BPHNCT05628025
Simulation-Based Enucleation Training: Initial Experience Using 3D-printed Organ Phantoms
An observational study of BPH, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- BPH
- What is being tested?
- Organ phantom of prostate
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2021to 24 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Urologists in training seeking to improve skills in LEP and experts in LEP.
Who may be able to join
- Participate in LEP MasterClass
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- BPH
- Being tested
- Organ phantom of prostate
- Keywords
- Simulator, Training, Laser Enucleation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organ phantom of prostateOther
Participants will operate on a 3D printed model of the prostate.
| Study group | Role | What they receive |
|---|---|---|
| Trainees | Residents in urology or urologists with little LEP experience. Trainee group will be stratified by level of experience. Receives: Other: Organ phantom of prostate | |
| Experts | Urologists with at least 5 years LEP experience. Receives: Other: Organ phantom of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content and face validity of the organ phantom model in LEP training.
Assessed with validated questionnaire using a Likert scale.
Measured: Up to one year post-workshop
Secondary outcomes (4)
Verify the reproducibility of each 3D printed model.
Assessed with validated questionnaire using a Likert scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to one year post-workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start23 Nov 2021
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628025
- Sponsor's protocol ID
- 2022-10107
- Status last verified
- Nov 2022
- First submitted
- 13 Sep 2021
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-Based Enucleation Training: Initial Experience Using 3D-printed Organ Phantoms
- ClinicalTrials.gov ID
- NCT05628025
- Acronym / sponsor ID
- 2022-10107
- Conditions
- BPH
- Keywords
- Simulator, Training, Laser Enucleation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trainees | – | Other: Organ phantom of prostateResidents in urology or urologists with little LEP experience. Trainee group will be stratified by level of experience. |
| Experts | – | Other: Organ phantom of prostateUrologists with at least 5 years LEP experience. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Urologists in training seeking to improve skills in LEP and experts in LEP.
Key inclusion criteria (1 listed)
- Participate in LEP MasterClass
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organ phantom of prostateParticipants will operate on a 3D printed model of the prostate. | Other | Experts, Trainees |
Primary outcome
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.
4 secondary outcomes
Verify the reproducibility of each 3D printed model.
Time frame: 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).
Time frame: Up to one year post-workshop
Assess the perceived difficulty of each step of LEP by trainees.
Time frame: Up to one year post-workshop
Gauge the feasibility and acceptability of integrating simulators in LEP training.
Time frame: Up to one year post-workshop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for BPH
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Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
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Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
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Anterior Bridge-Preserving Versus Conventional Early Apical Release During Holmium Laser Enucleation of the Prostate
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Perioperative Parameter and Treatment Outcomes of Surgical Treatment for Benign Prostate Hyperplasia in Hong Kong
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BPH, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content and face validity of the organ phantom model in LEP training. (time frame: Up to one year post-workshop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.