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With the increasing adoption of peroral endoscopic myotomy (POEM) as a first-line therapy for achalasia as well as a growing list of other indications, it is apparent that there is a need for effective training methods for both endoscopists in training and those already in practice. We present a hands-on-focused with pre- and post-testing methodology to teach these skills. Six POEM courses were taught by 11 experienced POEM endoscopists at two independent simulation laboratories. The training curriculum included a pre-training test, lectures and discussion, mentored hands-on instruction using live porcine and ex-plant models, and a post-training test. The scoring sheet for the pre- and post-tests assessed the POEM performance with a Likert-like scale measuring equipment setup, mucosotomy creation, endoscope navigation, visualization, myotomy, and closure. Participants were stratified by their experience with upper-GI endoscopy (Novices <100 cases vs. Experts ≥100 cases), and their data were analyzed and compared. Sixty-five participants with varying degrees of experience in upper-GI endoscopy and laparoscopic achalasia cases completed the training curriculum. Participants improved knowledge scores from 69.7 ± 17.1 (pre-test) to 87.7 ± 10.8 (post-test) (p< 0.01). POEM performance increased from 15.1 ± 5.1 to 25.0 ± 5.5 (out of 30) (p< 0.01) with the greatest gains in mucosotomy [1.7–4.4 (out of 5), p< 0.01] and equipment (3.4–4.7, p< 0.01). Novices had significantly lower pre-test scores compared with Experts in upper-GI endoscopy (overall pre-score: 11.9 ± 5.6 vs. 16.3 ± 4.6, p< 0.01). Both groups improved significantly after the course, and there were no differences in post-test scores (overall post-score: 23.9 ± 6.6 vs. 25.4 ± 5.1, p= 0.34) between Novices and Experts. A multimodal curriculum with procedural practice was an effective curricular design for teaching POEM to practitioners. The curriculum was specifically helpful for training surgeons with less upper-GI endoscopy experience.

Zenker’s diverticulum (ZD) is a rare upper esophageal pathology that is most prevalent in the sixth and seventh decade. Three different therapeutical options are available: (1) open trans-cervical approach, (2) rigid endoscopy and (3) flexible endoscopy. Our hypothesis is that a flexible endoscopic cricomyotomy represents a safe and effective treatment of ZD as well as cricopharyngeal spasm. A retrospective analysis of all patients that underwent a flexible endoscopic cricomyotomy at our institution between October 2008 and May 2014 was performed. Preoperative and postoperative (1 month and long-term follow-up) symptom scores and clinical outcomes were collected. Briefly, the ZD is carefully identified endoscopically and the common wall is divided using needle knife cautery with the help of an endoscopic cap. Clips are used to close the mucosal defect starting with the apex. Twenty-six patients underwent a flexible endoscopic myotomy for a ZD. Of 26 patients, five (19.2 %) had a history of previous open or stapled trans-oral myotomy and four (15.4 %) underwent a concomitant foregut procedure. Mean length of stay was 1.5 days (range 1–11). Mean operative time was 68 min (range 28–149). One patient presented with a postoperative leak, and one patient presented with a retained clip. Both were treated endoscopically. Recurrent weekly dysphagia was present in 3/26 (11.5 %). One patient (3.8 %) underwent an endoscopic bougie dilatation postoperatively. With regard to clinical outcomes, there was a statistically significant improvement in both short-term (1 month) and long-term (median follow-up 21.8 months; range 1–68.2 months) dysphagia (p< 0.001; p< 0.001), regurgitation (p= 0.001; p= 0.017), cough (p= 0.006; p= 0.025) and aspiration (p= 0.013; p= 0.013). Flexible endoscopic cricomyotomy offers durable relief of dysphagia, regurgitation, cough and aspiration in ZD patients. It appears to have a good safety profile with symptomatic recurrence occurring in up to 11.5 % of cases.

