Back to resultsThe Effect of Routine Video-recording on Colonoscopy Quality Indicators.
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Implementation of routine videorecording
No routine videorecording
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring colonoscopy, videorecording, quality indicators, screening, colorectal cancer
Eligibility Criteria
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
Sites / Locations
- Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Routine video recording group
Control group
Arm Description
Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal
Intervention: Behavioral: No routine videorecording (on demand videorecording possible)
Outcomes
Primary Outcome Measures
Change in screening centre adenoma detection rate before and after intervention
Proportion of patients with at least one adenoma identified (measured in screening program database).
Secondary Outcome Measures
Reported and audited ceacal intubation rates
Proportion of complete colonoscopies (measured in screening program database; audited ceacal intubation rates will be assessed through videorecording review)
Rates of painful colonoscopy
Severe or moderate pain on a four point verbal rating scale (measured in screening program database)
Rates of proximal (to the splenic flexure) serrated polyps ≥10mm in size
Measured in screening program database.
Full Information
NCT ID
NCT02054923
First Posted
January 31, 2014
Last Updated
August 3, 2015
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education, Foundation for Polish Science, European Union
1. Study Identification
Unique Protocol Identification Number
NCT02054923
Brief Title
The Effect of Routine Video-recording on Colonoscopy Quality Indicators.
Official Title
The Effect of Routine Video-recording on Colonoscopy Quality Indicators: a Cluster Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education, Foundation for Polish Science, European Union
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colonoscopy, videorecording, quality indicators, screening, colorectal cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Routine video recording group
Arm Type
Experimental
Arm Description
Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Intervention: Behavioral: No routine videorecording (on demand videorecording possible)
Intervention Type
Procedure
Intervention Name(s)
Implementation of routine videorecording
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No routine videorecording
Intervention Description
Screening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand.
Primary Outcome Measure Information:
Title
Change in screening centre adenoma detection rate before and after intervention
Description
Proportion of patients with at least one adenoma identified (measured in screening program database).
Time Frame
From the time of randomization up to 10 months (the end of screening program annual edition)
Secondary Outcome Measure Information:
Title
Reported and audited ceacal intubation rates
Description
Proportion of complete colonoscopies (measured in screening program database; audited ceacal intubation rates will be assessed through videorecording review)
Time Frame
From the time of randomization up to 10 months (the end of screening program annual edition)
Title
Rates of painful colonoscopy
Description
Severe or moderate pain on a four point verbal rating scale (measured in screening program database)
Time Frame
From the time of randomization up to 10 months (the end of screening program annual edition)
Title
Rates of proximal (to the splenic flexure) serrated polyps ≥10mm in size
Description
Measured in screening program database.
Time Frame
From the time of randomization up to 10 months (the end of screening program annual edition)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal F. Kaminski, MD, PhD
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jaroslaw Regula, MD, PhD
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Rupińska
Organizational Affiliation
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Official's Role
Study Director
Facility Information:
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
City
Warsaw
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
The Effect of Routine Video-recording on Colonoscopy Quality Indicators.
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