Prospective Study of Contamination Spread Produced During Open Surgical vs Conventional Percutaneous vs Novel Percutaneous Tracheostomy During COVID-19 Era in a Pig Model.

BACKGROUND: Because of concerns about provider contamination during tracheostomy procedures in a pandemic such as COVID-19, it is essential to objectively evaluate aerosol generation in all tracheostomy approaches, including newly developed tracheostomy procedures. We performed open surgical tracheostomy (OST), conventional percutaneous tracheostomy (CPT), and novel percutaneous tracheostomy (NPT), a modification of CPT designed to reduce contamination spread, in pig models and then compared the degree of contamination to providers using Glo Germ (Glo Germ, Moab, UT, USA). STUDY DESIGN: Six Yorkshire pigs were used for data collection. Either OST, CPT or NPT was performed on the pigs by the same team including a surgeon, anesthesiologist, and respiratory therapist. A mixture of Glo Germ and water was administered via atomizer into the oral cavity to the tracheal bifurcation before each procedure, and additionally dispersed via an aersolizer in the trachea and lungs through the endotracheal tube before and throughout the procedure. Before and immediately after each procedure, pre-specified body parts of the providers were photographed and two independent examiners blindly evaluated the photographs to determine degree of Glo Germ contamination using a 3-point Likert scale. RESULTS: Total contamination among provider team average score (min. 0, max. 2), was significantly lower for OST than CPT (0.29 ± 0.59 vs 0.63 ± 0.65; P<0.01) or NPT (0.29 ± 0.59 vs 0.59 ± 0.66; p <0.01). No significant difference was seen in overall contamination of any provider between CPT and NPT (0.63 ± 0.65 vs 0.59 ± 0.66; p =0.92). CONCLUSION: Our results suggest that OST causes significantly less aerosol contamination to providers than either CPT or NPT.

Using impedance planimetry (EndoFLIP) to determine ideal distensibility ranges for esophageal motility disorders.

OBJECTIVE: Use of impedance planimetry (EndoFLIP) has shown distensibility index ranges associated with improved patient-reported outcomes after antireflux surgery. Questions remain whether the previously described ideal distensibility index range can be used for patients with esophageal motility disorders. We hypothesized that patients with esophageal motility disorders would have a different ideal distensibility range for optimal outcomes. METHODS: A retrospective review of a prospectively maintained gastroesophageal database was performed for all patients undergoing Toupet and Nissen fundoplication and impedance planimetry. Demographic data, perioperative outcomes, and quality-of-life indicators (Reflux Symptom Index, Gastroesophageal Reflux Disease-Health Related Quality of Life Questionnaire, and gas/bloat and dysphagia scores) were analyzed and compared between patients by use of the χ2 and Wilcoxon rank-sum tests. RESULTS: From 2015 to 2024, 475 patients underwent laparoscopic fundoplication and impedance planimetry evaluation. Of those, 160 had a final distensibility index score in the ideal range, 165 with a final distensibility index score <2.5, and 150 with a final distensibility index >3.6. In the ideal-range cohort, there were no statistically significant differences between those with normal and abnormal motility in regards to outcomes or quality of life indicators. In the low distensibility index cohort, patients with abnormal motility had worse Gastroesophageal Reflux Disease-Health Related Quality of Life Questionnaire, gas/bloat, and dysphagia scores at 1 year postoperatively compared with those with normal motility. More patients in the low distensibility index cohort required dilations postoperatively, and more patients in the high distensibility index cohort had recurrences compared with those in the ideal range cohort. CONCLUSION: The previously described ideal distensibility index range of 2.5-3.6 for patients undergoing laparoscopic fundoplication may be used for patients with certain esophageal motility disorders.

Neoplastic Progression Risk in Females With Barrett's Esophagus: A Systematic Review and Meta-Analysis of Individual Patient Data.

BACKGROUND AND AIMS: Females with Barrett's esophagus (BE) have a lower risk of neoplastic progression than males, but sufficiently powered risk analyses are lacking. This systematic review and meta-analysis of individual patient data (IPD) aimed to provide more robust evidence on neoplastic progression risk in females. METHODS: We conducted a systematic literature search of 3 electronic databases (Medline, Embase, Google Scholar) from inception until August 2023. Eligible studies (1) reported original data on progression from nondysplastic BE, indefinite for dysplasia, or low-grade dysplasia to high-grade dysplasia or esophageal adenocarcinoma; and (2) included female and male patients. IPD were quality controlled by 2 independent reviewers. The primary outcome was the association between sex and neoplastic progression risk, adjusted for risk factors using multivariable Cox regression analysis. Secondary outcomes were sex differences in time to progression and annual progression rate. RESULTS: IPD were obtained from 11 of 66 eligible studies, including 2196 (31%) females. Neoplastic progression risk was lower in females (hazard ratio for males vs females, 1.44; 95% confidence interval, 1.13-1.82) after adjusting for age, smoking, medication use, hiatal hernia, BE length, and baseline pathology. The annual progression rate was 0.88% in females vs 1.29% in males. Time to progression was similar in both sexes: 3.7 years (interquartile range, 2.1-7.7 years) in females and 4.2 years (interquartile range, 2.0-8.1 years) in males. CONCLUSION: Although females had a lower neoplastic progression risk, sex differences were smaller than previously reported, and time to progression was similar for both sexes. Future research should focus on other factors than sex to identify low- and high-risk BE patients.

Comparable improvement and resolution of obesity-related comorbidities in endoscopic sleeve gastroplasty vs laparoscopic sleeve gastrectomy: single-center study.

BACKGROUND: Despite excellent surgical outcomes, a minority of qualified patients undergo weight loss surgery. Endoscopic Sleeve Gastroplasty (ESG), an incisionless procedure, has proven to be effective in achieving weight loss and comorbidity improvement. We aim to compare outcomes of ESG to those of Laparoscopic Sleeve Gastrectomy (LSG). METHOD: A retrospective review of a prospective database of patients who underwent ESG and LSG at NorthShore University HealthSystem from 2016 to 2023 was completed. Demographic and outcome data were analyzed. Pre- and post-surgical data were compared using chi-square and two-sample t tests. Improvement or resolution of obesity-related comorbidities were also assessed. RESULTS: A total of 212 LSG and 68 ESG patients were reviewed. ESG patients were older (47 ± 10 vs. 43 ± 12, p = 0.006) and less obese (BMI 37.0 ± 5.5 vs. 45.8 ± 0.4, p < 0.001) than LSG patients. Median length of stay after ESG was 0 days and after LSG 1 day (p < 0.001). Severe adverse events were seen less frequent after ESG (1.47%, vs 3.77%). LSG achieved more significant %TBWL at 6 months (25.2 ± 8.9 vs 14.9 ± 7.4), 1 year (27.5 ± 10.8 vs 14.1 ± 9.8), and 2 years (25.7 ± 10.8 vs 10.5 ± 8.8, all p < 0.001) after surgery when compared to ESG. LSG achieved significantly greater %EWL compared to ESG at 6 months (57.0 ± 20.7 vs 50.4 ± 29.2, p = 0.137), 1 year (61.4 ± 24.6 vs 46.5 ± 34.0, p = 0.026), and 2 years postoperatively (59.7 ± 25.5 vs 32.6 ± 28.2, p = 0.001). There were no statistically significant differences in rates of improvement or resolution of diabetes, obstructive sleep apnea, hyperlipidemia, or hypertension. CONCLUSION: ESG is an effective procedure for weight loss and comorbidity resolution. Obesity-related comorbidities are comparably improved and resolved following ESG vs LSG. Although the weight loss in LSG is significantly higher, patients can expect a shorter hospital length of stay and a lower rate of complications after ESG. ESG continues to show promise for long-term weight loss and improvement in health.

Higher rates of recurrence and worse quality of life in obese patients undergoing inguinal hernia repair.

PURPOSE: Prior investigations regarding the effect of obesity on inguinal hernia repair have been mixed. The aim of our study was to retrospectively compare perioperative outcomes, recurrence rate, and quality of life between obese and non-obese patients undergoing inguinal hernia repair. METHODS: Patients who underwent inguinal hernia repair by any approach at a single institution were identified from a prospectively maintained quality database. Patients with a body mass index (BMI) greater than or equal to 30 kg/m2 were considered obese. Quality of life was measured with the Surgical Outcomes Measurement System (SOMS) and Carolinas Comfort Scale (CSS) surveys. Differences between obese and non-obese patients were assessed using independent samples t-tests, Wilcoxon rank-sum, and chi-square tests. RESULTS: Between 2010 and 2021, a total of 5575 patients underwent inguinal hernia repair. Fifteen percent of patients were identified as obese (835 patients, mean BMI 33.2 ± 3.3 kg/m2). A significantly higher percentage of obese patients were diabetic, and operative time and estimated blood loss were higher in the obese group (all p < 0.001). Rates of hernia recurrence in obese patients was significantly more likely than in non-obese patients (4.2% vs 2.0%, p < 0.001). Up to 2 years postoperatively, a greater percentage of obese patients reported worse quality of life on the SOMS and more bothersome symptoms on the CCS. CONCLUSIONS: Inguinal hernia repair in obese patients is a more technically challenging operation. Long-term follow-up revealed a greater risk of hernia recurrence and worse quality of life up to 2 years postoperatively in this patient population.

Randomized Controlled Trial Based US Commercial Payor Cost-Effectiveness Analysis of Endoscopic Sleeve Gastroplasty Versus Lifestyle Modification Alone for Adults With Class I/II Obesity.

PURPOSE: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive day procedure that the MERIT randomized controlled trial (RCT) has demonstrated to be an effective and safe method of weight loss versus lifestyle modification alone. We sought to evaluate the cost-effectiveness of ESG from the perspective of a US commercial payer in a cohort of adults with class II and class I obesity with diabetes based on this RCT. MATERIALS: We used a Markov modelling approach with BMI group health states and an absorbing death state. Baseline characteristics, utilities, BMI group transition probabilities, and adverse events (AEs) were informed by patient-level data from the MERIT RCT. Mortality was estimated by applying BMI-specific hazard ratios to US general population mortality rates. We used BMI-based health state utilities to reflect the impact of obesity comorbidities and applied disutilities due to ESG AEs. Costs included intervention costs, AE costs, and BMI-based annual direct healthcare costs to account for costs associated with obesity comorbidities. A willingness-to-pay threshold of $100,000 per quality-adjusted life year (QALY) was assumed. RESULTS: In our base-case analysis over a 5-year time horizon, ESG was cost-effective versus lifestyle modification alone with an incremental cost-effectiveness ratio of $23,432/QALY. ESG remained cost-effective in all sensitivity analyses we conducted and was dominant in analyses with longer time horizons. CONCLUSION: ESG is a cost-effective treatment option for people living with obesity and should be considered in commercial health plans as an additional treatment option for clinically eligible patients.

Efficacy and outcomes of per oral plication of the (neo)esophagus (POPE) for impaired emptying in achalasia and post-esophagectomy patients.

BACKGROUND: Per-oral plication of the (neo)esophagus (POPE) is an endoscopic procedure used to improve emptying of the defunctionalized esophagus or gastric conduit, with the hope of improving symptoms and quality of life. As this procedure has only been performed in the United States for the past 4 years, safety and efficacy have not been well established. METHODS: This is a retrospective case series for patients who underwent POPE from a single institution between 2019 and 2023. Data collected included demographics, preoperative diagnoses and treatments, imaging, endoscopic data, operative intervention, 90-day complications, and response to treatment. Quality of life and patient satisfaction data were collected by phone survey. RESULTS: Seventeen cases were identified, encompassing 13 primary procedures and 4 repeat POPEs (re-POPE). Eight patients had end-stage achalasia and 5 had impaired gastric emptying after esophagectomy with gastric conduits. Median age was 65 years and median ASA was 3, with 38.5% female patients. POPE was performed with 2-6 plication sutures in an average of 75 min. The majority of patients discharged home the same day. For the 17 procedures, there were 4 complications. Two patients required antibiotics for pneumonia, while 4 required procedural intervention. There were no deaths. Preoperative symptoms improved or resolved at initial follow up in 82.3% of patients. Four patients experienced symptom recurrence and required re-POPE, 1 with achalasia and 3 with gastric conduits. Although all achalasia patients had an "end-stage esophagus," none have required esophagectomy since the introduction of POPE. CONCLUSIONS: POPE is an endoscopic procedure that is efficacious in relieving emptying difficulties for the end-stage esophagus and gastric conduit. It may obviate the need for esophagectomy or conduit replacement. Also, it can be repeated in select patients. While the risk profile of complications is favorable compared to alternative operations, patients with gastric conduits are at higher risk.

Impact of Toupet fundoplication with bougie on post-operative dysphagia and quality of life.

INTRODUCTION: Numerous studies comment on quality of life outcomes comparing complete and partial fundoplication with or without a bougie. Society guidelines are moving toward recommending partial fundoplication over complete fundoplication due to improved side effect profile with similar outcomes. Retrospective studies and randomized trials have elucidated that use of a bougie during Nissen fundoplication does impact long-term dysphagia. To date there are no retrospective or prospective data that guide practice for partial fundoplications. OBJECTIVE: The purpose of this project is to investigate the clinical implications of using a bougie for Toupet fundoplication with regard to short-term and long-term dysphagia and need for further therapeutic interventions. METHODS: A retrospective review of a prospectively maintained gastroesophageal database was performed. Demographic, pre-operative quality of life outcomes data, perioperative, and post-operative quality of life outcomes data of 373 patients from 2011 to 2022 undergoing Toupet fundoplication without bougie or with a traditional Savary 56Fr or 58Fr bougie were reviewed. The two groups were compared using student's t-test to identify statically significant differences between the groups. RESULTS: Between 2011 and 2022, 373 patients underwent Toupet fundoplication (276 with traditional bougie, 97 without). Median follow-up in the bougie group was 19 months, versus 9 months in the non bougie group. There was no difference between early (3 weeks) and late dysphagia scores (6 months). In the bougie group there were two mucosal perforations due to the bougie. There were no statistically significant differences in GERD-HRQL, gas bloat, and dysphagia scores between groups at one year. CONCLUSION: There is no difference observed in early or late dysphagia scores, GERD-HRQL, gas bloat or need for dilation in patients undergoing Toupet fundoplication with or without a traditional bougie. It is reasonable to discontinue the use of a traditional bougie during Toupet fundoplication, especially due to risk of esophageal perforation.

Gas and Bloat in Female Patients after Antireflux Procedures: Analysis of 934 Cases.

BACKGROUND: Antireflux procedures (ARPs) are effective treatments for GERD. However, variation in objective and patient-reported outcomes persists. Limited evidence and anecdotal experience suggest that patient sex may play a role. The objective of this study was to compare outcomes after ARPs between male and female patients. STUDY DESIGN: We performed a retrospective review of a prospectively maintained database at a single institution. All patients who underwent an ARP for GERD were included. Demographic, clinical, and patient-reported outcomes data (GERD health-related quality of life [HRQL] and reflux symptom index), and radiographic hernia recurrence were collected and stratified by sex. Univariable and multivariable logistic and mixed-effects linear regression were used to control for confounding effects. RESULTS: Between 2009 and 2022, 934 patients (291 men and 643 women) underwent an ARP. Reflux symptom index, GERD-HRQL, and gas and bloat scores improved uniformly for both sexes, though female patients were more likely to have higher gas and bloat scores 1 year postprocedure (mean ± SD 1.7 ± 1.4 vs 1.4 ± 1.3, p = 0.03) and higher GERD-HRQL scores 2 years postprocedure (6.3 ± 8.1 vs 4.7 ± 6.8, p = 0.04). Higher gas and bloat scores in women persisted on regression controlling for confounders. Hernia recurrence rate was low (85 patients, 9%) and was similar for both sexes. A final intraprocedural distensibility index 3 mm 2 /mmHg or more was significantly associated with a 7 times higher rate of recurrence (95% CI 1.62 to 31.22, p = 0.01). CONCLUSIONS: Although patients of either sex experience symptom improvement and low rate of recurrence after ARPs, women are more likely to endorse gas and bloat compared with men. Final distensibility index 3 mm 2 /mmHg or more carries a high risk of recurrence. These results may augment how physicians prognosticate during consultation and tailor their treatment in patients with GERD.

Endoscopic sleeve gastroplasty: the identification of the key procedural steps through a modified Delphi method.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an innovative, minimally invasive bariatric procedure with an excellent safety and efficacy profile in adults with obesity. The purpose of the procedure is to shorten and tubularize the stomach along its greater curvature. Nevertheless, there are some heterogeneities in the approach to ESG, which will be important to address as the procedure sees increasingly widespread clinical adoption. Here, an expert consensus on standardized ESG techniques is presented. METHODS: The modified Delphi method was used to establish the key procedural steps of an ESG. A panel of 8 experts was selected, of which 6 participated. The panel was selected based on their experience with performing the procedure and consisted of 1 bariatric surgeon and 5 interventional gastroenterologists. A neutral facilitator was designated and produced a skeletonized initial version of the key steps that was sent to each expert. Each survey began with the experts rating the given steps on a Likert scale of 1 to 5, with 1 being the most inaccurate and 5 being the most accurate. Furthermore, the final product was rated. The survey continued with open-ended questions designed to revise and polish the key steps. Areas of discrepancy were addressed using binary questions and a majority vote. The respondents were given 10 days to complete each survey. At the end of each round, the survey was redistributed with updated key steps and questions. This process was continued for a predesignated 3 rounds. RESULTS: Of the 8 experts who were queried, 6/8, 5/8, and 5/8 replied to each round. The given ratings for the accuracy of the steps in each round were 4.2, 4.6, and 4.4. The final rating was 4.8. Although expert opinion varied around smaller portions of the procedure, such as the placement of an overtube and the shape of each suture line, there was consensus on the need for full-thickness bites and appropriate swirling of the tissue with the helix device. Whether or not to include the fundus in the gastroplasty was an additional area of discrepancy. Of note, 4 of 5 experts agreed that the fundus should remain intact. The final protocol consisted of 21 steps curated from the summarized responses of the experts. CONCLUSION: Using the modified Delphi method, 21 key steps have been described for a safe and effective ESG. This rubric will be standardized across institutions and practitioners. Furthermore, these findings allow for the generation of educational assessment tools to facilitate training and increase the adoption of ESG by endoscopists.

Practice patterns and outcomes of endoscopic sleeve gastroplasty based on provider specialty.

Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons ( P <0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases ( P <0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists ( P <0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists ( P >0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.

Peroral endoscopic myotomy for spastic esophageal dysmotility among opioid users: a multicenter propensity score matching study.

BACKGROUND AND AIMS: Opioid-induced esophageal dysfunction (OIED) often presents as spastic esophageal disorders (SEDs) and esophagogastric junction outflow obstruction (EGJOO). The aim of this study was to evaluate and compare clinical outcomes of peroral endoscopic myotomy (POEM) for SEDs and EGJOO among opioid users and nonusers. METHODS: This propensity score (PS) matching study included consecutive opioid users and nonusers who underwent POEM for SEDs and EGJOO between January 2018 and September 2022. The following covariates were used for the PS calculation: age, sex, duration of symptoms, Eckardt score, type of motility disorder, and length of myotomy during POEM. Clinical response was defined as a post-POEM Eckardt score ≤3. RESULTS: A total of 277 consecutive patients underwent POEM during the study period. PS matching resulted in the selection of 64 pairs of patients strictly matched 1:1 (n = 128) with no statistically significant differences in demographic, baseline, or procedural characteristics or in the parameters considered for the PS between the 2 groups. Clinical response to POEM was significantly lower among opioid users (51 of 64 [79.7%]) versus nonusers (60 of 64 [93.8%]) (P = .03) at a median follow-up of 18 months. Among opioid users, higher opioid dose (>60 morphine milligram equivalents per day) was associated with a higher likelihood of failure to respond to POEM (odds ratio, 4.59; 95% confidence interval, 1.31-3.98; P = .02). CONCLUSIONS: Clinical response to POEM for SEDs and EGJOO is significantly lower among opioid users versus nonusers. There was a dose-relationship between opioids and response to POEM, with higher daily opioid usage associated with a higher likelihood of treatment failure.

Impedance planimetry and panometry (EndoFLIP™) can replace manometry in preoperative anti-reflux surgery assessment.

BACKGROUND: Endoluminal functional impedance planimetry and panometry assesses secondary peristalsis in response to volumetric distention under sedation. We hypothesize that impedance planimetry and panometry can replace high-resolution manometry in the preoperative assessment prior to anti-reflux surgery. METHODS: Single institution prospective data were collected from patients undergoing anti-reflux surgery between 2021 and 2023. A 16-cm functional luminal imaging probe (FLIP) assessed planimetry and panometry prior to surgery under general anesthesia at the start of each case. Panometry was recorded and esophageal contractile response was classified as normal (NCR), diminished or disordered (DDCR), or absent (ACR) in real time by a single panometry rater, blinded to preoperative HRM results. FLIP results were then compared to preoperative HRM. RESULTS: Data were collected from 120 patients, 70.8% female, with mean age of 63 ± 3 years. There were 105 patients with intraoperative panometry, and 15 with panometry collected during preoperative endoscopy. There were 60 patients (50%) who had peristaltic dysfunction on HRM, of whom 57 had FLIP dysmotility (55 DDCR, 2 ACR) resulting in 95.0% sensitivity. There were 3 patients with normal secondary peristalsis on FLIP with abnormal HRM, all ineffective esophageal motility (IEM). No major motility disorder was missed by FLIP. A negative predictive value of 91.9% was calculated from 34/37 patients with normal FLIP panometry and normal HRM. Patients with normal HRM but abnormal FLIP had larger hernias compared to patients with concordant studies (7.5 ± 2.8 cm vs. 5.4 ± 3.2 cm, p = 0.043) and higher preoperative dysphagia scores (1.5 ± 0.7 vs. 1.1 ± 0.3, p = 0.021). CONCLUSION: Impedance planimetry and panometry can assess motility under general anesthesia or sedation and is highly sensitive to peristaltic dysfunction. Panometry is a novel tool that has potential to streamline and improve patient care and therefore should be considered as an alternative to HRM, especially in patients in which HRM would be inaccessible or poorly tolerated.

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.

Outcomes and predictors of treatment failure after anti-reflux mucosectomy for management of gastroesophageal reflux disease.

BACKGROUND: Anti-reflux mucosectomy is a novel endoscopic treatment for gastroesophageal reflux disease that serves as an intermediate therapy between medical and surgical intervention. We aimed to evaluate outcomes and identify predictors of treatment failure in patients requiring anti-reflux mucosectomy. METHODS: A prospective quality database was retrospectively reviewed. Upper endoscopy, pH testing, and functional luminal impedance planimetry were obtained at preop and 1 year post-operation. Quality of life outcomes were assessed by Gastroesophageal Reflux Disease-Health Related Quality of Life, Reflux Symptom Index, and dysphagia scores preoperatively and up to 5 years postoperatively. RESULTS: Fifty-eight patients requiring anti-reflux mucosectomy were analyzed between 2016 and 2023. Preop Gastroesophageal Reflux Disease-Health Related Quality of Life mean scores improved at all time points 3 weeks to 2 years postoperatively (all P < .05). Preop mean Reflux Symptom Index scores also significantly improved at 6-month, 1-year, and 2-year timepoints (all P < .05). Dysphagia at 3 weeks was higher than preop scores (1.2 vs 2.1, P < .01) but returned to baseline. Upon follow-up, 43 patients (74.1%) had symptom improvement off proton pump inhibitors, 29 of whom reported complete symptom resolution. Out of 58 patients, 31 (53.4%) failed treatment due to DeMeester score (n = 22), erosive esophagitis (n = 2), Gastroesophageal Reflux Disease-Health Related Quality of Life ≥13 (n = 4), or <70% symptom resolution in the absence of pH or survey data (n = 3). Current smoking status was predictive of treatment failure (odds ratio 3.52, P < .031). Body mass index, DeMeester score, acid exposure time, and hiatal hernia ≤2 cm were not associated with treatment failure. CONCLUSION: Anti-reflux mucosectomy is associated with significant improvement in quality of life; however, symptom resolution may not correlate with objective reflux control. Smoking is a predictor of treatment failure and should be considered in patient selection.

Outcomes after per-oral endoscopic myotomy for Zenker's diverticula (Z-POEM) and correlation with impedance planimetry (FLIP).

INTRODUCTION: Zenker's diverticulum (ZD) is a false pulsion diverticulum of the cervical esophagus. It is typically found in older adults and manifests with dysphagia. The purpose of this study is to describe our experience with Per-oral endoscopic myotomy for Zenker's (Z-POEM) and intraoperative impedance planimetry (FLIP). METHODS: We performed a single institution retrospective review of patients undergoing Z-POEM in a prospective database between 2014 and 2022. Upper esophageal sphincter (UES) distensibility index (DI, mm2/mmHg) was measured by FLIP before and after myotomy. The primary outcome was clinical success. Secondary outcomes included technical failure, adverse events, and quality of life as assessed by the gastroesophageal health-related quality of life (GERD-HRQL), reflux severity index (RSI), and dysphagia score. A statistical analysis of DI was done with the paired t-test (p < 0.05). RESULTS: Fifty-four patients underwent Z-POEM, with FLIP measurements available in 30 cases. We achieved technical success and clinical success in 54/54 (100%) patients and 46/54 patients (85%), respectively. Three patients (6%) experienced contained leaks. Three patients were readmitted: one for aforementioned contained leak, one for dysphagia, and one post-operative pneumonia. Three patients with residual dysphagia underwent additional endoscopic procedures, all of whom had diverticula > 4 cm. Following myotomy, mean DI increased by 2.0 ± 1.7 mm2/mmHg (p < 0.001). In those with good clinical success, change in DI averaged + 1.6 ± 1.1 mm2/mmHg. Significant improvement was found in RSI and GERD-HRQL scores, but not dysphagia score. CONCLUSION: Z-POEM is a safe and feasible for treatment of ZD. We saw zero cases of intraoperative abandonment. We propose that large diverticula (> 4 cm) are a risk factor for poor outcomes and may require additional endoscopic procedures. An improvement in DI is expected after myotomy, however, the ideal range is still not known.

The Laparoscopy in Biliary Exploration Research and Training Initiative (LIBERTI) trial: simulator-based training for laparoscopic management of choledocholithiasis.

BACKGROUND: Laparoscopic cholecystectomy with common bile duct exploration (LCBDE) is equivalent in safety and efficacy to endoscopic retrograde cholangiopancreatography (ERCP) plus laparoscopic cholecystectomy (LC) while decreasing number of procedures and length of stay (LOS). Despite these advantages LCBDE is infrequently utilized. We hypothesized that formal, simulation-based training in LCBDE would result in increased utilization and improve patient outcomes across participating institutions. METHODS: Data was obtained from an on-going multi-center study in which simulator-based transcystic LCBDE training curricula were instituted for attending surgeons and residents. A 2-year retrospective review of LCBDE utilization prior to LCBDE training was compared to utilization up to 2 years after initiation of training. Patient outcomes were analyzed between LCBDE strategy and ERCP strategy groups using χ2, t tests, and Wilcoxon rank tests. RESULTS: A total of 50 attendings and 70 residents trained in LCBDE since November 2020. Initial LCBDE utilization rate ranged from 0.74 to 4.5%, and increased among all institutions after training, ranging from 9.3 to 41.4% of cases. There were 393 choledocholithiasis patients analyzed using LCBDE (N = 129) and ERCP (N = 264) strategies. The LCBDE group had shorter median LOS (3 days vs. 4 days, p < 0.0001). No significant differences in readmission rates between LCBDE and ERCP groups (4.7% vs. 7.2%, p = 0.33), or in post-procedure pancreatitis (0.8% v 0.8%, p > 0.98). In comparison to LCBDE, the ERCP group had higher rates of bile duct injury (0% v 3.8%, p = 0.034) and fluid collections requiring intervention (0.8% v 6.8%, p < 0.009) secondary to cholecystectomy complications. Laparoscopic antegrade balloon sphincteroplasty had the highest technical success rate (87%), followed by choledochoscopic techniques (64%). CONCLUSION: Simulator-based training in LCBDE results in higher utilization rates, shorter LOS, and comparable safety to ERCP plus cholecystectomy. Therefore, implementation of LCBDE training is strongly recommended to optimize healthcare utilization and management of patients with choledocholithiasis.

Roux-en-Y gastric bypass versus fundoplication for gastroesophageal reflux disease in patients with obesity results in comparable outcomes.

BACKGROUND: Roux-en-Y gastric bypass and fundoplication are effective treatments for gastroesophageal reflux disease, though the optimal procedure of choice in obesity is unknown. We hypothesize that Roux-en-Y gastric bypass is non-inferior to fundoplication for symptomatic control of gastroesophageal reflux disease in patients with obesity. METHODS: We conducted a retrospective review of a prospectively maintained quality database. Patients with a body mass index ≥of 35 who presented for gastroesophageal reflux disease and subsequently underwent Roux-en-Y gastric bypass or fundoplication were included. Perioperative outcomes and pH testing data were reviewed. Patient-reported outcomes included Reflux Symptom Index, Dysphagia, Gastroesophageal Reflux Disease-Health Related Quality of Life, and Short Form-36 scores. Data were analyzed using the Wilcoxon rank sum test. RESULTS: Ninety-five patients underwent fundoplication (n = 72, 75.8%) or Roux-en-Y gastric bypass (n = 23, 24.2%) during the study period. All patients saw an improvement in gastroesophageal reflux disease symptoms and overall quality of life. There were no significant differences in postoperative Reflux Symptom Index, Dysphagia, or Short-Form-36 scores. Significant differences in gastroesophageal reflux disease-Health Related Quality of Life scores were seen at preoperative, 1, 2, and 5 years postoperative (P < .05), with better symptom control in the fundoplication group. No significant difference was noted in postoperative DeMeester scores or percent time pH <4. Weight loss was significantly higher in the Roux-en-Y gastric bypass group at all postoperative time points up to 5 years (P < .05). CONCLUSION: Roux-en-Y gastric bypass and fundoplication both decrease gastroesophageal reflux disease symptoms. Subjective data shows that patients undergoing Roux-en-Y gastric bypass may complain of worse symptoms compared to patients undergoing fundoplication. Objective data notes no significant difference in postoperative pH testing. Despite previous data, offering fundoplication or Roux-en-Y gastric bypass to patients with a body mass index of ≥35 kg/m2 is appropriate. The choice of surgical approach should be more directed to patient needs and desired goals at the time of the initial clinic visit.

Teaching endoscopic management of gastrointestinal hemorrhage using a modular simulation curriculum.

BACKGROUND: As flexible endoscopy is increasingly adopted as a minimally invasive approach to surgical challenges, an efficient curriculum is needed to train surgeons in therapeutic endoscopy. We developed a simulation-based approach to teaching endoscopic management of gastrointestinal hemorrhage as part of a modular curriculum, complete with task performance pre- and post-testing. METHODS: Two sessions of our advanced flexible endoscopy course were taught using ex vivo porcine models to simulate active gastrointestinal hemorrhage and allow for training in hands-on endoscopic management. The module is composed of hands-on pretesting, didactics, mentored practice sessions, and postcourse assessments. Pre- and postcourse tests and surveys evaluated knowledge, confidence, and performance of participants and results were analyzed using the paired t test. RESULTS: Sixteen practicing surgeons participated in the course. After course completion, overall knowledge-based assessments improved from 3.4 (±1.9) to 5.8 (±2.0) (P < .001). Although participants with glove sizes >7.0 and ≥2 years in practice had higher pretest evaluator scores (P = .045 and P = .020), all participants demonstrated overall improvement in endoscopic management of hemorrhage, with postcourse evaluator score increases from 20.9 (±1.6) to 23.6 (±2.0) (P = .001) and specific improvements in identification of target bleeding (P = .015), endoscopic clip setup (P < .001), and clip deployment (P = .002). Surveys also found increased confidence in competency after curriculum completion, 11.6 (±3.4)-23.0 (±5.5) (P < .001). CONCLUSION: Our simulation-based approach to teaching the endoscopic management of gastrointestinal bleeding emphasizes hands-on pretesting and provides an effective training model to improve the knowledge, confidence, and technical performance of practicing surgeons.

A 13-year experience with biologic and biosynthetic absorbable mesh reinforced laparoscopic paraesophageal hernia repair.

BACKGROUND: Mesh reinforced cruroplasty during laparoscopic paraesophageal hernia repair remains controversial due to wide variation in surgical technique and mesh composition. This study aims to review outcomes and rates of recurrence following laparoscopic paraesophageal hernia repair (LPEHR) with mesh reinforced cruroplasty utilizing absorbable mesh at a single institution. METHODS: A retrospective review of all patients who underwent LPEHR with mesh was performed. Medical records were reviewed for patient reported, radiographic or endoscopic evidence of recurrence, defined as > 2 cm of vertical intrathoracic stomach. If no studies were available for review, patients were considered to have no recurrence. Outcomes and mesh-related complications were also reviewed. RESULTS: Between 10/2008 and 9/2021, 473 patients underwent LPEHR with absorbable mesh; 1.3% type 2 hernias, 86.0% type 3 hernias, 12.7% type 4 hernias. Three types of mesh were used: initially biologic mesh (n = 83), then heavyweight synthetic bioabsorbable mesh (n = 261), and finally lightweight synthetic bioabsorbable mesh (n = 111). There were no significant differences in age, ASA, BMI, gender, smoking status, chronic steroid use, preoperative acid suppression, hernia type, or recurrent hernia between groups. There were no significant differences in 30-day postoperative outcomes. Reflux Symptom Index, GERD-HRQL, and Dysphagia Scores at 1- and 2-year postoperative timepoints were not significantly different. The overall recurrence rate was 16.7%, with no significant differences in recurrence rates between biologic, heavyweight or lightweight biosynthetic absorbable mesh through 2 years after surgery. A shorter median time to recurrence (10 months, p = 0.016) was seen in the lightweight group. CONCLUSION: LPEHR with absorbable mesh reinforced cruroplasty is feasible and safe, with equivalent patient-reported outcomes, including dysphagia, up to 2-years postop regardless of mesh choice. No significant differences in recurrence rates between biologic, heavyweight, or lightweight synthetic bioabsorbable mesh were seen up to 2 years after LPEHR.