Condition category
Surgery
Date applied
26/10/2011
Date assigned
10/02/2012
Last edited
19/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr James Ansell

ORCID ID

Contact details

Welsh Institute for Minimal Access Therapy (WIMAT)
Cardiff Medicentre
Heath Park
Cardiff
CF14 4XN
United Kingdom

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 measures

Transfer of skills

Secondary outcome measures

Performance indicators

Overall trial start date

01/12/2011

Overall trial end date

01/08/2013

Reason abandoned

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

http://www.cardiff.ac.uk/pgmde/sections/wimat/

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

professional associations and societies

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/01/2016: Plain English summary added