American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Spontaneous Intragastric Balloon Hyperinflation: Two Cases and Outcomes.

Endoscopic bariatric therapies can provide treatment options for obesity in non-surgical candidates, as a part of combination or serial treatment plans, and for the reduction of obesity-related comorbidities. Several complications of intragastric balloons have been documented, but spontaneous hyperinflation is a risk that has not been well reported previously. We describe two cases of spontaneous intragastric balloon hyperinflation and their outcomes.

Meta-analysis: Impact of intragastric balloon therapy on NAFLD-related parameters in patients with obesity.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease affecting approximately 25% of adults in the western world. Intragastric balloon (IGB) is an endoscopic bariatric therapy -a therapeutic endoscopic tool that has shown promise in inducing weight loss. Its role in the treatment of NAFLD is yet to be established. AIM: To evaluate the effect of IGB as a treatment option in NAFLD. METHODS: We searched MEDLINE (PubMed) and EMBASE from inception to September 2022. We included studies evaluating the impact of IGB on obesity with the assessment of one or more liver-related outcomes and studies primarily evaluating the impact of IGB on NAFLD. We included comparative and non-comparative studies; primary outcomes were liver-related NAFLD surrogates. RESULTS: We included 19 studies with 911 patients. IGB demonstrated an effect on NAFLD parameters including NAFLD activity score (NAS): mean difference (MD): -3.0 [95% CI: -2.41 to -3.59], ALT: MD: -10.40 U/L [95% CI: -7.31 to -13.49], liver volume: MD -397.9 [95% CI: -212.78 to 1008.58] and liver steatosis: MD: -37.76 dB/m [95% CI: -21.59 to -53.92]. There were significant reductions in non-liver-related outcomes of body weight, BMI, glycated haemoglobin and HOMA-IR. CONCLUSION: Intragastric balloons may play an important role in addressing the treatment gap in NAFLD management.

Intragastric Balloon as a Noninvasive Method for Obesity Treatment: A Single-Center Retrospective Study.

BACKGROUND: The incidence of obesity is increasing globally, with approximately 1 in 3 adults either overweight or obese. Surgery provides the most effective treatment for advanced obesity; however, endoscopic treatment, including intragastric balloon therapy, is commonly used in patients who do not meet the indications for surgery. Our study aimed to evaluate short- and mid-term weight changes of patients who had intragastric balloon therapy. MATERIAL AND METHODS: In this single-center retrospective study, we enrolled 320 patients with body mass index (BMI) values between 30 and 40 kg/m2 and without comorbidities, who underwent intragastric balloon treatment. 284 patients successfully underwent the operation. All patients were followed-up at 6 months after treatment, balloons were removed, and BMIs were recorded. Further follow-up was performed 6 months after balloon removal, and patients' BMI and demographic data were recorded again. RESULTS: Overall, 320 patients were enrolled in this study. In this cohort, 82 returned to their preprocedural weight at 1 year postprocedure, whereas 260 had BMI lower than the preprocedural values, but higher than the values at 6 months postprocedure. None of the patients had lower BMI compared to their 6-month postprocedural values. CONCLUSIONS: Balloon therapy typically helps patients lose 10% of body weight. Intragastric balloons are effective when used as weight loss tools, but are ineffective at maintaining weight loss. An intragastric device placed for 6 months may also be expected to help the patients develop better eating habits; however, we did not encounter this lifestyle change in our series.

Changes in Food Preferences Before and After Intragastric Balloon Placement.

BACKGROUNDS: In recent years, numerous studies have tried to decode the way bariatric surgery works toward weight reduction by the use of food preference questionnaires. The intragastric balloon has gained popularity, mainly due to its limited invasiveness, in patients with obesity not fulfilling criteria for bariatric surgery. However, there is no study assessing the changes in food preferences [FP]. We decided to analyze the FP of individuals prior to intragastric balloon insertion and following its removal, on the strict condition that participants must complete the 6-month treatment period and attend at least 4 of the 7 follow-up interviews. METHODS: Patients were asked to rate the frequency of consumption of 63 food items before balloon insertion, at monthly intervals and after balloon removal. The food categories were protein, carbohydrates, fruit and vegetables, and sweets and fats. RESULTS: The questionnaires of 320 participants were analyzed. A reduced frequency in consumption of meat and meat products, high-fat, and high-carbohydrate/sugary products and an increase in raw vegetables and fruit was found in all individuals. CONCLUSION: The intragastric balloon seems to exert analogically similar mechanisms to bariatric surgery for weight loss, both functioning through alterations in FP. These are dictated by the anatomical re-configuration of the stomach, but mainly by counseling of dieticians and the self-education of the patient after experiencing unpleasant postprandial discomfort.

Clinical validation of the VIPUN™ gastric monitoring system versus manometry for the evaluation of gastric motility.

BACKGROUND: Gastrointestinal dysmotility is frequently suspected in patients with gastroparesis, functional dyspepsia, and ileus, and in the intensive care unit. Monitoring of gastric motility in clinical practice remains challenging. A novel technology was developed to meet the medical need for a widely available bedside tool to monitor gastric motility continuously. The VIPUN™ Gastric Monitoring System (GMS) comprises a nasogastric feeding tube with intragastric balloon to allow for measuring gastric contractions. AIMS: To compare the performance of the VIPUN GMS versus a reference technique (manometry). METHODS: In this validation study in healthy subjects, the investigational catheter and a solid-state manometry catheter were placed in the stomach concomitantly. Motility was recorded for 2.5 h: 2 h in a fasting state, followed by a 400-kcal liquid meal, and monitoring of the fed state for the remaining half hour. The performance of both systems was compared by automated recognition and manual identification of the contractile activity. Data are presented as mean (standard deviation). KEY RESULTS: The analysis set comprised 13 healthy subjects (6 women, age: 27.5 (8.1) years, BMI: 22.2 (2.46) kg/m2). Automatically-recognized contractility was strongly correlated between the two techniques (endpoint: contraction duration; Spearman ρ = 0.96, p < 0.001). A correlation was also observed between the number of individual contractions identified by expert gastroenterologists on both technologies independently (ρ = 0.71, p = .007) and between the contractions identified by the experts and by the GMS software (ρ = 0.87, p = 0.001). No serious or unanticipated adverse events occurred. CONCLUSIONS & INFERENCES: The observed strong correlations with the gold standard, manometry, validate the performance of the VIPUN GMS as a gastric monitoring system.

Effect of preoperative intragastric balloon treatment on perioperative and postoperative outcomes after laparoscopic sleeve gastrectomy: A retrospective cohort study.

<b><br>Introduction:</b> Intragastric balloon (IGB) insertion is used as a bridging therapy in patients with body mass index (BMI) ≥ 50 kg/m2 . We arranged a retrospective study to evaluate whether pre-operative IGB treatment influences perioperative and postoperative weight loss outcomes after laparoscopic sleeve gastrectomy (SG), and especially to evaluate the impact of post - IGB percentage of excessive weight loss (%EWL) on postoperative %EWL.</br> <b><br>Materials and methods:</b> Patients who underwent IGB placement followed by laparoscopic SG were divided into the following groups considering %EWL after IGB: Group 1 <=10.38%; Group 2 >10.38% and <=17.27%; Group 3 >17.27% and <=24.86%; Group 4 >24.86%. 1 year after SG data were collected. The following parameters were compared between groups: operative time, total blood loss, length of stay and weight, BMI, percentage of total weight loss (%TWL), %EWL.</br> <b><br>Results:</b> There were no statistically significant differences between groups in perioperative results. Post-SG %EWL was the highest in intermediate groups: 2 and 3. Post-treatment results were observed: body weight and BMI were the lowest in Group 4 and the highest in Group 1. Post-treatment %EWL was the highest in Group 4, the lowest in Group 1 and grew gradually in subsequent groups.</br> <b><br>Discussion:</b> The study confirmed the impact of weight loss on IGB on postoperative results. The study showed that %EWL after the IGB treatment influences %EWL after SG and most of all affects definitive %EWL after two-stage treatment and it could be a foreshadowing factor of these outcomes.</br> <b><br>Importance:</b> The importance of research for the development of the field %EWL after IGB influences the final BMI and final weight, which means that patients with the greatest %EWL after IGB are more likely to have the greatest postoperative weight loss and overall weight loss.</br>.

Emergent Management of Gastric Outlet Obstruction Post-Intragastric Balloon: A Case Report Highlighting the Importance of Preoperative Assessments and Postoperative Monitoring in Obesity Management.

BACKGROUND Obesity is a global epidemic often managed through surgical interventions, such as intragastric balloons. Despite the minimally invasive appeal of intragastric balloons, severe complications, such as gastric outlet obstruction, can occur with their use. The most recent guidelines recommend metabolic and bariatric surgery for specific body mass index categories but rarely discuss the potential complications and required postoperative monitoring. Guidelines encourage metabolic and bariatric surgery for patients with a body mass index of 30-34.9 kg/m² and presence of metabolic disease, or body mass index ≥35 kg/m², regardless of co-morbidities. CASE REPORT We report a case of a 35-year-old woman with severe nausea, vomiting, electrolyte imbalance, and chest pain, leading to ICU admission just 2 weeks after intragastric balloon placement in Mexico. Testing and diagnostics were concerning for metabolic imbalance and heart rhythm changes. Imaging and endoscopic investigations confirmed gastric outlet obstruction, necessitating emergent endoscopic balloon deflation and removal. Following the procedure, her symptoms resolved, and she was discharged with appropriate medication and scheduled follow-up. CONCLUSIONS Given the increasing prevalence of obesity and a corresponding surge in surgical interventions, this case serves as a cautionary tale. Selection of a type of metabolic and bariatric surgery should be patient specific, with the patient involved in the decision making. Rigorous preoperative assessments and sustained postoperative monitoring are imperative. This study aims to guide future research toward enhanced patient selection and prevention of severe complications, thus influencing practice and policy in obesity management.

Evaluating the Safety of the Intragastric Balloon: Spanish Multicenter Experience in 20,680 Cases and with 12 Different Balloon Models.

INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.

Economic Evaluations of Anti-obesity Interventions in Obese Adults: An Umbrella Review.

This umbrella review amalgamates the outcomes of economic evaluations pertaining to bariatric surgeries, pharmacotherapy, and gastric balloon for adult obesity treatment. Six databases were systematically searched. The inclusion criteria were established following the Patient/population Intervention Comparison and Outcomes (PICO) statement. Fifteen reviews met all the inclusion criteria. Eight studies focused on surgical interventions, four on pharmacotherapy, and three on both interventions. No systematic review of the economic evaluation of gastric balloons was identified. The majority of reviews advocated bariatric surgery as a cost-effective approach; however, there was discordance in the interpretation of pharmacological cost-effectiveness. Most of the economic evaluations were conducted from the payer and the healthcare system perspectives. We propose that future economic evaluations assessing weight loss interventions in adults adopt a societal perspective and longer-term time horizons.

