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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2017-12-31

Brief Summary

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

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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.

Conditions

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Prostatic Neoplasms Cancer of Prostate Prostate Cancer Prostate Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1: without simulator

without simulator

Group Type ACTIVE_COMPARATOR

Laparoscopic Radical Prostatectomy (without a simulator)

Intervention Type PROCEDURE

without simulator

2: with simulator

with simulator

Group Type EXPERIMENTAL

Laparoscopic Radical Prostatectomy (with a simulator)

Intervention Type PROCEDURE

Learning with a simulator

Interventions

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Laparoscopic Radical Prostatectomy (without a simulator)

without simulator

Intervention Type PROCEDURE

Laparoscopic Radical Prostatectomy (with a simulator)

Learning with a simulator

Intervention Type PROCEDURE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No