Clinical trial NCT02054923: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colonoscopy
videorecording
quality indicators
screening
colorectal cancer
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
name: Foundation for Polish Science
name: European Union
First posted: 2014-02-04
Enrollment: 5200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Change in screening centre adenoma detection rate before and after intervention
timeFrame: From the time of randomization up to 10 months (the end of screening program annual edition)
Secondary outcomes:
measure: Reported and audited ceacal intubation rates
timeFrame: From the time of randomization up to 10 months (the end of screening program annual edition)
measure: Rates of painful colonoscopy
timeFrame: From the time of randomization up to 10 months (the end of screening program annual edition)
measure: Rates of proximal (to the splenic flexure) serrated polyps ≥10mm in size
timeFrame: From the time of randomization up to 10 months (the end of screening program annual edition)
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Study officials:
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
name: Michal F. Kaminski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
name: Jaroslaw Regula, MD, PhD
role: STUDY_CHAIR
affiliation: The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
name: Maria Rupińska
role: STUDY_DIRECTOR
References: