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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01385-36 | Other Identifier | ANSM |
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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).
The secondary objectives of this research are to compare the following between the two groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic assistance, Nîmes | Experimental | The patients in this group will undergo robot-assisted radical prostatectomy at the University Hospital of Nîmes. |
|
| Laparotomy, Marseilles | Active Comparator | The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted radical prostatectomy | Procedure | Transperitoneal robot-assisted radical prostatectomy technique with the Da Vinci S |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall cost (€) of patient care | 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. | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost (€) of surgery via micro-costing | All human and material resources necessary for carrying out a prostatectomy will be evaluated. | Day 1 |
| Change in erectile function | the International Index of Erectile Function (IIEF-15) will be used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane Droupy, MD PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHM - Hôpital de la Conception | Marseille | 13385 | France | |||
| Clinique Beau Soleil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40616606 | Result | 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. |
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| Radical prostatectomy via laparotomy | Procedure | Classic radical prostatectomy via open retropubic approach |
|
| baseline to 1 month |
| Change in erectile function | the International Index of Erectile Function (IIEF-15) will be used. | baseline to 6 months |
| Change in erectile function | the International Index of Erectile Function (IIEF-15) will be used. | baseline to 12 months |
| Change in erectile function | the International Index of Erectile Function (IIEF-15) will be used. | baseline to 24 months |
| 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) | 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.) | 1 month |
| Presence/absence of complications (Clavien) | 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.) | 24 months |
| Presence/absence of complications (Pentafecta) | The Pentafecta classification will be used. | 1 month |
| Presence/absence of complications (Pentafecta) | The Pentafecta classification will be used. | 24 months |
| Montpellier |
| 34070 |
| France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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