Brian J. Dunkin

Global Evaluative Assessment of Robotic Skills: Validation of a Clinical Assessment Tool to Measure Robotic Surgical Skills

PURPOSE We developed and validated a standardized assessment tool for robotic surgical skills, and report its usefulness, reliability and construct validity in a clinical setting. MATERIALS AND METHODS The Global Evaluative Assessment of Robotic Skills is a tool developed by deconstructing the fundamental elements of robotic surgical procedures in consultation with expert robotic surgeons. Surgical performance was assessed during robot-assisted laparoscopic prostatectomy on a 5-point anchored Likert scale across 6 domains. An overall performance score was derived by summing the ratings in each domain. Expert surgeons and postgraduate year 4 to 6 urology residents were evaluated to determine construct validity. Assessments were completed by the attending surgeon, a trained observer and the operator. RESULTS A total of 29 evaluations of 25 trainees and 4 attending surgeons were completed. Experts scored significantly higher on the assessment than novice operators (p = 0.004). Postgraduate year 4 and 5 residents scored significantly lower than the expert group (p <0.05) while no difference was observed between mean performance scores of postgraduate year 6 trainees and attending surgeons (p >0.05). The internal consistency of the assessment tool was excellent (Cronbachs α = 0.90 to 0.93). The overall assessment score ICC among raters was 0.80 (95% CI 0.65-0.90). CONCLUSIONS The Global Evaluative Assessment of Robotic Skills is simple to administer and able to differentiate levels of robotic surgical expertise. This standardized assessment tool shows excellent consistency, reliability and validity. Further study is warranted to evaluate its usefulness for surgical education and the establishment of competency in robotic surgery.

Utility of Removable Esophageal Covered Self-Expanding Metal Stents for Leak and Fistula Management

BACKGROUND Esophageal or gastric leakage from anastomotic wound dehiscence, perforation, staple line dehiscence, or trauma can be a devastating event. Traditional therapy has often consisted of either surgical repair for rapidly diagnosed leaks or diversion for more complicated cases, commonly associated with a delayed diagnosis. This study summarizes our experience treating leaks or fistulas with novel, covered self-expanding metal stents (cSEMS). The primary objective of this study was to determine the efficacy and safety of covered self-expanding metal stents when used to treat complicated leaks and fistulas. METHODS Over 15 months, 25 patients with esophageal or gastric leaks were evaluated for stenting as primary treatment. A prospective database was used to collect data. Stents were placed endoscopically, with contrast evaluation used for leak evaluation. Patients who did not improve clinically after stenting or whose leak could not be sealed underwent operative management. RESULTS During a mean follow-up of 15 months, 23 of the 25 patients with esophageal or gastric leaks during a 15-month period were managed with endoscopic stenting as primary treatment. Healing occurred in patients who were stented for anastomotic leakage after gastric bypass or sleeve gastrectomy (n = 10). One patient with three esophageal iatrogenic perforations healed with stenting. Eight patients successfully avoided esophageal diversion and healed with stenting and adjunctive therapy. Two of the 4 patients with tracheoesophageal fistulas sealed with the assistance of a new pexy technique to prevent stent migration; 1 additional patient had this same technique used to successfully heal an upper esophageal perforation. CONCLUSIONS Esophageal leaks and fistulas can be effectively managed with cSEMS as a primary modality. The potential benefits of esophageal stenting are healing without diversion or reconstruction and early return to an oral diet.

FLS and FES: Comprehensive Models of Training and Assessment

The Fundamentals of Laparoscopic surgery (FLS) is a validated program for the teaching and evaluation of the basic knowledge and skills required to perform laparoscopic surgery. The educational component includes didactic, Web-based material and a simple, affordable physical simulator with specific tasks and a recommended curriculum. FLS certification requires passing a written multiple-choice examination and a proctored manual skills examination in the FLS simulator. The metrics for the FLS program have been rigorously validated to meet the highest educational standards, and certification is now a requirement for the American Board of Surgery. This article summarizes the validation process and the FLS-related research that has been done to date. The Fundamentals of Endoscopic Surgery is a program modeled after FLS with a similar mission for flexible endoscopy. It is currently in the final stages of development and will be launched in April 2010. The program also includes learning and assessment components, and is undergoing the same meticulous validation process as FLS. These programs serve as models for the creation of simulation-based tools to teach skills and assess competence with the intention of optimizing patient safety and the quality of surgical education.

