The Effect of Routine Video-recording on Colonoscopy Quality Indicators.
1 other identifier
interventional
5,200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Mar 2014
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2014
CompletedFirst Posted
Study publicly available on registry
February 4, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 5, 2015
August 1, 2015
9 months
January 31, 2014
August 3, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
From the time of randomization up to 10 months (the end of screening program annual edition)
Secondary Outcomes (3)
Reported and audited ceacal intubation rates
From the time of randomization up to 10 months (the end of screening program annual edition)
Rates of painful colonoscopy
From the time of randomization up to 10 months (the end of screening program annual edition)
Rates of proximal (to the splenic flexure) serrated polyps ≥10mm in size
From the time of randomization up to 10 months (the end of screening program annual edition)
Study Arms (2)
Routine video recording group
EXPERIMENTALIntervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal
Control group
ACTIVE COMPARATORIntervention: Behavioral: No routine videorecording (on demand videorecording possible)
Interventions
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.
Screening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maria Sklodowska-Curie National Research Institute of Oncologylead
- Centre of Postgraduate Medical Educationcollaborator
- Foundation for Polish Sciencecollaborator
- European Unioncollaborator
Study Sites (1)
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Warsaw, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michal F. Kaminski, MD, PhD
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- STUDY CHAIR
Jaroslaw Regula, MD, PhD
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
- STUDY DIRECTOR
Maria Rupińska
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2014
First Posted
February 4, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 5, 2015
Record last verified: 2015-08