Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator (PERLE)
Primary Purpose
Prostatic Neoplasms, Cancer of Prostate, Prostate Cancer
Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparoscopic Radical Prostatectomy (without a simulator)
Laparoscopic Radical Prostatectomy (with a simulator)
Sponsored by
About this trial
This is an interventional other trial for Prostatic Neoplasms focused on measuring Laparoscopy, Prostate, Cancer, Learning, Simulation, Simulator
Eligibility 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
Sites / Locations
- HOPITAL SAINT-LOUIS Service d'urologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1: without simulator
2: with simulator
Arm Description
without simulator
with simulator
Outcomes
Primary Outcome Measures
Operative time to perform the complete procedure
Secondary Outcome Measures
Operative time to complete each step of the procedure
Intraoperative bleeding
Transfusion rate
Complication rate
Conversion rate
Quantity of liquid obtained in drains
Duration of urethral stenting
Reintervention rate
Duration of hospital stay
Positive surgical margin
PSA value
Continence rate
Full Information
NCT ID
NCT00999960
First Posted
October 21, 2009
Last Updated
April 13, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00999960
Brief Title
Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator
Acronym
PERLE
Official Title
A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Suspended
Why Stopped
Decision of sponsor
Study Start Date
February 2010 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Cancer of Prostate, Prostate Cancer, Prostate Neoplasms
Keywords
Laparoscopy, Prostate, Cancer, Learning, Simulation, Simulator
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1: without simulator
Arm Type
Active Comparator
Arm Description
without simulator
Arm Title
2: with simulator
Arm Type
Experimental
Arm Description
with simulator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Radical Prostatectomy (without a simulator)
Intervention Description
without simulator
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Radical Prostatectomy (with a simulator)
Intervention Description
Learning with a simulator
Primary Outcome Measure Information:
Title
Operative time to perform the complete procedure
Time Frame
during the procedure
Secondary Outcome Measure Information:
Title
Operative time to complete each step of the procedure
Time Frame
each step of the procedure
Title
Intraoperative bleeding
Time Frame
during the procedure
Title
Transfusion rate
Time Frame
Hospital stay
Title
Complication rate
Time Frame
during the procedure
Title
Conversion rate
Time Frame
during the procedure
Title
Quantity of liquid obtained in drains
Time Frame
during the hospitalization
Title
Duration of urethral stenting
Time Frame
during the hospitalization
Title
Reintervention rate
Time Frame
during the patient participation
Title
Duration of hospital stay
Time Frame
during the patient participation
Title
Positive surgical margin
Time Frame
during the procedure
Title
PSA value
Time Frame
at 3,6 and 12 months after the procedure
Title
Continence rate
Time Frame
at 3, 6 and 12 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DESGRANDCHAMPS François, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOPITAL SAINT-LOUIS Service d'urologie
City
Paris
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator
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