Safety with Innovation in Colon and Rectal Robotic Surgery

Abstract

Robotic colorectal surgery has been touted as a possible way to overcome the limitations of laparoscopic surgery and has shown promise in rectal resections, thus shifting traditional open surgeons to a minimally invasive approach. The safety, efficacy, and learning curve have been established for most colorectal applications. With this and a robust sales and marketing model, utilization of the robot for colorectal surgery continues to grow steadily. However, this disruptive technology still requires standards for training, privileging and credentialing, and safe implementation into clinical practice.

Introduction of Robotic Surgery

Colorectal surgery has historically embraced technology as a means to improve efficiency and patient outcomes. The introduction of laparoscopic colorectal surgery was the largest disruptive technological advance to date. Laparoscopic colorectal surgery significantly improved postoperative recovery, length of stay, patient satisfaction, complications and readmission rates, and reduced overall health care costs compared with open colorectal surgery. ^{1 2 3 4 5 6 7 8} Despite the proven benefits, laparoscopic techniques are not pervasive in clinical practice, with utilization rates in approximately two-thirds of eligible cases, and significantly lower rates reported for cancer. ^{9 10} Robotic surgery is an emerging technology that could potentially expand use of minimally invasive colorectal surgery. Because of the growing demand by patients for less-invasive procedures, robotics has emerged as a technique that more colorectal surgeons are adopting. With more surgeons turning to robotics to improve their practices, and young surgeons graduating from colorectal residency programs, which facilitate robotic training, safety should be of utmost priority. Surgeons must be well versed in the technical and safety aspects of this technology for optimal outcomes.

Robotics have been in development for surgical applications for almost 30 years. The first robotic system to assist in a surgical procedure was the Programmable Universal Machine for Assembly (PUMA) 560 (Unimation, Danbury, CT) which was used by Kwoh et al in 1985 to create a stereotactic frame to perform a precise brain biopsy. ¹¹ This framework was used to develop the surgeon–assistant robot for prostatectomy (SARP), the prostate robot (PROBOT), and the UROBOT, which could be preprogrammed based on the fixed anatomic landmarks of each patient and applied to urological procedures, but could not be could not be applied in dynamic surgical targets, such as colorectal surgery. ^{12 13}

To expand the platform, scientists developed the “master-slave” robotic platform in the 1990's, which consisted of a robot with remote manipulators controlled by a surgeon at a surgical workstation. ¹⁴ In 1994, Sackier and Wang developed the Automated Endoscopic System for Optimal Positioning (AESOP; Computer Motion Inc., Goleta, CA). AESOP was approved as an endoscopic camera manipulator controlled by the surgeon's voice commands, eliminating the need for a bedside assistant. ^{15 16 17} It was used in multiple gastrointestinal procedures, including colectomy. ¹⁸ Sackier and Wang continued advancing the robotic technology, next developing the ZEUS system, a robot capable of reproducing the surgeon's arm movements. ¹⁹ The ZEUS emerged on the surgical scene in 2001, when a French surgeon used it for a laparoscopic cholecystectomy live at the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) annual meeting on a patient in France; use in other procedures, including colectomy, followed. ²⁰ In 2003, the Computer Motion, Inc., merged with Intuitive Surgical Inc. and discontinued development of the ZEUS platform. ²¹ All efforts were focused on Intuitive and the da Vinci platform.

In 1995, Intuitive Surgical Inc. was founded, introducing a prototype using master–slave software, three-dimensional (3D) immersive vision, and a sensor-based safety monitoring system. In 2000, Intuitive Surgical's da Vinci robotic system was FDA (Food and Drug Administration)-approved for human surgical applications in the United States. ¹⁴ The da Vinci Surgical System is currently the only available robotic surgical platform which is FDA-approved for intra-abdominal surgery. While we refer to the da Vinci Surgical System as a robot, it is technically a computer-assisted telemanipulator, as it lacks independent motions, has no preprogrammed actions, and there is a distance interposed between the surgeon and the patient. ²² The da Vinci system has evolved since the original version was released in 2000. In 2006, the S was released, followed by the Si in 2009, the Si-e in 2010, and the Xi in 2014. All versions use three main components: the control console, vision system cart, and the patient-side cart. The surgeon sits at a control console remote from the patient and controls the surgical instruments; the surgeon's hand and instrument tip movements are synchronous. The computer enhances the interaction between the surgeon and the bedside robotic device by eliminating tremor, scaling all motion for fine, precise movements, and providing a steady camera view directed by the surgeon. The vision system cart includes the processor, video monitor, light source, and camera equipment. The cart receives camera input and displays the live video for the surgeon at the control console. The patient-side cart has three to four robotic arms that execute the instrument motions and camera based on the surgeon's commands. ²² In the most modern Xi version, the arms are thinner, allowing for greater range of motion, and less external collisions. In addition, there is the flexibility to place the camera or instruments through any port, and docking is automated around the targeted specimen. With all versions, the da Vinci offers distinct technical benefits over traditional laparoscopic surgery, including highly magnified 3D vision, EndoWrist instruments with seven degrees of freedom, the preservation of natural eye–hand–instrument alignment, physiologic tremor filtering, motion scaling of up to 5:1, and better ergonomics for the surgeon, ²³ making use of robotic surgery appealing.

Growth and Utilization

Given these features, since the initial introduction of the da Vinci system, the use of robotic surgery has continued to grow. ^{24 25} For all general surgical procedures, which include colorectal surgery, use of the robot increased from 0.8 in 2008 to over 4% in 2009. ²⁵ For colorectal surgery specifically, a review of minimally invasive trends from the National Inpatient Sample (2009–2010) found almost 130,000 procedures were performed, with 2.8% through the robotic approach. ²⁴ Looking at procedures for colorectal cancer in U.S. hospitals, robotic-assisted surgery accounted for only 1.3% of procedures from 2010 to 2012, but adoption of robotic surgery increased from 20.1% of hospitals in 2010 to 27.4% by 2012, and the percentage of patients treated robotically continues to steadily increase over time (1.5% in 2010 to 3.6% in 2012). ²⁶ The uptake is increasing particularly for rectal cancer surgery (2010, 5.5%; 2012, 13.3%) and then colon cancer surgery (2010, 1.3%; 2012, 3.3%). ²⁶

Movement to Colorectal Surgery

The robotic platform may have specific benefit in pelvic surgery, especially rectal cancer, where the robot may help the surgeon overcome challenges associated with difficult pelvic anatomy when performing a total mesorectal excision (TME). ²⁷ In selected rectal cancer patients, such as the obese, male gender, those who had preoperative radiotherapy, and those with tumors in the lower two-thirds of the rectum, robotic surgery could potentially offer better short-term outcomes and justify use with its increased cost over other minimally invasive platforms. ^{28 29}

Safety and Efficacy

Several studies have affirmed the equivalent safety, clinical, and oncologic outcomes to traditional laparoscopic colorectal surgery. ^{25 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50} The theme of equivalent outcomes with longer operative times and significantly higher costs is nearly universal, leading surgeons to look for value proposition with this technology.

Since gaining FDA approval, this technology has mostly been applied to gynecology and urology, with most published data on safety and feasibility coming from those fields. The literature in colorectal surgery continues to evolve. The learning curve for colorectal procedures has been described. Studies have shown that robotics has an attenuated learning curve compared with other minimally invasive platforms for colorectal surgery. ^{51 52} This has been demonstrated even for specific procedures, such as TME. For inexperienced laparoscopic surgeons, the robot can facilitate a one-step transition from open to robotic surgery, especially for rectal cancer. ^{53 54} While robotics eliminated the early learning curve for inexperienced laparoscopic surgeons, it improved the economy of motion for expert laparoscopic surgeons, which may enable performing more complex procedures. ⁵⁵ The 3D magnification and stability of the camera, freedom of movement with the robotic arms, EndoWrist instruments with seven degrees of freedom, ambidextrous capability, and tremor filtering may also contribute to the shorter learning curve compared with conventional laparoscopy. ⁵⁶ In addition, the learning curve is multiphasic, with initial learning of the technique, consolidation, and then higher expertise or mastery. ^{54 56 57 58} Thus, as surgeons become more experienced and comfortable with robotic surgery, they will incorporate more challenging cases which inherently have longer operative times.

Acquiring technical skills is distinct from acquitting the privileges to perform robotic surgery at a hospital. The implementation of guidelines and proctoring recommendations is necessary to protect surgeons, proctors, institutions, and patients who are associated with the institutional introduction of a robotic surgery. Currently, there are no national guidelines endorsing training, privileging, and credentialing. With no current standardized guidelines to guidance, the SAGES TAVAC committee published a white paper on da Vinci safety and effectiveness. ²² The New Technology Committee of the American Society of Colon and Rectal Surgeons continues to work on a white paper with recommendations on surgeon certification and proctorship but it is yet to be published.

Training and Credentialing

As we await standards from the surgical societies, basic guidelines for use and training have been set forth by Intuitive. To use a da Vinci robot, the surgeon must first complete online, bedside, and didactic training with animal. The surgeon must independently log onto the Intuitive Surgical web site, register for an account, and complete the online da Vinci Surgical System course with examination: Introduction to the da Vinci Surgical System—Features and Function. Successful completion will result in a certificate e-mailed to the trainee, and the ability to progress to the next step in training. That step depends on the surgeon's level, trainee or practicing surgeon, and the specific hospital's exposure and case requirements. For example, at Baylor University Medical Center, where the author completed fellowship training, there is a standardized general surgery curriculum for trainees, which mandates completion of simulator exercises ( Fig. 1 ), an in service with an intuitive representative on the equipment and technology, then a case series, which includes 30 cases as the console surgeon and 5 cases as the bedside assist to be credentialed. For practicing surgeons, there is a distinction in training, as skill sets are needed, not knowledge of procedures. After completing their online course and a specialty-specific in-service course with an intuitive representative, practicing surgeons are required to attend an off-site training laboratory sponsored by the company which teaches skill sets using the technology. The physician receives a laboratory certificate, which is presented to their specific hospital, to be used as part of the hospital's specific credentialing guidelines. At Baylor University Medical Center, the laboratory certificate must be approved by the credentialing committee, and then must perform five proctored cases to be credentialed. This is a model that could be universally followed ( Fig. 2 ).

Fig. 1.

Surgical skills simulation checklist.

Fig. 2.

Robotic surgical credentialing.

Competency for Credentialing

There is increasing pressure with technological advancement for surgeons to demonstrate safety and efficiency in training and beyond, particularly with robotic surgery. With peer review processes in hospitals failing to recognize technical advancement, surgeons adding robotics into practice may be cumbersome and can hinder innovation. ⁵⁹ General surgery residents are currently required to successfully complete the fundamentals of laparoscopic surgery (FLS) program and the fundamentals of endoscopic surgery (FES) through the Society of Gastrointestinal and Endoscopic Surgeons (SAGES) to graduate; practicing surgeons are encouraged to complete these programs for privileging and credentialing at most institution. However, there is currently no current requirement for robotic training in residency. A standard training and competency tool is in development that parallels the FLS and FES goals, the fundamentals of robotic surgery (FRS). FRS program is a proficiency-based curriculum created by surgical educators with a grant from the Department of Defense and from Intuitive Surgical to train and assess surgeons to safely and efficiently perform robotic-assisted surgery. ⁶⁰ The program uses basic technical skills to train and assess surgeons to safely and efficiently perform robot-assisted surgery. The program is currently undergoing multi-institutional validation studies and could become the standard for demonstrating robotic surgery and competency.

The FRS curriculum could be a tool to help surgeons overcome the challenges associated with what can be seen as a disruptive technology. While we await its validation, many programs are developing their own proprietary curricula to introduce robotic surgery in training and to certify physicians as skilled and competent. While there is no standardized training, consistency is seen across programs in the basis tenets for skills acquisition. The stepwise progression includes an overview of basic port placement principles, including patient cart position and instrument arm position, inserting and removing instruments, utilizing the stapler and energy sources, docking the system, and assimilation of technical skills.

Surgical simulation is another tool for developing and demonstrating competency. Simulation can be used for system skill drills, including suturing and knot tying, needle handling, transection, and manipulation. To provide a safe training environment, virtual reality (VR) simulators are available and may aid the progression along the learning curve. ⁶¹ There are several simulators available on the market, including the Intuitive Surgical Inc. system, the Mimic dV-Trainer, ProMIS, the SimSurgery Educational Platform (SEP), and the Robotic Surgical Simulator system ( Fig. 3 ). A systematic review by Abboudi et al found the Intuitive, Mimic, ProMIS, and SEP trainers had face, content, and construct validity, while the Robotic Surgical Simulator had only face and content validity; all simulator systems except SEP demonstrated educational impact. ⁶¹ Simulation has great potential as an adjunct to traditional training methods for safely assimilating robotic colorectal surgery, but more research is needed to validate the effectiveness of simulated training environments.

Fig. 3.

Robotic simulation model. Simulation from mimic technologies (Seattle, WA).

Safety in the Operating Room

In addition to adequate training and competency, the workflow and operating room (OR) team are also opportunities to address safety with new technology. Surgeons must anticipate these challenges in the OR and work to reduce flow disruptions, with their associated increases in surgical time and complications. Robotic surgery is the epitome of this, as the complex equipment and procedures increases chances for technological failures and increases communication requirements for the entire surgical team. ⁶² Flow disruptions in robotic surgery are common; a study by Catchpole et al found almost 10 flow disruptions/hour. ⁶² Disruptions can be caused by patient factors, communication and equipment issues, surgeon decision-making, poor team coordination, or training problems. With increasing complexity of the surgery, these disruptions are more frequent but surgeon experience and training can make a significant impact. ⁶² This shows an opportunity for nontechnical skills, such as training and communication, to communication to improve safety and reduce these errors. A dedicated, well trained OR team can also contribute to safety in robotic surgery. There are different communication types in minimally invasive surgery, including equipment- and patient-related challenges. ⁶³ A systematic review has affirmed that fixed team for minimally invasive platforms, like robotics, improve workflow and communication and decreased interruptions, technologic malfunction, delays, and errors. ⁶³ These nontechnical skills, including situation awareness, decision-making, communication, teamwork, and leadership, have been proven to contribute to overall team performance. ⁶⁴ With increased integration of robotics, the importance of teamwork and surgeon awareness will be stressed.

Conclusion

With the safety, efficacy, and learning curve for robotic colorectal surgery established, utilization continues to grow in colorectal surgery. Standard curriculums are underway for evidence-based competency and effectiveness with robotic surgery. This could be applied to privileging and credentialing for safe implementation into clinical practice. While these models evolve, tools are available to guide training and mastery. An emphasis on technical and nontechnical skills, as well as communication and teamwork in the OR, will facilitate safety with communication in robotic colorectal surgery.