Objective assessment of surgical operative performance by observational clinical human reliability analysis (OCHRA): a systematic review.

BACKGROUND: Both morbidity and mortality data (MMD) and learning curves (LCs) do not provide information on the nature of intraoperative errors and their mechanisms when these adversely impact on patient outcome. OCHRA was developed specifically to address the unmet surgical need for an objective assessment technique of the quality of technical execution of operations at individual operator level. The aim of this systematic review was to review of OCHRA as a method of objective assessment of surgical operative performance. METHODS: Systematic review based on searching 4 databases for articles published from January 1998 to January 2019. The review complies with Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines and includes original publications on surgical task performance based on technical errors during operations across several surgical specialties. RESULTS: Only 26 published studies met the search criteria, indicating that the uptake of OCHRA during the study period has been low. In 31% of reported studies, the operations were performed by fully qualified consultant/attending surgeons and by surgical trainees in 69% in approved training programs. OCHRA identified 7869 consequential errors (CE) during the conduct of 719 clinical operations (mean = 11 CEs). It also identified 'hazard zones' of operations and proficiency-gain curves (P-GCs) that confirm attainment of persistent competent execution of specific operations by individual trainee surgeons. P-GCs are both surgeon and operation specific. CONCLUSIONS: Increased OCHRA use has the potential to improve patient outcome after surgery, but this is a contingent progress towards automatic assessment of unedited videos of operations. The low uptake of OCHRA is attributed to its labor-intensive nature involving human factors (cognitive engineering) expertise. Aside from faster and more objective peer-based assessment, this development should accelerate increased clinical uptake and use of the technique in both routine surgical practice and surgical training.

Structured cost analysis of robotic TME resection for rectal cancer: a comparison between the da Vinci Si and Xi in a single surgeon's experience.

BACKGROUND: Robotic-assisted surgery by the da Vinci Si appears to benefit rectal cancer surgery in selected patients, but still has some limitations, one of which is its high costs. Preliminary studies have indicated that the use of the new da Vinci Xi provides some added advantages, but their impact on cost is unknown. The aim of the present study is to compare surgical outcomes and costs of rectal cancer resection by the two platforms, in a single surgeon's experience. METHODS: From April 2010 to April 2017, 90 robotic rectal resections were performed, with either the da Vinci Si (Si-RobTME) or the da Vinci Xi (Xi-RobTME). Based on CUSUM analysis, two comparable groups of 40 consecutive Si-RobTME and 40 consecutive Xi-RobTME were obtained from the prospectively collected database and used for the present retrospective comparative study. Data costs were analysed based on the level of experience on the proficiency-gain curve (p-g curve) by the surgeon with each platform. RESULTS: In both groups, two homogeneous phases of the p-g curve were identified: Si1 and Xi1: cases 1-19, Si2 and Xi2: cases 20-40. A significantly higher number of full RAS operations were achieved in the Xi-RobTME group (p < 0.001). A statistically significant reduction in operating time (OT) during Si2 and Xi2 phase was observed (p < 0.001), accompanied by reduced overall variable costs (OVC), personnel costs (PC) and consumable costs (CC) (p < 0.001). All costs were lower in the Xi2 phase compared to Si2 phase: OT 265 versus 290 min (p = 0.052); OVC 7983 versus 10231.9 (p = 0.009); PC 1151.6 versus 1260.2 (p = 0.052), CC 3464.4 versus 3869.7 (p < 0.001). CONCLUSIONS: Our experience confirms a significant reduction of costs with increasing surgeon's experience with both platforms. However, the economic gain was higher with the Xi with shorter OT, reduced PC and CC, in addition to a significantly larger number of cases performed by the fully robotic approach.

Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study.

BACKGROUND: Despite many publications reporting on the increased hospital cost of robotic-assisted surgery (RAS) compared to direct manual laparoscopic surgery (DMLS) and open surgery (OS), the reported health economic studies lack details on clinical outcome, precluding valid health technology assessment (HTA). METHODS: The present prospective study reports total cost analysis on 699 patients undergoing general surgical, gynecological and thoracic operations between 2011 and 2014 in the Italian Public Health Service, during which period eight major teaching hospitals treated the patients. The study compared total healthcare costs of RAS, DMLS and OS based on prospectively collected data on patient outcome in addition to healthcare costs incurred by the three approaches. RESULTS: The cost of RAS operations was significantly higher than that of OS and DMLS for both gynecological and thoracic operations (p < 0.001). The study showed no significant difference in total costs between OS and DMLS. Total costs of general surgery RAS were significantly higher than those of OS (p < 0.001), but not against DMLS general surgery. Indirect costs were significantly lower in RAS compared to both DMLS general surgery and OS gynecological surgery due to the shorter length of hospital stay of RAS approach (p < 0.001). Additionally, in all specialties compared to OS, patients treated by RAS experienced a quicker recovery and significantly less pain during the hospitalization and after discharge. CONCLUSIONS: The present HTA while confirming higher total healthcare costs for RAS operations identified significant clinical benefits which may justify the increased expenditure incurred by this approach.

Current state of micro-robots/devices as substitutes for screening colonoscopy: assessment based on technology readiness levels.

BACKGROUND: Previous reports have described several candidates, which have the potential to replace colonoscopy, but to date, there is still no device capable of fully replacing flexible colonoscopy in the management of colonic disorders and for mass adult population screening for asymptomatic colorectal cancer. MATERIALS AND METHODS: NASA developed the TRL methodology to describe and define the stages of development before use and marketing of any device. The definitions of the TRLS used in the present review are those formulated by "The US Department of Defense Technology Readiness Assessment Guidance" but adapted to micro-robots for colonoscopy. All the devices included are reported in scientific literature. They were identified by a systematic search in Web of Science, PubMed and IEEE Xplore amongst other sources. Devices that clearly lack the potential for full replacement of flexible colonoscopy were excluded. ASSESSMENT OF THE CURRENT SITUATION: The technological salient features of all the devices included for assessment are described briefly, with particular focus on device propulsion. The devices are classified according to the TRL criteria based on the reported information. An analysis is next undertaken of the characteristics and salient features of the devices included in the review: wireless/tethered devices, data storage-transmission and navigation, additional functionality, residual technology challenges and clinical and socio-economical needs. CONCLUSIONS: Few devices currently possess the required functionality and performance to replace the conventional colonoscopy. The requirements, including functionalities which favour the development of a micro-robot platform to replace colonoscopy, are highlighted.

Proficiency assessment of gesture analysis in laparoscopy by means of the surgeon's musculo-skeleton model.

OBJECTIVE: This article presents the implementation of surgeon's musculo-skeletal model for gesture analysis in laparoscopy, thereby providing a complete account of the objective metrics needed to evaluate surgical performance and to improve the design of new surgical instruments including robotic instrumentation for surgical procedures. BACKGROUND: Previous published work has been based exclusively on the kinematics involved whereas, this study is focused on the dynamics and muscle contraction analysis to assess loads on bones and muscle fatigue during simulation of surgical interventions. METHODS: Nine medical students and 2 fully trained surgeons participated in the experimental sessions using a virtual laparoscopic simulator. Movement was acquired by means of an Optical Localization System and processed by means of the biomechanical software platform ADAMS-LifeMOD. RESULTS: The musculo-skeletal analysis allows calculation of how the muscles are used and their respective mean work during the exercises. Results, relative to biceps and trapezius for left and right arm, clearly demonstrate different proficiencies between surgeons and medical students and highlight differences in using different surgical instruments and assumption of different postures. CONCLUSIONS: The model provides data on the evaluation of biomechanical parameters of surgical gesture not only in kinematic terms but also includes analysis of the dynamics of muscle contraction analysis during surgical manipulations.

Economic evaluation of da Vinci-assisted robotic surgery: a systematic review.

BACKGROUND: Health technology assessment (HTA) is frequently used when a new and expensive technology is being introduced into clinical practice. This certainly is the case with the da Vinci surgical robot, with costs ranging from $1 to $2.5 million for each unit. This systematic review documents major variability in the reported cost evaluation studies of da Vinci robot-assisted operations compared with those performed by the direct manual laparoscopic approach. METHODS: Published studies in the English language related to the period 2000-2010 were searched using economic and clinical electronic databases. RESULTS: All 11 reports included some form of cost analysis, which made it possible for the authors to extract information on certain specific economic outcomes: operating room time, hospital stay, and total costs. With the exception of two studies, the reported operating room time was higher with the robotic approach than with manual laparoscopic surgery, and the hospital stay was the same for the two techniques. Robotic surgery is significantly more expensive if the purchase and maintenance costs of the robot system are included in the total costs. Only 3 of the 11 publications included these costs. CONCLUSIONS: The disadvantage of robotic surgery is its higher costs related to purchase and maintenance of technology and its longer operating room time. However, emerging evidence shows that operating room time decreases with experience using the robot. From the HTA viewpoint, the result of this review is that the jury still is out on the HTA of da Vinci-assisted robotic surgery.

EAES recommendations on methodology of innovation management in endoscopic surgery.

BACKGROUND: Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus of this guideline is patient safety, efficacy, and effectiveness. METHODS: An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon. RESULTS: The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given. CONCLUSIONS: Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.

Proficiency-gain curve for an advanced laparoscopic procedure defined by observation clinical human reliability assessment (OCHRA).

