Colorectal CancerCOMPLETENCT03115008
Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback (COMPLETE)
A study testing Video-based terminal feedback in people with Colorectal Cancer, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
Trial summary
I plan to investigate the value of video-based feedback in endoscopic training - specifically, the role of terminal video feedback as compared to usual concurrent feedback on cold snare polypectomy technique in trainees, using Direct Observation of Polypectomy Skills (DOPyS) competency score. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Video-based terminal feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 Aug 2020
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants: Senior level UCSF gastroenterology trainees (2nd and 3rd year GI fellows) rotating at the San Francisco Veterans Affairs Medical Center (SFVAMC).
- Patients undergoing elective routine colonoscopy procedure.
Who cannot join
- Participants: Junior level University of California, San Francisco (UCSF) gastroenterology trainees (1st year GI fellows) rotating at the San Francisco Veterans Affairs Medical Center, and senior level trainees who are not rotating at the SFVAMC.
- Patients: Patients undergoing undergoing emergency colonoscopy procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
Official title: Training for COMPLETE Polyp Resection During Colonoscopy -Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback
I plan to investigate the value of video-based feedback in endoscopic training - specifically, the role of terminal video feedback as compared to usual concurrent feedback on cold snare polypectomy technique in trainees, using Direct Observation of Polypectomy Skills (DOPyS) competency score. I have focused the study on the competency of cold snare polypectomy for subcentimeter polyps. The majority (>75%) of colon polyps are smaller than one centimeter. Cold snare polypectomy has been shown, and recommended by the American Society for Gastrointestinal Endoscopy (ASGE), to be an effective removal technique. However, its widespread use and moreover, its teaching to trainees is lacking. It takes time and resources to learn and teach endoscopic techniques. Our study will hope to identify a mechanism through video-based feedback that could help to improve the translation of the training of polypectomy skills to its actual performance, and to accelerate the learning curve.
- Conditions
- Colorectal Cancer
- Being tested
- Video-based terminal feedback
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based terminal feedbackBehavioural
Terminal feedback is given after skill performance using video-based coaching coupled with a validated polypectomy assessment tool
| Study group | Role | What they receive |
|---|---|---|
| Video-based terminal feedback | Experimental | Not described Receives: Behavioral: Video-based terminal feedback |
| Conventional concurrent feedback | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of polypectomies for gastroenterology trainees to achieve competency
Observing cold snare polypectomy of polyps <1cm as assessed by DOPyS (score greater or equal to 3)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start1 Aug 2017
- Primary completion1 Jun 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Colorado, Denver, Colorado Clinical & Translational Sciences Institute, University of Kansas Medical Center
- Responsible party
- Principal investigator, Tonya Kaltenbach, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115008
- Sponsor's protocol ID
- COMPLETE 16-21096
- Acronym
- COMPLETE
- Status last verified
- Nov 2020
- First submitted
- 11 Apr 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaltenbach T, Patel SG, Nguyen-Vu T, Malvar C, Keswani RN, Hall M, Aagaard E, Asokkumar R, Chin YK, Hammad H, Rastogi A, Shergill A, Simon V, Soetikno A, Soetikno R, Wani S. Varied Trainee Competence in Cold Snare Polypectomy: Results of the COMPLETE Randomized Controlled Trial. Am J Gastroenterol. 2023 Oct 1;118(10):1880-1887. doi: 10.14309/ajg.0000000000002368. Epub 2023 Jun 13.
PubMed 37307537
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training for COMPLETE Polyp Resection During Colonoscopy -Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback
- ClinicalTrials.gov ID
- NCT03115008
- Acronym / sponsor ID
- COMPLETE / COMPLETE 16-21096
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Collaborators
- University of Colorado, Denver, Colorado Clinical & Translational Sciences Institute, University of Kansas Medical Center
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 14 Apr 2017 (actual)
- 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.
I plan to investigate the value of video-based feedback in endoscopic training - specifically, the role of terminal video feedback as compared to usual concurrent feedback on cold snare polypectomy technique in trainees, using Direct Observation of Polypectomy Skills (DOPyS) competency score. I have focused the study on the competency of cold snare polypectomy for subcentimeter polyps. The majority (>75%) of colon polyps are smaller than one centimeter. Cold snare polypectomy has been shown, and recommended by the American Society for Gastrointestinal Endoscopy (ASGE), to be an effective removal technique. However, its widespread use and moreover, its teaching to trainees is lacking. It takes time and resources to learn and teach endoscopic techniques. Our study will hope to identify a mechanism through video-based feedback that could help to improve the translation of the training of polypectomy skills to its actual performance, and to accelerate the learning curve.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video-based terminal feedback | Experimental | Behavioral: Video-based terminal feedback |
| Conventional concurrent feedback | No intervention | – |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants: Senior level UCSF gastroenterology trainees (2nd and 3rd year GI fellows) rotating at the San Francisco Veterans Affairs Medical Center (SFVAMC).
- Patients undergoing elective routine colonoscopy procedure.
Key exclusion criteria (2 listed)
- Participants: Junior level University of California, San Francisco (UCSF) gastroenterology trainees (1st year GI fellows) rotating at the San Francisco Veterans Affairs Medical Center, and senior level trainees who are not rotating at the SFVAMC.
- Patients: Patients undergoing undergoing emergency colonoscopy procedure.
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 |
|---|---|---|
| Video-based terminal feedbackTerminal feedback is given after skill performance using video-based coaching coupled with a validated polypectomy assessment tool | Behavioural | Video-based terminal feedback |
Primary outcome
Number of polypectomies for gastroenterology trainees to achieve competency
Time frame: 2 years
Observing cold snare polypectomy of polyps <1cm as assessed by DOPyS (score greater or equal to 3)
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 Nov 2020.
- Derived from this study: PubMed 37307537Kaltenbach T, Patel SG, Nguyen-Vu T, Malvar C, Keswani RN, Hall M, Aagaard E, Asokkumar R, Chin YK, Hammad H, Rastogi A, Shergill A, Simon V, Soetikno A, Soetikno R, Wani S. Varied Trainee Competence in Cold Snare Polypectomy: Results of the COMPLETE Randomized Controlled Trial. Am J Gastroenterol. 2023 Oct 1;118(10):1880-1887. doi: 10.14309/ajg.0000000000002368. Epub 2023 Jun 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based terminal feedback in people with Colorectal Cancer, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
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 2 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 Nov 2020. 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 United States. 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?
Number of polypectomies for gastroenterology trainees to achieve competency (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03115008, which also lists 1 linked publication.
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 Nov 2020.