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

Assistance Publique - Hôpitaux de Paris29 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Enrollment

Conditions

Prostatic Neoplasms Cancer of Prostate Prostate Cancer Prostate Neoplasms

Interventions

Laparoscopic Radical Prostatectomy (without a simulator)PROCEDURE

without simulator

Laparoscopic Radical Prostatectomy (with a simulator)PROCEDURE

Learning with a simulator

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

HOPITAL SAINT-LOUIS Service d'urologie

Paris, France

Outcomes

Primary Outcomes

Operative time to perform the complete procedure

Time frame: during the procedure

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

Data from ClinicalTrials.gov

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