Abstract
Background
ArtiSential, a new articulating laparoscopic instruments, addresses the limited movement associated with conventional laparoscopic instruments. This study was conducted to assess the clinical effectiveness of ArtiSential in detailed steps of various renal surgery.
Methods
This study was approved by the Institutional Review Board of our institution and registered on the Clinical Research Information Service site of the Korea Disease Control and Prevention Agency. Participants meeting all inclusion and exclusion criteria were included in the clinical trial and underwent renal surgery. The clinical effectiveness of ArtiSential was assessed in terms of the feasibility and objective and subjective parameters across 9 detailed steps.
Results
Of the 15 potential candidates enrolled from October 2021 to November 2021, 1 patient dropped out due to anaphylaxis from an anesthetic agent, and 14 patients underwent laparoscopic surgery using ArtiSential. Of the 14 patients, 2 patients were converted to laparoscopic surgery using straight-shaped instruments due to the ischemia time exceeding 30 min, and 1 patient due to excessive bleeding. The feasibility for most steps was more than 90%, except the renorrhaphy step. The median total operation time and ischemia time were 161 and 23 min, respectively. The median estimated blood loss was 58.5 mL. Two cases of venous injury occurred during renal pedicle dissection step. The accuracy of the procedure judged by reviewers and usability judged by the operator were acceptable in all steps. The surgeon’s quantitatively measured stress score was the highest during renorrhaphy step.
Conclusions
Laparoscopic surgery using ArtiSential is feasible for most steps except the renorrhaphy step. The difficulty of performing renorrhaphy is attributed to prolonged ischemia time, which could be addressed by overcoming the learning curve.
Trial registration
Clinical Research Information Service site of the Korea Disease Control and Prevention Agency, KCT0006532. Registered 03/09/2021, https://cris.nih.go.kr/cris/search/detailSearch.do?seq=24071.
Keywords: Articulating, Laparoscopy, Kidney, Feasibility
Background
Favorable perioperative and oncologic outcomes associated with laparoscopic surgery have led to its rapid displacement of open surgery as the preferred method in surgical procedures, resulting in the development of specialized instruments for minimally invasive surgery. Although traditional straight-shaped laparoscopic instruments are being improved, the surgeon's experience remains crucial, especially in narrow anatomic space. In contrast, the da Vinci robotic system, introduced in the early 2000s, facilitates intuitive and articulated movements, allowing skilled surgical maneuvers even in complex areas such as anastomosis sites [1–3]. The effectiveness of this system has led to its rapid global adoption. However, despite its advantages, robotic surgery has certain limitations. Specifically, the use of a robotic platform requires specialized instruments and environmental considerations, excludes haptic feedback, and carries a higher cost relative to alternative surgical approaches [4, 5].
ArtiSential (LIVSMED, Seongnam, Republic of Korea) overcomes the limitations of conventional instruments by allowing the free movement of the joint over a 360° range and offers a lower cost compared to that of robotic surgery in terms of both the platform setup cost required for the surgery and the cost borne by patients. In our previous study, ArtiSential was comparable to the da Vinci surgical system or straight-shaped instruments for most steps in terms of objective and subjective parameters in renal surgery using a porcine model [6]. Several studies have reported initial clinical feasibility on the use of ArtiSential in gastrointestinal or thoracic surgery [7–9]. However, clinical applications across various surgical fields are still in the early stages [10]. This study was conducted following the IDEAL (Idea, Development, Exploration, Assessment, and Long-term follow-up) framework as a stage 1 study to evaluate the clinical effectiveness of ArtiSential in detailed steps of various renal surgery [11], establish potential clinical indications, and provide feedback for improving ArtiSential.
Methods
Study design and data collection
The study protocol was approved by the Institutional Review Board of Asan Medical Center, Seoul, Korea (No. 2021–1288), and the study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. The brief study protocol was registered on the Clinical Research Information Service site of the Korea Disease Control and Prevention Agency (No. KCT0006532, Registered 03/09/2021).
Potential candidates were those who needed renal surgery, including radical nephrectomy, partial nephrectomy, and nephroureterectomy. They were aged ≥ 18 to < 80 years. The potential candidates provided written informed consent before participating in this clinical trial. The candidates were excluded if they were unable to undergo laparoscopic surgery due to previous abdominal surgery, were unwilling to participate in this study, or were unfit to participate in the study according to the investigator. Radical nephrectomy in clinical T3 or less cases (excluding renal vein thrombosis), partial nephrectomy in clinical T1 cases, and nephroureterectomy in clinical T3 or less cases were performed via laparoscopic surgery using ArtiSential [12, 13]. Patients with positive lymph node status or metastasis on preoperative examination were excluded. Candidates fulfilling all of the inclusion and exclusion criteria were enrolled in the clinical trial, and renal surgery was performed by a single surgeon (DY). The surgeon had over 10 years of experience with laparoscopic renal surgery before the start of this study and had performed more than 400 renal surgeries, including 10 procedures using ArtiSential. In addition, the surgeon had experience performing renal surgery using ArtiSential on a total of six kidneys in three pigs in a preclinical study [6].
The clinical effectiveness of ArtiSential was assessed in terms of the feasibility and objective and subjective parameters. Additionally, baseline data and operative and convalescence parameters were prospectively collected. Baseline data included the patients’ age, sex, height, body weight, medical and surgical histories, laterality, size of tumor, and RENAL nephrometry score.
ArtiSential, a new articulating laparoscopic instruments
An ArtiSential consists of an end-effector, a shaft, and a head, including a locking lever and handle. This end-effector facilitates the wrist-like movement of instruments by allowing the free movement of the joint over a 360° range. When surgeons position their thumb and forefinger on the handle of the head and initiate movement, the end-effector can replicate a motion that corresponds precisely to their manual dexterity. The locking lever of the head controls the functionality of the vertical and horizontal joints of the end-effector, allowing for the fixation of movements. Additionally, the shaft is available in three lengths (25 cm, 38 cm, and 45 cm), providing options for different procedures according to the surgeons’ preference (Fig. 1).
Fig. 1.
Illustration of a multi degree-of-freedom articulating laparoscopic surgical instrument (ArtiSential)
Detailed steps in renal surgery
As categorized in our IDEAL stage 0 study, representative renal surgeries, which included radical nephrectomy, partial nephrectomy, and nephroureterectomy with bladder cuff excision, were subdivided into 10 detailed steps [6]. In this study, we categorized renal surgery into 9 detailed steps: (1) Kidney mobilization; (2) Renal pedicle dissection; (3) Tumor detection using intraoperative sonography; (4) Tumor resection; (5) Renorrhaphy; (6) Renal pedicle ligation; (7) Ureter dissection and ligation; (8) Bladder cuff excision; (9) Bladder repair. ArtiSential were utilized for the majority of the steps, and ArtiSential monopolar spatula was employed as the energy instrument. Due to the unavailability of certain ArtiSential, conventional bulldog clip-applying forceps were utilized for renal pedicle clamping, and conventional laparoscopic scissors were used for detailed steps requiring cutting. Additionally, in detailed steps requiring clipping, a laparoscopic clip applier was used. The surgical instruments used for each step are shown in Fig. 2.
Fig. 2.
Overview of the use of ArtiSential for 9 detailed steps in renal surgery
Primary outcomes
Feasibility was assessed by determining the proportion of surgeries in which ArtiSential could be used by the surgeon without difficulty in each detailed step. We have defined three situations that could potentially restrict the execution of surgery as follows: (1) When the surgeon determines that surgery using ArtiSential is no longer possible due to the instrument being unmanipulable or due to collisions, etc.; (2) in the event of a critical complication above Satava grade 3 occurring during surgery using ArtiSential; (3) when the warm ischemia time exceeds 30 min. In all three situations, the operation is converted to straight-shaped instruments. Evaluation criteria and reporting methods for feasibility were the ratio of subjects who underwent surgery using ArtiSential as planned to all of those who planned to undergo laparoscopic renal surgery, detailed by each step.
For the evaluation of clinical effectiveness, a combination of objective and subjective parameters was utilized. Objective parameters were categorized into operation time, estimated blood loss, warm ischemia time, and intraoperative complications for a comprehensive assessment in each step. For patients who underwent partial nephrectomy, the warm ischemia time was defined as the time from renal artery clamping to renal artery declamping. Intraoperative complications were evaluated and graded based on the modified Satava classification system [14]. Subjective parameters included the usability of the instruments as judged by the operator, the accuracy of the procedure as appraised by reviewers, and the stress level of the surgeon measured by a wearable instrument. The accuracy of the procedure was judged by 6 reviewers who examined recorded videos of each step and assigned a score based on established criteria. Each procedure was assessed for its usability and accuracy using a 5-point Likert scale, where ratings of 5, 4, 3, 2, and 1 denoted excellent, good, fair, poor, and very poor, respectively. To assess the stress level of the surgeon, a wearable device was used for measurement. The wearable device performs heart rate variability (HRV) analysis to determine the user’s stress level. To measure stress using HRV data, the device relies on photoplethysmography sensors that detect changes in the blood volume with each heartbeat through light absorption. HRV data were recorded during sleep the night before surgery to establish the baseline. HRV recordings were subsequently taken at predetermined times in each step during renal surgery [15–17]. The stress level presented in Samsung Health is displayed in graphic form. In order to express the data quantitatively, the stress level displayed in graphic form was presented as numeric data from a minimum of 0 to a maximum of 10.
Secondary outcomes
Postoperative parameters were categorized into convalescence parameters and postoperative complications for a comprehensive assessment of the overall surgery or each detailed step. Convalescence parameters included interval to drain removal, interval to return to regular diet, hospital stay, postoperative hemoglobin level, and postoperative creatinine level. Postoperative complications were evaluated and graded based on the Clavien-Dindo classification. All postoperative complications were monitored until 30 days after the end of the surgery.
Statistical analysis
Categorical variables are presented as the number (%), and continuous variables are presented as the median (range). Feasibility was analyzed in an intention-to-treat population. Objective and subjective parameters were analyzed for patients who underwent renal surgery using ArtiSential in each detailed step.
Results
Patient data
A total of 15 patients were enrolled in the clinical trial from October 2021 to November 2021. A single patient was excluded from the study prior to surgery due to an anaphylactic reaction from an anesthetic agent; thus, 14 patients underwent renal surgery using ArtiSential (Fig. 3). Of the 14 patients, 5 patients underwent radical nephrectomy, 7 patients underwent partial nephrectomy, and 2 patients underwent nephroureterectomy with bladder cuff excision. The median (range) total operation time and estimated blood loss were 161 (98–280) min and 58.5 (18–200) mL, respectively. Table 1 shows the baseline characteristics of the included patients.
Fig. 3.
Flow diagram of the IDEAL stage 1 study
Table 1.
Baseline characteristics
| Characteristics | Median (range) or N (%) |
|---|---|
| Age, years | 59.5 (35–78) |
| Sex | |
| Male | 12 (86) |
| Female | 2 (14) |
| Height, cm | 169.7 (159.0–176.1) |
| Body weight, kg | 78.2 (47.7–105.2) |
| Body mass index, kg/m2 | 27.2 (19.7–33.9) |
| Diabetes mellitus | 3 (21) |
| Hypertension | 7 (50) |
| History of abdominal surgery | 4 (29) |
| Type of surgery | |
| Radical nephrectomy | 5 (36) |
| Partial nephrectomy | 7 (50) |
| Nephroureterectomy | 2 (14) |
| Laterality | |
| Right | 6 (43) |
| Left | 8 (57) |
| Size of tumor, cm | 3.4 (0.8–8.5) |
| RENAL nephrometry score | |
| (Patients who underwent partial nephrectomy) | 4 (4–9) |
| Preoperative hemoglobin, g/dL | 14.2 (7.8–16.7) |
| Preoperative creatinine, mg/dL | 0.9 (0.75–4.44) |
Primary outcomes
All detailed steps were successfully completed using the planned instruments and procedures for 5 patients who underwent radical nephrectomy and 2 patients who underwent nephroureterectomy. Of the 7 patients who underwent partial nephrectomy, 1 patient was excluded from feasibility assessment after kidney mobilization step as the surgical procedure required the use of straight-shaped instruments due to significant bleeding and intra-abdominal adhesions. Of the remaining 6 patients who underwent partial nephrectomy, 2 patients required a transition to straight-shaped laparoscopic instruments during renorrhaphy. The feasibility of ArtiSential for renorrhaphy step was 67%, which was the lowest among all steps. The feasibility for the other steps were all above 90% (Table 2).
