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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Implementation of routine videorecording; Behavioral: No routine videorecording

• Study Type: Interventional
• Enrollment (Actual): 5200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: Centre of Postgraduate Medical Education; European Union; Foundation for Polish Science
• Investigators: Study Director: Maria Rupińska, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Estimate): August 5, 2015
• Last Update Submitted That Met QC Criteria: August 3, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: colorectal cancer; colonoscopy; screening; quality indicators; videorecording
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: REC-QUALY