Obtaining an adequate mucosal closure is one of the crucial steps in per-oral endoscopic myotomy (POEM). Thus far, there have been no objective data comparing the various available closure techniques. This case-controlled study attempts to compare the application of endoscopic clips versus endoscopic suturing for mucosotomy closure during POEM cases. A retrospective review of our prospective POEM database was performed. All cases in which endoscopic suturing was used to close the mucosotomy were matched to cases in which standard endoclips were used. Overall complication rate, closure time and mucosal closure costs between the two groups were compared. Both techniques offer good clinical results with good mucosal closure and the absence of postoperative leak. Closure time was significantly shorter (p= 0.044) with endoscopic clips (16 ± 12 min) when compared to endoscopic suturing (33 ± 11 min). Overall, the total closure cost analysis showed a trend toward lower cost with clips (1502 ± 849 USD) versus endoscopic suturing (2521 ± 575 USD) without reaching statistical significance (p= 0.073). The use of endoscopic suturing seems to be a safe method for mucosal closure in POEM cases. Closure time is longer with suturing than conventional closure with clips, and there is a trend toward higher overall cost. Endoscopic suturing is likely most cost-effective for difficult cases where conventional closure methods fail.

Surgical options for symptomatic delayed gastric emptying include gastric stimulator implantation, subtotal gastrectomy, and pyloroplasty. Pyloroplasty has been shown to improve gastric emptying yet is seldom described as a primary treatment for gastroparesis. We present a single-institution experience of laparoscopic Heineke–Mikulicz pyloroplasty (LP) as treatment for gastroparesis. A prospective foregut surgery database was queried for LP over a 5-year period. Charts were reviewed for indications, complications, symptom score, and outcomes. Gastroparesis was defined by (1) abnormal gastric emptying study, (2) endoscopic visualization of retained food after prolonged NPO status, or (3) clinical symptoms suspicious of vagal nerve injury following complex re-operative foregut surgery. Results were analyzed using a paired Ttest and single-factor ANOVA. One hundred and seventy-seven LP patients were identified and reviewed. One hundred and five had a concurrent fundoplication for objective reflux. There were no intraoperative complications or conversions to laparotomy. Overall morbidity rate was 6.8 % with four return to OR and two confirmed leaks (1.1 % leak rate). Average length of stay was 3.5 days, and readmission rate was 7 %. Eighty-six percent had improvement in GES with normalization in 77 %. Gastric emptying half-time decreased from 175 ± 94 to 91 ± 45 min. Nineteen patients (10.7 %) had subsequent surgical interventions: gastric stimulator implantation (12), feeding jejunostomy and/or gastrostomy tube (6), or subtotal gastrectomy (4). Symptom severity scores for nausea, vomiting, bloating, abdominal pain, and early satiety decreased significantly at 3 months. Laparoscopic pyloroplasty improves or normalizes gastric emptying in nearly 90 % of gastroparesis patients with very low morbidity. It significantly improves symptoms of nausea, vomiting, bloating, and abdominal pain. Some patients may go on to another surgical treatment for GP, but it remains a safe and less invasive alternative to a subtotal gastrectomy in these clinically challenging patients.

Laparoscopic surgery for gastrointestinal reflux disease was introduced in 1991. Early safety, efficacy, and 5–10-year durability have been amply documented, but long-term patient outcomes have been criticized. This study presents 20-year outcomes after laparoscopic fundoplication (LF) in a consecutive patient cohort. Patients who underwent primary LF procedures for gastroesophageal reflux disease (GERD) were identified from a prospectively collected IRB-approved database (1991–1995). A phone symptom questionnaire was administered using a 5-point validated GERD scoring system (heartburn, regurgitation, and dysphagia). Symptomatic success was defined by a lack of surgical re-intervention and a low symptom score. One-hundred and ninety-three patients were identified during the time period. Fifty-one patients completed the survey (100 lost to follow-up, 40 deceased, 2 declined to answer). Respondents had a median follow-up of 19.7 years. Overall, 38/51 (74.5 %) of patients reported complete control of heartburn and regurgitation. Ten patients reported only occasional heartburn. Eight of fifty-one (16 %) reported daily dysphagia, and 22/51 (43 %) of respondents were using proton pump inhibitors at the time of telephone interview. Nine of fifty-one (18 %) underwent revision of the original surgery which did not negatively impact the satisfaction rating, with 8/9 (89 %) of these patients reporting the highest satisfaction rating. Overall, 46/51 (90 %) were satisfied with their choice of surgery. Long-term results from the early experience with LF are excellent with 94 % of patients reporting only occasional or fewer reflux symptoms at 20-year follow-up. However, 18 % required surgical revision surgery to maintain their results. There is a relatively high rate of daily dysphagia but 90 % of patients are happy to have had LF.

Gastroparesis is a condition characterized by delayed gastric emptying, and a constellation of symptoms, including nausea, vomiting, early satiety, and bloating. Although current surgical options such as pyloroplasty have been shown to be effective, an endoscopic submucosal myotomy technique may be applied to divide the pyloric sphincter without surgical access. Such endoscopic technique may provide the benefits of a natural orifice procedure, and improve gastric emptying in gastroparetic patients. Per-oral pyloromyotomy (POP) was performed in seven female patients aged 33–65 years (mean 51 years). All patients had a pre-operative work-up that included upper endoscopy, and a gastric emptying study. A pH study, and esophageal manometry were also performed when a concomitant fundoplication was considered. POP was technically successful in all seven cases. There were no immediate procedural complications. Perioperative, complications included: one patient with an upper GI bleed 2 weeks post-procedure, necessitating transfusions, and endoscopic clipping of a pyloric channel ulcer; one patient who experienced difficulty swallowing post operatively, delaying discharge by 1 day; and one patient who developed a hospital-acquired pneumonia, delaying discharge by several days. Six of the seven patients experienced significant symptomatic improvement following the procedure. Three month follow-up nuclear medicine solid-phase gastric emptying studies are currently available for 5 of the 7 patients. Normal gastric emptying at 4 h was noted in four of five patients (80 %). One patient did not respond to endoscopic management subsequently underwent an uneventful laparoscopic pyloroplasty, which also failed to significantly improve her symptoms. POP is a technically safe and feasible endoscopic procedure. Early follow-up suggests promising symptomatic improvement as well as objective improvement in gastric emptying. Additional clinical experience is required to establish the role of this technique in the management of gastroparesis.

Abstract: Background: During natural orifice transluminal endoscopic surgery (NOTES), surgeons often have difficulties orienting the surgical view and manipulating instruments accurately, which increases their level of mental and physical fatigue. This study quantified mental workload by measuring the spared mental resources of surgeons performing NOTES training tasks. Methods: Assessment of mental workload was conducted in both a benchtop and a hybrid animal model. Using the benchtop model, surgeons were required to pass a ring as many times as possible in 6 min. Using the hybrid model, surgeons were required to dissect the gallbladder. While performing those primary tasks, the surgeon was required to identify true visual signals among many false signals displayed on an adjacent monitor. They were asked to repeat the trials using laparoscopy. The surgeons’ performance on the primary and secondary tasks using the NOTES and laparoscopic approaches were recorded and compared. Results: The nine surgeons who completed the trials in the benchtop model successfully transferred 13 ± 4 rings between targets using laparoscopy compared with a mean of 1.2 ± 1.0 rings transferred using NOTES (P < 0.001). The surgeons detected visual signals at a 74% rate using laparoscopy, which was significantly higher than the 54% detection rate with the NOTES procedure (P = 0.005). Using the hybrid model, 10 surgeons achieved a 55% accuracy rate performing the laparoscopic task. This was found to be significantly higher (P = 0.006) than when the task was performed using the NOTES platform (39%). Conclusion: The results showed that performance of a task using the NOTES platform increases surgeons’ mental workload. Because difficulty performing NOTES is associated with flexible endoscopy, the authors expect that new operating systems providing stable platforms will help to decrease the mental workload of surgeons and enhance eye–hand coordination in performing NOTES.

