Robotic surgery (RS) has become increasingly widespread, particularly among adult urologists and gynecologists (1–3). However, since its introduction in 2001, its adoption in pediatric practice has faced significant challenges (4). These challenges encompass the complex development of pediatric-specific instruments, the need for a fundamental shift in the surgical team's approach, and the substantial economic and ethical considerations that must be addressed.

RS represents the advancement of minimally invasive surgery (MIS), offering all the benefits associated with this approach, including reduced operative trauma, lower postoperative pain, decreased need for analgesic medications, shorter hospital stays, faster recovery, and improved aesthetic outcomes (5, 6).

Numerous published studies and reports demonstrate the feasibility of RS, particularly in pediatric urology. Over time, the use of robotic systems in pediatric surgery has expanded to include a variety of procedures, extending beyond urology to encompass gastrointestinal (GI), thoracic, and hepatic surgeries (7–11).

RS overcomes some limitations of laparoscopic and thoracoscopic procedures by using da Vinci™ EndoWrist® technology (Intuitive Surgical Inc., Sunnyvale, California), which allows 7 degrees of freedom compared to the 4 degrees of laparoscopic instruments. RS also provides enhanced precision with a movement scaling of up to 5:1, eliminating the surgeon's postural tremor at the console (6, 11). This is complemented by high-resolution imaging from the endoscope, offering three-dimensional visualization and magnification up to 10–15 times. Moreover, the incorporation of fluorescence technology (Firefly®, Novadaq Technologies, Mississauga, ON) significantly improves the visualization of vascular structures, aiding in more precise surgical dissection (12, 13).

With enhanced precision and dexterity, robotic surgery proves ideal for complex procedures in confined spaces. Despite its established benefits in both adult and pediatric settings, economic challenges have limited its broader implementation in pediatric care (8, 10, 14).

This study investigates the feasibility and organizational implications of implementing robotic surgery in pediatric hospitals. Particular attention is given to the assessment of clinical advantages, infrastructural requirements, staff training needs and the integration of robotic systems within existing workflows. The objective is to offer a comprehensive analysis to support strategic decision-making for the safe, efficient, and sustainable adoption of robotic-assisted surgical technologies in pediatric care settings.

The first pediatric case series on RS was published in 2001. Since then, RS has been applied to numerous gastrointestinal, genitourinary, and thoracic procedures in children (15–17). Most surgeries traditionally performed using conventional laparoscopic or thoracoscopic techniques have now been successfully replicated through a robotic approach. This trend has been largely driven by the growing number of urological procedures. Over time, an increasing number of complex reconstructive surgeries—such as Kasai portoenterostomy, Mitrofanoff Appendicovescicostomy, choledochal cyst excision, and tumor resections—have been performed successfully with robotic assistance, underscoring the continuous evolution and expanding capabilities of RS in pediatric care (15).

Comparative effectiveness studies on robotic pyeloplasty and gastric fundoplication have demonstrated that clinical outcomes are generally comparable to, or slightly superior to, those achieved with conventional techniques (15). However, for many low-volume procedures where robotic assistance is increasingly advocated, high-quality comparative effectiveness data may take considerable time to emerge.

A decade of experience at our center has confirmed the safety and efficacy of RS across a range of selected pediatric procedures. Despite its significant economic demands—especially in pediatric healthcare settings—we strongly advocate that centralization of care is essential to ensuring truly patient-centered management. In line with this principle, we have progressively and prospectively developed a dedicated robotic surgery program tailored to the pediatric population.

The robotic surgical system was initially introduced at our institution on a trial basis in 2015 for a period of 14 months. Subsequently, in March 2020, the system was permanently acquired for exclusive use within our pediatric hospital. During the interim period, two low-complexity cases were performed at an adult hospital, with patients transferred postoperatively via ambulance. This experience revealed significant logistical and clinical limitations, leading to the decision to fully integrate the robotic platform within our pediatric facility to ensure continuity of care and procedural sustainability.

Since March 2020, the permanent integration of the robotic platform at IRCCS Giannina Gaslini has enabled the safe and efficient execution of robotic procedures within the pediatric hospital itself. This has facilitated the management of more complex cases, eliminated the need for inter-hospital transfers, and ensured a higher standard of care in a dedicated pediatric setting.

Although this study shares some limitations with previous reports, it significantly expands the spectrum of surgical indications and case diversity, demonstrating safe and encouraging outcomes even in the youngest patients. We firmly believe that pediatric surgical care should be delivered by a dedicated multidisciplinary team within institutions specifically committed to pediatric healthcare—where quality, ethical standards, and the unique needs of children are prioritized. 1.

Technology and safety

Robot-assisted surgery is particularly well-suited for procedures requiring meticulous dissection and precise intracorporeal suturing. Optimal port placement must account for several critical factors: (a) patient size, (b) the location and dimensions of the target anatomical structure, and (c) the unique “geometry” of robotic systems, which favor a linear alignment of access points over the traditional triangulation used in conventional minimally invasive surgery. This conceptual shift allows for better planning of the number and positioning of robotic arms, minimizing both internal and external collisions during the procedure.

