An interventional study of Implementation of routine videorecording and No routine videorecording in Colorectal Cancer, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Completed at 1 site in Poland. Per ClinicalTrials.gov, last updated 2015-08-05.
Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Not applicable, Interventional, and Health services research
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.
5,600 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 5,200 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal
Procedure: Implementation of routine videorecording
Intervention: Behavioral: No routine videorecording (on demand videorecording possible)
Behavioral: No routine videorecording
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.
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).
Time frame: From the time of randomization up to 10 months (the end of screening program annual edition)
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)
Time frame: From the time of randomization up to 10 months (the end of screening program annual edition)
Rates of painful colonoscopy
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)
Rates of proximal (to the splenic flexure) serrated polyps ≥10mm in size
Measured in screening program database.
Time frame: From the time of randomization up to 10 months (the end of screening program annual edition)
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Maria Sklodowska-Curie National Research Institute of Oncology