Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator

Study Overview
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Brief Summary
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To evaluate the clinical impact of an online video simulator during the learning period of laparoscopic radical prostatectomy.

Detailed Description
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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.

Official Title
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A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator

Conditions
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Prostatic Neoplasms, Cancer of Prostate, Prostate Cancer, Prostate Neoplasms

Intervention / Treatment
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* Procedure: Laparoscopic Radical Prostatectomy (without a simulator)
* Procedure: Laparoscopic Radical Prostatectomy (with a simulator)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: without simulator<br>without simulator | Procedure: Laparoscopic Radical Prostatectomy (without a simulator)<br>* without simulator<br>|
| Experimental: 2: with simulator<br>with simulator | Procedure: Laparoscopic Radical Prostatectomy (with a simulator)<br>* Learning with a simulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time to perform the complete procedure |  | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time to complete each step of the procedure |  | each step of the procedure | 
| Intraoperative bleeding |  | during the procedure | 
| Transfusion rate |  | Hospital stay | 
| Complication rate |  | during the procedure | 
| Conversion rate |  | during the procedure | 
| Quantity of liquid obtained in drains |  | during the hospitalization | 
| Duration of urethral stenting |  | during the hospitalization | 
| Reintervention rate |  | during the patient participation | 
| Duration of hospital stay |  | during the patient participation | 
| Positive surgical margin |  | during the procedure | 
| PSA value |  | at 3,6 and 12 months after the procedure | 
| Continence rate |  | at 3, 6 and 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Prostate, Cancer, Learning, Simulation, Simulator