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

April 13, 2017 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • HOPITAL SAINT-LOUIS Service d'urologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Operative time to perform the complete procedure
Time Frame: during the procedure
during the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: DESGRANDCHAMPS François, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (ESTIMATE)

October 22, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2017

Last Update Submitted That Met QC Criteria

April 13, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOR 07074-NI07008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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