The Effect of Routine Video-recording on Colonoscopy Quality Indicators.
August 3, 2015 updated by: Maria Sklodowska-Curie National Research Institute of Oncology
The Effect of Routine Video-recording on Colonoscopy Quality Indicators: a Cluster Randomized Trial.
Routine video recording of the colonoscopy examination has been proposed as a simple and easy to implement method that could improve the quality of colonoscopy.
The purpose of this study is to investigate whether implementation of routine video recording of screening colonoscopy withdrawal is effective as a means of supporting quality performance of colonoscopy.
The study will be performed in 8 screening centers within the framework of a national colonoscopy screening program in Poland (the Polish Colonoscopy Screening Platform; PCSP).
Individuals aged 55-64 years are eligible to participate in the PCSP.
In the run-in period colonoscopy quality measures will be monitored through a dedicated joint database.
Then eligible screening centres will be randomly assigned in a 1:1 ratio to the video recording group or the control group.
Screening centres assigned to the video recording group will receive videorecorders and DVDs and will be asked to video record all screening colonoscopies (only withdrawal).
Control group will be allowed to record colonoscopies on demand only.
Then , the colonoscopy quality measures will again be monitored through a dedicated joint database.
All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5200
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
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Warsaw, Poland
- Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Screening centres participating in the Polish Colonoscopy Screening Platform (PCSP) between 2012 and 2013, in which no routine video recording of screening colonoscopies is performed
- Screening centres which will sign informed consent
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Routine video recording group
Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal
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All screening centres (clusters) assigned to the routine video recording group will receive an appropriate number of video recorders and DVDs for each colonoscopy room.
Screening centre coordinators will be responsible for the implementation of routine video recording of all screening colonoscopies (only withdrawal) in the centres.
Every three months screening centre coordinators will be asked to send back all recorded DVDs.
All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team and then stored.
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Active Comparator: Control group
Intervention: Behavioral: No routine videorecording (on demand videorecording possible)
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Screening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in screening centre adenoma detection rate before and after intervention
Time Frame: From the time of randomization up to 10 months (the end of screening program annual edition)
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Proportion of patients with at least one adenoma identified (measured in screening program database).
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From the time of randomization up to 10 months (the end of screening program annual edition)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reported and audited ceacal intubation rates
Time Frame: From the time of randomization up to 10 months (the end of screening program annual edition)
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Proportion of complete colonoscopies (measured in screening program database; audited ceacal intubation rates will be assessed through videorecording review)
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From the time of randomization up to 10 months (the end of screening program annual edition)
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Rates of painful colonoscopy
Time Frame: From the time of randomization up to 10 months (the end of screening program annual edition)
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Severe or moderate pain on a four point verbal rating scale (measured in screening program database)
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From the time of randomization up to 10 months (the end of screening program annual edition)
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Rates of proximal (to the splenic flexure) serrated polyps ≥10mm in size
Time Frame: From the time of randomization up to 10 months (the end of screening program annual edition)
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Measured in screening program database.
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From the time of randomization up to 10 months (the end of screening program annual edition)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Maria Rupińska, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
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
March 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 31, 2014
First Submitted That Met QC Criteria
February 3, 2014
First Posted (Estimate)
February 4, 2014
Study Record Updates
Last Update Posted (Estimate)
August 5, 2015
Last Update Submitted That Met QC Criteria
August 3, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-QUALY
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