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.

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.

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.

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.

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.

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.

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.

"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.

Impact of Chemoradiation-to-Surgery Interval on Pathological Complete Response and Short- and Long-Term Overall Survival in Esophageal Cancer Patients.

BACKGROUND: The impact of the neoadjuvant chemoradiation-to-surgery (CRT-S) interval in patients with esophageal cancer is not clear. We aimed to determine the relationship between CRT-S interval and pathological complete response rate (pCR) and overall survival (OS). METHODS: National Cancer Data Base patients with CRT followed by surgery were studied. CRT-S interval was studied as a continuous (weeks) and categorical variable (quintiles: 15-37, 38-45, 46-53, 54-64, and 65-90 days, with n = 1016, 1063, 1081, 1083, and 938 patients, respectively). RESULTS: A total of 5181 patients were included; 81% had adenocarcinoma. There was a significant increase of pCR rate across quintiles (18%, 21%, 24%, 25%, and 29%, p < 0.001) and per week increase of CRT-S interval [odds ratio (OR) 1.11, p < 0.001]. The 90-day mortality increased as CRT-S increased across quintiles (5.7%, 6.2%, 6.8%, 8.5%, and 8.2%, p = 0.02) and through weeks (OR 1.05, p = 0.03). Mean OS across CRT-S quintiles was 36.4, 35.1, 33.9, 33.2, and 30.7 months, respectively. Multivariate Cox regression showed significantly worse OS per week increase in CRT-S interval [hazard ratio (HR) 1.02, p = 0.02], especially among the last quintile (CRT-S = 65-90 days: HR 1.2, p = 0.009). The squamous cell carcinoma (SCC) and pCR groups had similar OS across CTR-S intervals. CONCLUSIONS: Despite the higher pCR rate with longer CRT-S interval, surgery is optimal less than 65 days after CRT to avoid worse 90-day mortality and achieve better OS. In patients with SCC and those with pCR, prolonged CRT-S interval had no impact on OS. Further studies are needed to consolidate our findings.

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.

Patient-Perceived Barriers to Accessing Cleft Care at a Tertiary Referral Center in São Paulo, Brazil.

BACKGROUND: In low- and middle-income countries, poor access to care can result in delayed surgical repair of orofacial clefts leading to poor functional outcomes. Even in Brazil, an upper middle-income country with free comprehensive cleft care, delayed repair of orofacial clefts commonly occurs. This study aims to assess patient-perceived barriers to cleft care at a referral center in São Paulo. METHODS: A 29-item questionnaire assessing the barriers to care was administered to 101 consecutive patients (or their guardians) undergoing orofacial cleft surgery in the Plastic Surgery Department in Hospital das Clínicas, in São Paulo, Brazil, between February 2016 and January 2017. RESULTS: A total of 54.4% of patients had their first surgery beyond the recommended time frame of 6 months for a cleft lip or cleft lip and palate and 18 months for a cleft palate. There was a greater proportion of isolated cleft palates in the delayed group (66.7% vs 33.3%). Almost all patients had a timely diagnosis, but delays occurred from diagnosis to repair. The mean number of barriers reported for each patient was 3.8. The most frequently cited barriers related to lack of access to care include (1) lack of hospitals available to perform the surgery (54%) and (2) lack of availability of doctors (51%). CONCLUSION: Delays from diagnosis to treatment result in patients receiving delayed primary repairs. The commonest patient-perceived barriers are related to a lack of access to cleft care, which may represent a lack of awareness of available services.

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.

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.

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.

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.

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.

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.