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To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy with "Sandwich" Technique of Total Urethral Reconstruction on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) and Laparoscopic Radical Prostatectomy for the treatment of clinically localized prostate cancer (PCa).Purpose: The trial compares outcomes between three groups.
300 consecutive patients with clinically localized PCa underwent RS-RARP-S (Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction) or S-RARP (Standard RARP) or LRP by 6 experienced surgeons regardless of clinicopathological features. The indication for one technique or the others were surgeon preference; one surgeon exclusively performed RS-RARP-S( did not exclude high risk cases or those with apical and anterior tumors), two surgeons performed S-RARP, and three surgeons exclusively performed LRP. The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.
The primary outcome is early recovery of urinary continence compared to the conventional approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RS-RARP-S | Experimental | Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction |
|
| S-RARP | Experimental | Standard RARP |
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| LRP | Sham Comparator | Laparoscopic Radical Prostatectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction | Procedure | Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction |
| Measure | Description | Time Frame |
|---|---|---|
| immediate urinary continence analysis | Primary outcome was UC (defined as 0 pads/one security liner per day) after catheter removal | 1day,1month, 3 months after removal of the urinary cathete |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Standard Robot-Assisted Radical Prostatectomy | Procedure | Standard Robot-Assisted Radical Prostatectomy |
|
| Laparoscopic Radical Prostatectomy | Procedure | Laparoscopic Radical Prostatectomy |
|