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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Implementation of routine videorecording; Behavioral: No routine videorecording

• Registration Number: NCT02054923
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-31
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Study Start: 2014-03
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine video recording group	Implementation of routine videorecording	Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal
Control group	No routine videorecording	Intervention: Behavioral: No routine videorecording (on demand videorecording possible)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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)
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.

Trial Locations

Locations (1)

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology; 🇵🇱 Warsaw, Poland