ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00999960
Recruitment Status : Suspended (Decision of sponsor)
First Posted : October 22, 2009
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : February 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Operative time to perform the complete procedure [ Time Frame: during the procedure ]

Secondary Outcome Measures :
  1. Operative time to complete each step of the procedure [ Time Frame: each step of the procedure ]
  2. Intraoperative bleeding [ Time Frame: during the procedure ]
  3. Transfusion rate [ Time Frame: Hospital stay ]
  4. Complication rate [ Time Frame: during the procedure ]
  5. Conversion rate [ Time Frame: during the procedure ]
  6. Quantity of liquid obtained in drains [ Time Frame: during the hospitalization ]
  7. Duration of urethral stenting [ Time Frame: during the hospitalization ]
  8. Reintervention rate [ Time Frame: during the patient participation ]
  9. Duration of hospital stay [ Time Frame: during the patient participation ]
  10. Positive surgical margin [ Time Frame: during the procedure ]
  11. PSA value [ Time Frame: at 3,6 and 12 months after the procedure ]
  12. Continence rate [ Time Frame: at 3, 6 and 12 months after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999960


Locations
France
HOPITAL SAINT-LOUIS Service d'urologie
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: DESGRANDCHAMPS François, MD,PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00999960     History of Changes
Other Study ID Numbers: AOR 07074-NI07008
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Laparoscopy
Prostate
Cancer
Learning
Simulation
Simulator

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases