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

NCT ID: NCT02054923

Last Updated: 2015-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Routine video recording group

Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal

Group Type EXPERIMENTAL

Implementation of routine videorecording

Intervention Type PROCEDURE

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.

Control group

Intervention: Behavioral: No routine videorecording (on demand videorecording possible)

Group Type ACTIVE_COMPARATOR

No routine videorecording

Intervention Type BEHAVIORAL

Screening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre of Postgraduate Medical Education

OTHER

Sponsor Role collaborator

Foundation for Polish Science

UNKNOWN

Sponsor Role collaborator

European Union

OTHER

Sponsor Role collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michal F. Kaminski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Jaroslaw Regula, MD, PhD

Role: STUDY_CHAIR

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

Maria RupiƄska

Role: STUDY_DIRECTOR

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

Locations

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Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Warsaw, , Poland

Site Status

Countries

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Poland

Other Identifiers

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REC-QUALY

Identifier Type: -

Identifier Source: org_study_id

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