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Abstract: Peroral endoscopic myotomy (POEM) is a novel treatment for achalasia that is based on the principles of a surgical myotomy. POEM emulates an established surgical procedure, namely Heller myotomy, with endoscopic equipment through the mouth. POEM has been rapidly adopted into clinical practice over the past 3 years. It is a technically demanding procedure that is performed by gastroenterologists and surgeons with different training backgrounds. There is growing interest in dedicated training programs for POEM to enhance its safe clinical introduction. Training programs should help participants gain expertise in the management of achalasia and alternative treatment strategies, development of technical expertise and endoscopic skills, the surgical anatomy, and how a myotomy can be safely performed using endoscopic equipment. Training programs should also provide recommendations on how to start a successful POEM program and how to prevent the potential complications that could arise from inadequate preparation or premature implementation. [Copyright &y& Elsevier]

Background: Endoscopic submucosal dissection (ESD) is increasingly used for en bloc removal of GI lesions. Current ESD techniques have limitations including long procedure times, technical difficulty, and complications. Objective: To compare mesna with saline solution for ESD. Design: Blinded, randomized, controlled, porcine study in live animals. Setting: Animal laboratory. Intervention: Twelve gastric lesions were marked by using electrocautery. After submucosal injection, a circumferential mucosal incision was created, and ESD was performed by using a flexible Maryland dissector. Half of the ESDs were performed with submucosal injection of mesna. Main Outcome Measurements: Primary outcome was the time to dissect the submucosal plane. Secondary outcomes were total ESD time, specimen size, and procedure related complications. Results: The average (± SD) time for dissecting the submucosal plane was 15 minutes (range 10-22 ± 4.8 min) in the group with submucosal mesna injection and 16 minutes (range 8-29 ± 8.3 min) in the control group (P = 1.0). Complete en bloc resection including all of the electrocautery markings was achieved in all cases. Injection of mesna did not provide any benefit over saline solution in terms of overall ESD time (24 ± 7.3 min vs 28 ± 11 min; P = .42). There were no perforations. Four hemorrhages requiring intervention were encountered during the procedures in the control group, compared with no bleeding in the mesna group (P = .09). Limitations: Animal model, limited sample size. Conclusion: Submucosal mesna injection did not affect procedure times but was associated with a trend toward a lower incidence of intraprocedural bleeding. [ABSTRACT FROM AUTHOR]

Abstract: Historically, surgical competence has been evaluated subjectively. Fundamental changes in surgical technology and training have focused attention on the use of objective measurement of performance to improve patient safety and reduce errors. Surgical performance can be measured using a variety of tools, both in the clinical and simulated environments. Objective assessments can play a role in training by improving the evaluation and feedback. At the end of training or when a new skill is acquired, objective assessments may be used to ensure that a proficiency level has been reached and potentially as a condition for independent practice. When assessments are used for high-stakes evaluations like certification, they must be demonstrably reliable and valid. The definition of assessment, and the necessary components of a valid instrument, will be summarized. An overview of practical applications of objective assessment as it applies to training, selection, and certification of surgeons will be presented. [Copyright &y& Elsevier]

Background: Endoscopic full-thickness resection (eFTR) is a minimally invasive method for en bloc resection of GI lesions. Objective: The aim of this pilot study was to evaluate the feasibility of a grasp-and-snare technique for eFTR combined with an over-the-scope clip (OTSC) for defect closure. Design: Nonsurvival animal study. Setting: Animal laboratory. Animals: Fourteen female domestic pigs. Interventions: The eFTR was performed in porcine colons using a novel tissue anchor in combination with a standard monofilament snare and 14 mm OTSC. In the first group (n = 20), closure of the colonic defects with OTSC was attempted after the resection. In the second group (n = 8), an endoloop was used to secure the resection base before eFTR was performed. Results: In the first group (n = 20), eFTR specimens ranged from 2.4 to 5.5 cm in diameter. Successful closure was achieved in 9 out of 20 cases. Mean burst pressure for OTSC closure was 29.2 mm Hg (range, 2-90; SD, 29.92). Injury to adjacent organs occurred in 3 cases. Lumen obstruction due to the OTSC closure occurred in 3 cases. In the second group (n = 8), the diameter of specimens ranged from 1.2 to 2.2 cm. Complete closure was achieved in all cases, with a mean burst pressure of 76.6 mm Hg (range, 35-120; SD, 31). Lumen obstruction due to the endoloop closure occurred in one case. No other complications or injuries were observed in the second group. Limitations: Nonsurvival setting. Conclusions: Colonic eFTR using the grasp-and-snare technique is feasible in an animal model. Ligation of the resection base with an endoloop before eFTR seems to reduce complication rates and improve closure success and leak test results despite yielding smaller specimens. [Copyright &y& Elsevier]

