Validation of a novel porcine polypectomy trainer
| ISRCTN | ISRCTN41736707 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41736707 |
| Secondary identifying numbers | Awaiting |
- Submission date
- 26/10/2011
- Registration date
- 10/02/2012
- Last edited
- 24/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Welsh Institute for Minimal Access Therapy (WIMAT)
Cardiff Medicentre
Heath Park
Cardiff
CF14 4XN
United Kingdom
Study information
| Study design | Randomised controlled validation study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Validation of a novel porcine polypectomy trainer: a randomised controlled validation study |
| Study objectives | Can a novel colonic polypectomy simulator develop transfer skills for use in colonoscopy? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Transfer of skills |
| Secondary outcome measures | Performance indicators |
| Overall study start date | 01/12/2011 |
| Completion date | 01/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Trainees specialising in general surgery or gastroenterology 2. Consultant colorectal surgeons and gastroenterologists |
| Key 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 |
| Date of first enrolment | 01/12/2011 |
| Date of final enrolment | 01/08/2013 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
CF14 4XN
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mr James Ansell
Cardiff Medicentre
Heath Park
Cardiff
CF14 4XN
Wales
United Kingdom
| Website | http://www.cardiff.ac.uk/pgmde/sections/wimat/ |
|---|---|
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Research organisation
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RCS
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration 2014 results in thesis https://orca.cf.ac.uk/64961/2/2014anselljmd.pdf |
| IPD sharing plan |
Editorial Notes
24/01/2020: The following changes have been made:
1. Thesis added to publication and dissemination plan.
2. The final enrolment number has been added from the thesis.
17/01/2020: Internal review.
19/01/2016: Plain English summary added
28/02/2018: No publications found
