyp Detection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01395173
First received: July 13, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention
Colonic Polyp
Procedure: Position change
Procedure: Standard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Position Changes During Colonoscope Withdrawal to Increase Polyp Detection: a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Polyp detection rate [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 776
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01395173     History of Changes
Other Study ID Numbers: H11-00087
Study First Received: July 13, 2011
Last Updated: September 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
detection

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

ClinicalTrials.gov processed this record on August 21, 2014