Clinical trial NCT00999960: Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator
Official title: A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Prostatic Neoplasms
Cancer of Prostate
Prostate Cancer
Prostate Neoplasms
Keywords: Laparoscopy
Prostate
Cancer
Learning
Simulation
Simulator
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-10-22
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Operative time to perform the complete procedure
timeFrame: during the procedure
Secondary outcomes:
measure: Operative time to complete each step of the procedure
timeFrame: each step of the procedure
measure: Intraoperative bleeding
timeFrame: during the procedure
measure: Transfusion rate
timeFrame: Hospital stay
measure: Complication rate
timeFrame: during the procedure
measure: Conversion rate
timeFrame: during the procedure
measure: Quantity of liquid obtained in drains
timeFrame: during the hospitalization
measure: Duration of urethral stenting
timeFrame: during the hospitalization
measure: Reintervention rate
timeFrame: during the patient participation
measure: Duration of hospital stay
timeFrame: during the patient participation
measure: Positive surgical margin
timeFrame: during the procedure
measure: PSA value
timeFrame: at 3,6 and 12 months after the procedure
measure: Continence rate
timeFrame: at 3, 6 and 12 months after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: HOPITAL SAINT-LOUIS Service d'urologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: DESGRANDCHAMPS François, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: