Safety Of Robot-assisted Surgery Research Articles

Clinical efficacy of robotic spine surgery: an updated systematic review of 20 randomized controlled trials

Purpose To determine whether using robots in spine surgery results in more clinical advantages and fewer adverse consequences. Methods Between October 1990 and October 2022, a computer-based search was conducted through the databases of PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, China Biology Medicine, VIP databases, and WAN FANG. The study only included randomized controlled trials (RCTs) comparing the clinical efficacy and safety of robot-assisted surgery with those of conventional spine surgery. The review was conducted following PRISMA 2020, and AMSTAR-2 was used to evaluate the methodological quality. R version 4.2.1 was used in the meta-analysis. The Cochrane Collaboration Tool was used for evaluating the risk of bias. Results This study analyzed 954 participants from 20 RCTs involving cervical spondylosis, lumbar degenerative disease, scoliosis, etc. The robot-assisted group outperformed the freehand group in terms of intraoperative blood loss, number of screws in grade A position, grade A + B position, radiation dose, and hospital stay. Operation duration, visual analog scale scores of low back pain, Oswestry disability index, and radiation exposure time did not significantly differ between the two groups. Conclusions Although robotic spine surgery is more accurate in pedicle screw placement than conventional methods, the robot group did not demonstrate an advantage in terms of clinical efficacy. Studies of complications and cost-effectiveness are still very rare.

A Stability and Safety Control Method in Robot-Assisted Decompressive Laminectomy Considering Respiration and Deformation of Spine

Robot-assisted decompressive laminectomy is a new strategy in clinical applications. However, a stable contact force between the bone-cutting device and lamina is needed to keep it working correctly, which may be affected by respiration and deformation. The surgeon can adapt to this dynamic process quickly, but the robot could cause a considerable force that may damage the patient. This paper proposes a compensation control method based on a respiration-spine model to first improve the stability of the contact force. The model is established based on human morphology and ventilator parameters for anaesthetised patients. The control method is a combination of a surgery sleeve and active fuzzy control to improve the robustness of the robot. The control of the sleeve is related to the thickness of the bone layer, which can be calculated from the image. Furthermore, the lower boundary of the lamina in the CT image is extracted as a safety constraint that can protect the spinal nerves. Finally, an experiment is conducted to verify the safety constraint and compare the changes in contact force with or without the control method. The statistical experiment shows that the control error is 2.47 N without the force control method, while the force control error is 0.223 N when the target control force is 2 N. The robot will hover on the surface of the spine after completing the laminectomy of the planned area. These results show that the robot can be controlled safely and stably. Note to Practitioners—The purpose of this paper is to propose a stable and safe control method for lamina grinding robots under the influence of breathing and deformation factors. Most previous research only considered one of the two factors, and both factors are considered in this paper. Unlike the surgeon, who has the ability to adapt to physiological movements, the robot may cause a considerable force to be exerted on the device, which may damage the patient. Therefore, a controller based on human experience is longitudinally designed, and position constraints are added in three directions. This application can improve the stability and safety of robot-assisted surgery, which may be suitable for remote surgery and can help rural areas solve the problem of a lack of medical resources. Spinal model bone experiments have been completed and will be tested on animals in the future.

Experience of reconstructive plastic robot-assisted surgery in patients with isthmocele after cesarean section

BACKGROUND: According to several Russian researchers, the number of cesarean deliveries in different regions of Russia varies from 15.2% to 42%. The incidence of complications inconsistency of the uterine scar (isthmocele) after surgery is 10%15%.
 AIM: This study aimed to assess the efficiency and safety of robot-assisted surgery in the correction of isthmoceles after cesarean section in patients of reproductive age.
 MATERIALS AND METHODS: The study involved seven patients aged 2734 years with signs of isthmoceles after urgent or elective cesarean section 12 months to 6 years prior to hospitalization. A comprehensive dynamic examination (echography, magnetic resonance imaging, and office hysteroscopy), surgical treatment with the da Vinci Si robotic complex, and outpatient monitoring in the early and long-term period (1, 6, 12, 24, and 36 months) were performed.
 RESULTS: The patients were satisfied with the results of surgical treatment during outpatient monitoring due to the improved quality of life resulting from the reduction of pathological symptoms. The control echography (1, 6, and 12 months later) showed normal myometrial thickness (911 mm) and adequate blood flow in the metroplasty area in all patients. The niche was not visualized during office hysteroscopy 6-months after the metroplasty. Three patients became pregnant 1620 months after the reconstructive uteroplasty and ended with a timely operative delivery. Two patients were followed up for their pregnancies at 12 and 29 weeks of gestation, while two women continued taking oral contraceptives and planned their next pregnancy at least a year later.
 CONCLUSIONS: The use of the da Vinci Si robotic system for surgical correction of isthmoceles provides volumetric three-dimensional visualization of anatomical structures, reduces the duration of surgery and intraoperative blood loss, minimizes the number of intraoperative and postoperative complications, and contributes to accelerated postoperative rehabilitation of patients.

Efficacy and safety of robotic-assisted surgery in challenging hysterectomies - a single institutional experience.

An increasing number of robotic hysterectomies are being performed and the most common indication is fibroids. Fibroid uterus is common indication for hysterectomy for enlarged uteri. The role of robotic approach for complex pathologies as enlarged uterus is still debatable. The study aimed to analyze the feasibility of robotic hysterectomy in patients with enlarged uteri and the impact of uterine weight on surgical outcomes and on operative time length. One hundred and thirty-eight patients who underwent robotic hysterectomy for benign indications at the 2nd Division of Obstetrics and Gynecology, Azienda Ospedaliero-Universitaria Pisana, University of Pisa were consecutively enrolled. Data of patients undergoing robotic surgery for benign indications were collected. Patients were stratified in two groups based on their uterine weight, to analyze the effective impact of uterine weight and dimension on surgical performance, operative time and postoperative outcomes. Conversion rate was 0%. Median uterine weight was 615 g (range 400-1900 g). Median total operating time was 131 minutes (range 70-255 minutes). Increase in uterine weight significantly increased operative times (p=0.003) and morcellation time (p=0.001). On the other hand, operative time was just partially influenced by route for removal of the uterus (p=0.085) but significantly affected by uterine weight (p=0.008), previous surgeries (p=0.003) and BMI of the patient (p=0.005). Robotic hysterectomy is feasible and safe for challenging cases as large uteri. This technique could enable patients with outsized uteri, not suitable for vaginal hysterectomy, to undergo minimally invasive surgery with excellent results. Larger studies to investigate and compare robotic with other surgical approaches for difficult hysterectomies are needed to confirm these data.

Current Advances in Robotics for Head and Neck Surgery—A Systematic Review

Background. In the past few years, surgical robots have recently entered the medical field, particularly in urology, gynecology, and general surgery. However, the clinical effectiveness and safety of robot-assisted surgery (RAS) in the field of head and neck surgery has not been clearly established. In this review, we evaluate to what extent RAS can potentially be applied in head and neck surgery, in which fields it is already daily routine and what advantages can be seen in comparison to conventional surgery. Data sources. For this purpose, we conducted a systematic review of trials published between 2000 and 2021, as well as currently ongoing trials registered in clinicaltrials.gov. The results were structured according to anatomical regions, for the topics "Costs," "current clinical trials," and "robotic research" we added separate sections for the sake of clarity. Results. Our findings show a lack of large-scale systematic randomized trials on the use of robots in head and neck surgery. Most studies include small case series or lack a control arm which enables a comparison with established standard procedures. Conclusion. The question of financial reimbursement is still not answered and the systems on the market still require some specific improvements for the use in head and neck surgery.

Robotic Assisted Surgery: The Gap Between Challenges And Solutions

A roboticist by the name of Rodney Brooks once said, “the benefits of having robots could vastly outweigh the problems.” While this may be true, it is important to assess these problems and understand how they may be mitigated. The use of robots is growing in many industries and can be found in areas such as manufacturing, healthcare, agriculture, food preparation and national defense. Within healthcare, robots are commonly used in surgery to perform procedures such as sacrocolpopexies, prostatectomies, hysterectomies, hernia repairs and nephrectomies. The benefits of robotic-assisted surgery (RAS) are similar to laparoscopy and include decreased blood loss, faster recovery time, and shorter lengths of stay at the hospital. Unlike purely laparoscopic surgery, the robot provides wrist dexterity, allowing for more complex surgeries to be performed in a minimally invasive fashion by surgeons who may not have expertise in laparoscopy. However, recent reports have heightened challenges facing RAS operating room (OR) teams. Effects of the OR layout, team communication, team coordination, disruptions to workflow, and equipment malfunctions were among the issues observed in a variety of RAS procedures. Issues such as disruptions to the workflow trigger delays and inefficiencies, which in turn could affect patient safety and quality of care. As part of a wider study to implement and evaluate multiple interventions associated with improving efficiency and safety of RAS, a literature search was conducted to investigate issues experienced by the OR team in RAS and the interventions developed and tested to resolve these issues. The literature search excluded studies concerned with laparoscopic and open surgery; proficiency training; and articles that were not written in English. Commentaries, editorials, and abstracts were further excluded. At the conclusion of the literature search, 17 articles involving the implementation or evaluation of interventions surrounding RAS were evaluated and categorized based on the issues that were addressed. Seven articles discussed disruptions to the OR team’s workflow; five articles discussed issues with patient safety, surgical complications, or risk assessment; three papers discussed issues with teamwork; and the remaining articles discussed issues with communication, efficiency, cognitive load, and surgical performance. Despite the number of articles that were found to discuss issues in RAS, only four of the 17 articles implemented interventions. The interventions primarily included the use of checklists and nontechnical skills training. The scarce number of articles focusing on interventions aimed at improving the safety, quality, and efficiency of RAS demonstrates the wide gap that exists between known problems and potential solutions. As the number of robotic-assisted procedures continue to grow, it is important to improve OR team efficiency and patient care. The current study is part of a five-year, four-site study investigating the nature of issues that exist in RAS. The larger study will also design and implement interventions based on RAS observations conducted by the researchers in an effort to ensure that the benefits of robotic surgery truly do outweigh the existing problems.

Abstract OT2-01-03: A prospective pilot study of simultaneous robotic assisted nipple sparing mastectomy and immediate reconstruction

Abstract Endoscopic breast surgery was expected to be an adequate technique to complete cancer clearance and preservation of the patient's body image. However, this technique has limitations including incomplete internal movements and unstable vision of a two dimensional camera due to inflexible endoscopic instruments especially during the skin flap formation. High resolution, ten-fold image magnification, and three-dimensional optics of robotic surgery help overcome the limitations of endoscopic surgery, and thus robotic surgery has been adopted in a wide range of intracorporeal procedures including breast surgery. However, few studies have evaluated feasibility and safety of robotic assisted nipple sparing mastectomy (RANSM) and immediate breast reconstruction (IBR) for the treatment of breast cancer. There were not any investigation to assess patients' satisfaction of cosmetic effect after performing RANSM and IBR. This study is aim to verify the feasibility and the safety of RANSM and IBR and to analyze cosmetic effect of the procedure and satisfaction of patients. The target number of enrollments is 15 patients. Patients who are diagnosed with early breast cancer or BRCA 1/2 mutation carriers are enrolled. Female patients over 20 years old who are candidates to preserve nipple areolar complex and considered to perform reconstruction with implants are prospectively collected. Written informed consents are mandatory. Patients who are considered the high possibility of postoperative radiation therapy according to preoperative stage are not included in this study. We exclude patients who want to undergo other methods of breast reconstruction than breast reconstruction with implants. Patients will undergo RANSM and IBR through a single axillary skin incision simultaneously. Regular follow-up at 1 month and 6 months after RANSM and IBR is scheduled to record recovery of a patient, amount of a drain, date of drain removal, and postoperative complications. Patient satisfaction questionnaire will be completed on the last follow-up day. To evaluate the safety of robotic assisted surgery, the oncologic safety (margin status of nipple areolar complex), postoperative recovery of a patient, and postoperative complications are investigated. We compare preoperative and postoperative 6 month photographs of patients and estimate the surgical outcome by objective indicators to evaluate the cosmetic grading by plastic surgeons. Patients' satisfaction are assessed by questionnaire (BREAST-Q) at the 6-month visit. Citation Format: Lee J, Park HS, Kim JH, Lee DW, Song SY, Lew DH, Kim JY, Kim SI, Cho YU, Lee H, Lee KB, Yoon KH. A prospective pilot study of simultaneous robotic assisted nipple sparing mastectomy and immediate reconstruction [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT2-01-03.