Table 2.
Feasibility of using ArtiSential for each detailed step
| Renal surgery | Detailed step | N | Feasibility (%) | ||
|---|---|---|---|---|---|
| Radical nephrectomy | Partial nephrectomy | Nephroureterectomy | |||
| ∨ | ∨ | ∨ | Kidney mobilization | 14 | 93 |
| ∨ | ∨ | ∨ | Renal pedicle dissection | 14 | 93 |
| ∨ | Tumor detection | 6 | 100 | ||
| ∨ | Tumor resection | 6 | 100 | ||
| ∨ | Renorrhaphy | 6 | 67 | ||
| ∨ | ∨ | Renal pedicle ligation | 7 | 100 | |
| ∨ | ∨ | Ureter dissection/ligation | 7 | 100 | |
| ∨ | Bladder cuff excision | 2 | 100 | ||
| ∨ | Bladder repair | 2 | 100 | ||
The objective parameters are outlined in Table 3. The median warm ischemia time for patients undergoing partial nephrectomy was 23 (17–41) min. There were 2 cases of venous injury classified as modified Satava classification grade 2 in the renal pedicle dissection step. Except for 1 patient with liver cirrhosis, the objective parameters were similar to the median values of all analyzed cases for each detailed step.
Table 3.
Objective parameters of each detailed step
| Surgical step | N | Operation time (min) |
Blood loss (mL) |
Intraoperative complication (%) |
|---|---|---|---|---|
| Kidney mobilization | 14 | 14 (8–71) | 4 (0–68) | 0 (0) |
| Renal pedicle dissection | 14 | 13 (8–57) | 6 (1–33) | 2 (14) |
| Tumor detection | 6 | 24 (17–38) | 6 (1–37) | 0 (0) |
| Tumor resection | 6 | 8 (5–16) | 12 (4–22) | 0 (0) |
| Renorrhaphy | 6 | 15 (8–21) | 23 (11–58) | 0 (0) |
| Renal pedicle ligation | 7 | 8 (5–17) | 6 (4–16) | 0 (0) |
| Ureter dissection/ligation | 7 | 16 (11–26) | 12 (7–49) | 0 (0) |
| Bladder cuff excision | 2 | 34 (9–58) | 35 (21–48) | 0 (0) |
| Bladder repair | 2 | 10 (8–12) | 9 (7–10) | 0 (0) |
Data are presented as the median (range)
In subjective assessment, usability and accuracy were found to have a median Likert score of over 4 (“good”) for all steps. The quantitatively measured stress score based on the heart rate variability of the surgeon was higher during renorrhaphy step (7, 5–8) and bladder cuff excision step (8, 8–8) as shown in Table 4.
Table 4.
Subjective parameters of each detailed step
| Surgical step | N | Usability | Accuracy | Stress score |
|---|---|---|---|---|
| Kidney mobilization | 14 | 4 (3–5) | 5 (4–5) | 5 (1–8) |
| Renal pedicle dissection | 14 | 5 (3–5) | 4 (2.5–5) | 6 (2–8) |
| Tumor detection | 6 | 5 (4–5) | 4 (3.5–5) | 6 (2–8) |
| Tumor resection | 6 | 5 (4–5) | 5 (4–5) | 6 (4–8) |
| Renorrhaphy | 6 | 5 (2–5) | 4 (3–5) | 7 (5–8) |
| Renal pedicle ligation | 7 | 5 (4–5) | 5 (3–5) | 5 (4–8) |
| Ureter dissection/ligation | 7 | 4 (3–5) | 5 (4–5) | 6 (4–8) |
| Bladder cuff excision | 2 | 4 (4) | 5 (4–5) | 8 (8) |
| Bladder repair | 2 | 4 (4) | 5 (4.5–5) | 6 (4–7) |
Data are presented as the median (range)
Secondary outcomes
Data on convalescence parameters and postoperative complications are presented in Table 5. The median interval to drain removal, interval to return to regular diet, and hospital stay were 4, 3, and 5 days, respectively, and 11 patients (78.5%) experienced a total of 21 postoperative complications (Table 5). The most common postoperative complication was aspartate aminotransferase/alanine aminotransferase elevation, followed by incision site pain. There were no postoperative complications due to renal surgery using ArtiSential and no postoperative complications classified as Clavien-Dindo grade III or higher.
Table 5.
Postoperative complications and convalescence parameters
| Convalescence parameters, median (range) | |
|---|---|
| Interval to drain removal, days | 4 (3–7) |
| Interval to return to regular diet, days | 3 (2–6) |
| Hospital stay, days | 5 (5–17) |
| Hemoglobin on postoperative day 0, g/dL | 13.9 (8.2–16.9) |
| Creatinine on postoperative day 0, mg/dL | 1.06 (0.72–5.81) |
| Hemoglobin on postoperative day 30, g/dL | 12.9 (10.1–15.3) |
| Creatinine on postoperative day 30, mg/dL | 1.20 (0.79–4.20) |
| Postoperative complications | |
| Grade I | |
| Aspartate aminotransferase/alanine aminotransferase elevation | 5 |
| Incision site pain | 3 |
| Generalized edema | 2 |
| Hyperkalemia | 1 |
| Headache | 1 |
| Dyspepsia | 1 |
| Atelectasis | 1 |
| Lower urinary tract symptoms | 1 |
| Grade II | |
| Hypertension | 3 |
| Transfusion | 2 |
| Desaturation | 1 |
Discussion
Robotic surgery has been widely adopted across a wide range of surgical procedures, offering notable advantages such as improved visualization, enhanced dexterity, and reduced tissue contact to mitigate infection risks [18]. Nevertheless, concerns have arisen regarding potentially higher costs [19, 20], and there are questions about whether it is markedly superior in terms of efficacy [21, 22] when compared with well-established surgical techniques, such as traditional laparoscopic or open surgery.
In our IDEAL stage 0 study, we confirmed that ArtiSential demonstrates comparable usability to straight-shaped laparoscopic instruments, and it is similar in performance to robotic arms [6]. This study was conducted following the IDEAL framework as a stage 1 study to assess the clinical effectiveness of ArtiSential in renal surgery within the field of urology. Several recent studies on the feasibility and safety of ArtiSential in gastrointestinal surgery have predominantly reported positive perioperative outcomes [7, 8, 23]. As this study demonstrates the novel applications of ArtiSential in renal surgery, we aimed to assess clinical effectiveness of ArtiSential in each detailed step.
In most detailed steps, ArtiSential achieved a feasibility of over 90%; however, during renorrhaphy step, the feasibility was only 67% as the ischemia time of 2 patients exceeded 30 min, leading to conversion to straight-shaped laparoscopic needle holders. There are several possible explanations for this outcome. First, for surgeons to shorten the ischemia time during renorrhaphy, it is essential to overcome the significant learning curve of ArtiSential. Existing studies on the clinical use of ArtiSential suggest a relatively stable learning curve [7, 8, 24]. However, these studies evaluated the maneuverability of ArtiSential for tasks such as grasping, dissection, and retraction, excluding suturing. Renorrhaphy primarily involves suturing, and completing it in a timely manner is beneficial for the perioperative outcome of patients [25]. Moreover, some improvements are needed for the current ArtiSential needle holder. As shown in Table 4, due to the need to establish an appropriate suture angle and point penetration force, surgeons could experience relatively higher stress with suturing compared to other surgical tasks. Unlike the traditional laparoscopic needle holder, the current ArtiSential needle holder allows for the intuitive movement of the end-effector tip but lacks a mechanism for securely holding the needle in place. Consequently, surgeons need to use their wrists to maintain a grip on the needle while creating an appropriate suture angle between the end-effector and the tissue, resulting in considerable strain on the wrists and fingers. While holding the needle in place, surgeons could not exert sufficient penetrating force into the tissue during renorrhaphy, leading to reduced performance. Therefore, there is a need for an additional needle locking mechanism in the ArtiSential needle holder. Notably, a multi-articulating needle holder may be advantageous in surgeries involving deep and narrow areas with a horizontal orientation, such as bladder repair, where tissue manipulation results in an insufficient suture angle; thus, the multi-articulating movement and joint-locking functions of the ArtiSential needle holder’s end-effector could be beneficial [26–28].
Surgeons typically perform laparoscopic renal surgery in a standing position, covering a wide area from the 11th to the 12th rib section down to the iliac crest. Therefore, ArtiSential monopolar energy instrument may be more suitable than foot-controlled ones for the manual control of electrodes. In port placement for ArtiSential, positioning the camera port and working port slightly closer (around 1–2 cm compared to a straight-line instruments) and placing them at an angle of 110–120° between the two ports can enhance instrument usability.
Excluding a patient with liver cirrhosis and severe intraperitoneal adhesions, which are contraindications to laparoscopic surgery [29], objective parameters with median values for the entire patient population were determined in each detailed step in this study. For intraoperative complications in this patient cohort, including the single patient mentioned above, two cases of Satava grade 2 complications were observed throughout the surgery. These complications appeared to be attributed to accidental vascular injuries rather than instrument malfunction. Furthermore, compared to the results of our preclinical study, this IDEAL stage 1 study demonstrated improvements in subjective parameters of usability and accuracy, with scores of 4 or higher in all steps [6].
This study has several limitations. First, it was conducted at a single center with a single surgeon and a small sample size. It did not compare ArtiSential to conventional laparoscopic instruments or robot-assisted surgery due to its descriptive nature. However, this first-in-human study evaluated ArtiSential as an IDEAL stage 1 study in the field of urologic surgery. Through this clinical trial, we were able to confirm the appropriate patient position and port placement in the operating room. Second, with current ArtiSential, the absence of laparoscopic scissors and clip appliers that can accommodate various sizes necessitated the use of conventional laparoscopic instruments. In this regard, for future instrument development and exploration, the selection and effective cross-utilization of ArtiSential with existing laparoscopic instruments in specific steps would be crucial.
Conclusions
Laparoscopic renal surgery using ArtiSential is feasible for most detailed steps except the renorrhaphy step. The difficulty of performing renorrhaphy is attributed to prolonged ischemia time, and this issue could be resolved by overcoming the learning curve and improving the suturing instrument.
Acknowledgements
The authors thank the participating investigators at LIVESMED for performing experimental tasks. We would like to acknowledge Se Young Choi, Wook Nam, Jae Hyeon Han, Han Kyu Chae, and Wonchul Lee, who evaluated the accuracy of each procedure (together, they had a median of 3 (2–8) years of actual experience after acquisition of urology board certificate and had been working in a tertiary hospital when they participated in this study).
Authors’ contributions
Conceptualization: Dalsan You, Jong Keun Kim, Donghwan Bae. Data curation: Jong Keun Kim, Bosik Kang, Myoung Jin Jang, Yunhwa Cha. Funding acquisition: Dalsan You. Investigation: Dalsan You, Jong Keun Kim, Yu Seon Kim, Yunhwa Cha. Writing – original draft: Dalsan You, Jong Keun Kim. Supervision: Dalsan You, Jong Keun Kim.
Funding
This work was supported by a ‘Supporting Project to Evaluate New Domestic Medical Devices in Hospitals’ grant funded by the Ministry of Health and Welfare (MOHW) and by the Korea Health Industry Development Institute (KHIDI).
Availability of data and materials
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.
Declarations
Ethics approval and consent to participate
The study protocol was approved by the Institutional Review Board of Asan Medical Center, Seoul, Korea (No. 2021–1288), and the study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonization Guidelines for Good Clinical Practice. The potential candidates provided written informed consent before participating in the clinical trial.