Abstract: Introduction: Dysphagia is a common postoperative symptom after laparoscopic antireflux surgery, usually attributed to postoperative edema or a “too tight” fundoplication. Although it is usually self-limited, it occasionally requires endoscopic dilation and rarely revisionary surgery. It has not been previously described whether postoperative dysphagia is associated with poorer long-term reflux control after fundoplication. Methods: We hypothesized that the presence of dysphagia in the early postoperative period is associated with long-term failure of the antireflux procedure and recurrence of gastroesophageal reflux disease (GERD) symptoms. A retrospective review of a prospectively maintained database of patients undergoing antireflux surgery was performed. The study population included patients, who underwent primary laparoscopic Nissen fundoplication between the years 1991 and 2010. The presence of dysphagia on their first postoperative visit (<30 days) was used to classify them in the early-dysphagia (ED) and the no-early-dysphagia (NED) groups. The recurrence of heartburn or regurgitation, as well as the pH studies on long-term follow-up (more than 6 months) were compared between the two groups. A grading system (range 0–4) was used to measure the severity of foregut symptoms. Results: 1223 patients underwent primary laparoscopic Nissen fundoplications during the study period and met the inclusion criteria. Both short and long-term follow-up was available in 821 patients, who were analyzed. 423 patients were included in the ED group, whereas 398 in the NED group. The mean regurgitation score of the ED group on the long-term follow-up was 0.25 compared to 0.20 for the NED group (P = 0.21). The heartburn score was 0.38 for the ED group compared to 0.33 for the NED group (P = 0.38). Long-term dysphagia was higher in the ED group. These findings were confirmed when ED patients were subclassified based on the degree of early post-operative dysphagia. Of the 821 patients, 599 underwent routine postoperative pH testing. The mean DeMeester score in the ED group (n = 308) was 11.7 compared to 13.2 for the NED group (n = 291; P = 0.54). The percentage of patients with abnormal pH testing was similar between the two groups. Conclusions: Early postoperative dysphagia is not associated with worse long-term GERD symptom control after primary laparoscopic antireflux surgery.

Abstract: Background: The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. Methods: A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0–4, five-point Likert scale questionnaire) and 24-h pH testing at 6–12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann–Whitney U test, Wilcoxon signed rank test, and Freidman’s test. Results: Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6–12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH < 4 were not significant between the two groups. Abnormal acid reflux was present in 10 of 24 Dor group patients (41.7%) and in 4 of 19 Toupet patients (21.0%) (p = 0.152). Dysphagia and regurgitation symptom scores improved significantly in both groups compared to preoperative scores. No significant differences in any esophageal symptoms were noted between the two groups preoperatively or at follow-up. SF-36 quality-of-life measures changed significantly from pre- to postoperative for five of ten domains in the Dor group and seven of ten in the Toupet patients (not significant between groups). Conclusion: Laparoscopic Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

Abstract: Background: Computed tomography (CT)-guided radiofrequency ablation (RFA) is presumed to be less morbid and less costly than laparoscopic RFA. This analysis investigates the 30-day morbidity, hospital cost, and reimbursement for CT-guided RFA versus laparoscopic RFA used to manage hepatocellular carcinoma (HCC) and colorectal liver metastases (CRLM). Methods: A retrospective review was performed for all patients with CRLM or HCC who underwent CT-guided RFA or laparoscopic RFA between January 2002 and August 2008. Demographics, risk stratification, and procedural data were analyzed. Hospital financial data were queried for total cost, reimbursement, and itemized departmental charges. The CRLM and HCC patients were evaluated separately. Results: The study analyzed 18 RFA procedures for the treatment of HCC (8 CT-guided RFA; 10 laparoscopic RFA) and 25 RFA procedures for the treatment of CRLM (6 CT-guided RFA; 19 laparoscopic RFA). Immediate local failures were reported for 33.3% and 12.5% of the CT-guided RFA procedures for CRLM and HCC and for 5.2% and 0.0% of the laparoscopic RFA procedures for CRLM and HCC, respectively. The mean hospital cost was higher for the patients who underwent laparoscopic RFA ($11,808.70 ± $7,238.90 for HCC vs $9,882.40 ± $1,926.90 for CRLM) than for those who underwent CT-guided RFA ($7,186.10 ± $3,899.60 for HCC vs $5,767.50 ± $2,869.00 for CRLM). The mean reimbursement was lower than the mean hospital cost for the patients who underwent CT-guided RFA for CRLM ($4,329.10 vs $5,767.50). Conclusion: Although CT-guided RFA is less expensive, it is poorly reimbursed. Also, CT-guided RFA is associated with a higher immediate local failure rate for both CRLM and HCC and a higher complication rate for patients with CRLM. For patients with HCC, CT-guided RFA is associated with a lower complication rate. Our data suggest that laparoscopic RFA should be used for most patients with CRLM and only selectively for patients with HCC.

