Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett's Esophagus.

BACKGROUND & AIMS: Antireflux treatment is recommended to reduce esophageal adenocarcinoma in patients with Barrett's esophagus. Antireflux surgery (fundoplication) counteracts gastroesophageal reflux of all types of carcinogenic gastric content and reduces esophageal acid exposure to a greater extent than antireflux medication (eg, proton pump inhibitors). We examined the hypothesis that antireflux surgery prevents esophageal adenocarcinoma to a larger degree than antireflux medication in patients with Barrett's esophagus. METHODS: This multinational and population-based cohort study included all patients with a diagnosis of Barrett's esophagus in any of the national patient registries in Denmark (2012-2020), Finland (1987-1996 and 2010-2020), Norway (2008-2020), or Sweden (2006-2020). Patients who underwent antireflux surgery were compared with nonoperated patients using antireflux medication. The risk of esophageal adenocarcinoma was calculated using multivariable Cox regression, providing hazard ratios (HRs) and 95% CIs adjusted for age, sex, country, calendar year, and comorbidity. RESULTS: The cohort consisted of 33,939 patients with Barrett's esophagus. Of these, 542 (1.6%) had undergone antireflux surgery. During up to 32 years of follow-up, the overall HR was not decreased in patients having undergone antireflux surgery compared with nonoperated patients using antireflux medication, but rather increased (adjusted HR, 1.9; 95% CI, 1.1-3.5). In addition, HRs did not decrease with longer follow-up, but instead increased for each follow-up category, from 1.8 (95% CI, 0.6-5.0) within 1-4 years of follow-up to 4.4 (95% CI, 1.4-13.5) after 10-32 years of follow-up. CONCLUSIONS: Patients with Barrett's esophagus who undergo antireflux surgery do not seem to have a lower risk of esophageal adenocarcinoma than those using antireflux medication.

Outcomes of Transoral Incisionless Fundoplication (TIF 2.0): A Prospective, Multicenter Cohort Study in Academic and Community Practices (with video).

BACKGROUND AND AIMS: Transoral incisionless fundoplication (TIF) is an established safe endoscopic technique for the management of GERD but with variable efficacy. In the last decade, the TIF technology and technique have been optimized and more widely accepted but data on outcomes outside clinical trials are limited. We tracked patient-reported and clinical outcomes of GERD patients after TIF 2.0. METHODS: Patients with BMI < 35, hiatal hernia < 2cm, and confirmed GERD with typical and/or atypical symptoms from 9 academic and community medical centers were enrolled in a prospective registry and underwent after TIF 2.0 performed by gastroenterologists and surgeons. The primary outcomes were safety and clinical success (response in >2 of 4 endpoints). Secondary endpoints were symptom improvement, acid exposure time (AET), esophagitis healing, proton pump inhibitor (PPI) use, and satisfaction. Outcomes were assessed at last follow-up within 12 months. RESULTS: 85 patients underwent TIF 2.0, 81 were included in the outcomes analysis. Clinical success was achieved in 94%, GERD-HRQL scores improved in 89%, and elevated RSI score normalized in 85% of patients with elevated baseline. Patient satisfaction improved from 8% to 79% (p <0.0001). At baseline, 81% were taking at least daily PPI, while 80% were on no or occasional PPI after TIF 2.0 (p<0.0001). Esophageal AET was normal in 72%, greater with an optimized TIF 2.0 valve >300 degree circumference, >3cm length (94% vs 57%, p=0.007). There were no TIF 2.0-related serious adverse events. CONCLUSION: TIF 2.0 is a safe and effective endoscopic outpatient treatment option for select patients with GERD.

Nissen Fundoplication in Infants With Severe Bronchopulmonary Dysplasia: A Propensity-Matched Analysis.

INTRODUCTION: Bronchopulmonary dysplasia (BPD) is a common respiratory morbidity among premature infants. Nissen fundoplication may be performed on infants with BPD to protect the lungs from gastroesophageal reflux-related aspiration, but the indications and benefits associated with fundoplication are not well-defined. This study evaluated associations of Nissen with clinical outcomes in infants with severe BPD (sBPD), using propensity score matching to minimize bias and confounding. METHODS: Infants ≤31 wk gestational age with sBPD (grade 2-3) admitted to a single neonatal intensive care unit (NICU) between January 2016 and October 2021 were included. Patients with sBPD who underwent Nissen fundoplication during initial NICU admission were propensity score-matched at a 1:2 ratio with control patients who did not undergo Nissen (no-Nissen). Outcomes were compared, including time to freedom from respiratory support (defined as ≤2 L nasal cannula), time to initial NICU discharge, and incidence of hospital readmission or death within 1 y postdischarge. RESULTS: After propensity score matching, 18 Nissen infants were compared with 30 no-Nissen infants. The Nissen group trended toward longer time to freedom from respiratory support (median 105 versus 70 d, P = 0.09), and had longer initial hospital stays (188 versus 111 d, P = 0.002), more 1-y hospital readmissions (83% versus 50%, P = 0.04), and more tracheostomies (28% versus 0%, P = 0.005). Mortality during first-year postdischarge was similar (6% versus 10%, P = 1.0). CONCLUSIONS: Despite adjustment for confounding variables, Nissen fundoplication was associated with prolonged support and greater resource utilization among infants with sBPD. Prospective studies are needed to clarify indications for fundoplication in this population.

