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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02054923
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : August 5, 2015
Sponsor:
Collaborators:
Centre of Postgraduate Medical Education
Foundation for Polish Science
European Union
Information provided by (Responsible Party):
Maria Sklodowska-Curie National Research Institute of Oncology

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Implementation of routine videorecording Behavioral: No routine videorecording Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: The Effect of Routine Video-recording on Colonoscopy Quality Indicators: a Cluster Randomized Trial.
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Routine video recording group
Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal
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.

Active Comparator: Control group
Intervention: Behavioral: No routine videorecording (on demand videorecording possible)
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054923


Locations
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Poland
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Warsaw, Poland
Sponsors and Collaborators
Maria Sklodowska-Curie National Research Institute of Oncology
Centre of Postgraduate Medical Education
Foundation for Polish Science
European Union
Investigators
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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
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Responsible Party: Maria Sklodowska-Curie National Research Institute of Oncology
ClinicalTrials.gov Identifier: NCT02054923    
Other Study ID Numbers: REC-QUALY
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015
Keywords provided by Maria Sklodowska-Curie National Research Institute of Oncology:
colonoscopy
videorecording
quality indicators
screening
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases