Simulation-Based Enucleation Training: Initial Experience Using 3D-printed Organ Phantoms

NCT05628025 | Completed

• 1 other identifier: 2022-10107
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

There are many possible surgical treatments when a patient presents with lower urinary tract symptoms due to an enlarged prostate, termed benign prostatic hyperplasia or BPH. One technique consists of using a laser to remove prostatic tissue through the penis, called laser enucleation of the prostate or LEP. LEP also has excellent properties to reduce blood loss and results in shorter hospital stays. Trainees must observe and perform several procedures before mastering the LEP technique. Different models have been used to mimic the LEP experience for surgeon trainees, such as virtual simulators or synthetic models. While these simulators offer an alternative to LEP procedures on real patients, they may lack realism which renders the simulator less representative than the real procedure.The 3D-printed prostate model of the present study mimics the properties of real-life prostatic tissue. In the setting of the MasterClass, trainees will perform LEP on the 3D models under the supervision of three experts. While the 3D organ phantom has been used to practice performing other procedures, this is the first time it will evaluated for LEP training. For this reason, the investigators will be assessing this model as a training tool.

Conditions

BPH

Keywords

Simulator; Training; Laser Enucleation

Outcome Measures

Primary Outcomes (1)

• Content and face validity of the organ phantom model in LEP training.

  Assessed with validated questionnaire using a Likert scale.

  Up to one year post-workshop

Secondary Outcomes (4)

• Verify the reproducibility of each 3D printed model.

  Up to one year post-workshop

• Determine the surgical performance outcomes of trainees based on level of expertise, and compared with LEP experts (construct validity).

  Up to one year post-workshop

• Assess the perceived difficulty of each step of LEP by trainees.

  Up to one year post-workshop

• Gauge the feasibility and acceptability of integrating simulators in LEP training.

  Up to one year post-workshop

Study Arms (2)

Trainees

Residents in urology or urologists with little LEP experience. Trainee group will be stratified by level of experience.

Other: Organ phantom of prostate

Experts

Urologists with at least 5 years LEP experience.

Other: Organ phantom of prostate

Interventions

Organ phantom of prostate OTHER

Participants will operate on a 3D printed model of the prostate.

Experts; Trainees

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Urologists in training seeking to improve skills in LEP and experts in LEP.

You may qualify if:

• Participate in LEP MasterClass

You may not qualify if:

• None.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: November 28, 2022
• Study Start: November 23, 2021
• Primary Completion: November 24, 2021
• Study Completion: November 24, 2021
• Last Updated: November 28, 2022

Record last verified: 2022-11

Locations

CA (1)