Developments in Gastroesophageal Reflux Disease over the Last 40 Years.

BACKGROUND: The last 40 years have seen a remarkable change in our understanding of reflux disease. SUMMARY: These changes encompass disease definition and impact, pathophysiology, diagnostic testing, regulatory oversight of clinical trials, pharmacotherapy, endoscopic, and surgical treatment. We have also seen a number of promising therapies fail. KEY MESSAGES: The future holds the promise of further advances. Adaptive artificial intelligence will take over diagnostics in manometry and pH impedance testing and patient-driven outcomes may be changed by interactions with artificial intelligence rather than humans. Changes in chip technology will allow higher resolution chips to be carried on smaller devices making extra-esophageal areas where reflux may play a role more accessible to prolonged observation and testing.

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.

To wean or not to wean: proton pump inhibitor management after anti-reflux surgery amongst foregut experts.

BACKGROUND: Most patients undergoing anti-reflux surgery (ARS) have a history of preoperative proton pump inhibitor (PPI) use. It is well-established that ARS is effective in restoring the anti-reflux barrier, eliminating the ongoing need for costly PPIs. Current literature lacks objective evidence supporting an optimal postoperative PPI cessation or weaning strategy, leading to wide practice variations. We sought to objectively gauge current practice and opinion surrounding the postoperative management of PPIs among expert foregut surgeons and gastroenterologists in the United States. METHODS: We created a survey of postoperative PPI management protocols, with an emphasis on discontinuation and timing of PPI cessation, and aimed to determine what factors played a role in the decision-making. An electronic survey tool (Qualtrics XM, Qualtrics, Provo, UT) was used to distribute the survey and to record the responses anonymously for a period of three months. RESULTS: The survey was viewed 2658 times by 373 institutions and shared with 644 members. In total, 121 respondents participated in the survey and 111 were surgeons (92%). Fifty respondents (42%) always discontinue PPIs immediately after ARS. Of the remaining 70 respondents (58%), 46% always wean or taper PPIs postoperatively and 47% wean or taper them selectively. The majority (92%) of practitioners taper within a 3-month period postoperatively. Five respondents never discontinue PPIs after ARS. Overall, only 23 respondents (19%) stated their protocol is based on medical literature or evidence-based medicine. Instead, decision-making is primarily based on anecdotal evidence/personal preference (42%, n = 50) or prior training/mentors (39%, n = 47). CONCLUSIONS: There are two major protocols used for PPI discontinuation after ARS: Nearly half of providers abruptly stop PPIs, while just over half gradually tapers them, most often in the early postoperative period. These decisions are primarily driven by institutional practices and personal preferences, underscoring the need for evidence-based recommendations.

The impact of obesity on gastroesophageal reflux disease recurrence following re-operative anti-reflux surgery.

INTRODUCTION: Obese patients represent a large proportion of patients experiencing recurrent reflux and re-operations after initial anti-reflux surgery. However, there is a limited data describing the impact of obesity on GERD recurrence following re-operative procedures. METHODS: A review of patients who underwent re-operative anti-reflux surgery (Re-ARS) between 2012 and 2023. Peri-operative characteristics and post-operative Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) scores were compared across the three BMI categories: (BMI < 25 kg/m2, 25 ≤ BMI > 30 kg/m2, and BMI ≥ 30 kg/m2) over 12 IQR (9-14.9) months follow-up. Impedance planimetry measurements were included when it was utilized intraoperatively. RESULTS: Of 718 patients who underwent robotic ARS, 84 patients (11.6%) underwent Re-ARS, of which 29.7% had a BMI < 25 kg/m2, 35.7% were ≤ 25 BMI < 30 kg/m2, and 34.5% had a BMI ≥ 30 kg/m2. The lower esophageal sphincter distensibility decreased similarly between groups with no differences in post-induction [3.2 ± 2 vs 4.5 ± 3.1 vs 3.9 ± 2.5 mm2/mmHg, p = 0.44] or post-fundoplication values [1 ± 0.6 vs 1.3 ± 0.7 vs 1.2 ± 0.6 mm2/mmHg, p = 0.46]. There was a significant improvement in GERD-HRQL scores postoperatively compared to preoperative levels across the three BMI classes (BMI < 25 kg/m2: pre 17 IQR (12-22), post 7.5 (1.5-15), p = 0.04 vs ≤ 25 BMI < 30 kg/m2: pre 26 IQR (10-34), post 8 IQR (0-17), p < 0.01 vs BMI ≥ 30 kg/m2: pre 44 IQR (26-51), post 5 IQR (3.5-14.5), p < 0.001) during 12 IQR (9-14.9) months follow-up. The rates of hiatal hernia recurrence on barium swallow [5.2 vs 15.7 vs 13.7%, p = 0.32] during 7 IQR (5.2-9.2) months follow-up, and endoscopy [13.3 vs 16.6 vs 7.1%, p = 0.74] during 11.8 (IQR 5.6-17.1) months follow-up period were also similar between groups. CONCLUSION: GERD-HRQL scores in obese patients are expected to improve similarly compared to non-obese patients. Indicating that Re-ARS may be appropriate for patients across a range of BMIs.

Fundoplication vs. gastric fixation for the management of emergency hiatal hernia repairs: a retrospective cohort study.

INTRODUCTION: There is a paucity of literature comparing safety outcomes between formal fundoplication and gastric fixation procedures for hiatal hernia repairs, especially in the emergency setting. The objective of this study was to evaluate 30-day clinical outcomes between fundoplication and gastric fixation performed in emergency hiatal hernia repairs. METHODS: A retrospective cohort study using the National Surgery Quality Improvement Program (NSQIP) database from 2011 to 2021 was conducted. The study population was determined using ICD9/10 codes describing diaphragmatic hernia without obstruction or gangrene, with obstruction, and with gangrene. Elective cases were excluded. CPT codes were used to group fundoplication procedures and gastric fixation procedures. The primary outcome was the 30-day complication rate. Secondary outcomes included 30-day readmission, reoperation and mortality rates. A multivariable logistic regression analysis was used to adjust for clinically relevant confounding variables. RESULTS: A total of 971 and 346 were in the fundoplication and gastric fixation groups, respectively. Fundoplication was associated with a significantly lower (p < 0.05) 30-day complication, reoperation and mortality rates. There was no statistically significant difference with respect to readmission. After adjustment, fundoplication was significantly associated with a decrease in odds of 30-day complications (OR 0.53, p < 0.001 95% CI 0.40-0.71) and mortality (OR 0.55, p = 0.033 95% CI 0.32-0.95). However, there was no significant difference with respect to 30-day readmission (OR 0.86, p = 0.449 95% CI 0.59-1.27) and reoperation (OR 0.66, p = 0.063 95% CI 0.42-1.02). CONCLUSION: Patients with hiatal hernias that underwent emergent repair with fundoplication had a significantly lower 30-day complication and mortality rates compared to those who underwent gastric fixation procedures. Fundoplication is a safe and feasible approach to manage hiatal hernias in the emergency setting for select patients.

SAGES guidelines for the surgical treatment of hiatal hernias.

BACKGROUND: Hiatal hernia (HH) is a common condition. A multidisciplinary expert panel was convened to develop evidence-based recommendations to support clinicians, patients, and others in decisions regarding the treatment of HH. METHODS: Systematic reviews were conducted for four key questions regarding the treatment of HH in adults: surgical treatment of asymptomatic HH versus surveillance; use of mesh versus no mesh; performing a fundoplication versus no fundoplication; and Roux-en-Y gastric bypass (RYGB) versus redo fundoplication for recurrent HH. Evidence-based recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluations methodology by subject experts. When the evidence was insufficient to base recommendations on, expert opinion was utilized instead. Recommendations for future research were also proposed. RESULTS: The panel provided one conditional recommendation and two expert opinions for adults with HH. The panel suggested routinely performing a fundoplication in the repair of HH, though this was based on low certainty evidence. There was insufficient evidence to make evidence-based recommendations regarding surgical repair of asymptomatic HH or conversion to RYGB in recurrent HH, and therefore, only expert opinions were offered. The panel suggested that select asymptomatic patients may be offered surgical repair, with criteria outlined. Similarly, it suggested that conversion to RYGB for management of recurrent HH may be appropriate in certain patients and again described criteria. The evidence for the routine use of mesh in HH repair was equivocal and the panel deferred making a recommendation. CONCLUSIONS: These recommendations should provide guidance regarding surgical decision-making in the treatment of HH and highlight the importance of shared decision-making and consideration of patient values to optimize outcomes. Pursuing the identified research needs will improve the evidence base and may allow for stronger recommendations in future evidence-based guidelines for the treatment of HH.

Clinical outcomes of endoscopic balloon dilation for dysphagia after anti-gastroesophageal reflux surgery.

BACKGROUND: Dysphagia is a potential complication following anti-gastroesophageal reflux surgery (ARS), with challenging management. Endoscopic balloon dilation is recommended for patients with significant dysphagia from tight wraps or strictures. We aim to evaluate factors associated with the need for post-ARS dilation and the outcomes of balloon dilation. Additionally, we assessed the predictors of sustained clinical failure after dilation. METHODS: A retrospective analysis was conducted on patients who underwent robotic or laparoscopic ARS between January 2012 and April 2023. Patients were divided based on whether they received balloon dilation using a through-the-scope wire-guided dilator. Excluded were those with pre-existing achalasia, other dilation devices, or inadequate follow-up. RESULTS: Of 1002 patients, 69 underwent 94 postoperative dilations, and the remainder were controls. The dilation cohort was older (63.78 vs. 56.14 years, P = 0.032) and had more magnetic sphincter augmentations (MSA) (P = 0.004), a prior history of ARS (P = 0.039), and a higher rate of laparoscopic surgery (P = 0.009) compared to controls. Of all dilations, 54 (57.5%) patients reported immediate dysphagia improvement, and 39 (41.5%) had sustained improvement. Sixteen (23.2%) patients required reoperation, primarily for hiatal hernia recurrence or slipped wrap. Multivariable logistic regression showed that MSA (OR 0.04, 95% CI 0.01-0.46, P = 0.031) and requiring multiple dilations (OR 0.16, CI 0.03-0.68) predicted sustained dilation failure. CONCLUSIONS: Factors including older age, history of prior ARS, and MSA are correlated with higher post-ARS dilation rates. Although dilation improves symptoms in approximately half of patients initially, one-fourth may eventually require reoperation, mostly due to a slipped wrap or hernia recurrence. Thus, in cases of persistent dysphagia, consideration for surgical failure is important, and further imaging and workup are warranted. Patients who undergo MSA and those who have more than one dilation are more likely to experience dilation failure.

Long-term disease-specific quality of life after laparoscopic Nissen fundoplication in patients with borderline GERD.

BACKGROUND: Historically, DeMeester score over 14.7 has been used to diagnose GERD. The 2022 American Gastroenterological Association clinical guidelines define GERD based on acid exposure time (AET) instead of DeMeester score. We aim to compare outcomes after laparoscopic Nissen fundoplication (LNF) in patients based on differing GERD diagnostic criteria. METHODS: Patients who underwent first-time LNF between 2009 and 2017 were identified. Demographics, objective GERD evaluation, and outcomes were maintained in an IRB-approved database. Disease-specific quality of life was assessed with a survey (GERD-HRQL) with higher values representing more symptomatic disease. Descriptive statistics, Fischer's exact test and logistic regression were used to analyze the data, p-value < 0.05. RESULTS: 225 patients were stratified into two groups: borderline GERD (AET 4-6%, n = 25.11%) and GERD (AET ≥ 6%, n = 200.89%). The mean age was 50.1 ± 13.4 years and 169 (75%) were female. Baseline GERD-HRQL was lower in the borderline group (24.3 vs 30.0, p = 0.031). Short-term (5 weeks [IQR 4, 8]), medium-term (14 months [IQR 7.25, 31]) and long-term (6.75 years [IQR 5.5, 8]) follow-up was performed. GERD-HRQL scores did not differ between borderline and GERD patients at short-(6.0 vs 7.1, p = 0.630), medium-(12.0 vs 12.1, p = 0.818), or long-term follow-up (10.0 vs 9.0, p = 0.757). The absolute long-term improvement in GERD-HRQL was -12.3 (p = 0.022) vs. -21.3 (p < 0.001). At long-term follow-up there was no difference in PPI use (50% vs 47%, p = 0.852), satisfaction (58% vs 76%, p = 0.187), willingness to repeat the procedure given the benefit of hindsight (75% vs 85%, p = 0.386), or need for reoperation (14% vs 13%, p = 0.910). CONCLUSION: Both patients with borderline GERD and GERD achieve GERD-HRQL improvements at 7 years following laparoscopic Nissen fundoplication and demonstrate similar long-term PPI usage and satisfaction with surgical results. Borderline GERD patients have lower GERD-HRQL at baseline, and thus have smaller improvements in their QOL scores. Anti-reflux surgery should be considered for patients with a diagnosis of borderline GERD refractory to medical therapy.

A decade of experience with minimally invasive anti-reflux operations: robot vs. LESS.

BACKGROUND: The increasing use of robotic systems for anti-reflux operations prompted this study to evaluate and compare the efficacy of robotic and Laparo-Endoscopic Single-Site (LESS) approaches. METHODS: From 2012, 228 robotic fundoplication and 518 LESS fundoplication patients were prospectively followed, analyzing perioperative metrics. Data are presented as median (mean ± SD); significance at p ≤ 0.05. RESULTS: Patients undergoing a robotic vs. LESS fundoplication were 67 (64 ± 13.7) vs. 61 (59 ± 15.1) years-old with BMIs of 25 (25 ± 3.2) vs. 26 (25 ± 3.9) kg/m2 (p = 0.001 and 1.00, respectively). 72% of patients who underwent the robotic approach had a previous abdominal operation(s) vs 44% who underwent the LESS approach (p = 0.0001). 38% vs. 8% had a re-operative fundoplication (p = 0.0001), 59% vs. 45% had a type IV hiatal hernia (p = 0.0004). Operative duration was 160 (176 ± 76.7) vs. 130 (135 ± 50.5) min (p = 0.0001). There were 0 (robotic) vs. 5 (LESS) conversions to a different approach (p = 0.33). 5 Patients vs. 3 patients experienced postoperative complications (p = 0.06), and length of stay (LOS) was 1 (2 ± 2.6) vs. 1 (1 ± 3.2) days (p = 0.0001). Patient symptomatic dysphagia preoperatively for the robotic vs. LESS approach was scored as 2 (2.4 ± 1.9) vs. 1 (1.9 ± 1.6). Postoperatively, symptomatic dysphagia was scored as 1 (1.5 ± 1.6) vs. 1 (1.7 ± 1.7). The change in these scores was - 1 (- 1 ± 2.2) vs. 0 (- 0.5 ± 2.2) (p = 0.004). CONCLUSION: Despite longer operative times and LOS in older patients, the robotic approach is efficient in undertaking very difficult operations, including patients with type IV or recurrent hiatal hernias. Furthermore, preoperative anti-reflux operations were more likely to be undertaken with the robotic approach than the LESS approach. The patient's postoperative symptomatic dysphagia improved relatively more than after the LESS approach. The vast majority of patients who underwent the LESS approach enjoyed improved cosmesis, thus, making LESS a stronger candidate for more routine operations. Despite patient selection bias, the robotic and LESS approaches to anti-reflux operations are safe, efficacious, and should be situationally utilized.

Management of symptomatic, asymptomatic, and recurrent hiatal hernia: a systematic review and meta-analysis.

BACKGROUND: The surgical management of hiatal hernia remains controversial. We aimed to compare outcomes of mesh versus no mesh and fundoplication versus no fundoplication in symptomatic patients; surgery versus observation in asymptomatic patients; and redo hernia repair versus conversion to Roux-en-Y reconstruction in recurrent hiatal hernia. METHODS: We searched PubMed, Embase, CINAHL, Cochrane Library and the ClinicalTrials.gov databases between 2000 and 2022 for randomized controlled trials (RCTs), observational studies, and case series (asymptomatic and recurrent hernias). Screening was performed by two trained independent reviewers. Pooled analyses were performed on comparative data. Risk of bias was assessed using the Cochrane Risk of Bias tool and Newcastle Ottawa Scale for randomized and non-randomized studies, respectively. RESULTS: We included 45 studies from 5152 retrieved records. Only six RCTs had low risk of bias. Mesh was associated with a lower recurrence risk (RR = 0.50, 95%CI 0.28, 0.88; I2 = 57%) in observational studies but not RCTs (RR = 0.98, 95%CI 0.47, 2.02; I2 = 34%), and higher total early dysphagia based on five observational studies (RR = 1.44, 95%CI 1.10, 1.89; I2 = 40%) but was not statistically significant in RCTs (RR = 3.00, 95%CI 0.64, 14.16). There was no difference in complications, reintervention, heartburn, reflux, or quality of life. There were no appropriate studies comparing surgery to observation in asymptomatic patients. Fundoplication resulted in higher early dysphagia in both observational studies and RCTs ([RR = 2.08, 95%CI 1.16, 3.76] and [RR = 20.58, 95%CI 1.34, 316.69]) but lower reflux in RCTs (RR = 0.31, 95%CI 0.17, 0.56, I2 = 0%). Conversion to Roux-en-Y was associated with a lower reintervention risk after 30 days compared to redo surgery. CONCLUSIONS: The evidence for optimal management of symptomatic and recurrent hiatal hernia remains controversial, underpinned by studies with a high risk of bias. Shared decision making between surgeon and patient is essential for optimal outcomes.

Short term safety of magnetic sphincter augmentation vs minimally invasive fundoplication: an ACS-NSQIP analysis.

PURPOSE: Magnetic Sphincter Augmentation (MSA) is an FDA-approved anti-reflux procedure with comparable outcomes to fundoplication. However, most data regarding its use are limited to single or small multicenter studies which may limit the generalizability of its efficacy. The purpose of this study is to evaluate the outcomes of patients undergoing MSA vs fundoplication in a national database. MATERIALS AND METHODS: The 2017-2020 American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Registry was utilized to evaluate patients undergoing MSA or fundoplication. Patients requiring Collis gastroplasty, paraesophageal hernia repair, and emergency cases, were excluded. Patient outcomes included overall complication rates, readmissions, reoperations, and mortality. RESULTS: A total of 7,882 patients underwent MSA (n = 597) or fundoplication (n = 7285). MSA patients were younger (51 vs 57, p < 0.001), and more often male (49.6 vs 34.3%, p < 0.001). While patients undergoing MSA experienced similar rates of reoperation (1.0 vs 2.0%, p = 0.095), they experienced fewer readmissions (2.2 vs 4.7%, p = 0.005), complications (0.6 vs 4.0%, p < 0.001), shorter mean (SD) hospital length of stay(days) (0.4 ± 4.3 vs 1.8 ± 4.6, p < 0.001) and operative time(min) (80.8 ± 36.1 vs 118.7 ± 63.7, p < 0.001). Mortality was similar between groups (0 vs 0.3%, p = 0.175). On multivariable analysis, MSA was independently associated with reduced postoperative complications (OR 0.23, CI 0.08 to 0.61, p = 0.002), readmissions (OR 0.53, CI 0.30 to 0.94, p = 0.02), operative time (RC - 36.56, CI - 41.62 to - 31.49. p < 0.001) and length of stay (RC - 1.22, CI - 1.61 to - 0.84 p < 0.001). CONCLUSION: In this national database study, compared to fundoplication MSA was associated with reduced postoperative complications, fewer readmissions, and shorter operative time and hospital length of stay. While randomized trials are lacking between MSA and fundoplication, both institutional and national database studies continue to support the use of MSA as a safe anti-reflux operation.

Validity and reliability evidence support task-specific metrics for laparoscopic fundoplication.

BACKGROUND: Laparoscopic hiatal hernia repair (LHHR) is a complex operation requiring advanced surgical training. Surgical simulation offers a potential solution for learning complex operations without the need for high surgical volume. Our goal is to develop a virtual reality (VR) simulator for LHHR; however, data supporting task-specific metrics for this procedure are lacking. The purpose of this study was to develop and assess validity and reliability evidence of task-specific metrics for the fundoplication phase of LHHR. METHODS: In phase I, structured interviews with expert foregut surgeons were conducted to develop task-specific metrics (TSM). In phase II, participants with varying levels of surgical expertise performed a laparoscopic Nissen fundoplication procedure on a porcine stomach explant. Video recordings were independently assessed by two blinded graders using global and TSM. An intraclass correlation coefficient (ICC) was used to assess interrater reliability (IRR). Performance scores were compared using a Kruskal-Wallis test. Spearman's rank correlation was used to evaluate the association between global and TSM. RESULTS: Phase I of the study consisted of 12 interviews with expert foregut surgeons. Phase II engaged 31 surgery residents, a fellow, and 6 attendings in the simulation. Phase II results showed high IRR for both global (ICC = 0.84, p < 0.001) and TSM (ICC = 0.75, p < 0.001). Significant between-group differences were detected for both global (χ2 = 24.01, p < 0.001) and TSM (χ2 = 18.4, p < 0.001). Post hoc analysis showed significant differences in performance between the three groups for both metrics (p < 0.05). There was a strong positive correlation between the global and TSM (rs = 0.86, p < 0.001). CONCLUSION: We developed task-specific metrics for LHHR and using a fundoplication model, we documented significant reliability and validity evidence. We anticipate that these LHHR task-specific metrics will be useful in our planned VR simulator.

Enhanced recovery after surgery may mitigate the risks associated with robotic-assisted fundoplication in lung transplant patients.

INTRODUCTION: A history of lung transplantation is a risk factor for poor outcomes in patients undergoing laparoscopic fundoplication. We wanted to determine whether enhanced recovery after a robotic-assisted surgery program would mitigate these risks. METHODS: We performed a single-center retrospective analysis of the Society of Thoracic Surgery database for patients who underwent elective antireflux procedures from 1/2018 to 2/2021 under the enhanced recovery after surgery program using robotic assistance. We identified the patient and surgical characteristics, morbidity, length of stay, and 30-day readmission rates. RESULTS: Among 386 patients who underwent barrier creation, 41 had previously undergone a lung transplant, either bilateral (n = 28) or single (n = 13). There were no significant differences in postoperative complications (9.8% vs. 5.2%, p = 0.27), median hospital length of stay (1 d vs. 1 d, p = 0.28), or 30-day readmission (7.3% vs. 4.9%, p = 0.46). Bivariate analysis showed that older age (p = 0.03), history of DVT/PE (p < 0.001), history of cerebrovascular events (p = 0.03), opioid dependence (p = 0.02), neurocognitive dysfunction (p < 0.001), and dependent functional status (p = 0.02) were associated with postoperative complications. However, lung transplantation was not associated with an increased risk of postoperative complications (p = 0.28). DISCUSSION: The risk of surgical complications in patients with a history of lung transplantation may be mitigated by the combination of ERAS and minimally invasive surgery such as robot-assisted surgery.

Video consent significantly improves patient knowledge of general surgery procedures.

INTRODUCTION: Informed consent is essential in ensuring patients' understanding of their medical condition, treatment, and potential risks. The objective of this study was to investigate the impact of utilizing a video consent compared to standard consent for patient knowledge and satisfaction in selected general surgical procedures. METHODS AND PROCEDURES: We included 118 patients undergoing appendectomy, cholecystectomy, inguinal hernia repair, and fundoplication at two hospitals in Omaha, NE. Patients were randomized to either a standard consent or a video consent. Outcomes included a pretest and posttest objective knowledge assessment of their procedure, as well as a satisfaction survey which was completed immediately after consent and following discharge. Given the pre-post design, a linear mixed-effect model was estimated for both outcomes. A two-way interaction effect was of primary interest to assess whether pre-to-post change in the outcome differed between patients randomized to standard or video consent. RESULTS: Baseline characteristics were mostly similar between groups except for patient sex, p = 0.041. Both groups showed a statistically significant increase in knowledge from pretest to posttest (standard group: 0.25, 95% CI 0.01 to 0.51, p = 0.048; video group: 0.68, 95% CI 0.36 to 1.00, p < 0.001), with the video group showing significantly greater change (interaction p = 0.043) indicating that incorporating a video into the consent process resulted in a better improvement in patient's knowledge of the proposed procedure. Further, both groups showed a decrease in satisfaction post-discharge, but no statistically significant difference in the magnitude of decrease between the groups (interaction p = 0.309). CONCLUSION: Video consent lead to a significant improvement in a patient's knowledge of the proposed treatment. Although the patient satisfaction survey didn't show a significant difference, it did show a trend. We propose incorporating videos into the consent process for routine general surgical procedures.

Determination of causes of post-operative dysphagia after anti-reflux surgery based on intra-operative planimetry.

INTRODUCTION: Dysphagia after anti-reflux surgery (ARS) is one of the most common indications for re-operative anti-reflux surgery and a leading cause of patient dissatisfaction. Unfortunately, the factors affecting its development are poorly understood. We investigated the correlation between pre-operative manometric and the intra-operative impedance planimetry (EndoFLIP™) measurements and development of post-operative dysphagia. METHODS: A review of patients who underwent index robotic ARS in our institution. Patients who underwent pre-operative manometry and intra-operative EndoFLIP™ were included in our study. Dysphagia was assessed pre-operatively and at 3-month after surgery. RESULTS: Fifty-five patients (26.9%) reported post-operative dysphagia, and 34 (16.6%) reported new or worsening dysphagia. On pre-operative manometry, patients with post-operative dysphagia had a lower distal contractile integral [868.7 (IQR 402.2-1447) mmHg s cm vs 1207 (IQR 612.1-2111) mmHg s cm, p = 0.006) and lower esophageal sphincter (LES) pressure [14.7 IQR (8.9-23.6) mmHg vs 20.7 IQR (10.2-32.6) mmHg, p = 0.01] compared to those without post-operative dysphagia. They were also found to have higher pre-operative cross-sectional surface area (CSA) [83 IQR (44.5-112) mm2 vs 66 IQR (42-93) mm2, p = 0.02], and distensibility index (DI) [4.2 IQR (2.2-5.5) mm2/mmHg vs 2.9 IQR (1.6-4.6) mm2/mmHg, p = 0.003] compared to patients without post-operative dysphagia. Additionally, the decrease in CSA [- 34 (- 18.5, - 74.5) mm2 vs - 26.5 (- 10.5, - 53.7) mm2, p = 0.03] and DI [- 2.3 (- 1.2, - 3.7) mm2/mmHg vs - 1.6 (- 0.7, - 3.3) mm2/mmHg, p = 0.03] measurements were greater in patients with post-operative dysphagia. CONCLUSION: Patients who developed dysphagia post-operatively had poorer pre-operative motility and a greater change in LES characteristics intra-operatively. This finding suggests the utility of pre-operative manometry and intra-operative EndoFLIP in identifying patients at risk of developing dysphagia post-operatively.

