Gas and Bloat in Female Patients after Anti-Reflux Procedures: Analysis of 934 Cases.

BACKGROUND: Anti-reflux procedures (ARPs) are effective treatments for gastroesophageal reflux disease (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, Reflux Symptom Index), as well as radiographic hernia recurrence were collected and stratified by sex. Uni- and multivariable logistic and mixed effects linear regression were used to control for confounding effects. RESULTS: Between 2009 and 2022, 934 patients (291 males, 643 females) underwent an ARP. Reflux Symptom Index, GERD-HRQL, and gas/bloat scores improved uniformly for both sexes, though female patients were more likely to have higher gas/bloat scores one year post-procedure (mean ± SD 1.7 ± 1.4 vs 1.4 ± 1.3, p=0.03) and higher GERD-HRQL scores two years post-procedure (6.3 ± 8.1 vs 4.7 ± 6.8, p=0.04). Higher gas/bloat scores in females persisted on regression controlling for confounders. Hernia recurrence rates were low (85 patients, 9%) and were similar for both sexes. A final intraprocedural DI ≥3mm 2/mmHg was significantly associated with a 7 times higher rate of recurrence (95% CI 1.62-31.22, p=0.01). CONCLUSIONS: While patients of either sex experience symptom improvement and low rates of recurrence after ARPs, females are more likely to endorse gas/bloat compared to males. Final distensibility ≥3mm 2/mmHg carries a high risk of recurrence. These results may augment how physicians prognosticate during consultations and tailor their treatments in patients with GERD.

Personalized anti-reflux surgery: connecting GERD phenotypes in 690 patients to outcomes.

BACKGROUND: Anti-reflux operations are effective treatments for GERD. Despite standardized surgical techniques, variability in post-operative outcomes persists. Most patients with GERD possess one or more characteristics that augment their disease and may affect post-operative outcomes-a GERD "phenotype". We sought to define these phenotypes and to compare their post-operative outcomes. METHODS: We performed a retrospective review of a prospective gastroesophageal database at our institution, selecting all patients who underwent an anti-reflux procedure for GERD. Patients were grouped into different phenotypes based on the presence of four characteristics known to play a role in GERD: hiatal or paraesophageal hernia (PEH), hypotensive LES, esophageal dysmotility, delayed gastric emptying (DGE), and obesity. Patient-reported outcomes (GERD-HRQL, dysphagia, and reflux symptom index (RSI) scores) were compared across phenotypes using the Wilcoxon rank-sum test. RESULTS: 690 patients underwent an anti-reflux procedure between 2008 and 2022. Most patients underwent a Nissen fundoplication (302, 54%), followed by a Toupet or Dor fundoplication (205, 37%). Twelve distinct phenotypes emerged. Non-obese patients with normal esophageal motility, normotensive LES, no DGE, with a PEH represented the most common phenotype (134, 24%). The phenotype with the best post-operative GERD-HRQL scores at one year was defined by obesity, hypotensive LES, and PEH, while the phenotype with the worst scores was defined by obesity, ineffective motility, and PEH (1.5 ± 2.4 vs 9.8 ± 11.4, p = 0.010). There was no statistically significant difference in GERD-HRQL, dysphagia, or RSI scores between phenotypes after five years. CONCLUSIONS: We have identified distinct phenotypes based on common GERD-associated patient characteristics. With further study these phenotypes may aid surgeons in prognosticating outcomes to individual patients considering an anti-reflux procedure.

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.

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.

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.

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.

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.

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.

Target distensibility index on impedance planimetry during fundoplication by choice of wrap and choice of bougie.

INTRODUCTION: Impedance planimetry (FLIP) provides objective feedback to optimize fundoplication outcomes. Ideal FLIP ranges for differing wraps and bougies have not yet been established. We report FLIP measurements during fundoplication grouped by choice of wrap and bougie with associated outcomes. METHODS: A retrospective review of a prospective gastroesophageal database was performed for all Nissen or Toupet fundoplication with intraoperative FLIP using an 8-cm catheter, 30-mL and/or 40-mL fill and/or 16-cm catheter, 60-mL fill. Surgeons used no bougie, the FLIP balloon as bougie, or a hard bougie. Outcomes included perioperative data, Reflux Symptom Index, GERD-HRQL, Dysphagia scores, need for dilation, postoperative EGD findings, and hernia recurrence. Group comparisons were made using two-tailed Kruskal-Wallis and Fisher's exact tests. RESULTS: Between 2016 and 2022, 333 patients underwent fundoplication and intraoperative FLIP. Procedures included Toupet with hard bougie (TFHB, N = 147), Toupet with FLIP bougie (TFFB, N = 69), Toupet without bougie (TFNB, N = 78), Nissen with hard bougie (NFHB, n = 20), or Nissen with FLIP bougie (NFFB, N = 19). FLIP measurements at 30-mL/40-mL fills varied significantly between groups, notably distensibility index at crural closure (CCDI) and post-fundoplication (FDI). No significant differences in FLIP measurements were seen between those who developed poor postoperative outcomes and those who did not, including when grouping by choice of wrap and bougie. At a 40-mL fill, abnormal motility patients with CCDI > 3.5 mm2/mmHg developed zero postoperative dysphagia. TFFB abnormal motility patients with CCDI > 3.5 mm2/mmHg or FDI > 3.6 mm2/mmHg developed zero postoperative dysphagia. CONCLUSION: Intraoperative FLIP measurements vary by fundoplication and bougie choice. A CCDI > 3.5 mm2/mmHg (40 mL fill) should be sought in abnormal motility patients, regardless of wrap or bougie, to avoid postoperative dysphagia. TFFB abnormal motility patients with FDI > 3.6 mm2/mmHg (40 mL fill) also developed zero postoperative dysphagia. FDI > 6.2 mm2/mmHg (40 mL fill) was seen in all postoperative hernia recurrences.

Acid exposure time better predicts outcomes following anti-reflux surgery than DeMeester score.

BACKGROUND: Criteria to diagnose gastroesophageal reflux disease (GERD) vary. The American Gastroenterology Association (AGA) 2022 Expert Review on GERD focuses on acid exposure time (AET) rather than DeMeester score from ambulatory pH testing (BRAVO). We aim to review outcomes following anti-reflux surgery (ARS) at our institution, grouped by differing criteria for the diagnosis of GERD. METHODS: A retrospective review of a prospective gastroesophageal quality database was performed for all patients undergoing evaluation for ARS with preoperative BRAVO ≥ 48 h. Group comparisons were made using two-tailed Wilcoxon rank-sum and Fisher's exact tests and two-tailed statistical significance of p < 0.05. RESULTS: Between 2010 and 2022, 253 patients underwent an evaluation for ARS with BRAVO testing. Most patients (86.9%) met our institution's historical criteria: LA C/D esophagitis, Barrett's, or DeMeester ≥ 14.72 on 1+ days. Fewer patients (67.2%) met new AGA criteria: LA B/C/D esophagitis, Barrett's, or AET ≥ 6% on 2+ days. Sixty-one patients (24%) met historical criteria only, with significantly lower BMI, ASA, less hiatal hernias, and less DeMeester and AET-positive days, a less severe GERD phenotype. There were no differences between groups in perioperative outcomes or % symptom resolution. Objective GERD outcomes (need for dilation, esophagitis, and postop BRAVO) were equivalent between groups. Patient-reported quality of life scores, including GERD-HRQL, RSI, and Dysphagia Score did not differ between groups from preop through 1 year postop. Those who met our historical criteria only reported significantly worse RSI scores (p = 0.03) and worse GERD-HRQL scores at 2 years postop, though not statistically significant (p = 0.07). CONCLUSION: Updated AGA GERD guidelines exclude a portion of patients who historically would have been diagnosed with and surgically treated for GERD. This cohort appears to have a less severe GERD phenotype but equivalent outcomes up to 1 year, with more atypical GERD symptoms at 2 years postop. AET may better define who should be offered ARS than DeMeester score.

Experience with Impedance Planimetry for Surgical Foregut Disease in 1,097 Cases.

BACKGROUND: The geometry and compliance of gastrointestinal sphincters may be assessed by impedance planimetry using a functional lumen imaging probe (FLIP). We describe our institutional foregut surgeon experience using FLIP in 1,097 cases, highlighting instances where FLIP changed operative decision making. STUDY DESIGN: A retrospective review of an IRB-approved prospective quality database was performed. This included operative and endoscopic suite foregut procedures using FLIP between February 2013 and May 2022. RESULTS: During the study period, FLIP was used a total of 1,097 times in 919 unique patients by 2 foregut surgeons. Intraoperative FLIP was used during 573 antireflux procedures and 272 endoscopic myotomies. FLIP was also used during 252 endoscopic suite procedures. For those undergoing preoperative workup of GERD, starting in 2021, esophageal panometry was performed in addition to standard FLIP measurements at the lower esophageal sphincter. In 77 cases, intraoperative FLIP changed operative decision making. During antireflux procedures, changes included adding or removing crural sutures, adjusting a fundoplication tightness, choice of full vs partial wrap, and magnetic sphincter augmentation sizing. For endoscopic procedures, changes included aborting peroral endoscopic myotomy or Zenker's peroral endoscopic myotomy, performing a myotomy when preoperative diagnosis was unclear, or performing additional myotomy. CONCLUSIONS: FLIP is a useful tool for assessing the upper esophageal sphincter, lower esophageal sphincter, pylorus, and secondary esophageal peristalsis that can be used in a wide variety of clinical situations within a foregut surgeon's practice. It can also function as an adjunct in intraoperative decision making.

Patient-reported outcomes in 645 patients after laparoscopic fundoplication up to 10 years.

BACKGROUND: Laparoscopic fundoplication is the gold-standard surgical management for gastroesophageal reflux disease. Optimal patient outcomes include resolution of symptoms with minimal postoperative side effects of dysphagia or gas-bloat. This study aims to review outcomes at a single institution up to 10 years after surgery. METHODS: This is a retrospective review of a prospectively maintained quality database. Patients who underwent laparoscopic fundoplication from 2009 to 2021 were included. Transition in surgical practice mid-2017 with incorporation of fundoplication algorithm and impedance planimetry. Patient-reported outcome scores include Reflux Symptom Index, gastroesophageal reflux disease-health-related quality of life, and dysphagia score. Comparisons were made using two-tailed Wilcoxon rank sum tests. RESULTS: Six hundred forty-five patients underwent laparoscopic fundoplication (2009-July 2017 n = 355, July 2017-November 2021 n = 290) from January 2009 to November 2021. Patients had an improvement in patient-reported outcomes and did not worsen from 2 to 10 years after surgery. Comparison of each time period showed that the second time period had fewer gas-bloat symptoms at 2 years (P = .04). Paraesophageal hernia was present in 66% of patients. Preoperative patient-reported outcomes in non-paraesophageal hernia include worse Reflux Symptoms Index (P < .01) and gastroesophageal reflux disease-health-related quality of life (P < .01) than the paraesophageal hernia group. Patient-reported outcomes were similar between the 2 except for worse gas-bloat in non-paraesophageal hernia patients at 2 years (P = .02). Endoscopy was performed in 10.9% (n = 58) of the study population at a median of 16 months, with 1.5% of patients (n = 8) from the entire cohort with abnormal DeMeester Scores. Median (interquartile range) preoperative DeMeester Score of 31 (17-51) decreased to 5 (2-14) at postoperative evaluation. CONCLUSION: This single-institution study reports excellent long-term patient-reported outcomes after laparoscopic fundoplication that persist up to 10 years.

"Into the fire" approach to teaching endoscopic foreign body removal using a modular simulation curriculum.

BACKGROUND: As flexible endoscopy becomes an increasingly valuable minimally invasive approach to surgical challenges, an efficient and comprehensive training curriculum is needed to train surgeons in therapeutic endoscopy. We developed a modular curriculum utilizing a simulation-based, "into the fire" approach to endoscopic foreign body removal for practicing physicians with task performance pre- and post-testing. METHODS: From 2020 to 2021, two sessions of our advanced flexible endoscopy course were taught by two expert surgical endoscopists using ex-vivo porcine models. The course focused on safe removal techniques for various foreign bodies as part of an overall endoscopy curriculum that uses hands-on simulation-based pre-testing, didactics, and mentored practice sessions, followed by post-course examination. Pre- and post-course assessments and surveys were used to evaluate knowledge, performance, and confidence of participants, and subsequently analyzed using the Wilcoxon-signed rank test. RESULTS: Of the 16 practicing physicians who participated in the course, 43.8% were certified in Fundamentals of Endoscopic Surgery, and 62.5% had completed > 200 prior upper endoscopies. Upon course completion, scoring on knowledge-based written examinations improved from 3.4 ± 1.9 to 5.8 ± 2.0 (p < 0.001). Technical facility of each participant demonstrated significant overall improvement with post-course score increased from 15.8 ± 2.5 to 23.6 ± 1.6 (p < 0.001), with skill refinement noted in technical subcategories of appropriate instrument use (p < 0.001), foreign body manipulation (p < 0.001), and successful foreign body removal (p < 0.001). Confidence surveys likewise demonstrated significant increase in confidence after completion of the curriculum 11.6 ± 3.4 to 23.0 ± 5.5 (p < 0.001). CONCLUSIONS: The "into the fire" approach to teaching endoscopic foreign body removal utilizing our simulation module provides an effective curriculum to improve knowledge, confidence, and overall technical performance. Our methodology utilizes hands-on, simulation-based pre-testing prior to instruction. This introduces clinical scenarios and technical challenges, while accounting for and tailoring to provider-specific variation in knowledge and experience, facilitating training efficiency.

Esophagogastric junction compliance on impedance planimetry (EndoFLIP™) following peroral endoscopic myotomy (POEM) predicts improvement in postoperative eckardt score.

BACKGROUND: Peroral endoscopic myotomy (POEM) is a mainstay of treatment for achalasia. Tailored myotomy based on compliance, as measured with impedance planimetry (FLIP), has yet to be described. In this study we describe the associations between Eckardt score, postoperative GERD, and compliance. METHODS: A retrospective review of a prospectively maintained database was performed, evaluating patients who underwent POEM and intraoperative FLIP between January 2019 and November 2021. Group comparisons were made using two-tailed Wilcoxon rank-sum and Fisher's exact tests. Spearman's correlation coefficients (r) were used to assess the relationship between compliance and outcomes, all with two-tailed statistical significance of p < 0.05. RESULTS: Thirty five patients underwent POEM with intraoperative FLIP. At a 30 mL and 40 mL fill, respectively, compliance increased by 80% (180 ± 152%) and 77% (177 ± 131%) from pre to post myotomy. Mean Eckardt score improved from 5.5 ± 2.6 preoperatively to 1.3 ± 1.6 and 1.8 ± 1.9 at first and second follow up, respectively. Median times to first and second follow up were 22 days (IQR 16-23) and 65 days (IQR 58-142). A higher compliance at 40 mL fill was moderately associated with lower Eckardt score at first (r = -0.49, p = 0.012) and second (r = -0.64, p = 0.014) follow up. Post myotomy compliance ≥ 125 mm3/mmHg at 40 mL fill was associated with lower Eckardt scores, < 3, at first (0.4 ± 0.5 vs 1.8 ± 1.3, p = 0.008) and second (0.4 ± 0.5, vs 2.0 ± 1.4, p = 0.027) follow up. Compliance ≥ 125 mm3/mmHg performed better than previously defined ideal ranges of DI and CSA in predicting postoperative Eckardt scores. Compliance was not significantly associated with development of postoperative GERD. CONCLUSIONS: A target post myotomy compliance of ≥ 125 mm3/mmHg at a 40 mL fill is associated with normal Eckardt scores at first and second postoperative visits, and performs better than previously defined ideal ranges of DI and CSA in predicting post-operative Eckardt scores. Compliance is a poor predictor of developing GERD after POEM.

Laparoscopic and robotic inguinal hernia repair are safe and effective after prior pelvic or low abdominal surgery.

BACKGROUND: The ideal approach to inguinal hernia repair (IHR) after prior pelvic or low abdominal surgery is not agreed upon. We compared safety and outcomes of IHR between open, laparoscopic, and robotic approaches. METHODS: This retrospective review of a prospective database analyzed demographic, perioperative, and quality of life data for patients who underwent IHR after pelvic or low abdominal surgery. RESULTS: 286 qualifying patients underwent IHR between 2008 and 2020; 119 open, 147 laparoscopic, and 20 robotic. Laparoscopic repair led to faster cessation of narcotics and return to ADLs than open repair (all p <0.05). Post-operative complications, 30-day readmission, recurrences, and quality of life outcomes were equivalent, except less pain at 3-weeks post-op in the minimally invasive groups, p < 0.01. CONCLUSION: Minimally invasive IHR after prior pelvic or low abdominal surgery is safe compared to an open approach. Laparoscopic repair provides faster recovery, yet patient satisfaction is equivalent regardless of surgical approach.

The Usefulness of the Pretreatment Neutrophil/Lymphocyte Ratio as a Predictor of the 5-Year Survival in Stage 1-3 Triple Negative Breast Cancer Patients.

