RoboProstate: Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The secondary objectives of this research are to compare the following between the two groups:
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The actual cost of the surgical prostatectomy.
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Erectile function at 0, 1, 6, 12 and 24
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Oncological results at 1, 6, 12 and 24 months.
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Functional results at 0, 1, 6, 12 and 24 months.
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Quality of life at 0, 1, 6, 12 and 24 months.
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Complication rates at 1 and 24 months.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Robotic assistance, Nîmes The patients in this group will undergo robot-assisted radial prostatectomy at the University Hospital of Nîmes. |
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Laparotomy, Marseilles The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles. |
Outcome Measures
Primary Outcome Measures
- Overall cost (€) of patient care [60 months]
Cost of surgical treatment of localized prostate cancer by radical prostatectomy (robot-assisted or conventional retropubic laparotomy) and its follow-up for 5 years. All medical resources consumed will be evaluated during the first 5 years after surgery.
Secondary Outcome Measures
- Cost (€) of surgery via micro-costing [Day 1]
All human and material resources necessary for carrying out a prostatectomy will be evaluated.
- Change in erectile function [baseline to 1 month]
the International Index of Erectile Function (IIEF-15) will be used.
- Change in erectile function [baseline to 6 months]
the International Index of Erectile Function (IIEF-15) will be used.
- Change in erectile function [baseline to 12 months]
the International Index of Erectile Function (IIEF-15) will be used.
- Change in erectile function [baseline to 24 months]
the International Index of Erectile Function (IIEF-15) will be used.
- the % of positive margins after resection [baseline (Day 1)]
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [1 month]
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [6 months]
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [12 months]
- presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [24 months]
- Change in function as estimated by the PR25 questionnaire [baseline to 1 month]
- Change in function as estimated by the PR25 questionnaire [baseline to 6 months]
- Change in function as estimated by the PR25 questionnaire [baseline to 12 months]
- Change in function as estimated by the PR25 questionnaire [baseline to 24 months]
- Change in quality of life as estimated by the QLQC-30 questionnaire [baseline to 1 month]
- Change in quality of life as estimated by the QLQC-30 questionnaire [baseline to 6 months]
- Change in quality of life as estimated by the QLQC-30 questionnaire [baseline to 12 months]
- Change in quality of life as estimated by the QLQC-30 questionnaire [baseline to 24 months]
- Presence/absence of complications (Clavien) [1 month]
The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.)
- Presence/absence of complications (Clavien) [24 months]
The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.)
- Presence/absence of complications (Pentafecta) [1 month]
The Pentafecta classification will be used.
- Presence/absence of complications (Pentafecta) [24 months]
The Pentafecta classification will be used.
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient must have given his informed and signed consent
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The patient must be insured or beneficiary of a health insurance plan
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The patient is available for 24 months of follow up
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Patient has localised prostate cancer
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Patient is eligible for radical prostatectomy
Exclusion Criteria:
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The patient is participating in another study
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The patient is in an exclusion period determined by a previous study
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The patient is under judicial protection, under tutorship or curatorship
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The patient refuses to sign the consent
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It is impossible to correctly inform the patient
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Patient has a contraindication for a treatment necessary for this study
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Patients with psychiatric disorders
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | APHM - Hôpital de la Conception | Marseille Cedex 5 | France | 13385 | |
2 | Clinique Beau Soleil | Montpellier | France | 34070 | |
3 | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 09 | France | 30029 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Stéphane Droupy, MD PhD, Centre Hospitalier Universitaire de Nîmes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AOI/2011/SD-03
- 2011-A01385-36