Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT00999960
Status:
SUSPENDED
Last Update Posted:
2017-04-14
First Post:
2009-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator
Status:
SUSPENDED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision of sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERLE
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: