Plain English Summary
Background and study aims
Concerns about patient safety and clinical risk reduction have become a matter of national priority and are regularly reported in the national press. As services develop and treatment options become more complex, there are considerable time pressures put on consultants and senior medical staff to deliver clinical services. Shorter waiting times and higher levels of activity have increased the daily workload of hospital clinicians significantly over the past decade. This has led to a reduction in the time available to train and support surgical skills development in the next generation and to ensure all new surgeons have a high level of competency in all areas of practice. Junior surgeons should be offered the opportunity to train in a safe environment to prevent or reduce mistakes in the clinical setting. Simulation has the potential to provide such an environment, whereby surgeons can practice and master their craft on various forms of models and simulators as well fully immersive non-technical skills training. Surgeons can improve and practice their skills in a simulation environment prior to operating on patients under supervision. They can also receive detailed feedback about their performance during simulated procedures. This has the potential to improve surgical competency and patient outcomes world-wide. The aim of this study is to evaluate the effectiveness of simulation-based training in urology surgery (surgery on the urinary system).
Who can participate?
Urology trainees/residents who haven’t performed more than 10 ureteroscopies (examinations of the upper urinary tract with a special camera that it passed through the urinary system).
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in a 2-3 day educational program where they are taught the basic principles of performing a ureteroscopy followed by hands-on simulation training using virtual reality simulators and models or cadavers (deceased people) where available. Those in the second group are taught how to perform the procedures in the operating room, as is standard practice. Participants in both groups are followed for a total of 25 procedures or 18 months and their performance will be compared in order to assess which group is more capable performing the procedure and less causes less complications in patients.
What are the possible benefits and risks of participating?
Participants who receive the simulation training may benefit from improved performance in urological surgical procedures. There are no notable risks associated with this study.
Where is the study run from?
1. Guy's Hospital and British Association Urological Surgeons (UK)
2. Paracelsus Medical University (Austria)
3. SLK Kliniken, Klinikum Sindelfingen-Böblingen and Siloah St. Trudpert Klinikum (Germany)
4. University of Bern (Switzerland)
5. Sismanoglio General Hospital and Red Cross Hospital (Greece)
6. Health Sciences University Kartal Training & Research Hospital (Turkey)
7. Hokkaido University Hospital (Japan)
8. First Affiliated Hospital of Guangzhou Medical University (China)
10. Icahn School of Medicine at Mount Sinai (NY, USA)
11. Dalhousie University (NS) and University of British Columbia (Canada)
When is the study starting and how long is it expected to run for?
September 2015 to October 2019
Who is funding the study?
The Urology Foundation (UK)
Who is the main contact?
1. Dr Abdullatif Aydin (public)
abdullatif.aydin@kcl.ac.uk
2. Mr Kamran Ahmed (scientific)
kamran.ahmed@kcl.ac.uk
3. Professor Prokar Daspupta (scientific)
prokar.dasgupta@kcl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Abdullatif Aydin
ORCID ID
http://orcid.org/0000-0002-5440-7741
Contact details
5th Floor
Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom
+44 207 188 5906
abdullatif.aydin@kcl.ac.uk
Type
Scientific
Additional contact
Mr Kamran Ahmed
ORCID ID
Contact details
5th Floor
Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom
+44 207 188 5906
kamran.ahmed@kcl.ac.uk
Type
Scientific
Additional contact
Prof Prokar Dasgupta
ORCID ID
Contact details
5th Floor
Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom
+44 207 188 5906
prokar.dasgupta@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BDM/14/15-68
Study information
Scientific title
Simulation in Urological Training and Education (SIMULATE): A Randomised Controlled Clinical and Educational Trial to Determine the Effect of Structured Simulation-Based Surgical Training
Acronym
SIMULATE
Study hypothesis
Structured simulation-based training will be more effective and require less number of procedures in the operating room to achieve proficiency in a given surgical procedure.
Ethics approval
King's College London, 28/04/2015, ref: BDM/14/15-68
Study design
Multi-centre prospective interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Simulation-based surgical training
Intervention
Participants will be recruited and randomized to one of two groups using block randomisation.
SBT arm: Participants will receive a 2-3 day educational intervention where they will be taught the principles of ureteroscopy followed by hands-on training through a simulation curriculum using virtual reality simulators and bench models as well as cadavers, where available. Furthermore, participants will receive integrated technical and non-technical skills training in a novel and portable full immersion simulation environment.
NSBT arm: Participants will be taught how to perform the procedures in the operating room, as is current practice.
Participants in both arms of the study will be followed for a total of 25 procedures or 18 months and their performance will be compared in order to assess which group is more proficient and less complications.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Current primary outcome measure as of 18/10/2019:
Number of uretero(reno)scopy procedures required to achieve proficiency is measured using the generic Objective structured assessment of technical skill (OSATS) by their clinical supervisors for a total of 25 procedures, to assess and compare the learning curves of both arms.
