Safety and Efficacy of a Novel Miniaturized Robotic-Assisted Surgery System in Colectomy: A Prospective, Investigational Device Exemption Clinical Study Using the IDEAL Framework

Abstract

BACKGROUND:

Robotics has increased rates of minimally invasive surgery, with distinct advantages over open surgery. However, current commercially available robotic platforms have device and system issues that limit robotic-assisted surgery expansion.

OBJECTIVE:

To demonstrate the safety and efficacy of a novel miniaturized robotic-assisted surgery device in colectomy.

DESIGN:

Prospective, Investigational Device Exemption clinical study following the idea, development, exploration, assessment, and long-term follow-up framework (stage 2b, exploration).

SETTINGS:

Three centers with high-volume robotic colorectal cases and surgeons.

PATIENTS:

Patients scheduled for a right or left colectomy for benign or malignant disease.

INTERVENTION:

Colectomy with the novel miniaturized robotic-assisted surgery device.

MAIN OUTCOME MEASURES:

For safety, intraoperative and device-related adverse events and 30-day morbidity. For efficacy, successful completion of predefined procedural steps without conversion.

RESULTS:

Thirty patients (13 women, 17 men) were analyzed. The mean age was 59.4 (SD 13.4) years. Seventy percent of patients (n = 21) were overweight/obese and 53.3% of patients (n = 16) had prior abdominal surgery. Forty percent of patients had malignant and 60% had benign disease. Cases were 15 right and 15 left colectomies. Overall operative time was a median of 146 (range, 80–309) minutes; console time was 70 (range, 34–174) minutes. There were no conversions to open surgery and no intraoperative or device-related adverse events. In 100% of patients (n = 30), the primary dissection was completed, and hemostasis was maintained with the novel miniaturized robotic-assisted surgery device. The morbidity rate was 26.7% minor and 3.3% major. The median length of stay was 2 days. There were no mortalities.

LIMITATIONS:

Single-arm study, short-term follow-up.

CONCLUSIONS:

This first clinical study of a novel miniaturized robotic-assisted surgery device along the IDEAL framework demonstrated that it was safe and effective. Given this success, further assessment and long-term follow-up of the miniaturized robotic-assisted surgery device are planned for comparative clinical and economic effectiveness in colorectal surgery. See Video Abstract.

SEGURIDAD Y EFICACIA DE UN NOVEDOSO SISTEMA DE CIRUGÍA ASISTIDA POR ROBOT MINIATURIZADO EN COLECTOMÍA: UN ESTUDIO CLÍNICO PROSPECTIVO DE INVESTIGACIÓN DE EXENCIÓN DE DISPOSITIVO QUE UTILIZA EL MARCO IDEAL

ANTECEDENTES:

La robótica ha aumentado las tasas de cirugía mínimamente invasiva, con claras ventajas sobre la cirugía abierta. Sin embargo, las plataformas robóticas actualmente disponibles comercialmente tienen problemas con los dispositivos y sistemas que limitan la expansión de la cirugía asistida por robot.

OBJETIVO:

Demostrar la seguridad y eficacia de un novedoso dispositivo de cirugía asistida por robot miniaturizado en colectomía.

DISEÑO:

Estudio clínico prospectivo de investigación de exención de dispositivo siguiendo el marco IDEAL (Etapa 2b, exploración).

ESCENARIO:

Tres centros con cirujanos y casos colorrectales robóticos de gran volumen.

PACIENTES:

Pacientes programados para colectomía derecha o izquierda por enfermedad benigna o maligna.

INTERVENCIÓN:

Colectomía con el nuevo dispositivo de cirugía asistida por robot miniaturizado.

PRINCIPALES MEDIDAS DE RESULTADO:

Para la seguridad, eventos adversos intraoperatorios y relacionados con el dispositivo y morbilidad a 30 días. Para la evaluación de la eficacia, la finalización exitosa de los pasos predefinidos sin conversión.

RESULTADOS:

Se analizaron treinta pacientes (13 mujeres, 17 hombres). La edad media fue 59,4 (DE 13,4) años. El 70% (n=21) tenía sobrepeso/obesidad y el 53,3% (n=16) había tenido cirugía abdominal previa. El 40% tenía enfermedad maligna y el 60% benigna. Los casos fueron 15 colectomías derechas y 15 izquierdas. La mediana del tiempo operatorio general fue de 146 (rango, 80-309) minutos; 70 (rango, 34-174) minutos fue el tiempo de consola. No hubo conversiones a cirugía abierta ni eventos adversos intraoperatorios o relacionados con el dispositivo. En el 100% (n=30), se completó la disección primaria y se mantuvo la hemostasia con el novedoso dispositivo de cirugía asistida por robot miniaturizado. La tasa de morbilidad menor fue de un 26,7% y mayor un 3,3%. La mediana de estadía fue de 2 días. No hubo mortalidad.

LIMITACIONES:

Estudio de un solo brazo, corto plazo de seguimiento.

CONCLUSIONES:

Este primer estudio clínico de un novedoso dispositivo de cirugía asistida por robot miniaturizado según el marco IDEAL demostró que era seguro y eficaz. Dado este éxito, se planean evaluaciones adicionales y seguimiento a largo plazo del dispositivo de cirugía asistida por robot miniaturizado para comparar la efectividad clínica y económica en la cirugía colorrectal. (Traducción—Dr. Felipe Bellolio)

Video Abstract

Video Abstract.

Download video file ^{(30.8MB, mov)}

There is growing evidence that short-term outcomes, complications, and quality of life are all improved after a minimally invasive approach to colon surgery.^1–3 The question of whether robotic surgery is superior to laparoscopic techniques remains a topic of debate. However, robotic surgery was associated with a decreasing trend in overall morbidity in a cohort study of 78,987 elective colectomy procedures (2013–2018) reviewed within the American College of Surgeon-National Surgical Quality Improvement Program Program.⁴ This study demonstrated that robotic surgery is independently associated with a lower rate of short-term morbidity and surgical conversion compared to both open and laparoscopic approaches while allowing a decrease in length of stay (LOS). Laparoscopic and robotic colectomy are also proven to be more cost-effective than open resection.⁵ Moreover, robotic surgery had a steady increase in use over the years, reaching 12% of all colectomies and 22% of all proctectomies, nationally, in 2015.⁶

The miniaturized robotic-assisted surgery device (mRASD), MIRA Surgical System (Virtual Incision Corporation, NE), investigated in this study was developed as a minimally invasive platform that can be deployed anywhere, eliminating the need for dedicated robotic rooms and assigned blocks. Its design simplifies setup time and optimizes both access to the patient and communication with the operating team while allowing seamless operating in multiple quadrants. This lightweight, reusable design and the potential cost reductions promise to allow wider adoption of the mRASD, allowing more patients to benefit from better outcomes and faster recovery associated with minimally invasive procedures. Moreover, the mRASD is reusable for 15 uses after sterilization by vaporized hydrogen peroxide (Sterrad or Steris).

The technical difference between mainframe robotics and motorized robotic arms is that they triangulate inside the patient’s abdominal cavity instead of externally. Figure 1 shows the mRASD system architecture, and Table 1 presents mRASD measurements. Using a support arm, the mRASD and integrated camera are mounted to any operating table. The mRASD has 2 motorized arms that have 6 degrees of freedom (Fig. 2). Its cross-sectional workspace is 6.7 inches (170 mm) wide and 3.125 inches (80 mm) deep. This cross-section is swept approximately 180° about the shoulder pitch joint (Fig. 3). The mRASD functions equally over any sweep angle from +90° to –90°, whereas the articulating camera ensures that the instruments can be always in view. Repositioning can be easily performed by adjusting the support arm. This ability to change the overall position of mRASD, combined with the reach and dexterity of the arms, enables surgery throughout the abdominal cavity.

FIGURE 1.

The mRASD surgical system architecture (MIRA): surgical mini bot, articulated camera, and surgeon console. mRASD = miniaturized robotic-assisted surgery device.

TABLE 1.

mRASD measurements

	Surgeon console	Patient cart	Vision cart
Height	65.5 in (166 cm)	87.5 in (222 cm)	81.5 in (207 cm)
Width	48 in (122 cm)	50 in (127 cm)	49 in (124 cm)
Depth	47.5 in (121 cm)	70 in (178 cm)	44 in (112 cm)
Weight	793 lb (360 kg)	2292 lb (1039.6 kg)	788 lb (357.4 kg)

mRASD = miniaturized robotic-assisted surgery device.

FIGURE 2.

The mRASD arms have 6 degrees of freedom, including the open/close function of the tool. The shoulder joint can yaw (θ₁), pitch (θ₂), and roll (θ₃) about the upper arm segment. These first 3 axes of rotation approximately intersect at the shoulder joint. The mRASD elbow allows rotation (θ₄) of the forearm with respect to the upper arm. Finally, the instrument can roll (θ₅) about the long axis of the instrument with instruments having an open/close actuation (θ₆) capability. mRASD = miniaturized robotic-assisted surgery device.

FIGURE 3.

The mRASD reachable workspace: the cross section is swept approximately 180° about the shoulder pitch joint. The workspace cross section is approximately 6.7 inches (170 mm) wide and 3.125 inches (80 mm) deep. The mRASD functions equally over any sweep angle from +90° to –90°. The camera can sweep between +70° to –70°. mRASD = miniaturized robotic-assisted surgery device.

The goal of this study was to demonstrate the safety and efficacy of this novel mRASD in colectomy procedures. We report results based on idea, development, exploration, assessment, and long-term follow-up (IDEAL) stage 2B format.⁷

MATERIALS AND METHODS

Study Design

A prospective, multicenter, single-arm study with standardized data collection was performed at 3 sites in the United States. The study was performed in accordance with the IDEAL framework for implementing surgical innovation into practice and deemed stage 2b exploration.⁷ Four surgeons performed the procedures; all were experienced in laparoscopic and robotic procedures, having all performed more than 250 colectomies both laparoscopically and robotically.

Study Population

Patients were eligible for enrollment if they had a malignant or benign indication for colectomy and were deemed appropriate for a minimally invasive resection by the surgeon.

Inclusion and Exclusion Criteria

Eligible patients were included if they were aged between 22 and 85 years, able to provide informed consent, and willing to comply with follow-up data collection for 30 days postprocedure and/or until resolution of all reported adverse events (AEs). Patients were excluded if they had a diagnosis of rectal cancer, clinical T4 or stage IV colon cancer, had an active infection, or were ASA class IV to VI. Patients were also excluded if they had polyps that could be completely removed with negative surgical margins by colonoscopy, had a history of abdominal adhesions or bowel obstruction, end-stage renal disease, liver cirrhosis, were pregnant or lactating, had major surgery within 30 days of study enrollment, were participating in another clinical study, had hemoglobin <8.0 g/dL, or were coagulopathic. Finally, if, in the opinion of the investigator, the patient was not likely to comply with the required protocol, patients were excluded. To assure that the mRASD would fit within the abdominal space and be able to reach target areas, criteria for the patient’s built were defined as BMI >19.5 or <45 kg/m², height >60 inches (152 cm), and weight >100 pounds (45.4 kg).

