Colorectal CancerNCT02054923
The Effect of Routine Video-recording on Colonoscopy Quality Indicators.
A study testing Implementation of routine videorecording and No routine videorecording in people with Colorectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Implementation of routine videorecording and No routine videorecording
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,200 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Warsaw
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Being tested
- Implementation of routine videorecording, No routine videorecording
- Keywords
- colonoscopy, videorecording, quality indicators, screening, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of routine videorecordingProcedure or surgery
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.
No routine videorecordingBehavioural
Screening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand.
| Study group | Role | What they receive |
|---|---|---|
| Routine video recording group | Experimental | Intervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal Receives: Procedure: Implementation of routine videorecording |
| Control group | Active comparator | Intervention: Behavioral: No routine videorecording (on demand videorecording possible) Receives: Behavioral: No routine videorecording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the time of randomization up to 10 months (the end of screening program annual edition)
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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.
Measured: From the time of randomization up to 10 months (the end of screening program annual edition)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education, Foundation for Polish Science, European Union
- Responsible party
- Sponsor
- Investigators
- Michal F. Kaminski, MD, PhD, Principal investigator, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of OncologyJaroslaw Regula, MD, PhD, Study chair, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, PolandMaria Rupińska, Study director, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054923
- Sponsor's protocol ID
- REC-QUALY
- Status last verified
- Aug 2015
- First submitted
- 31 Jan 2014
- Last updated
- 5 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Routine Video-recording on Colonoscopy Quality Indicators: a Cluster Randomized Trial.
- ClinicalTrials.gov ID
- NCT02054923
- Acronym / sponsor ID
- REC-QUALY
- Conditions
- Colorectal Cancer
- Keywords
- colonoscopy, videorecording, quality indicators, screening, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,200 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education, Foundation for Polish Science, European Union
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine video recording group | Experimental | Procedure: Implementation of routine videorecordingIntervention: Procedure: Implementation of routine videorecording of colonoscopy withdrawal |
| Control group | Active comparator | Behavioral: No routine videorecordingIntervention: Behavioral: No routine videorecording (on demand videorecording possible) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of routine videorecordingAll 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. | Procedure or surgery | Routine video recording group |
| No routine videorecordingScreening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand. | Behavioural | Control group |
Primary outcome
Change in screening centre adenoma detection rate before and after intervention
Time frame: 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).
3 secondary outcomes
Reported and audited ceacal intubation rates
Time frame: From the time of randomization up to 10 months (the end of screening program annual edition)
Rates of painful colonoscopy
Time frame: 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
Time frame: From the time of randomization up to 10 months (the end of screening program annual edition)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal F. Kaminski, MD, PhD principal investigator
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Jaroslaw Regula, MD, PhD study chair
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
Maria Rupińska study director
The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of routine videorecording and No routine videorecording in people with Colorectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in screening centre adenoma detection rate before and after intervention (time frame: From the time of randomization up to 10 months (the end of screening program annual edition)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2015.