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

BPH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628025
• Other study ID #: 2022-10107
• Status: Completed
• Start date: November 23, 2021
• Est. completion date: November 24, 2021

Study information

• Verified date: November 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 24, 2021
• Est. primary completion date: November 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participate in LEP MasterClass

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• BPH

Intervention

Other:
• Organ phantom of prostate
Participants will operate on a 3D printed model of the prostate.

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'Université de Montréal	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Verify the reproducibility of each 3D printed model.	Assessed with validated questionnaire using a Likert scale.	Up to one year post-workshop
Secondary	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
Secondary	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
Secondary	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