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The evolution of Natural Orifice Translumenal Endoscopic Surgery®(NOTES®) represents a case study in surgical procedural evolution. Beginning in 2004 with preclinical feasibility studies, and followed by the creation of the NOSCAR®collaboration between The Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Gastrointestinal Endoscopy, procedural development followed a stepwise incremental pathway. The work of this consortium has included white paper analyses, obtaining outside independent funding for basic science and procedural development, and, ultimately, the initiation of a prospective randomized clinical trial comparing NOTES®cholecystectomy as an alternative procedure to laparoscopic cholecystectomy. Ninety patients were randomized into a randomized clinical trial with the primary objective of demonstrating non-inferiority of the transvaginal and transgastric arms to the laparoscopic arm. In the original trial design, there were both transgastric and transvaginal groups to be compared to the laparoscopic control group. However, after enrollment and randomization of 6 laparoscopic controls and 4 transgastric cases into the transgastric group, this arm was ultimately deemed not practical due to lagging enrollment, and the arm was closed. Three transgastric via the transgastric approach were performedin total with 9 laparoscopic control cases enrolled through the TG arm. Overall a total of 41 transvaginal and their 39 laparoscopic cholecystectomy controls were randomized into the study with 37 transvaginal and 33 laparoscopic cholecystectomies being ultimately performed. Overall total operating time was statistically longer in the NOTES®group: 96.9 (64.97) minutes versus 52.1 (19.91) minutes. There were no major adverse events such as common bile duct injury or return to the operating room for hemorrhage. Intraoperative blood loss, length of stay, and total medication given in the PACU were not statistically different. There were no conversions in the NOTES®group to a laparoscopic or open procedure, nor were there any injuries, bile leaks, hemorrhagic complications, wound infections, or wound dehiscence in either group. There were no readmissions. Visual Analogue Scale (VAS) pain scores were 3.4 (CI 2.82) in the laparoscopic group and 2.9 (CI 1.96) in the transvaginal group (p= 0.41). The clinical assessment on cosmesis scores was not statistically different when recorded by clinical observers for most characteristics measured when the transvaginal group was compared to the laparoscopic group. Taken as a whole, the results slightly favor the transvaginal group. SF-12 scores were not statistically different at all postoperative time points except for the SF-12 mental component which was superior in the transvaginal group at all time points (p< 0.05). The safety profile for transvaginal cholecystectomy demonstrates that this approach is safe and produces at least non-inferior clinical results with superior cosmesis, with a transient reduction in discomfort. The transvaginal approach to cholecystectomy should no longer be considered experimental. As a model for intersociety collaboration, the study demonstrated the ultimate feasibility and success of partnership as a model for basic research, procedural development, fundraising, and clinical trial execution for novel interventional concepts, regardless of physician board certification.

Sessile serrated polyps (SSPs) are associated with higher rates of incomplete resection compared to conventional adenomas after traditional snare polypectomy. Outcomes after endoscopic mucosal resection (EMR) are less established. The aim of this study was to evaluate the rate of residual neoplasia at surveillance colonoscopy for SSPs compared to conventional adenomas ≥ 10 mm after en bloc EMR. Retrospective cohort study of consecutive patients referred for EMR of a colonic lesion ≥ 10 mm from 2005 to 2013. Data on procedures, histopathology, and surveillance colonoscopies were recorded. The primary outcome was rate of macroscopically evident residual neoplasia at surveillance colonoscopy for SSPs compared to adenomas. Secondary outcomes included rate of neoplasia at the resection margin. 283 consecutive patients with 293 polyps underwent en bloc EMR including 101 SSPs and 192 adenomas. Pathology commented on the lateral resection margins of the specimen in 235 cases (80%). Of these, neoplasia was noted at the resection margin in 29/64 SSPs (45.3%) compared to 65/171 adenomas (38.0%; P= .37). Surveillance data were available for 153 index lesions with a median interval of 13 months (interquartile range, 10.75–23.25 months). Ten resection sites (6.5%) were found to have residual neoplasia, including 2/52 SSPs (3.8%) and 8/101 adenomas (7.9%; P= .50). Of the cases with surveillance data 128/153 (84%) commented on the lateral margin of the resection specimen. Residual neoplasia was noted in 3/68 lesions (4.4%) with negative margins compared to 5/60 lesions (8.3%) with positive margins (P= .47). En bloc EMR for colonic lesions ≥ 10 mm is associated with a 6.5% rate of macroscopic residual neoplasia. Although 45% of SSPs had neoplasia extending to the resection margin, rates of residual neoplasia at surveillance colonoscopy were low. These results suggest that when feasible en bloc EMR is a reasonable option to resect SSPs ≥ 10 mm.

