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.
Study Type
OBSERVATIONAL
Enrollment
625
Ichinomiyanishi Hospital
Ichinomiya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan
Kyoto City Hospital
Kyoto, Kyoto, Japan
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.
Time frame: Within 6 and 12 months after surgery
Urinary continence rate
Achievement of urinary continence after robot assisted radical prostatectomy.
Time frame: Within 6 and 12 months after surgery
Total operative time
Total operative time measured in minutes.
Time frame: During surgery
Console time
Console time measured in minutes.
Time frame: During surgery
Estimated blood loss
Estimated blood loss measured in milliliters.
Time frame: During surgery
Intraoperative transfusion rate
Proportion of patients requiring blood transfusion during surgery.
Time frame: During surgery
Nerve sparing rate
Proportion of patients undergoing nerve sparing procedures.
Time frame: During surgery
Drain placement rate
Proportion of patients requiring surgical drain placement.
Time frame: During surgery
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Mie University Hospital
Tsu, Mie-ken, Japan
Ageo Central General Hospital
Ageo, Saitama, Japan
National Cancer Center Hospital
Tokyo, Tokyo, Japan
Tokyo Medical Center
Tokyo, Tokyo, Japan
Intraoperative complication rate
vascular injury / organ injury / nerve injury / others
Time frame: During surgery
Conversion rate
Conversion to open surgery
Time frame: During surgery
Positive surgical margin rate
Proportion of patients with positive surgical margins
Time frame: Immediately after surgery
Length of hospital stay
Number of days from the date of surgery (Day 0) to hospital discharge.
Time frame: 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.
Time frame: 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
Time frame: At 1, 3, 6 and 12 months after surgery
Biochemical recurrence rate
Defined as PSA ≥ 0.2 ng/mL
Time frame: Within 6 and 12 months after surgery
Readmission rate
Time frame: 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.
Time frame: 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
Time frame: At 6 months and 12 months after surgery