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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00999960
First received: October 21, 2009
Last updated: June 14, 2012
Last verified: June 2012

October 21, 2009
June 14, 2012
February 2010
February 2013   (final data collection date for primary outcome measure)
Operative time to perform the complete procedure [ Time Frame: during the procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00999960 on ClinicalTrials.gov Archive Site
  • Operative time to complete each step of the procedure [ Time Frame: each step of the procedure ] [ Designated as safety issue: No ]
  • Intraoperative bleeding [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]
  • Transfusion rate [ Time Frame: Hospital stay ] [ Designated as safety issue: Yes ]
  • Complication rate [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]
  • Conversion rate [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]
  • Quantity of liquid obtained in drains [ Time Frame: during the hospitalization ] [ Designated as safety issue: Yes ]
  • Duration of urethral stenting [ Time Frame: during the hospitalization ] [ Designated as safety issue: Yes ]
  • Reintervention rate [ Time Frame: during the patient participation ] [ Designated as safety issue: Yes ]
  • Duration of hospital stay [ Time Frame: during the patient participation ] [ Designated as safety issue: Yes ]
  • Positive surgical margin [ Time Frame: during the procedure ] [ Designated as safety issue: Yes ]
  • PSA value [ Time Frame: at 3,6 and 12 months after the procedure ] [ Designated as safety issue: Yes ]
  • Continence rate [ Time Frame: at 3, 6 and 12 months after surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator
A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Prostatic Neoplasms
  • Cancer of Prostate
  • Prostate Cancer
  • Prostate Neoplasms
  • Procedure: Laparoscopic Radical Prostatectomy (without a simulator)
    without simulator
  • Procedure: Laparoscopic Radical Prostatectomy (with a simulator)
    Learning with a simulator
  • Active Comparator: 1: without simulator
    without simulator
    Intervention: Procedure: Laparoscopic Radical Prostatectomy (without a simulator)
  • Experimental: 2: with simulator
    with simulator
    Intervention: Procedure: Laparoscopic Radical Prostatectomy (with a simulator)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: DESGRANDCHAMPS François, MD,PhD +33(0) 1 42 49 93 37 francois.desgrandchamps@sls.aphp.fr
Contact: MESSAS Aurel, MD +33(0) 1 47 69 65 94 aurelmessas@gmail.com
France
 
NCT00999960
AOR 07074-NI07008
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: DESGRANDCHAMPS François, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP