Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator (PERLE)
This study is currently recruiting participants.
Verified June 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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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
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 June 18, 2013