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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)

About this trial

This is an interventional other trial for Prostatic Neoplasms focused on measuring Laparoscopy, Prostate, Cancer, Learning, Simulation, Simulator

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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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