Study End Points

The primary efficacy end point was the successful completion of predefined procedural steps without conversion to open surgery. Although the specifics of each operation were at the discretion of the surgeon, the required predefined steps with the device involved manipulating the tissue and primarily exposing and dissecting the right or left colon using the device. The use of laparoscopic ports for ancillary tasks involving suction, stapling, retraction, or advanced energy devices was permitted and documented. The primary safety end points were overall intraoperative and postoperative AEs and the incidence of serious AEs (device and/or procedure-related). All AEs were captured, and an independent Clinical Events Committee and Data Safety Monitoring Board oversaw the study conduct and adjudicated AEs, which were categorized as serious or nonserious and device or procedure related. Events were recorded as Preferred Term and classified under System Organ Class as per MedDRA Common Terminology Criteria for Adverse Events (CTCAE) coding guidelines.⁸ The clinical complications were separately analyzed per the Clavien-Dindo classification system.⁹ Secondary end points were operative time, number of trocars placed, postoperative LOS, pathological assessment of completeness of resection, number of lymph nodes (in malignant cases), and reoperation, readmission, and reencounter rates within 30 days.

Surgical Procedure

Training

All surgeons underwent the same 1.5-day training program designed to provide the technical knowledge to ensure the safe and effective use of the MIRA Surgical System. This training included the introduction of a technological system, the use of a simulator, benchtop skills training, and surgical skill laboratories consisting of a live porcine model and a cadaveric colonic dissection.

mRASD Setup

A hand-assist port is placed periumbilically, and the abdomen is insufflated up to 15 mm Hg. Inspection is performed using the 5-mm robotic camera, and then a 12-mm trocar is placed under direct visualization, 10–12 cm away from the hand-assist port, in the right lower quadrant for left/sigmoid colectomy and along the left costal margin for right colectomy. Table tilt and degree of Trendelenburg can be adjusted as needed. A support arm (comparable to the single post of a Martin arm) is attached to the table’s side rail. The mRASD is deployed through the hand-assist port under direct visualization. However, a hand-assist technique was not used during the procedure. The arms open inside the abdomen and are oriented toward the target anatomy. Multiquadrant access is achieved by 360° rotation around its axis, and the surgical space is further enhanced by sweeping the arms and plunging the mRASD system in and out (Fig. 3). Setup time of the robot was determined by the time of introduction of the camera into the ancillary port to visualize insertion of the mRASD through the gel port and the time of insertion of the camera into the robot, which allows initiation of the surgery from the console.

Left Colon

A medial-to-lateral dissection is performed. All dissection is performed using robotic manipulations with the bipolar grasper and monopolar scissors. Major vessels are divided using laparoscopic vessel sealers, and the bowel is transected using a laparoscopic linear stapler by the bedside assistant. Splenic flexure mobilization is performed per the surgeon’s discretion, depending on length and redundancy of the anatomy. The proximal colon is exteriorized through the wound protector of the hand-assist port, and extracorporeal resection and anvil placement are performed (see Fig. 4). The colon is returned to the abdomen and an end-to-end anastomosis is created. Fluorescence angiography and leak testing are performed at the surgeon's discretion.

FIGURE 4.

Left hemicolectomy. A, Position mRASD and ancillary port(s). B, Mobilization left colon. C, Mobilization sigmoid colon. D, Mobilization splenic flexure. mRASD = miniaturized robotic-assisted surgery device.

Right Colon

A medial-to-lateral dissection is performed. The dissection is performed with the robotic tools. Laparoscopic vessel sealers are used by the bedside assistant to ligate the ileocolic pedicle. Once fully mobilized, the right colon is extracted, and a stapled extracorporeal anastomosis is performed. The bowel is returned to the abdominal cavity and inspected (see Fig. 5). Hemostasis is ensured, and fluorescence angiography is performed at the surgeon's discretion. At the end of the procedure, the mRASD system is extracted using direct visualization. The fascia and skin are closed in a standard manner.

FIGURE 5.

Right hemicolectomy. A, Position mRASD and ancillary port. B, Cecum mobilization. C, Mobilization hepatic flexure. D, Division of the ileocolic vessels. mRASD = miniaturized robotic-assisted surgery device.

Statistical Analysis

A sample size of 30 would provide an 80% chance to observe at least 1 safety event if the event occurred in at least 5.3% of subjects. The upper bound of the event rate if no events were observed or for the rate of conversions to open surgery if no conversions were reported was 11.6%. The study would be considered to have demonstrated the effectiveness of the device if the observed conversion rate is less than 17% or, equivalently, had no more than 5 of the patients converting to open surgery. Descriptive statistics were used with incidence and percentages for categorical variables. For primary and secondary outcomes, 2-sided 95% CIs were performed on the basis of the exact binomial interval or for the mean value using a 2-sided T-distribution.

Ethical Information

This study was performed under an investigational device exemption (No. G200257; Clinicaltrials.gov identifier NCT04703829) from the Food and Drug Administration. All clinical sites received Institutional Board Approval. All patients had full disclosure on the novelty of the device, risks, and benefits and signed informed consent to participate. Objectivity was ensured by the Clinical Events Committee and the independent Data Safety Management Board.

RESULTS

Between August 2021 and February 2023, 30 patients with a mean age of 59.4 (SD 13.4) years were consented and enrolled (Fig. 6). Patient demographics are reported in Table 2. The indications for surgery were cancer (40.0%), polyp(s) (40.0%), diverticulitis (16.7%), and cecal mass (3.3%). Seventy percent of patients were overweight or obese, and 53.3% had prior abdominal surgery. Sixty percent of patients had mild systemic disease (ASA II) and 40% had severe systemic disease (ASA III).

FIGURE 6.

Summary of patient enrollment and accountability. I/E = inclusion/exclusion criteria.

TABLE 2.

Patient demographics and characteristics

Parameters	N = 30
Sex, n (%)
Male	17 (56.7)
Female	13 (43.3)
Age, y, n (%)
<55	10 (33.3)
55–64	7 (23.3)
65–74	11 (36.7)
≥75	2 (6.6)
Age, y, mean (SD)	59.4 (13.4)
Race n (%)
White	28 (93.3)
Black	2 (6.7)
BMI Classification,a n (%)
Normal, 18.5–24.9	9 (30)
Overweight, 25.0–29.9	13 (43)
Obese, ≥30	8 (27)
BMI, kg/m2, mean (SD)	28.2 (6.1)
ASA Classification,b n (%)
I, Normal healthy patient	0 (0)
II, Patient with mild systemic disease	18 (60)
III, Patient with severe systemic disease	12 (40)
Indications for surgery, n (%)
Diverticulitis	5 (16.7)
Known cancerc	12 (40.0)
Tubulovillous adenoma	8 (26.7)
Polyp	3 (10)
Cecal mass	1 (3.3)
Polyposis	1 (3.3)
Prior abdominal surgery, n (%)
Yes	16 (53.3)
No	14 (46.7)

^aRanges provided are based on guidelines from the Centers for Disease Control and Prevention.

^bPatients with ASA IV were excluded from enrollment in the study.

^cDiagnosis before enrollment.

The cases performed were 15 (50.0%) right colectomy and 15 (50.0%) left colectomy. The mRASD setup time was a median of 5 minutes (range, 1–20 minutes). The overall mean operating time was 163 (SD 56.5) minutes, with an average console time of 77 minutes. For right colectomy, it was 147 minutes (range, 80–228), whereas for left colectomy, it was 179 minutes (range, 112–309). One assist port (in addition to the GelPort) was placed in 63% of patients, and 2 were used in 37% of patients. No relevant device issues were noted, and the arms consistently performed the surgeons’ commands from the console. The device was manually repositioned a mean of 6 times. Repositioning was not measured specifically. It took approximately 30 to 90 seconds, depending on the change of distance or quadrant. Anastomoses were performed extracorporeally in all right colectomies. For left colectomies, the specimen was extracted, the pursestring and anvil were placed extracorporeally, and the anastomosis was performed intracorporeally. One hundred percent of cases successfully had the primary dissection completed, and hemostasis was achieved with the device. The inferior mesenteric artery and the colic arteries were transected, after dissection by the mRASD, using a laparoscopic vessel sealer indicated for the transection of named vessels. Assessment of efficacy was self-evaluated by the operating surgeon and confirmed through video review by the clinical study team. No patients required intraoperative conversion to open surgery (95% CI, 0%–11.6%). There were no intraoperative AEs or surgical complications. On pathology, all malignant cases had a complete resection with negative margins and adequate lymph node sampling (>12 nodes; median 26; range, 17–64). The mean intraoperative blood loss was 55.8 mL, and 1 patient received a postoperative transfusion during the management of an anastomotic leak.

The median LOS was 2 days (range, 2–26). There was 1 unplanned reoperation (3.3%) within 30 days. There were no readmissions, and 4 patients had an unplanned follow-up visit related to surgical site concerns. There were no device-related complications and no mortality. A total of 22 events were recorded in 10 patients (excluding minor and expected AEs, such as nausea, rashes, and postoperative pain). According to the Clavien-Dindo classification, 15 surgical complications were observed in 9 patients (Gr I: 6, Gr II: 5, GrIIIa: 2, GrIIIb: 1, GrIVb: 1), as listed in Table 3.

TABLE 3.

Summary and description of surgical AEs

Patient	Adverse event term	Clavien-Dindo classification
01-102	Incision site cellulitis	Grade I
01-109	Surgical site infection	Grade I
01-113	Surgical site infection	Grade I
01-101	Ileus	Grade I
01-110	Hematochezia	Grade I
01-115	Hematochezia	Grade I
01-112	Deep vein thrombosis	Grade II
04-101	Incision site wound dehiscence	Grade II
02-116	Superficial vein thrombosis	Grade II
02-116	Paroxysmal atrial fibrillation	Grade II
02-116	Anemia requiring transfusion	Grade II
02-116	Pneumonia with pleural effusion	Grade IIIa
02-116	Pelvic abscess	Grade IIIa
02-116	GI anastomotic leak	Grade IIIb
02-116	Septic shock	Grade IVb

All major/Clavien-Dindo grade III and greater complications occurred in a single patient. This patient, operated on for a stage II sigmoid adenocarcinoma, had an anastomotic leak initially managed with percutaneous drainage but ultimately required reoperation with a diverting ileostomy. This patient had severe comorbidities at baseline, including obesity, hypertension, insulin-dependent diabetes mellitus, and chronic renal disease. The anastomotic leak led to a sequence of complications, including atrial fibrillation, pelvic abscess, pleural effusion, and septic shock, from which the patient fully recovered.

DISCUSSION

This prospective study, representing the first experience with mRASD for left and right colectomies, demonstrated technical effectiveness and a surgical safety profile in line with the studied patient population. In all participants, the colon was adequately and primarily dissected and exposed with the graspers and scissors of the mRASD for tissue manipulation, cutting, blunt and sharp dissection, and tissue hemostasis with electrocautery, all while maintaining pneumo-peritoneum and visualization. The study demonstrated an acceptable safety profile for right and left colectomy, with all complications greater than Clavien-Dindo grade II occurring in a singular patient after an anastomotic leak not related to the use of the mRASD.

The aim of this study was not to establish superiority or noninferiority in current surgical approaches but to demonstrate safety and feasibility, which was accomplished. In addition, the study demonstrates that the miniaturized novel RASD may offer some unique benefits. As the RASD is based on triangulation of the arms of the robot inside instead of outside of the body, the platform seems able to accomplish similar outcomes to benchmark robotic and laparoscopic colectomies with low conversion rates. With the ease and short setup time, we could have achieved reduced operative times. However, further studies will be required to determine that. The ROLARR trial, a prospective randomized controlled trial with expert colorectal surgeons highly experienced in minimally invasive approaches, reported conversion rates of 12.2% in the conventional laparoscopic surgery group versus 8.1% in the robotic-assisted surgery group (95% CI, 1.4–9.6).¹⁰ Similar conversion rates in colectomy procedures have been reported in population-based and retrospective case studies.^1,11–13 Compared to an overall intraoperative complication rate of 0% in this study, the ROLARR trial reported a rate of 15%, with the most common intraoperative complications being organ damage, significant hemorrhage, and surgical equipment failure.¹⁰ Jayne et al¹⁰ reported an overall 30-day postoperative complication rate of 33.1% in the robotic-assisted surgery group, similar to the 33.3% in this study, including a 9.9% and 12.2% anastomotic leak rate in the laparoscopic and robotic surgery groups, respectively. Of note, although no problems or complications arose from the intracorporeal nature of the elbows, as with other minimally invasive surgery approaches, the arms need to be visualized with movements to avoid unrecognized difficulties.

