NCT03115008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

2.8 years

First QC Date

April 11, 2017

Last Update Submit

November 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    2 years

Study Arms (2)

Video-based terminal feedback

EXPERIMENTAL
Behavioral: Video-based terminal feedback

Conventional concurrent feedback

NO INTERVENTION

Interventions

Terminal feedback is given after skill performance using video-based coaching coupled with a validated polypectomy assessment tool

Video-based terminal feedback

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Medicine

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 14, 2017

Study Start

August 1, 2017

Primary Completion

June 1, 2020

Study Completion

August 30, 2020

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations