Simulation in urological training and education: Transfer of skills from the simulation laboratory to the operating room
| ISRCTN | ISRCTN12260261 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12260261 |
| Secondary identifying numbers | BDM/14/15-68 |
- Submission date
- 06/10/2016
- Registration date
- 21/10/2016
- Last edited
- 19/11/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
5th Floor, Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom
 ORCID ID |
0000-0002-5440-7741 |
|---|---|
| Phone | +44 207 188 5906 |
| abdullatif.aydin@kcl.ac.uk |
Scientific
5th Floor, Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom
| Phone | +44 207 188 5906 |
|---|---|
| kamran.ahmed@kcl.ac.uk |
Scientific
5th Floor, Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom
| Phone | +44 207 188 5906 |
|---|---|
| prokar.dasgupta@kcl.ac.uk |
Study information
| Study design | Multi-centre prospective interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | SIMULATE |
| Study objectives | 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(s) | King's College London, 28/04/2015, ref: BDM/14/15-68 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 08/09/2015 |
| Completion date | 30/10/2019 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 47 |
| Total final enrolment | 94 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 24/10/2016 |
| Date of final enrolment | 30/06/2017 |
Locations
Countries of recruitment
- Austria
- Canada
- China
- England
- Germany
- Greece
- Japan
- Switzerland
- Türkiye
- United Kingdom
- United States of America
Study participating centres
Great Maze Pond
London
SE1 9RT
United Kingdom
Salzburg
5020
Austria
Heilbronn
74078
Germany
Pforzheim
75179
Germany
Athens
151 26
Greece
Athens
115 26
Greece
Bern
3012
Switzerland
34890
Türkiye
Kita Ward
Sapporo
Hokkaido
060-8648
Japan
Tuebingen
-
Germany
Yuexiu Qu
Guangzhou
510000
China
New York
-
United States of America
-
Canada
Vancouver
V6T 1Z4
Canada
Sponsor information
University/education
K1.31
King's Building
Strand Campus
London
WC2R 2LS
England
United Kingdom
| Phone | +44 207 848 6391 |
|---|---|
| keith.brennan@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Hospital/treatment centre
R&D Department
16th Floor, Tower Wing
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 207 188 5736 |
|---|---|
| Jennifer.Boston@gstt.nhs.uk |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2020 | 20/03/2020 | Yes | No |
| Results article | 14/11/2021 | 19/11/2021 | Yes | No |
Editorial Notes
19/11/2021: Publication reference added.
20/03/2020: Publication reference added.
18/10/2019: The following changes have been made:
1. The overall trial end date has been changed from 28/02/2019 to 30/10/2019 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 30/04/2019 to 01/05/2020.
3. The final enrolment number has been added.
4. The primary outcome measure has been changed.
5. The secondary outcome measures have been changed.
03/10/2017: Overall trial end date has been updated from 30/04/2018 to 28/02/2019. The recruitment dates are updated from 30/07/2015-30/01/2017 to 24/10/2016-30/06/2017. The scientific title has been updated from "Simulation in Urological Training and Education: A Randomised Controlled Clinical and Educational Trial to Determine the Effect of Structured Simulation-Based Training for Ureterorenoscopy (SIMULATE)" to "Simulation in Urological Training and Education (SIMULATE): A Randomised Controlled Clinical and Educational Trial to Determine the Effect of Structured Simulation-Based Surgical Training." The ClinicalTrials.gov number "NCT183429" has been removed as it is incorrect.
22/09/2017: Internal review.
11/08/2017: Internal review.
08/08/2017: The following have been added as trial participating centres: Klinikum Sindelfingen-Böblingen, University of Tuebingen (Germany), First Affiliated Hospital of Guangzhou Medical University (China), Mount Sinai West and St. Luke's Hospitals, Icahn School of Medicine at Mount Sinai (NY, USA), Dalhousie University (Halifax, NS, Canada), University of British Columbia (Vancouver, Canada). The plain English summary has been updated accordingly.