BACKGROUND: We have previously shown that the neutrophil/lymphocyte ratio (NLR) is a predictor of survival among breast cancer patients. The aim of this study was to determine the predictive value of NLR among different nodal and chemotherapy subgroups of triple negative breast cancer (TNBC). METHODS: Patients with stage 1-3 TNBC who underwent treatment from 2007 to 2014 and had blood counts prior to treatments were included. Patients were categorized into high (≥2) and low (<2) NLR groups. Primary outcomes were overall survival (OS) and disease-free survival (DFS). RESULTS: The average follow-up time was 54 months. The high NLR group had worse OS (HR 2.8, CI 1.3-5.9, p < 0.001) and DFS (HR 2.3, CI 1.2-4.2, p < 0.001) than the low NLR group. After adjusting for confounding variables, high NLR was an independent prognostic factor for both OS (HR 5.5, CI 2.2-13.7, p < 0.0001) and DFS (HR 5.2, CI 2.3-11.6, p < 0.0001). Categorization of TNBC patients by NLR (high vs. low) and nodal status (positive vs. negative) resulted in four groups with significantly different OS and DFS (log rank p < 0.0001). Significant improvements in OS (p < 0.001) and DFS (p < 0.001) were observed for patients who received chemotherapy and had high NLR but not for patients with low NLR (p = 0.65 and p = 0.07, respectively). CONCLUSION: High pretreatment NLR is an independent predictor of poor OS and DFS among TNBC patients. Combining NLR and pN provides better risk stratification for TNBC patients. Chemotherapy appears to be beneficial only in patients with high NLR. Larger prospective studies are needed to validate these findings.

Cross-sectional study of surgical quality with a novel evidence-based tool for low-resource settings.

BACKGROUND: Adverse events from surgical care are a major cause of death and disability, particularly in low-and-middle-income countries. Metrics for quality of surgical care developed in high-income settings are resource-intensive and inappropriate in most lower resource settings. The purpose of this study was to apply and assess the feasibility of a new tool to measure surgical quality in resource-constrained settings. METHODS: This is a cross-sectional study of surgical quality using a novel evidence-based tool for quality measurement in low-resource settings. The tool was adapted for use at a tertiary hospital in Amazonas, Brazil resulting in 14 metrics of quality of care. Nine metrics were collected prospectively during a 4-week period, while five were collected retrospectively from the hospital administrative data and operating room logbooks. RESULTS: 183 surgeries were observed, 125 patient questionnaires were administered and patient charts for 1 year were reviewed. All metrics were successfully collected. The study site met the proposed targets for timely process (7 hours from admission to surgery) and effective outcome (3% readmission rate). Other indicators results were equitable structure (1.1 median patient income to catchment population) and equitable outcome (2.5% at risk of catastrophic expenditure), safe outcome (2.6% perioperative mortality rate) and effective structure (fully qualified surgeon present 98% of cases). CONCLUSION: It is feasible to apply a novel surgical quality measurement tool in resource-limited settings. Prospective collection of all metrics integrated within existing hospital structures is recommended. Further applications of the tool will allow the metrics and targets to be refined and weighted to better guide surgical quality improvement measures.

Quality of essential surgical care in low- and middle-income countries: a systematic review of the literature.

PURPOSE: Quality of care is an emerging area of focus in the surgical disciplines. However, much of the emphasis on quality is limited to high-income countries. To address this gap, we conducted a systematic review of the literature on the quality of essential surgical care in low- and middle- income countries (LMIC). DATA SOURCES: We searched PubMed, Cinahl, Embase and CAB Abstracts using three domains: quality of care, surgery and LMIC. STUDY SELECTION: We limited our review to studies of essential surgeries that pertained to all three search domains. DATA EXTRACTION: We extracted data on study characteristics, type of surgery and the way in which quality was studied. RESULTS OF DATA SYNTHESIS: 354 studies were included. 281 (79.4%) were single-center studies and nearly half (n = 169, 46.9%) did not specify the level of facility. 207 studies reported on mortality (58.47%) and 325 reported on a morbidity (91.81%), most commonly surgical site infection (n = 190, 53.67%). Of the Institute of Medicine domains of quality, studies were most commonly of safety (n = 310, 87.57%) and effectiveness (n = 180, 50.85%) and least commonly of equity (n = 21, 5.93%). CONCLUSION: We find that while there are numerous studies that report on some aspects of quality of care, much of the data is single center and observational. Additionally, there is variability on which outcomes are reported both within and across specialties. Finally, we find under-reporting of parameters of equity and timeliness, which may be critical areas for research moving forward.