Initial Outcomes and Methodologies of a Novel Single-Port Robotic Surgery in Gynecology.

Background and Objectives: The study aims to elucidate the initial results and methodologies employed in utilizing a recently introduced single-port (SP) robotic surgical system for the management for benign and malignant gynecological disorders.

A total of 33 patients with benign or malignant gynecologic conditions between 2022 and 2024 were included, all patients underwent SP robotic surgery.

A total of 33 patients were successfully enrolled. The study participants demonstrated a mean age of 43.9 ± 11.9 years, a mean body mass index of 21.9 ± 3.0 kg/m2, a mean operating time of 105.5 ± 52.4 minutes, and a mean estimated blood loss of 34.6 ± 30.5 mL. There were no cases of conversion to multiport laparoscopy or laparotomy, and only 1 patient developed postoperative fever. The postoperative pain score fell within an acceptable range, and satisfactory scar healing was seen in all cases.

The practicality and safety of the EDGE SP1000 system have been demonstrated in a subset of patients. However, more study and specific surgical skills are required to completely comprehend the benefits and long-term outcomes of robotic surgical systems.

Gynecologic diseases, Minimally invasive surgery, Robotic surgery, Single-port robotic surgical system

With the advancement of technology, laparoscopic minimally invasive surgery has been widely used in the management of benign and malignant gynecological diseases and has gradually become the preferred surgical method.1–3 Constant advancements in techniques have led to better surgical results, lower incidence of complications, and more aesthetically pleasing outcomes.4,5 Single-port (SP) laparoscopic surgery has been developed to reduce both the cosmetic result and the risks related to many incisions.6,7 However, this technique has serval obvious limitations, such as the lack of a surgical operating “triangle,” the need for special instruments, ergonomic challenges, crowding and collisions between instruments, and the need for special training.8 With the rise of robotic surgical platforms, led by the da Vinci robot, further reduced the invasiveness of laparoscopic surgery. The robotic surgical platform’s high-definition imaging technology, precise anatomical manipulation, and highly flexible robotic arm allow surgeons to perform precise surgeries in hard-to-reach or narrow areas, significantly increasing surgical efficiency and streamlining the surgical process.9–11 However, the fourth-generation da Vinci robotic surgical system, which is currently the most widely used globally, is still a multiport operation, with a robotic trocar that is larger in diameter than that of a conventional laparoscope, and often requires 3–4 incisions of 8–12 mm in the abdominal wall, often accompanied by a 12 mm auxiliary incision.12 The FDA authorized the da Vinci SP Surgical System in 2018 for urological surgery. Its purpose was to reduce trauma, promote postoperative recovery, and enhance cosmetic results.13 Three multijointed surgical instruments and a full-wrist 3D high-definition camera reach the surgical site through a 4-port channel via a single 2.5 cm umbilical metal trocar for surgical operations. The system for the first time enables flexible instruments to be single-ported and the surgical incision to be further reduced compared to previous systems.14 In the field of gynecology, the SP robotic surgical system has been applied in uterine myomectomy,15,16 hysterectomy,17,18 ovarian cystectomy,19 and other surgeries. The results of the studies showed that SP robotic surgery was comparable to traditional multiport laparoscopic surgery in terms of operative time, bleeding, hospital stay, and provided good cosmetic results.12,15,17 In addition, SP robotic surgery can achieve satisfactory surgical results in cases of greater surgical difficulty, such as large myomectomy.16 However, the da Vinci SP robotic surgical system has not been approved in China, The data of the da Vinci SP robotic surgery system in China were all in the preclinical trial research stage.20 In 2020, Shenzhen Jingfeng Medical Company successfully developed the SP robotic surgical system EDGE SP1000, which was approved for marketing by the National Medicines and Pharmaceutical Administration (NMPA) in 2023. The system consists of a robotic arm including 3 flexible and bendable surgical instruments and a 3D camera, here we reported the surgical data since we participated in the clinical study of the domestic bendable robotic surgical system EDGE SP1000.

We retrospectively reviewed 33 patients who underwent EDGE SP100 robotic surgery for benign or malignant gynecologic tumors between April 2022 and June 2024 in our hospital. All procedures were performed by a single surgeon with more than 20 years of experience in minimally invasive surgery. The Hospital Ethics Committee approved the study procedure. Every participant gave their informed consent. Inclusion criteria were women aged 18–85 years, with a body mass index (BMI) of 18–30 kg/m2, a diagnosis of benign or malignant gynecological disease, and indicators of minimally invasive surgery. Preoperative cardiopulmonary function and other evaluations revealed no contraindications. Patients with severe cardiopulmonary insufficiency, pregnancy and lactation, neuropsychiatric disorders, and active infection were excluded. We collected baseline data including age, BMI, gestational and delivery times, history of pelvic surgery, diagnosis of disease, and the way for operation. Perioperative outcome variables were recorded including robotic docking time, total operative time (defined as the time from initial umbilical skin incision to final skin closure), estimated blood loss, postoperative hemoglobin changes, number of transitions to robotic multiport surgery or open surgery, postoperative return of bowel activity, postoperative pain assessment, and scar assessment. Finally, intraoperative and postoperative complications were reviewed. Postoperative hospital stay data were also recorded. Postoperative pain was evaluated using a visual analogue scale (VAS) score ranging from 0 to 10, with 0 representing no pain and 10 representing severe pain. The evaluation of postoperative scar was performed using The Patient and Observer Scar Assessment Scale (POSAS) score, which was divided into the subject evaluation part and the doctor evaluation part. Patients and doctors gave comprehensive scores on scar healing from 1 to 10 points 1 month later, with 1 representing very unsatisfied and 10 representing very satisfied. The doctor's score was 1 for normal skin and 10 for the worst condition. The EDGE SP1000 robotic surgical system (Figure 1) has many similarities to the da Vinci SP system, including the endowrist manipulator, physician operating platform, high-definition naked-eye 3D field of view, hand fibrillation filter, flexible arm operating instrument and camera with multiple joints, and a virtual image superimposed on the surgical field of view called a “navigator.” After general anesthesia, a Trendelenburg position of the patient was taken, and the uterine manipulator could be placed to facilitate the operation. The median longitudinal incision of the umbilical incision was about 2.5 cm long, a common SP used in early operations (Figure 2A) or a special port for SP robotic surgery (gel-type port) (Figures 2B and 2C) was inserted into the umbilical incision, and a special metal trocar and a multiport channel were inserted into the gel-type port. After the pneumoperitoneum was established, the operating table was adjusted to the Trendelenburg position of about 30°F, and the surgical platform was placed on the right side of the patient. The metal trocar is connected and secured to the flexible SP robot manipulator arm. The surgeon adjusts the position of the camera and the angle of each operating arm joint to form an operating triangle. A 5 mm trocar was inserted into the left lower abdomen at the reverse McBurney's point to assist in the surgical operation. An accessory trocar can also be built next to an SP or on a gel-type port. The overall procedure for all procedures is the same as for laparoscopic surgery (Figures 2D and 2E), following surgery, the umbilical incision was sutured continuously with subcutaneous tissue and intradermal suture (Figure 2F). For women with large fibroids or a large uterus due to multiple fibroids, and extensive surgery, flexible SP robots can be difficult to install and operate the instruments. To solve this problem, we adopted the following methods when using the EDGE SP1000 robotic surgical system: (1) the abdominal incision was made above the umbilicus to ensure sufficient distance between the incision and the target location; (2) using the special gel-type port, the trocar can be pulled out or inserted during the operation according to the needs, to adjust the distance between the instrument and the surgical target, thereby creating an effective surgical space.

A total of 33 patients were collected in this study. Detailed patient statistics and perioperative results were shown in Table 1 and Table 2. The mean age of the patients was 43.9 ± 11.9 years, and the mean BMI was 21.9 ± 3.0 kg/m2. Six patients had a history of pelvic surgery, including myomectomy, tubal ligation, cesarean section, and cholecystectomy. Patients with comorbidities before surgery (including hypertension, diabetes, anemia, fatty liver and emphysema, etc.,) were controlled by routine medication after specialist consultation, and there were no contraindications to surgery. None of the cases in this study required referral to multiport laparoscopy or laparotomy. In terms of postoperative complications, 1 patient diagnosed with bilateral ovarian cysts developed postoperative fever, and the patient developed postoperative fever (38°C) on the second day after surgery, and the fever subsided after intravenous antibiotics. The types of operations included in this study were also shown in Table 1. Table 1. | Variables | Value (n = 33) | |---|---| | Age, year | 43.9 ± 11.9 | | BMI, kg/m2 | 21.9 ± 3.0 | | Gravidity | 1.9 ± 1.5 | | Parity | 0.9 ± 0.9 | | Previous pelvic surgery | | | Yes | 6 (18.2) | | No | 27 (81.8) | | Disease, % | | | Myoma | 7 | | Adenomyosis | 2 | | Tubal abstruction | 1 | | Ovarian cyst (benign) | 15 | | Hydrosalpinx | 1 | | Atypical hyperplasia of endometrium | 1 | | CIN | 5 | | Cervical cancer in situ | 1 | | Procedures | | | Myomectomy | 5 | | Total hysterectomy + adnexectomy | 12 | | Total hysterectomy + salpingetomy | 2 | | Ovarian cystectomy | 9 | | Adnexectomy | 3 | | Salpingostomy | 1 | | Tubal anastomosis | 1 | Continuous variables are presented as mean ± standard deviation; categorical variables are presented as numbers (percentage). Abbreviations: BMI, body mass index; CIN, cervical intraepithelial neoplasia. Table 2. | Surgical Outcomes | Results (n = 33) | |---|---| | Operative time (minutes) | 105.5 ± 52.4 | | Docking time (minutes) | 15.9 ± 7.3 | | Estimated blood loss (mL) | 34.6 ± 30.5 | | Return of bowel activity (hours) | 19.8 ± 4.0 | | Hemoglobin change (g/dL) | 11.2 ± 7.8 | | Operative complications | | | Postoperative fever | 1 (3.0%) | | Transfusion | 0 (0) | | Conversion to multiport laparoscopy or laparotomy | 0 (0) | | Hospitalization days (days) | 4.9 ± 1.3 | | Pain VAS scale 24 hours after surgery | 2.8 ± 2.0 | | Patient scar assessment at 1 month | 8.5 ± 2.4 | | Doctor scar assessment at 1 month | 1.5 ± 0.5 | Data are presented as mean ± standard deviation or n (%). The perioperative outcomes were shown in Table 2, the average docking time of all operations was 15.9 ± 7.3 min, and the average total operation time was 105.5 ± 52.4 min. The operation time of malignant diseases is longer than that of benign diseases. There were no cases converting to multiport laparoscopy or laparotomy. The estimated intraoperative blood loss was 34.6 ± 30.5 mL, and no intraoperative or postoperative blood transfusion was required in all cases. The mean hospital stay was 4.9 ± 1.3 days. The mean pain VAS score 24 hours after surgery was 2.8 ± 2.0, the mean value of the patient side in the bidirectional assessment of the POSAS score for scar assessment 1 month after surgery was 8.5 ± 2.4, and the mean value of the doctors’ was 1.5 ± 0.5.

Laparoscopic surgery, as a minimally invasive surgical method, has been widely used in the diagnosis and treatment of gynecological diseases. Compared with open surgery, laparoscopic surgery has the advantages of less trauma, faster recovery, fewer complications, and better cosmetic effects.3 However, laparoscopic surgery also has some limitations.21 Robot-assisted laparoscopic surgery has evolved rapidly over the past 2 decades. Da Vinci robotic surgical system is the most successful and widely used robotic endoscopic surgery system in the world. The SP robotic surgery system further combines the aesthetic advantages of SP surgery and the technical advantages of robotic surgery, which can reduce the surgical and aesthetic impact, while maintaining the same surgical complexity, reducing invasive surgery, and improving patient quality of life.22 The da Vinci SP surgical system entered clinical use in 2018. In recent years, reports on da Vinci SP surgical robot systems in benign and malignant diseases of gynecology have gradually increased. Additionally, the development of domestic SP robotic surgery systems is very rapid. EDGE SP1000, a novel robotic surgical system, has completed the first animal and preclinical trials in China, it was successfully marketed in 2023. Tongle et al reported the completion of ovarian teratoma resection using the domestically produced EDGE SP1000 robotic surgical system in 2023, demonstrating for the first time that the domestically produced SP robotic system has a certain degree of safety and operability.23 Currently, there are few reports about the SP robot EDGE SP1000 surgical system, and most of them are preclinical studies or animal testing.12,24 Chen et al reported that 18 patients with benign and malignant gynecological diseases received EDGE SP1000 robotic surgery. The mean docking time, operation time, EBL, and hospital stay were 21.3 ± 3.4 min, 218.7 ± 78.8 min, 25 (range 5–100) mL, and 3 (range 1–5) days, respectively. No complications occurred. The median pain VAS score 24 hours after surgery was 3 (range 1–6), and the scar assessment for patients 1 month after surgery was 9 (range 5–10). These results were mostly similar to ours, which had slightly lower scar assessment scores, yet our operative time was significantly shorter than the average time for their benign disease.12 There is much research on the application of da Vinci SP surgical system in various gynecological surgeries. In 2020, Shin et al10 reported the experience of using the da Vinci SP surgical system just for gynecological benign diseases. They retrospectively studied the data of 31 patients who underwent SP robotic surgery, their research revealed no significant problems or laparoscopic conversion. The length of hospital stay and operating time matched our findings but with more estimated blood loss.17 Misal et al reported in 2021 that 8 SP hysterectomy cases were successfully done with the da Vinci SP surgical system without conversion to another surgical procedure and complications.25 Lee et al reported 48 cases of single-incision robotic sacrocolpopexy, including Da Vinci Si or ξ-assisted single-site laparoscopic surgery in 40 cases and da Vinci SP surgery in 8 cases, concluding that the da Vinci SP system has advantages in shortening the surgical time.26 Kwak et al reported 100 cases of Da Vinci SP single-hole robotic surgery for gynecological diseases in 2022, 21 cases (21%) were malignant tumors, with the other cases being benign diseases. The findings demonstrated that no patients converted to porous robotic surgery or laparotomy.27 Seon et al compared the perioperative results of the ξ system with the da Vinci SP system in endometrial cancer staging surgery, concluding that the da Vinci SP system had lower postoperative hemoglobin changes, shorter postoperative hospital stay and lower pain scores, but required longer operative times compared with the ξ system.28 Studies of SP robotic surgical systems are at an early stage. These were all small sample research, and the results particularly that SP robotic surgery is safe and effective in gynecological benign and malignant diseases, especially in terms of operative time, hospital stay, blood loss, postoperative complications, and pain scores. The EDGE SP1000 robotic surgical system shares many similarities with the da Vinci SP or multiport system. Notably, it combines 3 key technologies to address the bottleneck of SP robotic surgery—the limitation of surgical scope. The first is the use of flexible arm technology, which allows the surgeon to independently control arm movement to alter the surgical region horizontally and increase the surgical range laterally; the second is the concealed sleeve technique, which can improve the longitudinal range of surgery, The support device was semihidden in the cannula, and the operation depth was extended from 12–24 to 7–27 cm; and lastly, the pressure anchor technology, which allows for extreme extension of longitudinal range. By supporting the retraction or advancement of the cannula and always maintaining zero pressure on the patient's incision, this technique extends the operating depth limit to 0 cm-34 cm. In terms of safety, the SP system is considered to be superior to the da Vinci porous robot system because it has no bouncing motion.17 Limitations of our study include the small sample size, the fact that only short-term follow-up data were collected, and the lack of information regarding the long-term safety and cosmetic effects of incisions.

Our research demonstrates that the EDGE SP1000 system can perform benign and malignant gynecological surgery in a practical and efficient manner. The procedure has the advantages of shorter operation time, less bleeding, shorter hospital stay, and fewer complications. This bendable flexible arm SP surgery platform can replace traditional endoscopic surgery and shows good results, paving the way for the future development of fully flexible endoscopy technology. Further research and technological advances will continue to refine and optimize the application of the robotic SP surgical platform in clinical practice. Footnotes Acknowledgments: We thank all the participants. Funding sources: The authors received no specific funding for this work. Disclosure: None. Conflict of interests: No conflict of interest. Ethical approval: The Hospital Ethics approved the study procedure. Consent to participate: Every participant gave their informed consent. Data availability: The data are available upon request. Contributor Information Pijun Gong, Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China (all authors). Hui Mao, Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China (all authors). Tingting He, Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China (all authors). Li Bai, Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China (all authors). Haiyan Wang, Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China (all authors). Jinyan Zhao, Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China (all authors). Zheng Ma, Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China (all authors). Xiang Xue, Department of Obstetrics and Gynecology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, People’s Republic of China (all authors).

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