Concomitant hiatal hernia repair with transoral incisionless fundoplication for the treatment of refractory gastroesophageal reflux disease: a systematic review.

BACKGROUND: Transoral incisionless fundoplication (TIF) is safe and effective in select patients with hiatal hernias ≤ 2 cm with refractory gastroesophageal reflux disease (GERD). For patients with hiatal hernias > 2 cm, concomitant hiatal hernia (HH) repair with TIF (cTIF) is offered as an alternative to conventional anti-reflux surgery (ARS). Yet, data on this approach is limited. Through a comprehensive systematic review, we aim to evaluate the efficacy and safety of cTIF for managing refractory GERD in patients with hernias > 2 cm. STUDY DESIGN: We conducted a systematic review of studies evaluating cTIF outcomes from PubMed, EMBASE, SCOPUS, and Cochrane databases up to February 14, 2024. Primary outcomes included complete cessation of proton pump inhibitors (PPIs). Secondary outcomes included objective GERD assessment, adverse events, and treatment-related side effects. Pooled analysis was employed wherever feasible. RESULTS: Seven observational studies (306 patients) met the inclusion criteria. Five were retrospective cohort studies and two were prospective observational studies. The median rate of discontinuation of PPIs was 73.8% (range 56.4-94.4%). Significant improvements were observed in disease-specific, validated GERD questionnaires. The median rate for complications was 4.4% (range 0-7.9%), and the 30-day readmission rate had a median of 3.3% (range 0-5.3%). The incidence of dysphagia was 11 out of 164 patients, with a median of 5.3% (range 0-8.3%), while the incidence of gas bloating was 15 out of 127 patients, with a median of 6.9% (range 0-13.8%). CONCLUSION: Current data on cTIF suggests a promising alternative to ARS with comparable short-term efficacy and safety profile for managing refractory GERD with a low side effect profile. However, longer-term data and comparative efficacy studies are needed.

Assessment of laparoscopic fundoplication with endoscopy: room for improvement.

INTRODUCTION: Gastroesophageal reflux disease affects a significant portion of the Australian and world population. Minimally invasive laparoscopic fundoplication is a highly effective treatment in appropriately selected patients, with a 90% satisfaction rate. However, up to 5% will undergo revisional surgery. Endoscopy is an important investigation in the evaluation of persistent or new symptoms after fundoplication. Our study sought to evaluate the inter-rater reliability and variability in assessing fundoplication with endoscopy. METHODS: Upper gastrointestinal (UGI) surgeons and gastroenterologists were invited to join the cohort study through their professional membership with two societies based in Australia. Participants completed a two part 25-item multiple choice questionnaire, involving the analysis of ten static endoscopic images post-fundoplication. RESULTS: A total of 101 participants were included in the study (64 UGI surgeons and 37 gastroenterologists). Over 95% of participants were consultant level, working in non-rural tertiary hospitals. Total accuracy for all 10 cases combined was 76% for UGI surgeons and 69.9% for gastroenterologists. In three of the 10 cases, UGI surgeons performed significantly better than gastroenterologists (p < 0.05). When assessing performance across each of the 4 questions for each case, UGI surgeons were more accurate than gastroenterologists in describing the integrity of the wrap (p = 0.014). Inter-rater reliability was low across both groups for most domains (kappa < 1). CONCLUSION: Our study confirms low inter-rater reliability between endoscopists and large variations in reporting. UGI surgeons performed better than gastroenterologists in certain cases, usually when describing the integrity of the fundoplication. Our study provides further support for the use of a standardized reporting system in post-fundoplication patients.