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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Study website

Contact information

Dr Abdullatif Aydin
Public

5th Floor, Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom

ORCiD logoORCID ID 0000-0002-5440-7741
Phone +44 207 188 5906
Email abdullatif.aydin@kcl.ac.uk
Mr Kamran Ahmed
Scientific

5th Floor, Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom

Phone +44 207 188 5906
Email kamran.ahmed@kcl.ac.uk
Prof Prokar Dasgupta
Scientific

5th Floor, Southwark Wing
Guy's Hospital
London
SE1 9RT
United Kingdom

Phone +44 207 188 5906
Email prokar.dasgupta@kcl.ac.uk

Study information

Study designMulti-centre prospective interventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSimulation in Urological Training and Education (SIMULATE): A Randomised Controlled Clinical and Educational Trial to Determine the Effect of Structured Simulation-Based Surgical Training
Study acronymSIMULATE
Study objectivesStructured 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) studiedSimulation-based surgical training
InterventionParticipants 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 typeOther
Primary outcome measureCurrent 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 measuresCurrent 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 date08/09/2015
Completion date30/10/2019

Eligibility

Participant type(s)Health professional
Age groupAdult
SexBoth
Target number of participants47
Total final enrolment94
Key inclusion criteria1. 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 criteria1. 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 enrolment24/10/2016
Date of final enrolment30/06/2017

Locations

Countries of recruitment

  • Austria
  • Canada
  • China
  • England
  • Germany
  • Greece
  • Japan
  • Switzerland
  • Türkiye
  • United Kingdom
  • United States of America

Study participating centres

Guy's Hospital
Guy's and St. Thomas' NHS Foundation Trust
Great Maze Pond
London
SE1 9RT
United Kingdom
Paracelsus Medical University
Strubergasse 21
Salzburg
5020
Austria
SLK Kliniken
Am Gesundbrunnen 20-26
Heilbronn
74078
Germany
Siloah St. Trudpert Klinikum
Wilferdinger Str. 67
Pforzheim
75179
Germany
Sismanoglio General Hospital
Sismanogliou 37
Athens
151 26
Greece
Red Cross Hospital
Erithrou Stavrou ke Athanasaki
Athens
115 26
Greece
University of Bern
Hochschulstrasse 6
Bern
3012
Switzerland
Kartal Education & Research Hospital
Istanbul
34890
Türkiye
Hokkaido University Hospital
5 Chome Kita 14 Jonishi
Kita Ward
Sapporo
Hokkaido
060-8648
Japan
Klinikum Sindelfingen-Böblingen
University of Tuebingen
Tuebingen
-
Germany
First Affiliated Hospital of Guangzhou Medical University
195 Dongfeng W Road
Yuexiu Qu
Guangzhou
510000
China
Icahn School of Medicine at Mount Sinai
Mount Sinai West and St. Luke's Hospitals
New York
-
United States of America
Dalhousie University
Halifax
-
Canada
University of British Columbia
2329 West Mall
Vancouver
V6T 1Z4
Canada

Sponsor information

King's College London
University/education

K1.31
King's Building
Strand Campus
London
WC2R 2LS
England
United Kingdom

Phone +44 207 848 6391
Email keith.brennan@kcl.ac.uk
Website http://www.kcl.ac.uk/index.aspx
ROR logo "ROR" https://ror.org/0220mzb33
Guy's and St. Thomas' NHS Foundation Trust
Hospital/treatment centre

R&D Department
16th Floor, Tower Wing
Great Maze Pond
London
SE1 9RT
England
United Kingdom

Phone +44 207 188 5736
Email Jennifer.Boston@gstt.nhs.uk

Funders

Funder type

Charity

The Urology Foundation

No information available

Results and Publications

Intention to publish date01/05/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal by up to one year after the end of the trial.
IPD sharing planThe 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.