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Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback (COMPLETE) (COMPLETE)

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ClinicalTrials.gov Identifier: NCT03115008
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborators:
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
University of Kansas Medical Center
Information provided by (Responsible Party):
Tonya Kaltenbach, San Francisco Veterans Affairs Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Video-based terminal feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Training for COMPLETE Polyp Resection During Colonoscopy -Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Video-based terminal feedback Behavioral: Video-based terminal feedback
Terminal feedback is given after skill performance using video-based coaching coupled with a validated polypectomy assessment tool

No Intervention: Conventional concurrent feedback



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115008


Locations
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United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
University of Kansas Medical Center

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Responsible Party: Tonya Kaltenbach, Associate Professor of Clinical Medicine, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03115008     History of Changes
Other Study ID Numbers: COMPLETE 16-21096
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases