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

Not Applicable

Suspended

• Conditions: Prostate Cancer; Prostate Neoplasms; Prostatic Neoplasms; Cancer of Prostate
• Interventions: Procedure: Laparoscopic Radical Prostatectomy (with a simulator); Procedure: Laparoscopic Radical Prostatectomy (without a simulator)

• Registration Number: NCT00999960
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Study Start: 2010-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-14
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2: with simulator	Laparoscopic Radical Prostatectomy (with a simulator)	with simulator
1: without simulator	Laparoscopic Radical Prostatectomy (without a simulator)	without simulator

Primary Outcome Measures

Name	Time	Method
Operative time to perform the complete procedure	during the procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

HOPITAL SAINT-LOUIS Service d'urologie; 🇫🇷 Paris, France