The Future and Challenges of Surgical Technology Implementation and Patient Safety



Fig. 10.1
The renal hilum , Intuitive Surgical



The da Vinci® Surgical System is widely employed across multiple surgical specialties to perform minimally invasive procedures such as prostatectomy, gynecologic procedures, gastrointestinal procedures such as Heller myotomy, Nissen fundoplication, gastric bypass, colectomy, rectal surgery, hepatic, and pancreaticobiliary surgery. The Society of American Gastrointestinal and Endoscopic Surgeons Technology and Value Assessment Committee reviewed the safety and efficacy of robotic assisted surgery in gastrointestinal procedures in July 2015. A comprehensive review of current available literature demonstrated a non-inferiority in all reviewed gastrointestinal surgeries; however, a demonstrable benefit in improved surgical outcome or decreased length of stay was not observed.

There are a number of current trials investigating the efficacy of robotic surgery , particularly in pelvic surgery, across multiple specialties. The ROLARR trial is an ongoing international, multicenter, randomized, controlled, unblended, parallel group trial of robotic total mesorectal excision (TME) versus laparoscopic total mesorectal excision . The benefits of laparoscopic TME compared to open TME have been evaluated in multiple studies, and there are clear short-term benefits to a minimally invasive approach. The da Vinci® surgical system offers theoretical benefits when operating in the confined area of the pelvis, which could translate into a decrease in the technical difficulties associated with laparoscopic TME. Many centers are employing robotic procedures based on these theoretical benefits. The ROLARR trial is a practical trial designed to evaluate the benefits of robotic TME.

Robotic surgery is associated with an inherent increase in procedural costs. Over 500,000 robotic assisted procedures were performed worldwide in 2013; yet despite the widespread incorporation of robotic procedures, the added benefit versus cost remains unclear. Insurance providers generally reimburse robotic procedures at the same level as laparoscopic cases, despite the increased cost of using the robot system , such as required service charges by the robotic company, as well as increased consumable charges associated with each procedure. Schwaitzberg [1] investigated the financial viability of performing outpatient, robotic assisted procedures on the current platform and concluded that, depending on payer source, it is unlikely that robotic assisted outpatient procedures can be financially viable until such time that acquisition and tooling prices come down to a lower price point (Fig. 10.2).

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Fig. 10.2
The future of robotic surgery will undoubtedly include a variety of platforms outside of the currently employed console-based platform

The future of robotic surgery will undoubtedly include a variety of platforms outside of the currently employed console-based platform. Miniature robots will most certainly play a role in advancing minimally invasive surgical techniques of the future. These robots will be deployed through a small primary incision and will be configured inside of the abdomen or chest or specialize functions and controlled wireless fully from the exterior. In addition, the opportunity for non-console robots really functioning as specialized hand instruments will bring these capabilities on an as-needed basis to selected portions of the procedure.

The ARES, or Assembling Reconfigurable Endoluminal Surgical system (Scuola Superiore di Studi Universitari e di Perfezionamento Sant’Anna), is a prototypical, ingestable, component-based miniature robotic platform that the patient ingests in multiple components. The components then assemble within the fluid-distended gastric lumen to perform procedures. The theoretical applications for this platform are wide ranging, but could include pH sampling, biopsies, direct optical vision, and even DNA analysis (Fig. 10.3).

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Fig. 10.3
The hurdles in implementing this technology in vivo are many, including the power source, location monitoring, tool payload, maneuverability, and propulsion

The hurdles in implementing newer robotic technologies in vivo are many, including the power source, location monitoring, tool payload, maneuverability, propulsion but also important human factors and ergonomic aspects addressing human limitations [2].



Endoluminal Surgery and NOTES


Current trends and surgery and therapeutic endoscopy suggest that these fields are intersecting to perform certain types of procedures in an increasingly less invasive fashion. This intersection will require the development of new devices in order to perform these innovative procedures. Endoluminal techniques such as per oral endoscopic myotomy (POEM) for the treatment of achalasia and endoluminal mucosal as well as full-thickness resections are already being performed. For instance, in Asia endoscopic resection of very early malignancies is routinely performed on therapeutic endoscopic platforms. Further advancements in endoluminal therapies are on the forefront of surgery.

NOTES or surgery through natural orifices of the body, often referred to as “incisionless” surgery, has the potential to eliminate complications associated with incisions in surgery. There are several proposed benefits to patients with these approaches including decreased postoperative pain, shorter hospital stays, faster postoperative recovery, and elimination of surgical site infections and abdominal wall hernias. Performing surgery via transvaginal, transgastric, and transanal approaches is appealing, but is not a widely adopted practice at this time. There are many technical challenges associated with NOTES surgery, however, particularly associated with the technical difficulty of the procedures given the current instrument technologies. The majority of NOTES procedures are therefore performed as hybrid procedures with laparoscopic assistance.

There is a large amount of variation present in NOTES procedures at this time. The route of entry: transgastric versus transvaginal, rigid versus flexible endoscopes, and the number and site of access points: True NOTES versus hybrid notes with laparoscopic assistance. A literature review by Chellali et al. [3] showed that 90 % of NOTES procedures reported are performed with hybrid laparoscopic assistance, and that a transvaginal approach was employed in the majority of cases (86 %). The most common procedure performed was cholecystectomy, comprising 84 % of reported cases. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) created the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) in order to assess the feasibility and safety of NOTES procedures. EURO-NOTES was also established in Europe to serve similar purposes. A review of current literature does not clearly establish the role or safety for NOTES procedures, although it does provide a proof of concept with hundreds of procedures performed. NOSCAR is currently investigating the efficacy of NOTES cholecystectomy in a multicenter human clinical trial in the USA.

Analysis of current NOTES literature does support a prolonged operative time in both hybrid NOTES and total NOTES procedures. Chellali et al. [3] reviewed a series of NOTES cholecystectomies recorded on video and surmise that the prolonged operative time is, at least in part, a result of instrumentation that is not adequately designed for these newly appointed tasks [4]. Reviewed the currently available multibranched laparoscopic and endoscopic instrumentation in light of the criteria suggested by NOSCAR findings. Future facilitation of NOTES procedures will require the design and implementation of less cumbersome instruments that will allow the surgeon to perform more complex bimanual tasks requiring triangulation, such as intracorporeal suture tying.

POEM is a procedure in which a gastroesophageal myotomy is made using a therapeutic endoscope via a transmucosal incision in the mid-esophagus for the treatment of achalasia . A submucosal tunnel is made along the length of the esophagus and the circular muscle fibers are incised, performing the myotomy. POEM was initially described in 2008 by Inoue, and has subsequently come to be performed in more than 50 centers worldwide. Several studies comprising hundreds of patients have been reported, confirming the safety and efficacy of POEM. The success rates of achalasia treatment using POEM are greater than 90 %, generally evaluating the symptoms using the Eckhart score. Postoperative gastroesophageal reflux symptoms have been reported in patients greater than 1 year postoperatively at rates between 35 and 40 %. These results are consistent with postoperative reflux rates in laparoscopic Heller myotomy. POEM represents a minimally invasive, incision-free alternative to laparoscopic Heller myotomy that has been reported as successful treatment in nearly all types of achalasia, including patients with previous interventions, as well as patients with sigmoid esophagus.


Telesurgery and Telementoring


The widespread adaptation of minimally invasive techniques faces several hurdles. One of the largest hurdles involves the dissemination of techniques and skills outside of residency training to surgeons in the community. Residency training represents the ideal setting for educating surgeons under the direct oversight of experienced surgeons on a day-to-day basis. New technologies and techniques are constantly under development throughout a surgeon’s career. There is a need to develop robust and validated assessment tools for surgical competency given growing potential for patient harm with more advanced surgical tools [5]. The current method for a surgeon to learn a new technique frequently involves a course or simulation that is insufficient to fully develop the necessary skills. A novel approach to the continued training of practicing surgeons has been implemented by a number of groups, including Ponsky et al. as described in 2014 [6]. The Karl Storz VisitOR1 telementoring robot cart was used to stream the procedure to a virtual mentor experienced in the procedure. The VisitOR1 robot cart allows the mentor to provide real-time advice on the procedure, including telestration capabilities. Previous studies have demonstrated equivalent levels of skill acquisition between surgeons that were remotely mentored and locally mentored in laparoscopic nephrectomy, Nissen fundoplication, and laparoscopic colectomies. This demonstrates the potential of telementoring to provide surgeons with the ability to further their training throughout their career irrespective of the availability of local expert mentors. Other questions arise around how best to prepare/rehearse given potential evidence about optimal techniques for performing physical rehearsal and warm-up. Preliminary findings suggest that preoperative rehearsal or warm-up can improve the performance of operators or operating teams, but there is a paucity of objective evidence and comparative clinical studies in the existing literature to support their routine use [7].

There is debate about the relationship between the telementor and practicing surgeon, and therefore the liability of the mentor. Some argue that the mentor is directly involved in intraoperative decision making, and therefore responsible for patient care. Other parties believe that the responsibility lies with the primary surgeon, and the mentor is only advising the primary surgeon, and not liable for patient care or outcome [8]. Currently, it is important that the primary surgeon be able to complete the procedure on his/her own, and that the mentor be present for guidance on optimal technique. Regardless, telementoring represents an avenue for continuing education and live intraoperative training of surgeons, without regard to geographic boundaries for the future (Fig. 10.4). Simulation-based training in conjunction with deliberate practice activities such as reflection, rehearsal, trial-and-error learning and feed- back in improving the quality of patient care will become mainstream in assessing expertise [9].
Oct 1, 2017 | Posted by in NURSING | Comments Off on The Future and Challenges of Surgical Technology Implementation and Patient Safety

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