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In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA < 0.2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-Assisted Radical Prostatectomy | Experimental | Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System |
|
| Laparoscopic Radical Prostatectomy | Active Comparator | Standard laparoscopic Radical Prostatectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-Assisted Radical Prostatectomy | Procedure |
| ||
| Laparoscopic Radical Prostatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile function | Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations. | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical margins | During surgery | |
| Prostate Specific Antigen (PSA) | Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Urologie - Clinique St Augustin | Bordeaux | 33074 | France | |||
| Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Procedure |
|
| Continence |
Continence is assessed by the International Prostate Symptom Score (IPSS) |
| Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery |
| Tolerance | Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery | Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery |
| Quality of life | Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores | Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery |
| Incremental cost-effectiveness ratio | Economic evaluation will be made to estimate direct costs of the five postoperative years along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment | 60 months afet surgery |
| Lyon |
| 69437 |
| France |
| Service d'Urologie - Institut Mutualiste Montsouris | Paris | 75014 | France |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |