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
  Purpose

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


Condition Intervention
Prostatic Neoplasms
Cancer of Prostate
Prostate Cancer
Prostate Neoplasms
Procedure: Laparoscopic Radical Prostatectomy (without a simulator)
Procedure: Laparoscopic Radical Prostatectomy (with a simulator)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Operative time to perform the complete procedure [ Time Frame: during the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: February 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999960

Contacts
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

Locations
France
HOPITAL SAINT-LOUIS Service d'urologie Recruiting
Paris, France, 75010
Contact: François DESGRANDCHAMPS, MD,PhD    +33(1)42-49-93-37    francois.desgrandchamps@sls.aphp.fr   
Contact: Aurel MESSAS, MD    +33(1)47-69-65-94    aurelmessas@gmail.com   
Principal Investigator: François DESGRANDCHAMPS, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: DESGRANDCHAMPS François, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00999960     History of Changes
Other Study ID Numbers: AOR 07074-NI07008
Study First Received: October 21, 2009
Last Updated: June 14, 2012
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 22, 2014