Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy (RoboProstate)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Procedure: Robot-assisted radical prostatectomy; Procedure: Radical prostatectomy via laparotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01577836

AOI/2011/SD-03

2011-A01385-36 (Other Identifier)

Details and patient eligibility

About

The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy.

The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).

Full description

The secondary objectives of this research are to compare the following between the two groups:

• The actual cost of the surgical prostatectomy.
• Erectile function at 0, 1, 6, 12 and 24
• Oncological results at 1, 6, 12 and 24 months.
• Functional results at 0, 1, 6, 12 and 24 months.
• Quality of life at 0, 1, 6, 12 and 24 months.
• Complication rates at 1 and 24 months.

Enrollment: 90 patients

Sex: Male

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have given his informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 24 months of follow up
• Patient has localised prostate cancer
• Patient is eligible for radical prostatectomy

Exclusion criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• Patient has a contraindication for a treatment necessary for this study
• Patients with psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Robotic assistance, Nîmes

Experimental group

Description:

The patients in this group will undergo robot-assisted radical prostatectomy at the University Hospital of Nîmes.

Treatment:

Procedure: Robot-assisted radical prostatectomy

Laparotomy, Marseilles

Active Comparator group

Description:

The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.

Treatment:

Procedure: Radical prostatectomy via laparotomy