Consent for publication
Not applicable.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
References
- 1.Mikhail D, Sarcona J, Mekhail M, Richstone L. Urologic robotic surgery. Surg Clin North Am. 2020;100(2):361–78. 10.1016/j.suc.2019.12.003 [DOI] [PubMed] [Google Scholar]
- 2.Osman NI, Mangir N, Mironska E, Chapple CR. Robotic surgery as applied to functional and reconstructive urology. Eur Urol Focus. 2019;5(3):322–8. 10.1016/j.euf.2019.06.016 [DOI] [PubMed] [Google Scholar]
- 3.Williamson T, Song SE. Robotic surgery techniques to improve traditional laparoscopy. JSLS. 2022;26(2):e2022.00002. [DOI] [PMC free article] [PubMed]
- 4.Jara RD, Guerron AD, Portenier D. Complications of robotic surgery. Surg Clin North Am. 2020;100(2):461–8. 10.1016/j.suc.2019.12.008 [DOI] [PubMed] [Google Scholar]
- 5.Turchetti G, Palla I, Pierotti F, Cuschieri A. Economic evaluation of da Vinci-assisted robotic surgery: a systematic review. Surg Endosc. 2012;26(3):598–606. 10.1007/s00464-011-1936-2 [DOI] [PubMed] [Google Scholar]
- 6.Kim JK, Kang B, Kim YS, Yun Y, Jang MJ, Bae D, You D. Laparoscopic renal surgery using multi degree-of-freedom articulating laparoscopic instruments in a porcine model. Investig Clin Urol. 2023;64(1):91–101. 10.4111/icu.20220182 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Darwich I, Abuassi M, Aliyev R, Scheidt M, Alkadri MA, Hees A, Demirel-Darwich S, Chand M, Willeke F. Early experience with the ARTISENTIAL((R)) articulated instruments in laparoscopic low anterior resection with TME. Tech Coloproctol. 2022;26(5):373–86. 10.1007/s10151-022-02588-y [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Darwich I, Abuassi M, Aliyev R, Scheidt M, Barganab A, Stephan D, Willeke F. Single-Center Results of colorectal procedures performed with fully articulated laparoscopic artisential(R) devices. Surg Technol Int. 2022;41:sti41–1605. [DOI] [PubMed]
- 9.Trevis J, Chilvers N, Freystaetter K, Dunning J. Surgeon-powered robotics in thoracic surgery; An era of surgical innovation and its benefits for the patient and beyond. Front Surg. 2020;7:589565. 10.3389/fsurg.2020.589565 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Vigneswaran HT, Dobbs RW, Huang J, Sofer LA, Halgrimson WR, Crivellaro S. Use of a Novel articulating laparoscopic needle driver for partial nephrectomy: An Initial Experience. Urology. 2019;132:123–9. 10.1016/j.urology.2019.05.049 [DOI] [PubMed] [Google Scholar]
- 11.Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM, Balliol C, Altman DG, Barkun JS, Blazeby JM, Boutron IC, et al. Evaluation and stages of surgical innovations. Lancet. 2009;374(9695):1089–96. 10.1016/S0140-6736(09)61083-7 [DOI] [PubMed] [Google Scholar]
- 12.Simone G, Tuderti G, Anceschi U, Papalia R, Ferriero M, Misuraca L, Minisola F, Mastroianni R, Costantini M, Guaglianone S, et al. Oncological outcomes of minimally invasive partial versus minimally invasive radical nephrectomy for cT1-2/N0/M0 clear cell renal cell carcinoma: a propensity score-matched analysis. World J Urol. 2017;35(5):789–94. 10.1007/s00345-016-1923-2 [DOI] [PubMed] [Google Scholar]
- 13.Ljungberg B, Bensalah K, Canfield S, Dabestani S, Hofmann F, Hora M, Kuczyk MA, Lam T, Marconi L, Merseburger AS, et al. EAU guidelines on renal cell carcinoma: 2014 update. Eur Urol. 2015;67(5):913–24. 10.1016/j.eururo.2015.01.005 [DOI] [PubMed] [Google Scholar]
- 14.Kazaryan AM, Rosok BI, Edwin B. Morbidity assessment in surgery: refinement proposal based on a concept of perioperative adverse events. ISRN Surg. 2013;2013:625093. 10.1155/2013/625093 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 15.Chalmers T, Hickey BA, Newton P, Lin CT, Sibbritt D, McLachlan CS, Clifton-Bligh R, Morley J, Lal S. Stress watch: the use of heart rate and heart rate variability to detect stress: A pilot study using smart watch wearables. Sensors (Basel). 2021;22(1):151. [DOI] [PMC free article] [PubMed]
