The Effect of Routine Video-recording on Colonoscopy Quality Indicators.

Overview

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.

Full Title of Study: “The Effect of Routine Video-recording on Colonoscopy Quality Indicators: a Cluster Randomized Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2014

Interventions

  • Procedure: Implementation of 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.
  • Behavioral: No routine videorecording
    • Screening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand.

Arms, Groups and Cohorts

  • Experimental: Routine video recording group
    • Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal
  • Active Comparator: Control group
    • Intervention: Behavioral: No routine videorecording (on demand videorecording possible)

Clinical Trial Outcome Measures

Primary Measures

  • 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)
    • Proportion of patients with at least one adenoma identified (measured in screening program database).

Secondary Measures

  • Reported and audited ceacal intubation rates
    • Time Frame: From the time of randomization up to 10 months (the end of screening program annual edition)
    • Proportion of complete colonoscopies (measured in screening program database; audited ceacal intubation rates will be assessed through videorecording review)
  • Rates of painful colonoscopy
    • Time Frame: From the time of randomization up to 10 months (the end of screening program annual edition)
    • 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
    • Time Frame: From the time of randomization up to 10 months (the end of screening program annual edition)
    • Measured in screening program database.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maria Sklodowska-Curie Institute – Oncology Center
  • Collaborator
    • Centre of Postgraduate Medical Education
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michal F. Kaminski, MD, PhD, Principal Investigator, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
    • Jaroslaw Regula, MD, PhD, Study Chair, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
    • Maria Rupińska, Study Director, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland

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