NCT01991522

Brief Summary

Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning colonoscopy typically learn the procedure experientially but simulation based teaching is increasingly being integrated into training programs. The optimal manner to teach colonoscopy on virtual-reality simulators is uncertain. We aim to test a curriculum in simulation-based colonoscopy with self-directed learning on simulators.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2011

Shorter than P25 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

Study Start

First participant enrolled

June 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

November 5, 2018

Completed
Last Updated

November 5, 2018

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

November 18, 2013

Results QC Date

April 28, 2017

Last Update Submit

February 19, 2018

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Transfer of Skills to Clinical Colonoscopy

    The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. These were measured across two endoscopic procedures, performed consecutively within two weeks of completion of the course. Data from two procedures were used to limit the influence of spurious findings from single procedures.

    less than 2 weeks

Secondary Outcomes (1)

  • Retention of Clinical Skills

    4-6 weeks after intervention

Study Arms (2)

Curriculum Group

EXPERIMENTAL

The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists.

Behavioral: Curriculum Group

Self-directed learning group

ACTIVE COMPARATOR

The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.

Behavioral: Self-directed learning group

Interventions

Curriculum GroupBEHAVIORAL
Curriculum Group
Self-directed learning groupBEHAVIORAL
Self-directed learning group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto

You may not qualify if:

  • Greater than 20 colonoscopies performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Related Publications (1)

  • Grover SC, Garg A, Scaffidi MA, Yu JJ, Plener IS, Yong E, Cino M, Grantcharov TP, Walsh CM. Impact of a simulation training curriculum on technical and nontechnical skills in colonoscopy: a randomized trial. Gastrointest Endosc. 2015 Dec;82(6):1072-9. doi: 10.1016/j.gie.2015.04.008. Epub 2015 May 23.

    PMID: 26007221DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Samir C. Grover
Organization
St. Michael's
samir.grover@utoronto.ca
416-864-5628

Study Officials

  • Samir C Grover, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 25, 2013

Study Start

June 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 5, 2018

Results First Posted

November 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)