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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT00999960
Date of registration:	21/10/2009
Prospective Registration:	Yes
Primary sponsor:	Assistance Publique - Hôpitaux de Paris
Public title:	Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Simulator PERLE
Scientific title:	A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator
Date of first enrolment:	February 2010
Target sample size:	20
Recruitment status:	Suspended
URL:	https://clinicaltrials.gov/show/NCT00999960
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
France

Contacts

Name:	DESGRANDCHAMPS François, MD,PhD
Address:
Telephone:
Email:
Affiliation:	Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Prostate Cancer

Prostatic Neoplasms

Cancer of Prostate

Prostate Neoplasms

Intervention(s)

Procedure: Laparoscopic Radical Prostatectomy (with a simulator)

Procedure: Laparoscopic Radical Prostatectomy (without a simulator)

Primary Outcome(s)

Operative time to perform the complete procedure [Time Frame: during the procedure]

Secondary Outcome(s)

Complication rate [Time Frame: during the procedure]

Duration of hospital stay [Time Frame: during the patient participation]

PSA value [Time Frame: at 3,6 and 12 months after the procedure]

Quantity of liquid obtained in drains [Time Frame: during the hospitalization]

Transfusion rate [Time Frame: Hospital stay]

Duration of urethral stenting [Time Frame: during the hospitalization]

Operative time to complete each step of the procedure [Time Frame: each step of the procedure]

Positive surgical margin [Time Frame: during the procedure]

Conversion rate [Time Frame: during the procedure]

Intraoperative bleeding [Time Frame: during the procedure]

Continence rate [Time Frame: at 3, 6 and 12 months after surgery]

Reintervention rate [Time Frame: during the patient participation]

Secondary ID(s)

AOR 07074-NI07008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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