Simultaneous Cadaver Pancreas Living-Donor Kidney Transplantation: A New Approach for the Type 1 Diabetic Uremic Patient

ObjectiveTo review the authors’ experience with a new approach for type I diabetic uremic patients: simultaneous cadaver-donor pancreas and living-donor kidney transplant (SPLK). Summary Background DataSimultaneous cadaver kidney and pancreas transplantation (SPK) and living-donor kidney transplantation alone followed by a solitary cadaver-donor pancreas transplant (PAK) have been the transplant options for type I diabetic uremic patients. SPK pancreas graft survival has historically exceeded that of solitary pancreas transplantation. Recent improvement in solitary pancreas transplant survival rates has narrowed the advantage seen with SPK. PAK, however, requires sequential transplant operations. In contrast to PAK and SPK, SPLK is a single operation that offers the potential benefits of living kidney donation: shorter waiting time, expansion of the organ donor pool, and improved short-term and long-term renal graft function. MethodsBetween May 1998 and September 1999, the authors performed 30 SPLK procedures, coordinating the cadaver pancreas transplant with simultaneous transplantation of a laparoscopically removed living-donor kidney. Of the 30 SPLKs, 28 (93%) were portally and enterically drained. During the same period, the authors also performed 19 primary SPK and 17 primary PAK transplants. ResultsOne-year pancreas, kidney, and patient survival rates were 88%, 95%, and 95% for SPLK recipients. One-year pancreas graft survival rates in SPK and PAK recipients were 84% and 71%. Of 30 SPLK transplants, 29 (97%) had immediate renal graft function, whereas 79% of SPK kidneys had immediate function. Reoperative rates, early readmission to the hospital, and initial length of stay were similar between SPLK and SPK recipients. SPLK recipients had a shorter wait time for transplantation. ConclusionsEarly pancreas, kidney, and patient survival rates after SPLK are similar to those for SPK. Waiting time was significantly shortened. SPLK recipients had lower rates of delayed renal graft function than SPK recipients. Combining cadaver pancreas transplantation with living-donor kidney transplantation does not harm renal graft outcome. Given the advantages of living-donor kidney transplant, SPLK should be considered for all uremic type I diabetic patients with living donors.

Which skills really matter? proving face, content, and construct validity for a commercial robotic simulator

BackgroundA novel computer simulator is now commercially available for robotic surgery using the da Vinci® System (Intuitive Surgical, Sunnyvale, CA). Initial investigations into its utility have been limited due to a lack of understanding of which of the many provided skills modules and metrics are useful for evaluation. In addition, construct validity testing has been done using medical students as a “novice” group—a clinically irrelevant cohort given the complexity of robotic surgery. This study systematically evaluated the simulator’s skills tasks and metrics and established face, content, and construct validity using a relevant novice group.MethodsExpert surgeons deconstructed the task of performing robotic surgery into eight separate skills. The content of the 33 modules provided by the da Vinci Skills Simulator (Intuitive Surgical, Sunnyvale, CA) was then evaluated for these deconstructed skills and 8 of the 33 determined to be unique. These eight tasks were used for evaluating the performance of 46 surgeons and trainees on the simulator (25 novices, 8 intermediate, and 13 experts). Novice surgeons were general surgery and urology residents or practicing surgeons with clinical experience in open and laparoscopic surgery but limited exposure to robotics. Performance was measured using 85 metrics across all eight tasks.ResultsFace and content validity were confirmed using global rating scales. Of the 85 metrics provided by the simulator, 11 were found to be unique, and these were used for further analysis. Experts performed significantly better than novices in all eight tasks and for nearly every metric. Intermediates were inconsistently better than novices, with only four tasks showing a significant difference in performance. Intermediate and expert performance did not differ significantly.ConclusionThis study systematically determined the important modules and metrics on the da Vinci Skills Simulator and used them to demonstrate face, content, and construct validity with clinically relevant novice, intermediate, and expert groups. These data will be used to develop proficiency-based training programs on the simulator and to investigate predictive validity.

How should we establish the clinical case numbers required to achieve proficiency in flexible endoscopy

BACKGROUND Recommended procedure numbers for upper endoscopy (UE) and colonoscopy (C) are 35 and 50 for surgical residents, and 130 and 140 for gastroenterology fellows, respectively. The purpose of this study was to challenge the methods used to determine proficiency in flexible endoscopy. METHODS Global assessment of gastrointestinal endoscopic skills (GAGES) was used to evaluate 139 procedures. Scores for UE were compared using self-reported case numbers and grouped according to requirements for each discipline. C scores were compared using the requirements to define novice and experienced endoscopists. Procedure volumes were plotted against GAGES scores. RESULTS Three groups were compared for UE based on case volumes: fewer than 35 cases (group 1), 35 to 130 cases (group 2), and more than 130 cases (group 3). There was no difference between group 2 (17.8 +/- 1.8) and group 3 (19.1 +/- 1.1), but both scored higher than group 1 (14.4 +/- 3.7; P < .05). For C, the scores were 11.8 +/- 3.8 (novices) and 18.8 +/- 1.34 (experienced; P < .001) at a 50-case minimum and 12.4 +/- 4.2 and 18.8 +/- 1.3 (P < .001) for a 140-case proficiency cut-off level, respectively. The curve of procedures versus GAGES plateaued at 50 (UE) and 75 (C). CONCLUSIONS The surgical and gastroenterology case recommendations may not represent the experience needed to achieve proficiency. GAGES scores could help define proficiency in basic endoscopy.

A technical modification eliminates early ureteral complications after laparoscopic donor nephrectomy.

