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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Traction Force (Newton, N)
研究概览
简要总结
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.
详细描述
This prospective, single-institution, investigator-initiated clinical trial investigates how the Force Feedback (haptic sensing) technology in the da Vinci 5 (dV5) robotic surgery platform influences technical skill acquisition and safety in robot-assisted radical prostatectomy (RARP). The study is conducted at Samsung Medical Center (Seoul, Korea) under the supervision of Professor Seong Soo Jeon and Dr. Jiwoong Yu from the Department of Urology.
Robotic-assisted surgery has revolutionized minimally invasive prostate cancer treatment, but conventional robotic systems (e.g., da Vinci Xi) lack tactile feedback, forcing surgeons to rely solely on visual cues. This limitation may lead to excessive force application and increase the risk of tissue injury. The dV5 system introduces a Force Feedback mechanism that allows surgeons to feel real-time resistance transmitted through the robotic arms. Preclinical reports suggest this reduces applied forces by up to 40-50% and improves precision, especially during the learning phase. However, objective clinical data quantifying these benefits are limited.
The present trial will enroll 60 patients diagnosed with clinically localized prostate cancer (cT1-T3a, N0, M0) eligible for RARP. Two surgeons-a senior faculty (expert) and a urology resident (trainee)-will each perform 30 RARP cases. For each surgery, the Force Feedback function will be randomly assigned (ON vs. OFF) while maintaining identical operative conditions. The seminal vesicle dissection step is chosen as the standardized assessment phase since it is technically demanding yet safe for educational evaluation.
Primary endpoints are:
Mean traction force applied to tissue (N)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged ≥19 years.
- •Histologically confirmed localized prostate cancer, clinical stage T1-T3a, N0, M
- •Scheduled to undergo robot-assisted radical prostatectomy (RARP) at Samsung Medical Center.
- •No radiologic evidence of distant metastasis, and disease deemed surgically resectable via robotic approach.
- •Medically fit for general anesthesia and laparoscopic surgery, classified as ASA physical status I-III.
- •Baseline erectile function preserved, defined as IIEF-5 ≥12 within 6 months prior to surgery.
- •Provided written informed consent for participation after full explanation of the study.
排除标准
- •Locally advanced or metastatic prostate cancer (clinical stage ≥T3b, N1, or M1**).
- •Prostate volume ≥60 cc on preoperative MRI, which may complicate robotic dissection standardization.
- •History of pelvic radiotherapy for any malignancy.
- •Previous androgen deprivation therapy (ADT) or other hormonal therapy for prostate cancer.
- •History of prior prostate surgery, such as TURP or HoLEP.
- •History of spinal cord injury or major pelvic surgery that may alter pelvic anatomy.
- •Medical contraindications to robotic/laparoscopic surgery or general anesthesia (e.g., severe cardiopulmonary disease, ASA ≥ IV).
- •Anatomic limitations (e.g., extreme obesity or deformity) precluding safe robotic access.
- •Device or software malfunction preventing proper activation or deactivation of the Force Feedback system.
- •Any other condition deemed inappropriate for study participation by the principal investigator (e.g., cognitive impairment affecting consent or follow-up).
研究组 & 干预措施
Force-feedback off
干预措施: Forece-feedback off (Device)
Force-feedback on
干预措施: Force-feedback on (Device)
结局指标
主要结局
Mean Traction Force (Newton, N)
时间窗: intraoperatively
Total Instrument Path Length (meters, m)
时间窗: intraoperatively
次要结局
未报告次要终点
研究者
Seong Soo Jeon
Professor
Samsung Medical Center