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Completed

NCT Number: NCT01991522

A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Greater than 20 colonoscopies performed

Treatment and study plan

Curriculum Group

Behavioral

Self-directed learning group

Behavioral

Primary outcomes

  1. Transfer of Skills to Clinical Colonoscopy

    Time frame: less than 2 weeks

    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.

Secondary outcomes

  1. Retention of Clinical Skills

    Time frame: 4-6 weeks after intervention

    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. The tool will be used to assess participants during an integrated scenario. A change in these ratings before and after intervention is the secondary outcome.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

A Comprehensive Simulation-based Curriculum as a Means to Enhance Technical and Non-technical Skills in Colonoscopy: a Randomized Control Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 25, 2013
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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