A Prospective, Randomized, Non-inferiority Clinical Protocol Comparing Single-port versus Multiport Extraperitoneal Robotic Radical Prostatectomy with the KangDuo Robotic System
Year: 2026
Type: preprint
Study design: Study Protocol
Abstract: Structured Abstract Background Robot-assisted radical prostatectomy is the standard minimally invasive treatment for localized prostate cancer. Conventional multiport robotic surgery is widely applied yet associated with more abdominal trauma and postoperative discomfort. Single-port robotic surgery can further minimize surgical injury. The domestic KangDuo robotic system has been gradually used in urological oncology, but high-level prospective evidence comparing single-port and multiport extraperitoneal radical prostatectomy remains scarce. This trial aims to compare the efficacy and safety of these two surgical approaches. Methods This is a single-center, prospective, 1:1 randomized, non-inferiority trial. Eligible patients diagnosed with cT1c–cT2cN0M0 localized prostate cancer will be randomized to receive either single-port (experimental group) or multiport (control group) extraperitoneal robotic radical prostatectomy using the KangDuo system. All participants will receive standardized enhanced recovery after surgery (ERAS) protocols. The primary endpoint is postoperative positive surgical margin rate. Perioperative parameters, postoperative recovery, medium-term functional recovery and oncological outcomes will be assessed comprehensively. Expected results We hypothesize that the single-port approach is non-inferior to the multiport approach in terms of oncological radical effect. The single-port technique is expected to provide better minimally invasive benefits, with comparable perioperative safety, urinary/sexual function recovery and mid-term oncological outcomes between groups. Conclusions This randomized trial will provide high-quality clinical evidence for the application of domestic single-port robotic surgery. The findings will facilitate individualized surgical selection for patients with localized prostate cancer.
Source: medRxiv
Institutions: Wenzhou Medical University, Lishui Central Hospital
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7222999046