Plain English Summary
Background and study aims:
The WIMAT colonoscopy suitcase is a simulator designed to teach trainee doctors how to perform colonic polypectomy (the removal of polyps in the colon to prevent them from turning cancerous). The Simbionix GI MentorTM is a Virtual Reality (VR) simulator that is also used to teach colonic polypectomy. Evidence suggests that those who train on the Simbionix GI Mentor perform better in the early phase of real colonoscopy training. However, this type of skills transfer has not been previously demonstrated for the WIMAT colonoscopy suitcase. The aims of this study are to assess whether using the WIMAT colonoscopy simulator results in skills transfer to the clinical setting, and to compare the level of skills transfer attained using the two simulators.
Who can participate?
ST3-7 level trainees in General Surgery or Gastroenterology who have performed 1-20 ‘real life’ endoscopic procedures and less than five colonic polypectomies.
What does the study involve?
Participants are randomly allocated to either WIMAT colonoscopy suitcase training or VR training. They attend 3 (1 hour) sessions of standardised self-directed learning on their assigned simulator over 3 weeks (one per week). The skills of the two groups are compared after 3 and 6 months.
What are the possible benefits and risks of participating?
Improved training in colonic polypectomy may improve patient outcomes.
Where is the study run from?
Welsh Institute for Minimal Access Therapy (UK)
When is the study starting and how long is it expected to run for?
December 2011 to August 2013
Who is funding the study?
Royal College of Surgeons of England (UK)
Who is the main contact?
James Ansell
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Awaiting
Study information
Scientific title
Validation of a novel porcine polypectomy trainer: a randomised controlled validation study
Acronym
Study hypothesis
Can a novel colonic polypectomy simulator develop transfer skills for use in colonoscopy?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled validation study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Training surgeons
Intervention
The cohort of trainees are divided into groups according to their previous experience in colonoscopy. Then their videoed performance will be measured on the colonoscopy trainer. This will tell us if the trainer is able to distinguish between levels of expertise.
The most novice group is randomised into two further groups. One will receive simulator training and the other standard training. The skills of each group will be compared to evaluate the overall use of the course in training.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Transfer of skills
Secondary outcome measures
Performance indicators
Overall trial start date
01/12/2011
Overall trial end date
01/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Trainees specialising in general surgery or gastroenterology
2. Consultant colorectal surgeons and gastroenterologists
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Any trainee who has performed more than 5 previous colonic polypectomies
2. Any trainee who has observed or taught on the advanced colonoscopy course at WIMAT
Recruitment start date
01/12/2011
Recruitment end date
01/08/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Welsh Institute for Minimal Access Therapy (WIMAT)
Cardiff
CF14 4XN
United Kingdom
Sponsor information
Organisation
Welsh Institute for Minimal Access Therapy (WIMAT) (UK)
Sponsor details
c/o Mr James Ansell
Cardiff Medicentre
Heath Park
Cardiff
CF14 4XN
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Royal College of Surgeons of England (UK)
Alternative name(s)
RCS
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list