Prostatic NeoplasmsPERLENCT00999960
Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator
A study testing Laparoscopic Radical Prostatectomy (without a simulator) and Laparoscopic Radical Prostatectomy (with a simulator) in people with Prostatic Neoplasms and Cancer of Prostate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
To evaluate the clinical impact of an online video simulator during the learning period of laparoscopic radical prostatectomy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prostatic Neoplasms, Cancer of Prostate, Prostate Cancer
- What is being tested?
- Laparoscopic Radical Prostatectomy (without a simulator) and Laparoscopic Radical Prostatectomy (with a simulator)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Dec 2017
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Surgeon beginning his clinical experience in laparoscopic radical prostatectomy and having performed less then 30 procedures before being enrolled in the study
- Surgeon who intends to begin laparoscopic radical prostatectomy clinical practice
- Surgeons who usually perform enough cases to enroll at least 10 patients during the study inclusion time
Who cannot join
- Surgeon who does not have access to high speed internet (>1024 Ko/s)
- Surgeons who do not intend to begin laparoscopic radical prostatectomy in his clinical practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator
To evaluate the clinical impact of an online video simulator during the learning period of laparoscopic radical prostatectomy.
Read the detailed description
Objectives: To compare two different approaches in learning laparoscopic radical prostatectomy , with or without using an online video simulator Design : Prospective randomized multicentric study
Methods: 20 surgeons considered as naive concerning their experience in laparoscopic radical prostatectomy will be randomized into two groups :1 group will use the online video simulator, 1 group will use usual learning methods except the online video simulator.
All procedures will be recorded from the beginning till the end.A video review will be preformed concerning all the videos in order to identify the total operative time and time to perform each one of the operative steps of the procedure.Clinical , biological and histological data will be collected in order to compare the two arms.
- Being tested
- Laparoscopic Radical Prostatectomy (without a simulator), Laparoscopic Radical Prostatectomy (with a simulator)
- Keywords
- Laparoscopy, Prostate, Cancer, Learning, Simulation, Simulator
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Radical Prostatectomy (without a simulator)Procedure or surgery
without simulator
Laparoscopic Radical Prostatectomy (with a simulator)Procedure or surgery
Learning with a simulator
| Study group | Role | What they receive |
|---|---|---|
| 1: without simulator | Active comparator | without simulator Receives: Procedure: Laparoscopic Radical Prostatectomy (without a simulator) |
| 2: with simulator | Experimental | with simulator Receives: Procedure: Laparoscopic Radical Prostatectomy (with a simulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time to perform the complete procedure
Measured: during the procedure
Secondary outcomes (12)
Operative time to complete each step of the procedure
Measured: each step of the procedure
Intraoperative bleeding
Measured: during the procedure
Transfusion rate
Measured: Hospital stay
Complication rate
Measured: during the procedure
Conversion rate
Measured: during the procedure
Quantity of liquid obtained in drains
Measured: during the hospitalization
Duration of urethral stenting
Measured: during the hospitalization
Reintervention rate
Measured: during the patient participation
Duration of hospital stay
Measured: during the patient participation
Positive surgical margin
Measured: during the procedure
PSA value
Measured: at 3,6 and 12 months after the procedure
Continence rate
Measured: at 3, 6 and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startFeb 2010
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DESGRANDCHAMPS François, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999960
- Sponsor's protocol ID
- AOR 07074-NI07008
- Acronym
- PERLE
- Status last verified
- Feb 2026
- First submitted
- 21 Oct 2009
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator
- ClinicalTrials.gov ID
- NCT00999960
- Acronym / sponsor ID
- PERLE / AOR 07074-NI07008
- Keywords
- Laparoscopy, Prostate, Cancer, Learning, Simulation, Simulator
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 22 Oct 2009 (estimated)
- 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.
To evaluate the clinical impact of an online video simulator during the learning period of laparoscopic radical prostatectomy.
Detailed description
Objectives: To compare two different approaches in learning laparoscopic radical prostatectomy , with or without using an online video simulator Design : Prospective randomized multicentric study
Methods: 20 surgeons considered as naive concerning their experience in laparoscopic radical prostatectomy will be randomized into two groups :1 group will use the online video simulator, 1 group will use usual learning methods except the online video simulator.
All procedures will be recorded from the beginning till the end.A video review will be preformed concerning all the videos in order to identify the total operative time and time to perform each one of the operative steps of the procedure.Clinical , biological and histological data will be collected in order to compare the two arms.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: without simulator | Active comparator | Procedure: Laparoscopic Radical Prostatectomy (without a simulator)without simulator |
| 2: with simulator | Experimental | Procedure: Laparoscopic Radical Prostatectomy (with a simulator)with simulator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Surgeon beginning his clinical experience in laparoscopic radical prostatectomy and having performed less then 30 procedures before being enrolled in the study
- Surgeon who intends to begin laparoscopic radical prostatectomy clinical practice
- Surgeons who usually perform enough cases to enroll at least 10 patients during the study inclusion time
Key exclusion criteria (2 listed)
- Surgeon who does not have access to high speed internet (>1024 Ko/s)
- Surgeons who do not intend to begin laparoscopic radical prostatectomy in his clinical practice
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 |
|---|---|---|
| Laparoscopic Radical Prostatectomy (without a simulator)without simulator | Procedure or surgery | 1: without simulator |
| Laparoscopic Radical Prostatectomy (with a simulator)Learning with a simulator | Procedure or surgery | 2: with simulator |
Primary outcome
Operative time to perform the complete procedure
Time frame: during the procedure
12 secondary outcomes
Operative time to complete each step of the procedure
Time frame: each step of the procedure
Intraoperative bleeding
Time frame: during the procedure
Transfusion rate
Time frame: Hospital stay
Complication rate
Time frame: during the procedure
Conversion rate
Time frame: during the procedure
Quantity of liquid obtained in drains
Time frame: during the hospitalization
Duration of urethral stenting
Time frame: during the hospitalization
Reintervention rate
Time frame: during the patient participation
Duration of hospital stay
Time frame: during the patient participation
Positive surgical margin
Time frame: during the procedure
PSA value
Time frame: at 3,6 and 12 months after the procedure
Continence rate
Time frame: at 3, 6 and 12 months after surgery
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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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.
DESGRANDCHAMPS François, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Radical Prostatectomy (without a simulator) and Laparoscopic Radical Prostatectomy (with a simulator) in people with Prostatic Neoplasms and Cancer of Prostate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Feb 2026. 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 France. 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 was stopped early (reason given: lack of inclusion). Results are not available in the source record.
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?
Operative time to perform the complete procedure (time frame: during the procedure). 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 25 Feb 2026.