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Clinical Trial
. 2024 May 10;18(1):210.
doi: 10.1007/s11701-024-01871-4.

Effectiveness and safety of SR-ENS-600endoscopic surgical system in benign and malignant gynecological diseases: a prospective, multicenter, clinical trial with 63 cases

Ren Chang  1 , Duan Ping  2 , Shen Yang  3 , Wang Yongjun  4 , Zhang Wei  5 , Zheng Ying  6 , Li Xingming  7 , Zhang Kexin  1 , Sun Dawei  8
Affiliations
Clinical Trial

Effectiveness and safety of SR-ENS-600endoscopic surgical system in benign and malignant gynecological diseases: a prospective, multicenter, clinical trial with 63 cases

Ren Chang et al. J Robot Surg. .

Abstract

Single-port laparoscopy has gained more attention, but inherent technical challenges hinder its wider use. To overcome the disadvantage of traditional single-port surgery, robotic laparoendoscopic single-site surgery system was designed and clinically utilized. This multi-center single-arm trial was aimed to present the clinical outcomes of the SHURUI robotic endoscopic single-site surgery system. 63 women with ovary cysts, myoma, cervical epithelial neoplasm, or endometrial carcinoma were recruited at 6 academic medical centers in different districts of China. The trial was registered on September 5, 2023, with the register number: ChiCTR2300075431, retrospectively registered. Patients underwent robotic LESS surgery with the SHURUI endoscopic surgical system from January 17 to May 26, 2023. Demographic information, perioperative parameters, complications, scar healing, and operator satisfaction scores were recorded. Patients were followed up for 30 ± 4 days. Average operative time and estimated blood loss were 157.03 ± 75.24 min and 63.86 ± 98.33 ml, respectively, for all surgeries. Average anal exhaust time and hospitalization stay were 30.99 ± 14.25 h and 3.63 ± 1.59 days, respectively. Patients' postoperative rehabilitation assessment showed satisfactory results on the day of discharge and 30 ± 4 days after surgery. The surgery achieved good cosmetic benefits and was surgeon friendly. There were no conversions to alternative surgical modalities, complications, or readmissions. The SHURUI endoscopic surgical system showed both the technical feasibility and safety of this surgical modality for gynecologic patients. Further randomized studies comparing this modality with traditional LESS surgery are suggested.

Keywords: Minimally invasive surgery; Single-incision surgery; Single-port laparoscopic surgery; Single-port robotic laparoscopic surgery.

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Conflict of interest statement

The trial received fund from single-port laparoendoscopic surgical system industry-university-research cooperation project sponsored by Beijing Surgerii Robotics Co., Ltd.

Figures

Fig. 1
Fig. 1
Surgical procedure of the operation A Making a transumbilical incision through the Hasson approach, B placement of the surgical port, C insertion of the four-channel trocar, D docking, E dissection of the ovary cyst, F closure of the umbilical incision.
Fig. 2
Fig. 2
Participant flow chart aEight patients underwent total hysterectomy + bilateral adnexectomy + pelvic sentinel lymphadenectomy, and 1 patient received total hysterectomy + bilateral adnexectomy + pelvic lymphadenectomy.
Fig. 3
Fig. 3
Demographic information of the patients compared with the literature4,5 SRC stands for single-port robotic cystectomy/adnexectomy, SRM stands for single-port robotic myomectomy, SRH stands for single-port robotic hysterectomy, All stands for all surgery. S represents the results of the present study, and L represents the results from the literature.
Fig. 4
Fig. 4
Perioperative indicators of the patients compared to the literature4,5 SRC stands for single-port robotic cystectomy/adnexectomy, SRM stands for single-port robotic myomectomy, SRH stands for single-port robotic hysterectomy, All stands for all surgery. S represents the results of the present study, and L represents the results from the literature.
Fig. 5
Fig. 5
Dual continuum mechanism
See this image and copyright information in PMC

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