Laparoscopic donor nephrectomy (LDN) is a new technique for removing a kidney from a living donor for transplantation. In comparison with the traditional open donor nephrectomy (ODN), LDN is associated with significantly decreased pain, time out of work, and length of stay, while improving cosmesis. The introduction of LDN has decreased the “cost” of donation (eg, lost wages, disability, time out of work, time required to return to normal function) for many prospective donors and, as a result, has increased the number of potential donors presenting for evaluation. But early experience with LDN indicates that the incidence of early ureteral complications is significantly higher than that of ODN. Centers have reported a 10% to 15% incidence of ureteral strictures or leaks in the first 3 postoperative months requiring operative, angiographic, or cystoscopic intervention. In comparison, the historic incidence of ureteral complications associated with ODN is approximately 2% to 3%. We hypothesized that ureteral complications associated with LDN are the result of ischemia after stripping of the ureter. We have modified the LDN procedure by mobilizing the ureter in combination with the gonadal vein as a single unit. Since institution of this technical modification in May 1998, 50 LDNs have been performed with a ureteral complication rate of 2% at both 3 and 12 months posttransplantation. We describe our technical modification of the ureteral dissection during LDN.

Fundamentals of endoscopic surgery cognitive examination: Development and validity evidence

BackgroundFlexible endoscopy is an integral part of surgical care. Exposure to endoscopic procedures varies greatly in surgical training. The Society of American Gastrointestinal and Endoscopic Surgeons has developed the Fundamentals of Endoscopic Surgery (FES), which serves to teach and assess the fundamental knowledge and skills required to practice flexible endoscopy of the gastrointestinal tract. This report describes the validity evidence in the development of the FES cognitive examination.MethodsCore areas in the practice of gastrointestinal endoscopy were identified through facilitated expert focus groups to establish validity evidence for the test content. Test items then were developed based on the content areas. Prospective enrollment of participants at various levels of training and experience was used for beta testing. Two FES cognitive test versions then were developed based on beta testing data. The Angoff and contrasting group methods were used to determine the passing score. Validity evidence was established through correlation of experience level with examination score.ResultsA total of 220 test items were developed in accordance with the defined test blueprint and formulated into two versions of 120 questions each. The versions were administered randomly to 363 participants. The correlation between test scores and training level was high (r = 0.69), with similar results noted for contrasting groups based on endoscopic rotation and endoscopic procedural experience. Items then were selected for two test forms of 75 items each, and a passing score was established.ConclusionsThe FES cognitive examination is the first test with validity evidence to assess the basic knowledge needed to perform flexible endoscopy. Combined with the hands-on skills examination, this assessment tool is a key component for FES certification.

Laparoscopic donor nephrectomy: current role in renal allograft procurement

O donor nephrectomy is relatively safe and produces a high-quality organ for transplantation. However, the morbidity of the flank incision is substantial in terms of pain, long-term structural stability, and cosmesis. If the act of renal donation becomes less traumatic, either real or perceived, perhaps the pool of volunteer renal donors will increase. Laparoscopic donor nephrectomy was conceived as an approach to decrease donor morbidity. The absolute requirements for a laparoscopic approach, however, include continued donor safety and equivalent renal allograft function. Debate over these two requirements has been extensive and heated.1–4 This review of laparoscopic donor nephrectomy concentrates on the surgical techniques used, the complications seen in the donor, and the transplant recipient success rates. The first laparoscopic donor nephrectomy was accomplished in 1995.5 Initially, the University of Maryland6 and Johns Hopkins University7,8 developed and modified the surgical technique. As enthusiasm for their initial results spread, most (if not all) surgeons visited the two Maryland programs before initiating programs of their own. The technique spread quickly and, by the end of 1999, more than 1000 laparoscopic donor nephrectomies had been done on five continents.

Pretreatment with allopurinol diminishes pancreatography-induced pancreatitis in a canine model

BACKGROUND The role of oxygen-derived free radicals in the pathogenesis of pancreatitis has been supported by data from previous studies using animal models. This study was conducted to determine whether prophylaxis with the xanthine oxidase inhibitor allopurinol would decrease the incidence and severity of pancreatography-induced pancreatitis in a canine model. METHODS Thirty-two dogs were randomized to receive either placebo or oral allopurinol 1 hour before the procedure. A laparotomy and duodenotomy were performed and a pancreatogram was obtained. Postoperatively, pancreatic enzymes were drawn for 5 days. The animals were then euthanized, and the pancreas was weighed and evaluated histologically. RESULTS The histologic incidence of pancreatitis was significantly reduced in the allopurinol pretreatment group (6.7%) as compared with the placebo group (41.2%, p < 0.01). A significant decrease in postoperative serum amylase levels among dogs pretreated with allopurinol was also noted. A similar trend was observed in lipase levels. The pancreas weight index was decreased in the allopurinol pretreatment group as well (control = 0.00246 vs. allopurinol = 0.00195, p < 0.02). CONCLUSIONS Pretreatment with oral allopurinol decreases the incidence of pancreatography-induced pancreatitis. These results support the role of xanthine oxidase inhibitors in the prevention of endoscopic retrograde cholangiopancreatography-induced pancreatitis.