This article represents an IDEAL stage 2b study reporting on the exploration of a novel robotic device designed to perform intra-abdominal soft tissue procedures.^14,15 The study was therefore conducted in a collaborative, multicenter study. The technique followed the current standard of care for colectomy procedures, and the steps evaluating the efficacy of mRASD were clearly defined in the study protocol. The evaluation confirmed the anticipated efficient setup times, based on its lightweight design, coming “off the shelf” in a compact sterile tray, and being able to be mounted to any operating room table without draping or docking. With respect to the surgical technique, it must be noted that the gel port was placed periumbilically during the initial phase of the study, as it was thought it would maximize the workspace. As the surgeon investigators gained confidence with the device, more off-midline muscle-splitting port placements occurred. This will likely benefit long-term outcomes, as muscle-splitting incisions reduce long-term hernia rates.¹⁶ As all participating surgeons were experienced with the daVinci robotic systems (Intuitive Surgical, Sunnyvale, CA), the main unlearning that needed to take place was shifting operating “from the wrist” to “from the elbow.” The straight-up position at the open console and the relaxed’ pistol grip position of the hands-on the controllers facilitate this method of operating, in contrast to the prolonged neck flexion associated with immersing oneself into the stereo viewer while grasping the controllers with finger and thumb in a confined space underneath the viewer.

We recognize the limitations of this study. The largest limitation is the uncontrolled design, which could introduce biases in the results, as well as the relatively small number of patients and surgeons. This could limit the generalizability of the results. The limited number of procedures and the extensive amount of mainframe robotic and preclinical surgical experience on the device by some investigators prevented the establishment of an operator learning curve for the use of the mRASD. Regardless of any limitations, there are valuable clinical implications and benefits of the novel innovation presented. The IDEAL framework for surgical innovation was followed, transforming a case series into a stepwise assessment of safety and best practices for efficient, effective implementation into clinical practice.^14,15 As other studies in robotic colon surgery have demonstrated, following the recommendations of the IDEAL framework helps address the applicable questions about the appropriate introduction of novel robotic-assisted surgical devices to assess their comparative effectiveness and safety.^17–19 To date, surgical robots are machines that can be reprogrammed for different movements, with increased degrees of wristed mobility compared to laparoscopic instruments. Robots are characterized by their capability to offer surgeons optimized visualization, precision, and control. All of these apply to the mRASD platform described in this study, which differentiates itself by being portable, namely coming out of a tray. The respective advantages and disadvantages between “mainframe” and “miniaturized” robotic-assisted surgery devices remain to be determined and will only transpire in their real-world use and reporting thereof. It must also be noted that only a bipolar grasper and monopolar scissor were available during this study. Features such as fluorescence capability, needle driving, and vessel sealing are desirable for certain procedures and will need to be added to allow for broader device adoption. Following the IDEAL framework for established procedures, the investigators are of the opinion that a device registry, aggregating real-world evidence, will be best positioned to provide ongoing safety surveillance and additional evidence for its clinical and economic effectiveness.^14,15

CONCLUSION

This first clinical study of a novel miniaturized robotic-assisted surgery device along the IDEAL framework demonstrated it was safe and effective. Given this success, following the decision of Food and Drug Administration, further assessment and long-term follow-up of the miniaturized robotic-assisted surgery device will be required to determine comparative clinical and economic effectiveness in colorectal surgery.