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| ID | Type | Description | Link |
|---|---|---|---|
| 1165953 | Other Identifier | IntuitiveSurgical |
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This multicenter retrospective observational study aims to compare perioperative and postoperative outcomes between the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in robot-assisted radical prostatectomy for localized prostate cancer.
This is a multicenter, retrospective, propensity score-matched observational cohort study conducted in Japan.
The study aims to compare perioperative and postoperative outcomes of robot-assisted radical prostatectomy (RARP) performed using the da Vinci SP extraperitoneal approach (SP-EA) and the robotic multi-port transperitoneal approach (MP-TA) in patients with localized prostate cancer.
Clinical data will be retrospectively and continuously collected from participating institutions and analyzed to evaluate the utility and potential clinical benefits of the SP-EA approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-EA group | Patients who underwent robot assisted radical prostatectomy using the da Vinci SP extraperitoneal approach. | ||
| MP-TA group | Patients who underwent robot assisted radical prostatectomy using the robotic multi port transperitoneal approach. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative complications and Clavien-Dindo Grade 3a or higher postoperative complications | Postoperative complications occurring after robot assisted radical prostatectomy, including complications classified as Clavien-Dindo Grade 3a or higher. | Within 6 and 12 months after surgery |
| Urinary continence rate | Achievement of urinary continence after robot assisted radical prostatectomy. | Within 6 and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total operative time | Total operative time measured in minutes. | During surgery |
| Console time | Console time measured in minutes. | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with localized prostate cancer who underwent robot assisted radical prostatectomy using either the da Vinci SP extraperitoneal approach or the robotic multi port transperitoneal approach at participating institutions in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Masashi Takenaka | Fujita Health University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ichinomiyanishi Hospital | Ichinomiya | Aichi-ken | 494-0001 | Japan | ||
| Fujita Health University Hospital |
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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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| Estimated blood loss | Estimated blood loss measured in milliliters. | During surgery |
| Intraoperative transfusion rate | Proportion of patients requiring blood transfusion during surgery. | During surgery |
| Nerve sparing rate | Proportion of patients undergoing nerve sparing procedures. | During surgery |
| Drain placement rate | Proportion of patients requiring surgical drain placement. | During surgery |
| Intraoperative complication rate | vascular injury / organ injury / nerve injury / others | During surgery |
| Conversion rate | Conversion to open surgery | During surgery |
| Positive surgical margin rate | Proportion of patients with positive surgical margins | Immediately after surgery |
| Length of hospital stay | Number of days from the date of surgery (Day 0) to hospital discharge. | From the date of surgery until the date of hospital discharge, assessed up to 30 days after surgery |
| Foley catheter duration | Number of days from the date of surgery (Day 0) to Foley catheter removal. | From the date of surgery until the date of Foley catheter removal, assessed up to 30 days after surgery |
| Postoperative serum PSA level | Postoperative serum prostate-specific antigen (PSA) level measured as an actual value in ng/mL | At 1, 3, 6 and 12 months after surgery |
| Biochemical recurrence rate | Defined as PSA ≥ 0.2 ng/mL | Within 6 and 12 months after surgery |
| Readmission rate | Within 6 and 12 months after surgery |
| Numeric Rating Scale (NRS) pain score | Numeric Rating Scale (NRS) ranging from 0 to 10, with higher scores indicating worse pain. | At hospital discharge, an average of 7 days |
| Sexual function score | Sexual Health Inventory for Men (SHIM), ranging from 1 to 25, with higher scores indicating better erectile function | At 6 months and 12 months after surgery |
| Toyoake |
| Aichi-ken |
| 470-1192 |
| Japan |
| Saiseikai Yokohamashi Tobu Hospital | Yokohama | Kanagawa | 230-0012 | Japan |
| Kyoto City Hospital | Kyoto | Kyoto | 604-8845 | Japan |
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan |
| Ageo Central General Hospital | Ageo | Saitama | 362-8588 | Japan |
| National Cancer Center Hospital | Tokyo | Tokyo | 104-0045 | Japan |
| Tokyo Medical Center | Tokyo | Tokyo | 152-8902 | Japan |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |