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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054923
• Other study ID #: REC-QUALY
• Status: Completed
• Phase: N/A
• First received: January 31, 2014
• Last updated: August 3, 2015
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5200
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	European Union, Foundation for Polish Science, Medical Centre of Postgraduate Education, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in screening centre adenoma detection rate before and after intervention	Proportion of patients with at least one adenoma identified (measured in screening program database).	From the time of randomization up to 10 months (the end of screening program annual edition)	No
Secondary	Reported and audited ceacal intubation rates	Proportion of complete colonoscopies (measured in screening program database; audited ceacal intubation rates will be assessed through videorecording review)	From the time of randomization up to 10 months (the end of screening program annual edition)	No
Secondary	Rates of painful colonoscopy	Severe or moderate pain on a four point verbal rating scale (measured in screening program database)	From the time of randomization up to 10 months (the end of screening program annual edition)	No
Secondary	Rates of proximal (to the splenic flexure) serrated polyps =10mm in size	Measured in screening program database.	From the time of randomization up to 10 months (the end of screening program annual edition)	No