A Prospective, Randomized, Non-inferiority Clinical Protocol Comparing the Efficacy and Safety of Single-port versus Multiport Extraperitoneal Robotic Radical Prostatectomy Using the KangDuo Robotic System
- 1Lishui Municipal Central Hospital: Lishui Central Hospital and Fifth Affiliated Hospital of Wenzhou Medical College
Abstract
Structured AbstractO_ST_ABSBackgroundC_ST_ABSRobot-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.
MethodsThis 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 resultsWe 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.
ConclusionsThis 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.
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BibTeX
@misc{gu2026prospective,
title = {{A Prospective, Randomized, Non-inferiority Clinical Protocol Comparing the Efficacy and Safety of Single-port versus Multiport Extraperitoneal Robotic Radical Prostatectomy Using the KangDuo Robotic System}},
author = {T. Gu},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.15.26365703},
url = {https://www.medrxiv.org/content/10.64898/2026.10.15.26365703v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - A Prospective, Randomized, Non-inferiority Clinical Protocol Comparing the Efficacy and Safety of Single-port versus Multiport Extraperitoneal Robotic Radical Prostatectomy Using the KangDuo Robotic System
AU - T. Gu
PY - 2026
DA - 2026/10/15
PB - medRxiv
DO - 10.64898/2026.10.15.26365703
UR - https://www.medrxiv.org/content/10.64898/2026.10.15.26365703v1
AB - Structured AbstractO_ST_ABSBackgroundC_ST_ABSRobot-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. MethodsThis 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 resultsWe 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. ConclusionsThis 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.
ER -