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Completed

NCT Number: NCT02054923

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Warsaw, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implementation of routine videorecording

Procedure

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.

No routine videorecording

Behavioral

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 outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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.

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Collaborators

  • Centre of Postgraduate Medical Education
  • European Union
  • Foundation for Polish Science

Registry information

Official study title

The Effect of Routine Video-recording on Colonoscopy Quality Indicators: a Cluster Randomized Trial.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2014
Registry last updated
Aug 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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