Prostate Cancer
Conditions
Keywords
Robot assisted radical prostatectomy, RARP, Single port, da Vinci SP, Extraperitoneal approach, Transperitoneal approach, Propensity score matching
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Intuitive Surgical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
1. Patients with localized prostate cancer (clinical stage T1-T3a, N0, M0) eligible for radical prostatectomy 2. Patients who underwent RARP via SP-EA or MP-TA on or after January 1, 2023 3. Patients with available postoperative follow-up data for ≥6 months (≥166 days) \*note 1)
Exclusion criteria
1. Patients who have expressed an intention to refuse the use of their data for this study 2. Patients who underwent RARP using surgical approaches other than those specified in the inclusion criteria (e.g., transvesical approach) 3. Patients who underwent RARP with pelvic lymph node dissection (PLND) 4. Patients with a history of radiotherapy for prostate cancer 5. Any other patients whom the principal investigator or a co-investigator deem inappropriate, such as those with missing outcome data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative complications and Clavien-Dindo Grade 3a or higher postoperative complications | Within 6 and 12 months after surgery | Postoperative complications occurring after robot assisted radical prostatectomy, including complications classified as Clavien-Dindo Grade 3a or higher. |
| Urinary continence rate | Within 6 and 12 months after surgery | Achievement of urinary continence after robot assisted radical prostatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total operative time | During surgery | Total operative time measured in minutes. |
| Console time | During surgery | Console time measured in minutes. |
| Estimated blood loss | During surgery | Estimated blood loss measured in milliliters. |
| Intraoperative transfusion rate | During surgery | Proportion of patients requiring blood transfusion during surgery. |
| Nerve sparing rate | During surgery | Proportion of patients undergoing nerve sparing procedures. |
| Drain placement rate | During surgery | Proportion of patients requiring surgical drain placement. |
| Intraoperative complication rate | During surgery | vascular injury / organ injury / nerve injury / others |
| Conversion rate | During surgery | Conversion to open surgery |
| Positive surgical margin rate | Immediately after surgery | Proportion of patients with positive surgical margins |
| Length of hospital stay | From the date of surgery until the date of hospital discharge, assessed up to 30 days after surgery | Number of days from the date of surgery (Day 0) to hospital discharge. |
| Foley catheter duration | From the date of surgery until the date of Foley catheter removal, assessed up to 30 days after surgery | Number of days from the date of surgery (Day 0) to Foley catheter removal. |
| Postoperative serum PSA level | At 1, 3, 6 and 12 months after surgery | Postoperative serum prostate-specific antigen (PSA) level measured as an actual value in ng/mL |
| Biochemical recurrence rate | Within 6 and 12 months after surgery | Defined as PSA ≥ 0.2 ng/mL |
| Readmission rate | Within 6 and 12 months after surgery | — |
| Numeric Rating Scale (NRS) pain score | At hospital discharge, an average of 7 days | Numeric Rating Scale (NRS) ranging from 0 to 10, with higher scores indicating worse pain. |
| Sexual function score | At 6 months and 12 months after surgery | Sexual Health Inventory for Men (SHIM), ranging from 1 to 25, with higher scores indicating better erectile function |
Countries
Japan
Contacts
PRINCIPAL_INVESTIGATORMasashi Takenaka
Fujita Health University
Outcome results
None listed