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

Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT02054923
Collaborator
Centre of Postgraduate Medical Education (Other), Foundation for Polish Science (Other), European Union (Other)
5,200
1
2
9
575.5

Study Details

Study Description

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
  • Procedure: Implementation of routine videorecording
  • Behavioral: No routine videorecording
N/A

Study Design

Study Type:
Interventional
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 :
Mar 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in screening centre adenoma detection rate before and after intervention [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 [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 [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 [From the time of randomization up to 10 months (the end of screening program annual edition)]

    Measured in screening program database.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Sklodowska-Curie National Research Institute of Oncology
ClinicalTrials.gov Identifier:
NCT02054923
Other Study ID Numbers:
  • REC-QUALY
First Posted:
Feb 4, 2014
Last Update Posted:
Aug 5, 2015
Last Verified:
Aug 1, 2015
Keywords provided by Maria Sklodowska-Curie National Research Institute of Oncology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2015