Kwon Wooil, Jang Jin-Young, Jeong Chang Wook, Anselme Sylvain, Pradella Fabio, Woods Jacklyn
Department of General Surgery, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Urology, Seoul National University Hospital, Seoul, Republic of Korea.
Surg Endosc. 2025 Jan;39(1):171-179. doi: 10.1007/s00464-024-11334-4. Epub 2024 Oct 28.
The Hugo™ Robotic-Assisted Surgery (RAS) System is an emergent device in the robotic surgery field. This study aims to describe the first general surgery-focused clinical study in Korea using the novel Hugo™ RAS System.
This study was a prospective, single-center, single-arm, confirmatory clinical study conducted at Seoul National University Hospital where 20 cholecystectomies were performed. To evaluate the safety and performance of the Hugo™ RAS System the incidence of conversion to laparoscopy or open surgery, major complication (Clavien-Dindo Grade ≥ III) rate, overall complication rate, readmission rate, and reoperation rate were evaluated. All parameters were assessed within 30 days post-procedure. Any device deficiencies encountered during our initial experience and device data such as setup, console, and operative times were also reported.
We confirmed that our trial achieved the primary objective with a success rate of at least 95%. This was accomplished with no conversions to other types of surgery due to serious system malfunction and with only one major complication within 24 h post-procedure. The 20 consecutively enrolled patients had a median age and BMI of 58 years old and 23.9 kg/m, respectively. The major complication rate was 10% (2/20 patients), the overall complication rate was 15% (3/20 patients), the readmission rate was 15% (3/20 patients), and the reoperation rate was 0% (0/20 patients). None of the complications were definitively device related. The median setup, console, and operative times were 16, 17, and 55 min, respectively. The device deficiency rate was 15% (3/20 patients), but all device deficiencies were minor, occurred before the first incision, and did not present a risk to the patient.
Based on our initial experience with the Hugo™ RAS System, cholecystectomy is feasible and safe. This trial is registered with ClinicalTrials.gov (NCT05715827).
雨果™机器人辅助手术（RAS）系统是机器人手术领域的一种新兴设备。本研究旨在描述韩国首例以普通外科为重点、使用新型雨果™RAS系统的临床研究。
本研究是一项在首尔国立大学医院进行的前瞻性、单中心、单臂验证性临床研究，共进行了20例胆囊切除术。为评估雨果™RAS系统的安全性和性能，评估了转为腹腔镜手术或开放手术的发生率、主要并发症（Clavien-Dindo分级≥III级）发生率、总体并发症发生率、再入院率和再次手术率。所有参数均在术后30天内进行评估。还报告了我们初次使用该设备时遇到的任何设备缺陷以及诸如设置、控制台和手术时间等设备数据。
我们确认我们的试验达到了主要目标，成功率至少为95%。这一目标的实现是因为没有因严重系统故障而转为其他类型的手术，且术后24小时内仅有一例主要并发症。连续入组的20例患者的中位年龄和BMI分别为58岁和23.9kg/m²。主要并发症发生率为10%（2/20例患者），总体并发症发生率为15%（3/20例患者），再入院率为15%（3/20例患者），再次手术率为0%（0/20例患者）。所有并发症均与设备无明确关联。设置、控制台和手术时间的中位数分别为16分钟、17分钟和55分钟。设备缺陷率为15%（3/20例患者），但所有设备缺陷均较轻微，发生在首次切口之前，且未对患者构成风险。
基于我们对雨果™RAS系统的初步经验，胆囊切除术是可行且安全的。本试验已在ClinicalTrials.gov注册（NCT05715827）。
