Clinical trial on 15 cases of gynecological surgeries using the Cornerstone laparoscopic robotic surgical system

Abstract

Objective

To evaluate the efficacy and safety of a Chinese robotic surgical system in complex gynecological surgeries.

Methods

Fifteen patients with cervical cancer and endometrial cancer who received treatment with a laparoscopic robotic surgical system at the First Medical Center of the PLA General Hospital between June and August 2024 were selected as study subjects. The surgical instrument used was the Cornerstone laparoscopic robotic surgical system (Model: C1000 system) from Shenzhen Cornerstone Technology Co., Ltd. (China). The primary surgical procedures included radical hysterectomy with pelvic lymphadenectomy, with or without para-aortic lymphadenectomy.

Results

A total of 15 patients were included, with a mean age of 50.80 ​± ​9.21 years and a mean BMI of 24.80 ​± ​2.23 ​kg/m². Diagnoses included eight cases of cervical squamous cell carcinoma, three cases of cervical adenocarcinoma, and four cases of endometrioid carcinoma; three patients received neoadjuvant chemotherapy. Intraoperative blood loss averaged 116.67 ​± ​102.93 ​mL, and the mean operative time was 153.47 ​± ​24.57 ​min. All surgeries were successfully completed without conversion to open surgery or the need for blood transfusion. The mean postoperative pain score was 3.53 ​± ​1.81, and the average length of hospital stay was 10.73 ​± ​4.53 days. All cases had negative surgical margins, achieving a 100% rate of negative resection margins. Complications occurred in two cases (13.3%), both involving ureteral injury. The evaluation of system functionality and performance scored 91.93 ​± ​3.06, operator satisfaction scored 92.93 ​± ​3.10, assistant satisfaction scored 93.40 ​± ​3.07, and the overall evaluation scored 92.74 ​± ​2.27. All cases received excellent satisfaction ratings.

Conclusion

This single-arm cohort study on robot-assisted surgery demonstrated the precision and stability of the Chinese robotic surgical system in performing complex gynecological procedures. However, further improvements are needed in the overall stability of the system's control and in reducing acquisition and maintenance costs to enable more patients to benefit from this technology.