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

Assistance Publique - Hôpitaux de Paris

Status: Suspended

Conditions: Prostate Neoplasms; Cancer of Prostate; Prostatic Neoplasms; Prostate Cancer

Treatments: Procedure: Laparoscopic Radical Prostatectomy (without a simulator); Procedure: Laparoscopic Radical Prostatectomy (with a simulator)

Study type: Interventional

Funder types: Other

Identifiers

NCT00999960

AOR 07074-NI07008

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1: without simulator

Active Comparator group

Description:

without simulator

Treatment:

Procedure: Laparoscopic Radical Prostatectomy (without a simulator)

2: with simulator

Experimental group

Description:

with simulator

Treatment:

Procedure: Laparoscopic Radical Prostatectomy (with a simulator)