Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy
NCT ID: NCT01577836
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2012-11-26
2021-03-22
Brief Summary
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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).
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robotic assistance, Nîmes
The patients in this group will undergo robot-assisted radical prostatectomy at the University Hospital of Nîmes.
Robot-assisted radical prostatectomy
Transperitoneal robot-assisted radical prostatectomy technique with the Da Vinci S
Laparotomy, Marseilles
The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.
Radical prostatectomy via laparotomy
Classic radical prostatectomy via open retropubic approach
Interventions
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Robot-assisted radical prostatectomy
Transperitoneal robot-assisted radical prostatectomy technique with the Da Vinci S
Radical prostatectomy via laparotomy
Classic radical prostatectomy via open retropubic approach
Eligibility Criteria
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Inclusion Criteria
* 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 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
45 Years
75 Years
MALE
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Stéphane Droupy, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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APHM - Hôpital de la Conception
Marseille, , France
Clinique Beau Soleil
Montpellier, , France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, , France
Countries
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References
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Bouvet S, Chkair S, Daures JP, Kabani S; OptiPRobot Study Group; Chevallier T, Lechevallier E, Droupy S. Robot-assisted approach versus open surgery and conventional laparoscopy for radical prostatectomy for prostate cancer: a micro-costing study. Health Econ Rev. 2025 Jul 5;15(1):55. doi: 10.1186/s13561-025-00652-5.
Other Identifiers
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2011-A01385-36
Identifier Type: OTHER
Identifier Source: secondary_id
AOI/2011/SD-03
Identifier Type: -
Identifier Source: org_study_id
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