Previous primary outcome measure:
Number of uretero(reno)scopy procedures required to achieve proficiency is measured using the generic Objective structured assessment of technical skill (OSATS) and the procedure-specific Uretero(reno)scopy assessment score (URSAS) tools at every procedure. Participants will be assessed on their uretero(reno)scopy performances using these assessment scales by their clinical supervisors for a total of 25 procedures, to assess and compare the learning curves of both arms.
Secondary outcome measures
Current secondary outcome measures as of 18/10/2019:
1. Number of intra- and post-operative complications are measured using patient notes at pre- and post-operation (48 hours)
2. Post-operative stone-free status of each patient
3. Feasibility, acceptability and educational impact of simulation-based training are assessed through qualitative and quantitative surveys designed for the purpose of this study at the end of each educational intervention delivered to the SBT arm
Previous secondary outcome measures:
1. Number of pre-, intra- and post-operative complications are measured using patient notes at pre- and post-operation (48 hours)
2. Costs are measured in GBP, taking into consideration the total cost of the available simulators
3. Feasibility, acceptability and educational impact of simulation-based training are assessed through qualitative and quantitative surveys designed for the purpose of this study at the end of each educational intervention delivered to the SBT arm
Overall trial start date
08/09/2015
Overall trial end date
30/10/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Urology trainees/residents
2. Not have independently performed more than 10 full uretero(reno)scopy procedures
3. No prior experience with structured simulation training in ureteroscopy (pportunistic simulation encounters, of no more than one hour, will be acceptable)
Participant type
Health professional
Age group
Adult
Gender
Both
Target number of participants
47
Total final enrolment
94
Participant exclusion criteria
1. Independent performance of more than 10 full ureteroscopy procedures
2. Prior experience with structured simulation training in ureteroscopy, of more than one hour
Recruitment start date
24/10/2016
Recruitment end date
30/06/2017
Locations
Countries of recruitment
Austria, Canada, China, Germany, Greece, Japan, Switzerland, Turkey, United Kingdom, United States of America
Trial participating centre
Guy's Hospital
Guy's and St. Thomas' NHS Foundation Trust
Great Maze Pond
London
SE1 9RT
United Kingdom
Trial participating centre
Paracelsus Medical University
Strubergasse 21
Salzburg
5020
Austria
Trial participating centre
SLK Kliniken
Am Gesundbrunnen 20-26
Heilbronn
74078
Germany
Trial participating centre
Siloah St. Trudpert Klinikum
Wilferdinger Str. 67
Pforzheim
75179
Germany
Trial participating centre
Sismanoglio General Hospital
Sismanogliou 37
Athens
151 26
Greece
Trial participating centre
Red Cross Hospital
Erithrou Stavrou ke Athanasaki
Athens
115 26
Greece
Trial participating centre
University of Bern
Hochschulstrasse 6
Bern
3012
Switzerland
Trial participating centre
Kartal Education & Research Hospital
Istanbul
34890
Turkey
Trial participating centre
Hokkaido University Hospital
5 Chome Kita 14 Jonishi
Kita Ward
Sapporo
Hokkaido
060-8648
Japan
Trial participating centre
Klinikum Sindelfingen-Böblingen
University of Tuebingen
Tuebingen
-
Germany
Trial participating centre
First Affiliated Hospital of Guangzhou Medical University
195 Dongfeng W Road
Yuexiu Qu
Guangzhou
510000
China
Trial participating centre
Icahn School of Medicine at Mount Sinai
Mount Sinai West and St. Luke's Hospitals
New York
-
United States of America
Trial participating centre
Dalhousie University
Halifax
-
Canada
Trial participating centre
University of British Columbia
2329 West Mall
Vancouver
V6T 1Z4
Canada
Sponsor information
Organisation
King's College London
Sponsor details
K1.31
King's Building
Strand Campus
London
WC2R 2LS
United Kingdom
+44 207 848 6391
keith.brennan@kcl.ac.uk
Sponsor type
University/education
Website
http://www.kcl.ac.uk/index.aspx
Organisation
Guy's and St. Thomas' NHS Foundation Trust
Sponsor details
R&D Department
16th Floor
Tower Wing
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 207 188 5736
Jennifer.Boston@gstt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
The Urology Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal by up to one year after the end of the trial.
IPD Sharing plan:
The dataset is not available as it consists of assessment forms of participants’ performance, which is considered confidential information. It will be stored in the MRC Centre for Transplantation, King’s College London computers, specific to the SIMULATE trial.
Intention to publish date
01/05/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2020 protocol in https://www.ncbi.nlm.nih.gov/pubmed/32189446 (added 20/03/2020)