Background: Endoscopic submucosal dissection (ESD) is a minimally invasive method for en bloc removal of GI lesions. Current ESD methods and devices have limitations, including long procedure times, technical difficulty, safety, and availability. Objective: The aim of this study was to evaluate a blunt submucosal dissection technique and compare it with ESD by using the insulated-tip (IT) knife. Design: Randomized, controlled, animal study. Setting: Animal facility laboratory. Intervention: Twelve gastric lesions were marked by using electrocautery. After submucosal injection, a circumferential mucosal incision was created. ESD was then performed by using either the IT knife 2 (n = 6) or the flexible endoscopic Maryland dissector (n = 6). Main Outcome Measurements: Median time for IT knife ESD versus median time for Maryland dissector ESD. Results: Median time (IQR) for IT knife ESD was 43 minutes (range 36-50 minutes). The median time (IQR) for Maryland dissector ESD was 32 minutes (range 22-41 minutes; P = .09). The resection specimens obtained with the Maryland dissector tended to be larger, with a median (IQR) of 20.2 cm2 (range 16.4-23 cm2) when compared with specimens resected with the IT knife, which yielded a median (IQR) resection area of 15.9 cm2 (14.8-18.7 cm2; P = .08). Complete en-bloc resection including all of the electrocautery markings was achieved in all cases. There were no perforations. There were two minor hemorrhages in the IT knife group and 3 in the Maryland dissector group. Limitations: Nonsurvival setting, small sample size. Conclusion: The flexible Maryland dissector was demonstrated to be efficient, safe, and feasible for facilitating gastric ESD in a live animal model. [Copyright &y& Elsevier]

Abstract: 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. [Copyright &y& Elsevier]

Background: Duodenal perforations during diagnostic upper endoscopy are rare; however, when therapeutic techniques are performed, the reported incidence is as great as 2.8%. Surgical repair is usually mandated, but it is associated with significant morbidity and mortality. Objective: To compare closure of duodenal perforations by using an over-the-scope clip (OTSC) with a surgical closure. Design: Randomized, controlled animal study. Setting: Animal facility laboratory. Animals: Domestic pigs (24 females). Interventions: Large (10-mm) duodenal perforations were created by using an endoscopic needle-knife. The animals were randomly assigned to either open surgical repair (n=12) or endoscopic closure by using the OTSC system (n=12). Pressurized leak tests were performed during necropsy. Main Outcome Measurements: One major bleed occurred because of a liver injury during creation of the duodenotomy. Mean time for endoscopic closure was 5 minutes (range, 3-8 min; SD ± 2). No complications occurred during any of the closure procedures. At necropsy, all OTSC and surgical closures demonstrated complete sealing of duodenotomy sites. Pressurized leak tests demonstrated a mean burst pressure of 166 mm Hg (range, 80-260; SD ± 65) for OTSC closures and 143 mm Hg (range, 30-300, SD ± 83) for surgical sutures. Ex vivo intact duodenal specimens exhibited a mean burst pressure of 247 mm Hg (range, 200-300; SD ± 35), which was significantly higher compared with in vivo OTSC and surgical closures (P < .01). There were no significant differences between burst pressures of OTSC and surgical closures (P= .461). Limitations: Nonsurvival setting. Conclusions: Endoscopic closure of duodenal perforations by using the OTSC system is comparable with surgical closure in a nonsurvival porcine model. This technique is easy to perform and seems suitable for repairing duodenal perforations. [Copyright &y& Elsevier]

