Evaluating the Effect of Force Feedback Technology in the da Vinci 5 Robotic System on Safety and Skill Development During Robotic Prostate Surgery

What this Trial Is About

Researchers are evaluating the Force Feedback function of the da Vinci 5 dV5 robotic surgical system to understand its impact on surgical skill learning and safety during robot-assisted radical prostatectomy RARP in patients with localized prostate cancer. This prospective single-center clinical trial involves 60 male patients and aims to provide objective evidence on how tactile feedback may improve surgical precision and reduce tissue injury compared to previous systems lacking this feature. The study randomly assigns the Force Feedback function to be ON or OFF during each surgery, with two surgeons one expert and one trainee each performing 30 RARP cases. The Force Feedback ON mode provides real-time tactile sensations through robotic instruments, allowing surgeons to feel tissue resistance and potentially improve control. The OFF mode relies solely on visual cues. The seminal vesicle dissection step is specifically assessed for traction force and instrument movement. Participants will undergo detailed intraoperative monitoring, including measurement of traction force, instrument path length, and surgical performance metrics like operative time and clutch counts. Safety is closely monitored through recording complications, blood loss, and patient-reported outcomes related to urinary and sexual function. All surgeries are video-recorded and analyzed to assess precision and learning curves, with follow-up continuing up to the studys completion in 2027.

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