wouters

This thesis focuses on some of the challenges associated with the implementation of technical innovations in complex abdominal surgery. Many skills and practices are mastered through the principle of trial and error. People hope to gain experience and insight from successes and failures and apply this to a subsequent effort. It is one of the basic principles in acquiring many life skills, such as learning how to walk or ride a bike. However, what if the nature of the skills to be mastered leaves little room for error? Technical innovations in surgery are important in enhancing the possibilities of modern surgical practice and should be supported, but such innovations should also be safely introduced.

Laparoscopic and robot assisted techniques have become standard practice for a wide range of abdominal surgical procedures. A minimally invasive approach to the abdominal cavity is associated with a shorter recovery after surgery, including less post-operative pain, allowing earlier discharge from hospital. These advantages are offset by increased costs and the potential hazard of learning curve associated excess patient morbidity. In other words, patients potentially receive suboptimal treatment during the early uptake of experience with a new surgical technique. Especially in highly complex procedures involving the liver, pancreas or duodenum, associated with high rates of morbidity and mortality, more insight into the safe introduction of minimally invasive techniques is warranted. The general aim of this thesis was to identify and explore aspects involved in the transition from conventional ‘open’ techniques to minimally invasive, laparoscopic techniques in hepatobiliary and pancreatic surgery (HPB).

Implementation and uptake of surgical skills

Hepatobiliary and pancreatic surgical procedures are highly complex, are often performed at relatively low volumes and carry significant patient morbidity. Aspiring novice surgeons face a significant challenge in acquiring proficiency in performing these procedures. It has been estimated that it takes a novice HPB fellowship trained surgeon up to 100 procedures to optimize outcomes in terms of procedure duration, blood loss and patient morbidity. The transition to minimally invasive techniques for procedures that in itself are difficult to master poses another significant challenge. The international HPB surgical community has expressed its concerns regarding learning curve associated excess patient morbidity and safety and emphasizes the need for more evidence-based training programs. It is necessary to improve supervision and standardization of implementation to guarantee safety and quality of care in order to exploit the benefits of minimally invasive techniques.

Addressing these concerns, chapter 2 of this thesis presents a retrospective, single center cohort study evaluating surgical performance during the transition from open surgery to a minimally invasive technique for an exemplary procedure (distal pancreatectomy). Healthcare quality before and after training for robotic distal pancreatectomy was compared using outcome domains suggested by the Institute of Medicine (safety, morbidity, efficiency, cumulative treatment burden and oncologic efficacy). The combination of didactics, team training, dry lab preparation, video review, virtual reality simulation, and hands-on procedural experience with surgical coaching ensured quality across all outcome domains, despite the obvious learning curve for mean operating time. Propensity-score matched analysis displayed that robot-assisted distal pancreatectomy was associated with reduced blood loss, transfusion risk and a one-day reduction in 90-day cumulative length of hospital stay, offset by a mean increase of 70 minutes of operative time compared to open distal pancreatectomy. These results display the safe and effective implementation of a new surgical technique at a single center and can be extrapolated to other complex abdominal procedures. Medical centers need to have sufficient prior experience with the invasive, index procedure and maintain a minimal yearly volume to guarantee proficiency and quality before commencing the learning curve for minimally invasive surgery. Proctorship by an experienced surgeon coach can help avoid common mistakes during the early implementation of minimally invasive surgical techniques.

During the process of innovation and uptake of experience in a high-risk environment like the surgical theater, real-time monitoring of outcomes to detect adverse trends is necessary to guarantee safety. Surgeons and surgical teams need to move from retrospective reviews of outcomes to detect adverse effects of implementation (only after patient harm is done) to prospective studies. Continuous feedback mechanisms should be put in place to identify adverse trends as early as possible to allow intervention before learning curve associated excess patient morbidity occurs.

Among the strategies to enhance safety during surgical innovation, an interesting option is to move the early implementation of innovation out of the operating room and away from patients towards a skills center and a simulation setting. In recent years augmented reality and surgical simulation programs to develop basic laparoscopic surgical skills have taken up an important spot in residency training. The early implementation of new technology needs to take place in a protected simulated environment as well.

The aviation industry provides an example were novice pilots are trained in a simulated environment and meet proficiency standards without compromising passenger safety. In an ideal surgical teaching environment, proficiency standards for new technologies are also mastered without compromising patient safety. Modern surgical residency training includes assessment of proficiency through the achievement of milestones. The adoption of complex minimally invasive surgery should ideally include similar mastery-based training programs in a simulated environment.

Moving the learning curve to a simulated environment means the uptake of proficiency can no longer be measured in terms of patient morbidity and mortality. Therefore, other surrogates for measuring surgical proficiency should be explored.

In the study presented in chapter 3 the value of viewing behavior during surgery as a marker for surgical proficiency was investigated. Two groups of experienced and novice surgeons were exposed to laparoscopic surgical videos while eye movement was captured through eye-tracking. The results displayed clear differences in viewing behavior between the groups, indicating that laparoscopic experts more quickly collect contextual information (low fixation frequency) and keep a longer focus on the region of interest (long single fixation time) compared to novice surgeons. Further research into this novel technology is warranted to explore its role in surgical learning and its potential as a marker for proficiency. Once validated, this technology might also prove to be valuable as a direct feedback mechanism in the operating theater for minimally invasive surgical trainees.