Background: Secure endoscopic closure of transgastric natural orifice transluminal endoscopic surgery (NOTES) access is of paramount importance. The over-the-scope clip (OTSC) system has previously been shown to be effective for NOTES gastrotomy closure. Objective: To compare OTSC gastrotomy closure with surgical closure. Design: Randomized, controlled animal study. Setting: Animal facility laboratory. Animals: Thirty-six female domestic pigs. Interventions: Gastrotomies were created by using a needle-knife and an 18-mm balloon. The animals were subsequently randomized to either open surgical repair with interrupted sutures or endoscopic repair with 12-mm OTSCs. In addition, pressurized leak tests were performed in ex vivo specimens of 18-mm scalpel incisions closed with suture (n = 14) and of intact stomachs (n = 10). Main Outcome Measurements: The mean time for endoscopic closure was 9.8 minutes (range 3-22, SD 5.5). No complications occurred during either type of gastrotomy closure. At necropsy, examination of all OTSC and surgical closures demonstrated complete sealing of gastrotomy sites without evidence of injury to adjacent organs. Pressurized leak tests showed a mean burst pressure of 83 mm Hg (range 30-140, SD 27) for OTSC closures and 67 mm Hg (range 30-130, SD 27.7) for surgical sutures. Ex vivo hand-sewn sutures of 18-mm gastrotomies (n = 14) exhibited a mean burst pressure of 65 mm Hg (range 20-140, SD 31) and intact ex vivo stomachs (n = 10) had a mean burst pressure of 126 mm Hg (range 90-170, SD 28). The burst pressure of ex vivo intact stomachs was significantly higher compared with OTSC closures (P < .01), in vivo surgical closures (P < .01), and ex vivo hand-sewn closures (P < .01). There was a trend toward higher burst pressures in the OTSC closures compared with surgical closures (P = .063) and ex vivo hand-sewn closures (P = .094). In vivo surgical closures demonstrated similar burst pressures compared with ex vivo hand-sewn closures (P = .848). Limitations: Nonsurvival setting. Conclusion: Endoscopic closure by using the OTSC system is comparable to surgical closure in a nonsurvival porcine model. This technique is easy to perform and is suitable for NOTES gastrotomy closure. [Copyright &y& Elsevier]

Abstract: Background: There is a pressing need for an intraoperative assessment tool that meets high standards of reliability and validity to use as an outcome measure for different training strategies. The aim of this study was to develop a tool specific for laparoscopic skills and to evaluate its reliability and validity. Methods: The Global Operative Assessment of Laparoscopic Skills (GOALS) consists of a 5-item global rating scale. A 10-item checklist and 2 visual analogue scales (VAS) for competence and case difficulty were also used. During laparoscopic cholecystectomy, 21 participants were evaluated by the attending surgeon, by 2 trained observers and by self-assessment while dissecting the gallbladder from the liver bed. Results: The intraclass correlation coefficient (ICC) for the total GOALS score was .89 (95% confidence interval [CI] .74 to .95) between observers, .82 (95% CI .67 to .92) between observers and attending surgeons, and .70 (95% CI .37 to .87) between participants and attending surgeons. The ICCs (observers) for the VAS (competence) and the checklist were .69 and .70, respectively. The mean total GOALS score (observers) for novices (postgraduate years [PGYs] 1 through 3) was 13 (95% CI 10.3 to 15.7) compared with 19.4 (95% CI 17.2 to 21.5) for experienced (PGY 4 through attending surgeons, P = .0006). The VAS demonstrated a difference in scores between novice and experienced participants (P = .001); however, the task checklist did not (P = .09). Conclusions: These data indicate that GOALS is feasible, reliable, and valid. They also suggest that it is superior to the task checklist and VAS for evaluation of technical skill by experienced raters. The findings support the use of GOALS in the training and evaluation of laparoscopic skills. [Copyright &y& Elsevier]

Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months after POEM, 97% of patients were in symptom remission (95% confidence interval, 89%–99%); symptom scores were reduced from 7 to 1 (P < .001) and lower esophageal sphincter pressures were reduced from 28 to 9 mm Hg (P < .001). The percentage of patients in symptom remission at 6 and 12 months was 89% and 82%, respectively. POEM was found to be an effective treatment for achalasia after a mean follow-up period of 10 months. Clinical Trials Gov Registration number: NCT01405417. [Copyright &y& Elsevier]

