Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)
NCT06238713 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480
Last updated 2024-08-05
Summary
This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.
Conditions
- Prostate Adenocarcinoma
- Localized Prostate Carcinoma
Interventions
- PROCEDURE
-
Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques
Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
- PROCEDURE
-
Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques
Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
collaborator OTHER -
ShuGuang Hospital
collaborator OTHER -
The Third Affiliated Hospital of Naval Medical University
collaborator UNKNOWN -
The First Affiliated Hospital of Guangzhou Medical University
collaborator OTHER -
Sir Run Run Shaw Hospital
collaborator OTHER -
Sichuan Provincial People's Hospital
collaborator OTHER -
Shanghai Changzheng Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-08
- Primary Completion
- 2025-06-30
- Completion
- 2025-12-31
Countries
- China
Study Locations
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