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The Impact of Force Feedback in the dV5 Robotic Surgical System on Learning Curve and Safety in Robot-Assisted Radical Prostatectomy - A Prospective, Single-Center, Investigator-Initiated Clinical Trial
Sponsor: Seong Soo Jeon
Summary
This single-center, investigator-initiated prospective clinical study aims to evaluate the impact of the Force Feedback function of the da Vinci 5 (dV5) robotic surgical system on surgical skill acquisition and intraoperative safety during robot-assisted radical prostatectomy (RARP). Although robotic surgery is well established in urology, the absence of tactile sensation remains a major limitation of previous systems. The new dV5 platform incorporates real-time haptic (force) feedback, potentially reducing excessive tissue traction and improving surgical precision. A total of 60 patients with clinically localized prostate cancer will be enrolled at Samsung Medical Center. Two surgeons (one faculty and one trainee) will each perform 30 RARP cases, with Force Feedback ON/OFF randomly assigned for each case. The primary endpoints are (1) mean traction force and (2) total instrument path length during seminal vesicle dissection. Secondary endpoints include surgical performance metrics (time, clutch counts), intraoperative safety, postoperative complications, and patient-reported outcomes (IPSS, IIEF-5, EPIC-CP, ICIQ-UI SF). Data will be analyzed using mixed-effects models accounting for surgeon-level random effects. This study seeks to provide quantitative evidence on how Force Feedback enhances surgical learning efficiency, precision, and patient safety in next-generation robotic prostate surgery.
Key Details
Gender
MALE
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-01-01
Completion Date
2027-12-31
Last Updated
2026-02-25
Healthy Volunteers
No
Conditions
Interventions
Force-feedback on
In this study, the "Force-Feedback ON" intervention refers to performing robotic-assisted radical prostatectomy using the da Vinci 5 (dV5) system with its haptic feedback function activated. When this mode is ON, miniature force sensors built into the robotic instruments continuously detect the mechanical resistance encountered at the instrument tips and transmit it back to the surgeon's hand controllers in real time. This tactile feedback allows the operator to feel the intensity and direction of traction or pressure applied to tissues, enabling finer motion control, reduced tissue stress, and safer dissection. In contrast, when Force Feedback is OFF, the surgeon relies solely on visual cues, as in all previous-generation robotic systems. Thus, "Force-Feedback ON" represents an active tactile-sensing mode designed to enhance precision, promote gentler handling, and improve training efficiency during robotic surgery.
Forece-feedback off
Off force-feedback function
Locations (1)
Samsung Medical Center
Soeul, South Korea