While it may seem intuitive that RS is ideally suited for the limited operative fields typical in pediatric patients, current RS systems and instruments are not specifically tailored for pediatric anatomy. Technical constraints may render their application challenging—or even unfeasible—in smaller patients. For example, the manufacturer of the da Vinci® surgical system recommends a minimum inter-port distance of 8 cm, which is often difficult to achieve in neonatal and infant cases. Instrument size and length also represent significant limitations. Neonatal procedures are typically performed using 3-mm instruments and endoscopes, which are substantially smaller than those currently available for robotic platforms. The absence of commercially available 3-mm robotic instruments remains a major constraint, limiting the applicability of robotic systems in neonates and small infants and hindering their widespread use in this population (18).

Furthermore, the da Vinci® system features integrated fluorescence imaging through near-infrared (NIR) technology—Firefly®—which enhances intraoperative visualization of vascular and anatomical structures. This technology utilizes fluorescent compounds—most commonly indocyanine green (ICG)—which, when activated by a near-infrared (NIR) light source at a wavelength of approximately 820 nm, emit fluorescence detectable only through dedicated imaging systems. The resulting images are particularly valuable in hepatobiliary surgery for the identification of bile ducts and vascular structures. Moreover, the application of this modality is expanding in pediatric oncologic surgery, where it shows promise in delineating tumor margins, identifying vascular anatomy, detecting metastases, guiding sentinel lymph node biopsies, preserving adjacent critical structures, and assisting in reconstructive steps. In pediatric urology, ICG fluorescence is primarily used intraoperatively to assess renal perfusion, particularly during pyeloplasty in cases of hydronephrosis secondary to crossing vessels (13, 14, 19, 20). 2.

Patient weight, surgical complexity and clinical considerations

Preoperative planning is essential to ensure the selection of instruments tailored to each procedure, thereby minimizing material waste and reducing the risk of conversion to open surgery. Even in smaller patients, we opted for the use of four trocars, maintaining inter-trocar distances of less than 4 m when necessary. This configuration allowed us to fully exploit the advantages of an additional robotic arm, thereby avoiding the need for an accessory trocar, which can be ergonomically challenging for the bedside assistant in certain scenarios. This approach also enhances control for the console surgeon, improving operative precision and efficiency.

In our cohort, 53 patients (9.3%) weighed less than 10 kg, with ages ranging from 4 to 25 months. Patients weighing between 10 and 15 kg accounted for 21.9% of the cohort. These findings suggest that low body weight (except when less than 5 g) is not a contraindication for robotic surgery.

We performed an analysis to assess whether there was an association between patient weight categories and the likelihood of conversion from robotic to open surgery. Patients were categorized into three weight groups (<15 kg, 15–30 kg, >30 kg). The Chi-square test showed no statistically significant association between these weight categories and conversion rates (χ² = 1.60, p = 0.45), indicating that conversion rates do not differ significantly across the defined weight groups. 3.

Complications and Conversions

The Chi-square test revealed a statistically significant association between patient complexity category and the likelihood of conversion from robotic to open surgery (χ² = 33.61, p < 0.001), indicating that the conversion rate varies significantly across complexity levels.

Our patient series confirms that gastrointestinal, thoracic, and urological reconstructive procedures can be successfully completed using robotic surgery. However, complex oncologic procedures, particularly those involving Image-Defined Risk Factors (IDRFs), are more likely to require conversion, with a conversion rate approaching 27.7% in our series.

Oncological procedures that required conversion to open surgery were, in most cases, not due to emergency situations, but rather due to significant anatomical alterations—especially in patients who had previously undergone radiotherapy, chemotherapy, or prior surgery. The decision to convert to open surgery was influenced by several factors, most commonly the complexity of vascular management. Additionally, conversions were sometimes required due to indistinct tumor margins or the presence of adhesions complicating the procedure. Based on this experience, it can be suggested that tumors subjected to preoperative treatments present challenges for minimally invasive surgery.

Postoperative major complications occurred in 47 out of 569 cases, representing a rate of 8%. The early complication rate observed in our patient series is consistent with previously published data, which report an incidence ranging between 2.5% and 8% (10, 15).

The Chi-square test did not reveal a statistically significant association between ASA class and the occurrence of postoperative complications (χ² = 5.69, p = 0.13). 4.

Laparoscopic vs. robotic surgery

A multicenter study involving 322 patients undergoing pyeloplasty reported that operative time was significantly shorter in open procedures compared to laparoscopic and robot-assisted laparoscopic approaches (p < 0.0001). The duration of hospital stay was reduced in the robotic-assisted group relative to the other techniques (p < 0.0001) (21).

Additionally, robotic-assisted nephrectomy has proven to be a valid and efficient alternative to conventional laparoscopic nephrectomy in managing renal duplication. Although robotic-assisted surgery generally incurs higher hospitalization costs, primarily attributable to equipment and technology, it demonstrates comparable overall cost-effectiveness with traditional laparoscopy (22). The literature indicates that robotic-assisted nephrectomy is associated with fewer complications, decreased postoperative pain, and shorter recovery periods, potentially reducing healthcare expenses and improving patient outcomes.

Other studies comparing gastrointestinal surgical approaches have evaluated standard laparoscopy against robotic surgery. A meta-analysis on the surgical treatment of Hirschsprung's disease (HSCR) confirms that RS appears to be a safe alternative to laparoscopy in pediatric patients. Four studies, totaling 291 pediatric patients (124 treated with robotic-assisted surgery and 167 with laparoscopic-assisted surgery), demonstrated that RS was associated with significantly reduced intraoperative blood loss (23). However, this benefit was counterbalanced by notably higher hospitalization costs.

Initial outcomes of the robotic-assisted Heller-Dor procedure for pediatric achalasia suggest several advantages over conventional laparoscopy, including reduced blood loss (23 ± 15 ml vs. 95 ± 15 ml; p < 0.001) and shorter operative time (178 ± 25 min vs. 239 ± 55 min; p = 0.009) (24). Notably, the RS group exhibited no recurrences, compared to five in the laparoscopic group (p = 0.039), a significantly lower reintervention rate (0% vs. 41.7%; p < 0.039), and markedly reduced overall healthcare costs ($28,660 vs. $60,360; p < 0.001) (24).

The clinical benefits of robotic surgery over laparoscopy become more evident in complex procedures. A study involving 90 pediatric patients (66 females and 24 males) comparing robotic (n = 20) and laparoscopic (n = 70) approaches for Roux-en-Y hepaticojejunostomy in cases of choledochal cysts found that RS yielded significantly lower intraoperative blood loss and shorter hepaticojejunostomy completion times (58 ± 12 min vs. 71 ± 11 min; p < 0.001) (25). However, the total operative time was longer in the robotic group (284 ± 14 min vs. 195 ± 18 min; p < 0.001). The robotic approach provided improved ergonomics and superior surgical conditions, supporting the integrity of the hepaticojejunostomy, which is essential for surgical success. 5.

Training, research and economic aspects

Some authors suggest that robotic surgery has achieved wider adoption more rapidly than traditional laparoscopy, primarily due to its ability to facilitate complex procedures with a shorter learning curve (26, 27). Enhanced wrist articulation, high-definition magnification, and three-dimensional visualization have transformed the laparoscopic landscape. These technological advances significantly reduce the number of cases required to achieve surgical proficiency, allowing even less experienced laparoscopists to perform advanced minimally invasive procedures with high precision and consistency (28).

However, this rapid adoption raises concerns, particularly regarding the potential for increased complication rates as access to robotic systems becomes more widespread. This is especially relevant in highly complex neonatal procedures, such as tracheoesophageal fistula repair, where the rarity of the condition limits the number of cases a surgeon can perform annually, making it difficult to overcome the steep learning curve.

The introduction of new surgical technologies not only brings novel tools but also introduces new paradigms in knowledge acquisition, cognitive processing, and intraoperative decision-making. It demands enhanced situational awareness, evolving team dynamics, and continuous reassessment of operative strategies (28). While robotic systems offer substantial advantages, their integration into clinical practice carries inherent risks—such as inefficiency, increased procedural complexity, and potential harm—if not carefully managed.

Economic considerations, primarily evaluated through incurred costs and revenues generated from national health system reimbursements, currently represent one of the main barriers to the widespread adoption of robotic surgery. Moreover, traditional cost-benefit analyses based solely on financial statements are often inadequate for evaluating innovative technologies with significant social and ethical implications. This is due to the limitations of purely accounting-based methods in capturing broader social impacts on healthcare organizations and their stakeholders.

As part of the Health Technology Assessment (HTA) throughout the entire life cycle of the technology and procedure, and with the goal of improving robotic surgery outcomes—including from an economic perspective—it may be both important and beneficial to enhance operating room planning in terms of staffing, scheduling, and procedural estimation. These improvements could help optimize resource utilization and support better negotiation of material costs.

The clinical benefits highlighted in this paper (and in the references) support the use of robotic systems in pediatric surgery and open the door for more comprehensive cost-benefit evaluations of this innovative technology.

In particular, it will be valuable to explore both HTA dimensions—such as safety, clinical effectiveness, economic evaluations, and organizational, ethical, legal, and social aspects—and the Social Return on Investment (SROI), a framework designed to measure the total social value created by an activity in relation to the costs incurred. Such analyses will allow for a more holistic understanding of the impact of robotic surgery and enable the development of robust proposals to revise diagnosis-related group (DRG) reimbursement rates for pediatric robotic interventions. This, in turn, would support the assessment of both financial and social returns, ultimately guiding more ethical and sustainable healthcare policies.

Pediatric RS marks a significant advancement in the evolution of minimally invasive surgical techniques. Our data suggest that RS provides substantial advantages in terms of precision, visibility, and control during complex procedures, even in pediatric patients with lower age and weight. The centralization of resources in specialized centers is crucial for optimizing outcomes and ensuring the safety and effectiveness of pediatric robotic surgery.