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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Suspended

CT.gov ID

NCT00999960

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prostatic Neoplasms Cancer of Prostate Prostate Cancer Prostate Neoplasms	Procedure: Laparoscopic Radical Prostatectomy (without a simulator) Procedure: Laparoscopic Radical Prostatectomy (with a simulator)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1: without simulator without simulator	Procedure: Laparoscopic Radical Prostatectomy (without a simulator) without simulator
Experimental: 2: with simulator with simulator	Procedure: Laparoscopic Radical Prostatectomy (with a simulator) Learning with a simulator

Arm

Intervention/Treatment

Active Comparator: 1: without simulator

without simulator

Procedure: Laparoscopic Radical Prostatectomy (without a simulator)

without simulator

Experimental: 2: with simulator

with simulator

Procedure: Laparoscopic Radical Prostatectomy (with a simulator)

Learning with a simulator

Outcome Measures

Primary Outcome Measures

Operative time to perform the complete procedure [during the procedure]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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