Abstract: Background: The purpose of this study was to develop an assessment tool specific to laparoscopic inguinal hernia repair (LIHR), and to evaluate its reliability and validity in the operating room (OR) and skills laboratory. Methods: The Global Operative Assessment of Laparoscopic Skills–Groin Hernia (GOALS-GH) was developed by surgeon-educators. Participants were assessed in the OR and/or on a physical simulator using GOALS-GH. Interrater reliability, internal consistency, and construct and concurrent validity were evaluated for 23 participants. Results: The interrater reliability of GOALS-GH was >.70 for all raters in the OR and during simulated LIHR. The internal consistency of GOALS-GH items was .97. The mean total GOALS-GH score for experts was significantly higher than for novices in both environments. The correlation between GOALS-GH scores in the OR and simulator was .81 (P < .01; n = 12). Conclusions: GOALS-GH is an objective, reliable, and valid measure of the skills required to perform LIHR. [Copyright &y& Elsevier]

Abstract: Background: The role of simulation for training in procedures such as laparoscopic incisional hernia repair (LIHR) is unknown. The purpose of this study was to determine whether performance in simulated LIHR correlates with operating room (OR) performance. Methods: Subjects performed LIHR in the University of Maryland Surgical Abdominal Wall (SAW) simulator and the OR. Trained observers used a LIHR-specific global rating scale (Global Operative Assessment of Laparoscopic Skills–Incisional Hernia) to assess performance. Global Operative Assessment of Laparoscopic Skills–Incisional Hernia includes 7 domains (trocar placement, adhesiolysis, mesh sizing, mesh positioning, mesh fixation, knowledge and autonomy in instrument use, and overall competence). The correlation between simulator and OR performance was assessed using the Pearson coefficient. Results: Fourteen surgeons from 2 surgical departments participated. Experienced surgeons (n = 9) were defined as attending surgeons and minimally invasive surgury (MIS) fellows, and novice surgeons (n = 5) were general surgery residents (postgraduate years 3–5). The correlation between performance in the OR and the simulator for the entire group was .87 (95% confidence interval, .63–.96; P < .001). Conclusions: There was an excellent correlation between LIHR performance in the simulator and clinical LIHR. This suggests that performance in the SAW simulator may predict performance in the operating room. [Copyright &y& Elsevier]

Background: Bile duct injuries from laparoscopic cholecystectomy remain a significant source of morbidity and are often the result of intraoperative errors in perception, judgment, and decision-making. This qualitative study aimed to define and characterize higher-order cognitive competencies required to safely perform a laparoscopic cholecystectomy.Study Design: Hierarchical and cognitive task analyses for establishing a critical view of safety during laparoscopic cholecystectomy were performed using qualitative methods to map the thoughts and practices that characterize expert performance. Experts with more than 5 years of experience, and who have performed at least 100 laparoscopic cholecystectomies, participated in semi-structured interviews and field observations. Verbal data were transcribed verbatim, supplemented with content from published literature, coded, thematically analyzed using grounded-theory by 2 independent reviewers, and synthesized into a list of items.Results: A conceptual framework was created based on 10 interviews with experts, 9 procedures, and 18 literary sources. Experts included 6 minimally invasive surgeons, 2 hepato-pancreatico-biliary surgeons, and 2 acute care general surgeons (median years in practice, 11 [range 8 to 14]). One hundred eight cognitive elements (35 [32%] related to situation awareness, 47 [44%] involving decision-making, and 26 [24%] action-oriented subtasks) and 75 potential errors were identified and categorized into 6 general themes and 14 procedural tasks. Of the 75 potential errors, root causes were mapped to errors in situation awareness (24 [32%]), decision-making (49 [65%]), or either one (61 [81%]).Conclusions: This study defines the competencies that are essential to establishing a critical view of safety and avoiding bile duct injuries during laparoscopic cholecystectomy. This framework may serve as the basis for instructional design, assessment tools, and quality-control metrics to prevent injuries and promote a culture of patient safety. [ABSTRACT FROM AUTHOR]