BACKGROUND: There is no established method for defining when a surgeon reaches the proficiency plateau in performing a specific operation. The published literature refers to "learning curves" based on retrospective evaluation of operative time, conversion rates, morbidity etc., which lack objectivity and do not address individual human factors. A more useful study of the gain in proficiency by the individual surgeon for a particular operation may be obtained using observational clinical-human reliability assessment (OCHRA). METHODS: Following an 8-month fellowship in advanced laparoscopic surgery, the surgeon M.T. performed, independently at his own hospital, a prospective series of 20 palliative bypass operations for advanced gastric or pancreatic cancer. Unedited videotapes of gastro-jejunostomy (GJ) or cholecysto-jejunostomy (CJ) were analyzed independently in the training institution by the OCHRA technique. RESULTS: For this surgeon proficiency in executing laparoscopic palliative bypass was reached after the 14th anastomosis when efficient execution (reduction in operative time) was accompanied by significant reduction in technical errors and improved economy of movement (reduction of the economy of movement index from 7-5 to 3-2). The majority of errors were enacted in component tasks associated with intracorporeal suturing. The declining incidence of these errors with experience was an integral component of the proficiency-gain curve. The important performance-shaping factors identified were: concentration lapses (n=1,321), misjudgments (n=209), poor camera work (n=193), fatigue (n=128), and impaired coordination (n=108). CONCLUSIONS: This study has confirmed that OCHRA can describe quantitatively the proficiency-gain curve for a laparoscopic operation and indicate the plateau stage when the individual surgeon attains maximal performance in the execution of a specific procedure.

Ergonomic assessment of optimum operating table height for hand-assisted laparoscopic surgery.

BACKGROUND: To investigate the influence of the working surface height on task performance and muscle workload in hand-assisted laparoscopic surgery. METHODS: The standard task used was closure of 5-cm enterotomy inside a hand-assisted laparoscopic surgery trainer. Surgeons were instructed to place the sutures 3-5 mm apart and from the enterotomy edge. Ten surgeons participated in each experiment and one task was performed with each level. The first experiment compared the quality of task performance and muscle workload with the working surface at: elbow level, 10 cm above, 15 cm above and 10 cm below the elbow. Further narrower levels (5 cm below, at the elbow and 5 cm above the elbow) were investigated in the second experiment. Outcome measures were execution time (s), placement error score (mm), leakage pressure (mmHg), number of execution errors, muscle workload as measured by integrated electromyography (mV x s) and visual analogue score of back discomfort (mm). RESULTS: The first experiment showed that 15 cm above the elbow level was associated with the longest execution time and similar quality of task performance. This level resulted in a higher workload of the deltoid of the extracorporeal limb, the arm extensor of the intracorporeal side and the trapezius and paraspinal muscles of both intra- and extracorporeal limbs. Also, the 10 cm above the elbow level was associated with increased muscle workload of the deltoid of extracorporeal limb and the trapezius of both limbs compared with the elbow height. The 10 cm below the elbow level was associated with increased back discomfort. The second experiment showed that 5 cm below the elbow height was associated with increased muscle workload of the arm flexor group of the intracorporeal dominant limb. CONCLUSIONS: The optimum table height for hand-assisted laparoscopic surgery allows the working surface of the extracorporal instrument handle to be at or 5 cm above the elbow level.

Thermographic assessment of tumor growth in mouse xenografts.

In human breast tumors, a 1-2 degrees C increase in skin surface temperature is usually observed at the periphery; it has been proposed that this change is due to the hypervascularity and increased blood flow resulting from tumor-associated angiogenesis. Here we tested the hypothesis that thermal imaging might represent a useful adjunctive technique in monitoring the growth dynamics of human tumor xenografts. Xenografts were established in immunocomprised nude mice using MDA-MB-231 or MCF7 breast cancer cells. We exploited the inherent noncontact and noninvasive advantages of infrared thermography to detect skin surface temperature changes. Continuous thermographic investigation was performed to detect and monitor tumor growth in vivo and high resolution digital images were analyzed to measure the tumor temperature dynamics. In contrast to the skin temperature increases associated with human breast cancer, a consistent temperature decrease was found in the xenograft mice. In one case, a smaller secondary tumor, otherwise undetectable, was clearly evident by thermal imaging. The tumors were cooler than the surrounding tissue with a maximum temperature reduction of 1.5 degrees C for MDA-MB-231 tumor and 3 degrees C for MCF7 tumors observed on day 14. In addition, the temperature of the xenograft tumors decreased progressively as they grew throughout the observation period. It was demonstrated that thermographic imaging could detect temperature changes as small as 0.1 degrees C on the skin surface at an early stage of tumor development. The findings of the study indicate that thermographic imaging might have considerable potential in monitoring human tumor xenografts and their response to anticancer drugs.