Robotic-assisted paraesophageal hernia repair—a case–control study

The da Vinci® telemanipulation system offers a wide range of precise movements and 3D visualization with depth perception and magnification effect. Such a system could be useful for improving minimally invasive procedures-as in the case of large hiatal hernia with paraesophageal involvement (PEH) repair. Studies reporting on the robotic-assisted PEH repair are scarce, and a comparison to the standard operation techniques is lacking. Therefore, we decided to investigate the feasibility and safety of robotic-assisted surgery (RAS) compared to conventional laparoscopic (CLS) and open surgery (OS) for the first time. We investigated 42 patients for the perioperative outcome after PEH repair. Twelve patients were operated on with RAS, 17 with CLS, and 13 with OS. Operating time, intraoperative blood loss, intra- and postoperative complications, mortality, and duration of hospital stay were analyzed in each method. On average, operating time in the RAS group was 38 min longer, and the intraoperative blood was loss 217 ml lower compared to OS. Both results were similar to the CLS group. The intraoperative complication rate was similar in all groups. The postoperative complication rate in the RAS group was significantly lower than the OS group, though again similar to the CLS group. The hospital stay was 5 days shorter in the RAS group than the OS group and once again similar to the CLS group. The results show that RAS is feasible and safe. It appears to be an alternative to OS due to lower intraoperative blood loss and potentially fewer postoperative complications, as well as shorter hospital stay. Though, RAS is not superior to CLS.

Nissen Fundoplication, Robotic-assisted Versus Laparoscopic Procedure: A Comparative Study in Children

Many reports have addressed the feasibility and safety of robotic-assisted surgery. However, few have compared the use of robots with the standard laparoscopic approach in various procedures. The aim of this study was to compare robotic-assisted Nissen fundoplication (RNF) with laparoscopic Nissen fundoplication (LNF). Children who underwent RNF were compared with those who underwent LNF during the same period at the same institution. Data collected included patient demographics, surgical indications, operative times, intraoperative and postoperative complications and clinical outcomes. Between January 2005 and July 2008, 25 patients underwent RNF and 25 underwent LNF. Both groups were similar with regard to age, male/female ratio, and body weight. The total operative time was comparable in both groups. There were no deaths, intraoperative complications or untoward events. There were no significant differences in postoperative complication rates, postoperative analgesic requirements or lengths of hospital stay between the groups. Short-term clinical results with respect to gastroesophageal reflux symptoms were comparable in both groups after 14 months of follow-up. RNF is a safe and feasible alternative to LNF. There were no significant differences in outcomes measured between groups. In view of the high cost of robotic devices, no clear benefits of using robotics in Nissen fundoplication were observed.

Robotic surgery: potentials, barriers, and limitations

BACKGROUND: The advent of laparoscopic surgery has created the room for the introduction of computer and robotic technologies in surgery. Robotic and computer technologies can be used to enhance dexterity, digitize gestures and video signals, and compress information that can be transmitted over a distance. METHODS: We reviewed current literature about clinical and experimental applications of robotics-assisted surgery. In this article we give an overview of the most important advances and issues deriving from the application of robotic technologies in surgery. RESULTS: Many clinical series have documented the feasibility and safety of robot-assisted surgery for virtually any kind of operation in general surgery. However, evidence of significant clinical benefits is still lacking. Important aspects of robotic technology, such as remote surgery and integration of robotic and virtual-reality technologies have not been fully exploited. CONCLUSIONS: Robotics-assisted surgery is feasible and safe for many operations in general surgery. Further technical development, particularly in the field of remote surgery and virtual-reality technology applied to robotics, will likely boost application of robotic surgery and possibly improve both patients' care and surgical education.