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

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.

Study Overview

• Status: Completed
• Conditions: BPH
• Intervention / Treatment: Other: Organ phantom of prostate

Detailed Description

Numerous surgical treatment options exist for benign prostatic hyperplasia (BPH). Laser enucleation of the prostate (LEP) was introduced in the therapeutic arsenal about twenty years ago, and has become a popular treatment due to its excellent hemostatic properties. Moreover, LEP is associated with less blood loss and shorter hospital stays. One disadvantage however may be the longer learning curve for trainees compared to transurethral resection of the prostate (TURP), which is the current gold standard for treatment.

It is estimated that a surgeon can safely and efficiently perform holmium LEP after about 50 cases. Simulator-based training has been widely proposed as a training tool for surgeons to learn LEP. Integrating simulators in surgical training allows surgeons to develop skills in LEP without negative consequences on real patients. Simulators range from virtual reality to synthetic bench models, and all face the same challenge of creating a realistic experience that accurately mimics real-life LEP, and helps surgeons develop skills they can transfer to the operating room.

The prostate organ phantom in the present study is composed of hydrogels and uses 3D molds to recreate prostatic tissue and anatomy. This model has successfully been used to practice TURP procedures, however has not yet been validated for LEP training. This observational, prospective and comparative study aims to validate the 3D prostate organ for LEP training. In the setting of a MasterClass, trainees will perform LEP on two 3D models under the supervision of three experts in LEP. The content and face validity of the organ phantoms will be evaluated by the MasterClass participants through a questionnaire. Performance outcomes of trainees will also be collected by visually examining the models and weighing the models pre- and post-operatively. By validating this simulator for LEP training, the investigators hope to elucidate the role of simulators, and specifically the role of a 3D organ phantom, in future training programs.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Canada
  • Montréal, Canada
    • Centre hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Participate in LEP MasterClass

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trainees; Residents in urology or urologists with little LEP experience. Trainee group will be stratified by level of experience.	Other: Organ phantom of prostate; Participants will operate on a 3D printed model of the prostate.
Experts; Urologists with at least 5 years LEP experience.	Other: Organ phantom of prostate; Participants will operate on a 3D printed model of the prostate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verify the reproducibility of each 3D printed model.	Assessed with validated questionnaire using a Likert scale.	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).	Percentage of prostatic tissue resected.	Up to one year post-workshop
Assess the perceived difficulty of each step of LEP by trainees.	Assessed with validated questionnaire using a Likert scale.	Up to one year post-workshop
Gauge the feasibility and acceptability of integrating simulators in LEP training.	Assessed with validated questionnaire using a Likert scale.	Up to one year post-workshop

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): November 24, 2021
• Study Completion (Actual): November 24, 2021

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Training; Simulator; Laser Enucleation
• Other Study ID Numbers: 2022-10107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No