Condition category
Surgery
Date applied
06/10/2016
Date assigned
21/10/2016
Last edited
03/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 April 2018

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

www.surgical-simulation.com/simulate

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 measures

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

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

28/02/2019

Reason abandoned

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

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

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

30/04/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.