- 16.Powezka K, Pettipher A, Hemakom A, Adjei T, Normahani P, Mandic DP, Jaffer U. A pilot study of heart rate variability synchrony as a marker of intraoperative surgical teamwork and its correlation to the length of procedure. Sensors (Basel). 2022;22(22):8998. [DOI] [PMC free article] [PubMed]
- 17.Jones KI, Amawi F, Bhalla A, Peacock O, Williams JP, Lund JN. Assessing surgeon stress when operating using heart rate variability and the State Trait Anxiety Inventory: will surgery be the death of us? Colorectal Dis. 2015;17(4):335–41. 10.1111/codi.12844 [DOI] [PubMed] [Google Scholar]
- 18.Marohn MR, Hanly EJ. Twenty-first century surgery using twenty-first century technology: surgical robotics. Curr Surg. 2004;61(5):466–73. 10.1016/j.cursur.2004.03.009 [DOI] [PubMed] [Google Scholar]
- 19.Wright JD, Ananth CV, Lewin SN, Burke WM, Lu YS, Neugut AI, Herzog TJ, Hershman DL. Robotically assisted vs laparoscopic hysterectomy among women with benign gynecologic disease. JAMA. 2013;309(7):689–98. 10.1001/jama.2013.186 [DOI] [PubMed] [Google Scholar]
- 20.Jeong IG, Khandwala YS, Kim JH, Han DH, Li S, Wang Y, Chang SL, Chung BI. Association of Robotic-assisted vs Laparoscopic radical nephrectomy with perioperative outcomes and health care costs, 2003 to 2015. JAMA. 2017;318(16):1561–8. 10.1001/jama.2017.14586 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379(20):1895–904. 10.1056/NEJMoa1806395 [DOI] [PubMed] [Google Scholar]
- 22.Melamed A, Margul DJ, Chen L, Keating NL, Del Carmen MG, Yang J, Seagle BL, Alexander A, Barber EL, Rice LW, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379(20):1905–14. 10.1056/NEJMoa1804923 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Jin HY, Ibahim AM, Bae JH, Lee CS, Han SR, Lee IK, Lee DS, Lee YS. Initial experience of laparoscopic complete mesocolic excision with D3 lymph node dissection for right colon cancer using Artisential((R)), a new laparoscopic articulating instrument. J Minim Access Surg. 2022;18(2):235–40. 10.4103/jmas.JMAS_88_21 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Darwich I, Abuassi M, Weiss C, Stephan D, Willeke F. The artisential(R) articulated laparoscopic forceps: A dry lab study to examine dexterity and learning effects in operators with different levels of laparoscopic experience. Surg Technol Int. 2021;38:29–36. [PubMed] [Google Scholar]
- 25.Simone G, Ferriero M, Papalia R, Costantini M, Guaglianone S, Gallucci M. Zero-ischemia minimally invasive partial nephrectomy. Curr Urol Rep. 2013;14(5):465–70. 10.1007/s11934-013-0359-0 [DOI] [PubMed] [Google Scholar]
- 26.Sanchez-Margallo FM, Sanchez-Margallo JA. Assessment of postural ergonomics and surgical performance in laparoendoscopic single-site surgery using a handheld robotic device. Surg Innov. 2018;25(3):208–17. 10.1177/1553350618759768 [DOI] [PubMed] [Google Scholar]
- 27.Aykan S, Akin Y, Pelit ES, Gulmez H, Tuken M, Colakerol A, Semercioz A, Muslumanoglu AY. Impact of motorized articulating laparoscopic devices with three-dimension visualizing system: A pilot study. J Endourol. 2017;31(2):174–9. 10.1089/end.2016.0406 [DOI] [PubMed] [Google Scholar]
- 28.Sieber MA, Fellmann-Fischer B, Mueller M. Performance of Kymerax(c) precision-drive articulating surgical system compared to conventional laparoscopic instruments in a pelvitrainer model. Surg Endosc. 2017;31(10):4298–308. 10.1007/s00464-017-5438-8 [DOI] [PubMed] [Google Scholar]
- 29.Cobb WS, Heniford BT, Burns JM, Carbonell AM, Matthews BD, Kercher KW. Cirrhosis is not a contraindication to laparoscopic surgery. Surg Endosc. 2005;19(3):418–23. 10.1007/s00464-004-8722-3 [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets used and analyzed during the current study are available from the corresponding author on reasonable request.