Simulation in urological training and education: Transfer of skills from the simulation laboratory to the operating room

• Register: ISRCTN
• Last refreshed on: 29 November 2021
• Main ID: ISRCTN12260261
• Date of registration: 21/10/2016
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: Simulation in urological training and education: Transfer of skills from the simulation laboratory to the operating room
• 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
• Date of first enrolment: 24/10/2016
• Target sample size: 47
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN12260261
• Study type: Interventional
• Study design: Multi-centre prospective interventional randomised controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

Austria, Canada, China, England, Germany, Greece, Japan, Switzerland, Turkey, United Kingdom, United States of America

Contacts

• Name: Abdullatif Aydin

• Name: Kamran Ahmed

Key inclusion & exclusion criteria

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)

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Simulation-based surgical training
Surgery
Simulation-based surgical training

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

BDM/14/15-68

Source(s) of Monetary Support

The Urology Foundation

Secondary Sponsor(s)

Guy's and St. Thomas' NHS Foundation Trust

Results

• Results available: Yes
• Date Completed: 30/10/2019