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OpenTrials
Completed

NCT Number: NCT05628025

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.

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Key information

Conditions

BPH

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier de l'Université de Montréal

Montreal, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participate in LEP MasterClass

Exclusion criteria

  • None.

Treatment and study plan

Organ phantom of prostate

Other

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

Primary outcomes

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

    Time frame: Up to one year post-workshop

    Assessed with validated questionnaire using a Likert scale.

Secondary outcomes

  1. Verify the reproducibility of each 3D printed model.

    Time frame: Up to one year post-workshop

    Assessed with validated questionnaire using a Likert scale.

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

    Time frame: Up to one year post-workshop

    Percentage of prostatic tissue resected.

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

    Time frame: Up to one year post-workshop

    Assessed with validated questionnaire using a Likert scale.

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

    Time frame: Up to one year post-workshop

    Assessed with validated questionnaire using a Likert scale.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2022
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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