- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433939
Position Changes During Colonoscope Insertion Increases Patient Comfort
April 30, 2018 updated by: Jennifer Telford
Position Changes During Colonoscope Insertion Increases Patient Comfort: a Prospective Trial
The investigators wish to study the effects of position changes during colonoscope insertion on patient comfort.
The investigators hypothesize that early position changes would reduce colonoscope loop formation and patient discomfort.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
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 1Y6
- 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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients referred to gastroenterologists for colonoscopy.
Description
Inclusion Criteria:
- age 19 years or older
- outpatient colonoscopy
Exclusion Criteria:
- inpatient
- unable to provide informed consent
- previous bowel resection, inflammatory bowel disease
- musculoskeletal disorder or other mobility issues 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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intensity and frequency of abdominal pain
Time Frame: 30min
|
Abdominal pain during colonoscopy.
|
30min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Telford, MD, The University of British Columbia
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
September 1, 2011
Primary Completion (Actual)
May 25, 2015
Study Completion (Actual)
May 25, 2015
Study Registration Dates
First Submitted
September 12, 2011
First Submitted That Met QC Criteria
September 13, 2011
First Posted (Estimate)
September 14, 2011
Study Record Updates
Last Update Posted (Actual)
May 2, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H11-01597
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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