NCT00999960

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

7.8 years

First QC Date

October 21, 2009

Last Update Submit

February 23, 2026

Conditions

Prostate NeoplasmsProstatic NeoplasmsCancer of ProstateProstate Cancer

Keywords

LaparoscopyProstateCancerLearningSimulationSimulator

Outcome Measures

Primary Outcomes (1)

  • Operative time to perform the complete procedure

    during the procedure

Secondary Outcomes (12)

  • Operative time to complete each step of the procedure

    each step of the procedure

  • Intraoperative bleeding

    during the procedure

  • Transfusion rate

    Hospital stay

  • Complication rate

    during the procedure

  • Conversion rate

    during the procedure

  • +7 more secondary outcomes

Study Arms (2)

1: without simulator

ACTIVE COMPARATOR

without simulator

Procedure: Laparoscopic Radical Prostatectomy (without a simulator)

2: with simulator

EXPERIMENTAL

with simulator

Procedure: Laparoscopic Radical Prostatectomy (with a simulator)

Interventions

Laparoscopic Radical Prostatectomy (without a simulator)PROCEDURE

without simulator

1: without simulator
Laparoscopic Radical Prostatectomy (with a simulator)PROCEDURE

Learning with a simulator

2: with simulator

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOPITAL SAINT-LOUIS Service d'urologie

Paris, 75010, France

Location

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • DESGRANDCHAMPS François, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 22, 2009

Study Start

February 1, 2010

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

FR(1)