Radiation therapy for head, neck, and esophageal cancer can result in esophageal strictures that may be difficult to manage. Radiation-induced esophageal strictures often require repeat dilation to obtain relief of dysphagia. This study aimed to determine the long-term clinical success and rates of recurrent and refractory stenosis in patients with radiation-induced strictures undergoing dilation. Retrospective cohort study of patients with radiation-induced strictures who underwent endoscopic dilation by a single provider from October 2007–October 2012. Outcomes measured included long-term clinical efficacy, interval between sessions, number of dilations, and proportion of radiation strictures that were recurrent or refractory. Risk factors for refractory strictures were assessed. 63 patients underwent 303 dilations. All presented with a stricture >30 days after last radiation session. Clinical success to target diameter was achieved in 52 patients (83 %). A mean of 3.3 (±2.6) dilations over a median period of 4 weeks was needed to achieve initial patency. Recurrence occurred in 17 (33 %) at a median of 22 weeks. Twenty-seven strictures (43 %) were refractory to dilation therapy. Fluoroscopy during dilation (OR 22.88; 95 % CI 3.19–164.07), severe esophageal stenosis (lumen <9 mm) (OR 10.51; 95 % CI 1.94–56.88), and proximal location with prior malignancy extrinsic to the lumen (OR 6.96; 95 % CI 1.33–36.29) were independent predictors of refractory strictures in multivariate analysis. (1) Radiation-induced strictures have a delayed onset (>30 days) from time of radiation injury. (2) Endoscopic dilation can achieve medium-term luminal remediation but the strictures have a high long-term recurrence rate of up to 33 %. (3) Remediation of radiation strictures following laryngectomy can be achieved but require frequent dilations. (4) Clinical and procedural predictors may identify patients at high risk of refractory strictures. (5) The optimal strategy in highly selected refractory patients is not clear.

The Fundamentals of Endoscopic Surgery™ (FES) program consists of online materials and didactic and skills-based tests. All components were designed to measure the skills and knowledge required to perform safe flexible endoscopy. The purpose of this multicenter study was to evaluate the reliability and validity of the hands-on component of the FES examination, and to establish the pass score. Expert endoscopists identified the critical skill set required for flexible endoscopy. They were then modeled in a virtual reality simulator (GI Mentor™ II, Simbionix™ Ltd., Airport City, Israel) to create five tasks and metrics. Scores were designed to measure both speed and precision. Validity evidence was assessed by correlating performance with self-reported endoscopic experience (surgeons and gastroenterologists [GIs]). Internal consistency of each test task was assessed using Cronbach’s alpha. Test–retest reliability was determined by having the same participant perform the test a second time and comparing their scores. Passing scores were determined by a contrasting groups methodology and use of receiver operating characteristic curves. A total of 160 participants (17 % GIs) performed the simulator test. Scores on the five tasks showed good internal consistency reliability and all had significant correlations with endoscopic experience. Total FES scores correlated 0.73, with participants’ level of endoscopic experience providing evidence of their validity, and their internal consistency reliability (Cronbach’s alpha) was 0.82. Test–retest reliability was assessed in 11 participants, and the intraclass correlation was 0.85. The passing score was determined and is estimated to have a sensitivity (true positive rate) of 0.81 and a 1-specificity (false positive rate) of 0.21. The FES hands-on skills test examines the basic procedural components required to perform safe flexible endoscopy. It meets rigorous standards of reliability and validity required for high-stakes examinations, and, together with the knowledge component, may help contribute to the definition and determination of competence in endoscopy.