Comparison of Perioperative and Postoperative Outcomes of Single-port (SP) Extraperitoneal Approach and Multi-port (MP) Transperitoneal Approach in Robot-assisted Radical Prostatectomy：A Propensity Score-matched Retrospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Intuitive Surgical
- Enrollment
- 625
- Locations
- 8
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with localized prostate cancer (clinical stage T1-T3a, N0, M0) eligible for radical prostatectomy
- •Patients who underwent RARP via SP-EA or MP-TA on or after January 1, 2023
- •Patients with available postoperative follow-up data for ≥6 months (≥166 days) *note 1)
Exclusion Criteria
- •Patients who have expressed an intention to refuse the use of their data for this study
- •Patients who underwent RARP using surgical approaches other than those specified in the inclusion criteria (e.g., transvesical approach)
- •Patients who underwent RARP with pelvic lymph node dissection (PLND)
- •Patients with a history of radiotherapy for prostate cancer
- •Any other patients whom the principal investigator or a co-investigator deem inappropriate, such as those with missing outcome data.
Arms & Interventions
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.