Avaliação de perda de peso após o uso de balão intragástrico não ajustável e ajustável / Assessment of weight loss after non-adjustable and adjustable intragastric balloon use

ABSTRACT BACKGROUND: Intragastric balloon (IGB) use is indicated for patients whose BMI precludes the option of bariatric surgery or who need to lose weight prior to undergoing surgery. It is a minimally invasive procedure and currently there are two main models of IGBs in use, the non-adjustable intragastric balloon (NIB), implanted for six months, and the adjustable intragastric balloon (AIB), implanted for up to 12 months. OBJECTIVE: Analyze clinical characteristics between patients receiving non-adjustable gastric balloon and the adjustable (prolonged implantation) intragastric balloon. METHODS: This was a cross-sectional study of 470 patients diagnosed as obese or overweight who had balloon implantation from October 2011 to July 2018. The associations between percentage excess weight loss versus clinical and demographic variables were calculated using the chi-squared test. Independent samples were submitted to the Student's t test to determine the quantitative variables, with a confidence interval of 95%. Calculation of excess weight was based on an estimated ideal weight that would correspond to a BMI of 24.99 kg/m2. RESULTS: A total of 414 patients completed the treatment achieving an average total body weight loss (%TBWL) of 15.4±7 with the NIB and 15.5±9.6 with the AIB. Overweight patients achieved higher excess weight loss (%EWL) values using AIBs (157.2±82.5) and obese patients did so with NIB use (56±29.7). Women achieved higher %EWL values (65.6±62.2) than men (48±27.1). Individuals who attended >4 consultations with a nutritionist (60.8%) achieved TBWL >18%. All of those P-values were <0.001. CONCLUSION: Obese individuals and women registered the greatest weight losses. Overweight patients achieved greater losses using AIB and obese patients did so using NIBs. NIB use was associated with higher EWL percentages. Nutritional accompaniment had a positive impact on the %TBWL.

RESUMO CONTEXTO: O uso do balão intragástrico (BIG) é indicado para pacientes cujo IMC contraindica a cirurgia bariátrica ou que necessitam perder peso antes da cirurgia. É um procedimento minimamente invasivo e atualmente existem dois modelos principais de BIG - o balão intragástrico não ajustável (BINA), implantado por seis meses, e o balão intragástrico ajustável (BIA), por até 12 meses. OBJETIVO: Analisar os fatores associados aos resultados clínicos comparando o uso de balão intragástrico não ajustável com o uso de balão intragástrico ajustável. MÉTODOS: Estudo transversal em 470 pacientes, com sobrepeso ou obesidade, submetidos ao tratamento entre outubro 2011 e julho de 2018. A associação entre as porcentagens da perda de excesso de peso (%PEP) e da perda do peso total (%PPT) com as variáveis demográficas e clínicas foram calculados com o teste qui-quadrado (P<0,05). Foi utilizado o teste t de Student para amostras independentes para comparar variáveis quantitativas, com IC 95%. O cálculo do excesso de peso foi estimado em peso ideal correspondente a um IMC de 24.99 kg/m2. RESULTADOS: Um total de 414 pacientes realizaram o tratamento até o final, com %PPT média de 15,4±7 no BINA e 15,5±9,6 no BIA. Os com sobrepeso apresentaram maiores %PEP no BIA (157,2±82,5) e os obesos maiores %PEP no BINA (56±29,7), com P<0,001. Mulheres (65,6±62,2) apresentaram maiores %PEP do que homens (48±27,1), com P<0,001. Os indivíduos que atenderam a >4 consultas com nutricionista obtiveram %PPT >18% (60,8%), com P<0,001. CONCLUSÃO: Obesos e mulheres tiveram maiores perdas ponderais. Maior perda de peso foi identificada em pacientes com sobrepeso que utilizaram BIA e em obesos os quais utilizaram BINA. O BINA esteve associado com maiores taxas de %PEP. O acompanhamento nutricional impactou positivamente na %PPT.