Implications for surgical teams

The surgical theater is a unique environment were a magnitude of information is gathered, processed and subsequently acted upon by a large number of individuals. The surgical environment changes constantly due to innovation and the ever-ongoing introduction of new technology into the operating theater. The tasks and competences of surgical teams need to evolve with these changes in order to maintain efficiency and patient safety during surgery. Adapting and acquiring new skills by the surgical team is essential in the successful transition from ‘open’ to minimally invasive surgery. In the current literature, information about learning curves and skill acquisition in laparoscopic surgery concerning the surgical team is underrepresented.

In the current thesis the literature on the different methods to identify and rate non-technical surgical skills was assessed. The systematic review presented in chapter 4 describes that the current literature is heterogeneous and of poor quality. The majority of published studies base their assessment of non-technical performance on construct-based assessment tools like the ‘Observational teamwork assessment for surgery’ or ‘Oxford non-technical skills system’. These tools measure performance on a number of set constructs like teamwork or back-up behavior and rate them on a Likert scale. This provides teams with a general score of their performance, but this lacks detail. Incident-based assessment tools identify adverse events related to non-technical skills and their subsequent impact on the surgical procedure at hand. Root cause analyses explores the lead-up towards an adverse event and provides the necessary data to identify errors and threats to patient safety in the complex surgical environment.

A number of studies have suggested an increase in non-routine events in laparoscopic compared to open surgery. The work documented in this thesis compared open and minimally invasive approaches to hepatobiliary and pancreatic procedures and further confirmed this hypothesis. The study in chapter 5 applied a systems approach to team behavior and non-technical skills in the surgical theatre by structured intra-operative observations at the Maastricht University Medical Center and Beth Israel Deaconess Medical Center. Nighty-nine cases were included comparing procedural workflow and non-technical skills between minimally invasive and open HPB surgical procedures. A minimally invasive approach was found to be the strongest independent predictor for impaired workflow in the operating theater. Impaired workflow was predominantly related to coordination and equipment handling or malfunctioning during surgery, with peak incidences surrounding the time of incision, start of transection or robot-docking. These results indicate an increase of non-technical demands and the reduced ability of minimally invasive surgical teams to maintain efficiency and ensure patient safety.

This study provides a clear indication for the need for enhanced team training. A multi-disciplinary approach including psychologists, human factors and crew resource management experts, as well as equipment developers from medical device companies will have to provide surgical teams with the skills and insights to maintain a safe and effective minimally invasive surgical environment.

The ever-changing surgical environment warrants the constant need to evaluate how surgeons and surgical teams are able to handle innovation. The current surgical climate does not have an effective feedback mechanism in place. Most surgical centers rely on retrospective analyses of self-reported data in morbidity and mortality rounds. These methods lack detail, are subject to recollection bias and fail to analyze errors or adverse events that did not directly result in patient morbidity or mortality. To truly maintain an effective and safe surgical environment surgical teams need to identify latent treats and system vulnerability regardless of patient outcomes. In order to allow effective feedback, accurate data from the surgical environment need to be collected in real time. The operating room black box captures data from multiple sources including video footage from laparoscopic and room overview camera’s, patient physiology and equipment sensors. The first results in a single center study have been published proving its potential to effectively capture large amounts of data from the surgical environment. However, widespread implementation of the surgical black box is lacking, probably due to concerns regarding team privacy and liability. For all stakeholders involved, including surgical teams and patients, there is a need to create a safe environment for the implementation of the surgical black box in order to allow detailed peer-to-peer review to identify lacking non-technical skills and tailor team training accordingly. The surgical climate will keep on innovating and with it the density of complex technology within the operating theatre will only increase. A bigger focus on how surgical teams adapt with these changes is warranted.

Robotic surgery for uncommon indications

In chapters 6 and 7 studies are presented investigating novel applications of robot-assisted laparoscopic surgery in the upper abdomen, displaying its efficacy and safety for a number of less common indications.

Surgical division of the median arcuate ligament with or without concurrent celiac bypass is the most widely accepted treatment for median arcuate ligament syndrome. A laparoscopic approach has been described with favorable morbidity and faster recovery compared with open, but suffers from a high risk of conversion for serious technical causes such as arterial bleeding and pneumothorax. The study in chapter 5 presenting the technique and outcomes of a case series of 9 patients undergoing laparoscopic robot-assisted minimally invasive division describes favorable results without conversions to open surgery. The robot-assisted minimally invasive approach combines high-definition three-dimensional visualization with superior manual dexterity and precision to permit circumferential dissection around the celiac plexus and control of bleeding, potentially creating superior surgical outcomes with fewer emergent conversion events.

In chapter 7 the laparoscopic robot-assisted techniques of transduodenal ampullectomy, transduodenal excision of mass and segmental duodenal resections are described. In a series of 26 patients from the Beth Israel Deaconess Medical Center and University of Pittsburg Medical Center undergoing robot-assisted transduodenal or segmental duodenal resections a 15% major complication rate was observed without conversions to open surgery. The observations in this study advocate a robot-assisted approach to symptomatic benign and premalignant pathologies of the duodenum not amendable for endoscopic resection providing a treatment with less morbidity and mortality compared to conventional open surgery.

New equipment and techniques are being introduced with increasing rates into the surgical field. The surgical theater has changed drastically in the past decade and will continue to do so in the future at an even greater pace. This thesis explores aspects that aid the safe and effective implementation of innovation into surgical practice. Moving implementation away from patients into a simulated setting, proficiency-based learning, real-time monitoring of outcomes and involvement of the entire surgical team might prove increasingly important in the future. If safe and effective implementation programs can keep up with innovation rates, surgeons and patients will benefit of the endless possibilities of future technology.