Abstract: Background: Natural orifice translumenal endoscopic surgery (NOTES) involves the use of flexible endoscopes to perform intra-abdominal or intra-thoracic surgeries. Surgery in the operating room usually involves sterile instrumentation, whereas in the endoscopy suite high-level disinfection seems to be sufficient. Our objective was to assess the necessity for endoscope sterilization for clinical NOTES and to develop an endoscope processing protocol based on a score for the available processing options. Methods: Score and processing protocol development for clinical NOTES endoscopes was based on a comprehensive review of the available relevant literature. Options for sterilization for flexible endoscopes in the Good Samaritan Hospital, Legacy Health in Portland, Oregon, were analyzed for patient safety, potential for recontamination, cost, and validation. Results: Literature survey indicated that there is controversy surrounding the necessity for sterilization of surgical endoscopes. However, standard of practice seems to call for sterile instrumentation for surgery and it is possible to terminally sterilize flexible endoscopes. Within our institution, a score was created to rank the available sterilization options. We successfully introduced a protocol for sterilization of endoscopes for use in clinical NOTES procedures. The protocol involved mechanical cleaning and high-level disinfection per Multi-Society Guidelines, with subsequent terminal sterilization using a validated peracetic acid protocol. Conclusions: It remains controversial whether sterile instrumentation is truly needed for surgery. It is difficult but possible to terminally sterilize flexible endoscopes. We recommend sterile instrumentation for clinical NOTES until well-designed, randomized, clinical trials are available and guidelines are published.

Abstract: Introduction: Mental workload is a finite resource and is increased while learning new tasks and performing complex tasks. Measurement of a surgeon’s mental workload may therefore be an indication of expertise. We hypothesized that surgeons who were expert at laparoscopic suturing would have more spare mental resources to perform a secondary task, compared with surgeons who had just started to learn suturing. Methods: Standardized suturing tasks were performed on a bench-top model. Twelve junior residents (novices) and nine fellows and attending surgeons (experts) were instructed to perform as many sutures as possible in 6 min. An adjacent monitor was placed 15° off axis to the first and randomly displayed 30 true visual signals among 90 false ones. Participants were required to identify the true signals while continuing to suture. Laparoscopic sutures were evaluated using the Fundamentals of Laparoscopic Surgery (FLS) scoring system. The secondary (visual detection) task was evaluated by calculating the rate of missed true signals or detection of false signals. Results: Experts completed significantly more secure sutures (6 ± 2) than novices (3 ± 1; p = 0.001). The suture performance score was 50 ± 20 for experts, significantly higher than for novices (29 ± 10; p = 0.005). The rate for detecting visual signals was higher for experts (98%) compared with for novices (93%; p = 0.041). Conclusion: Practice develops automaticity, which reduces the mental workload and allows surgeons to have sufficient spare mental resources to attend to a secondary task. Visual detection provides a simple and reliable way to assess mental workload and situation awareness abilities of surgeons during skills training, and may be an indirect measure of expertise.