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

Prostate Cancer Clinical Trial

— PERLE  

Official title:

A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00999960
• Other study ID #: AOR 07074-NI07008
• Status: Suspended
• Phase: N/A
• First received: October 21, 2009
• Last updated: April 13, 2017
• Start date: February 2010
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Prostate
• Neoplasms
• Prostate Cancer
• Prostate Neoplasms
• Prostatic Neoplasms

Intervention

Procedure:
• Laparoscopic Radical Prostatectomy (without a simulator)
without simulator
• Laparoscopic Radical Prostatectomy (with a simulator)
Learning with a simulator

Locations

Country	Name	City	State
France	HOPITAL SAINT-LOUIS Service d'urologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time to perform the complete procedure		during the procedure
Secondary	Operative time to complete each step of the procedure		each step of the procedure
Secondary	Intraoperative bleeding		during the procedure
Secondary	Transfusion rate		Hospital stay
Secondary	Complication rate		during the procedure
Secondary	Conversion rate		during the procedure
Secondary	Quantity of liquid obtained in drains		during the hospitalization
Secondary	Duration of urethral stenting		during the hospitalization
Secondary	Reintervention rate		during the patient participation
Secondary	Duration of hospital stay		during the patient participation
Secondary	Positive surgical margin		during the procedure
Secondary	PSA value		at 3,6 and 12 months after the procedure
Secondary	Continence rate		at 3, 6 and 12 months after surgery