Significados en torno a la experiencia de someterse a una segunda intervención quirúrgica para bajar de peso / MEANING ABOUT THE EXPERIENCE OF SUBMITTING A SECOND SURGICAL INTERVENTION TO LOSE WEIGHT

Diversos motivos inciden en que los pacientes se sometan a cirugía bariátrica para hacer frente a la obesidad. Pese a ser el procedimiento más eficaz contra el exceso de peso, existe una alta tasa de pacientes que después de la cirugía, recuperan un porcentaje importante del peso perdido. Esta re-ganancia de peso genera consecuencias médicas, físicas y psicológico-emocionales; y en muchos casos lleva a que los pacientes vuelvan a someterse a intervenciones quirúrgicas con el objetivo de reactivar la pérdida de peso. No obstante, las re-operaciones no suelen tener la misma eficacia en términos de la pérdida de peso y su mantención. Esta investigación se centra en los significados psicológicos de la experiencia de someterse a más de una intervención quirúrgica para perder peso, con el objetivo de comprender lo que implica este proceso para los pacientes, así como también las repercusiones que trae consigo someterse a más de una intervención de este tipo. La metodología que se utilizó fue cualitativa con un enfoque desde la Teoría Fundamentada y con un alcance descriptivo para comprender lo que deben vivir estos pacientes. Para llevar a cabo esta investigación, se realizaron entrevistas semi-estructuradas a cuatro mujeres y un hombre, quienes previamente se habían sometido a una intervención quirúrgica para perder peso, y luego de unos años y de haber recuperado el peso perdido se sometieron a una cirugía bariátrica. La elección de la segunda intervención se asoció a la creencia que la recuperación de peso se debió principalmente a la técnica de la primera intervención, evaluación que cambia hacia una percepción de bajo control en la alimentación, tras la re-ganancia de peso post-segunda intervención. Se observa niveles importantes de frustración tras esta segunda re-ganancia.

There are several reasons why patients choose to undergo bariatric surgery to cope with obesity. Despite being the most effective procedure against excess weight, there is a high rate of patients who, after surgery, recover a significant percentage of the weight lost. This regain of weight generates medical, physical and psychological-emotional consequences; and in many cases it leads to patients re-undergo surgery with the aim of reactivating weight loss. However, re-operations are usually not as effective in terms of weight loss and weight maintenance. This research focuses on the psychological meanings of a patient's experience of more than one surgical intervention to lose weight, with the aim of understanding what this process implies for patients, as well as the repercussions of obtaining more than one intervention of this type. The specified methodology was qualitative with an approach from the Grounded Theory and with a descriptive scope to understand what these patients must live. To carry out this research, semi-structured interviews were conducted with four women and one man, who had previously undergone surgery to lose weight, and after a few years and having recovered the lost weight, underwent surgery. bariatric The choice of the second intervention was associated with the belief that weight recovery was mainly due to the technique of the first intervention, an evaluation that changes towards a perception of low control in the diet, after the post-weight gain second intervention. Significant levels of frustration are seen after this second regain

Esophageal intramural pseudodiverticulosis in a patient with food bolus impaction / Pseudodiverticulosis intramural esofágica en un paciente con impactación de bolo alimentario

Esophageal intramural pseudodiverticulosis is an uncommon esophageal benign disease. The typical finding during endoscopy is the presence of numerous pinhead-sized outpouchings along the esophageal wall. We reported a case of food bolus impaction secondary to esophageal intramural pseudodiverticulosis. A 67-year-old man presented with sudden-onset dysphagia. Multiple tiny orifices were revealed during upper endoscopy. In addition, there were an impacted food bolus and an esophageal web. The patient was treated with balloon dilatation and proton pump inhibitors. As a result the symptoms disappeared completely. Esophageal intramural pseudodiverticulosis is a rare cause of food bolus impaction and its treatment is directed towards the underlying associated conditions as well as the resolution of complications.

La pseudodiverticulosis intramural esofágica es una enfermedad benigna del esófago poco común. El hallazgo típico durante la endoscopia es la presencia de numerosos sáculos del tamaño de una cabeza de alfiler a lo largo de la pared esofágica. Reportamos un caso de impactación de bolo alimentario secundario a pseudodiverticulosis esofágica intramural. Un hombre de 67 años presentó disfagia de aparición repentina. Se encontraron múltiples orificios pequeños en la endoscopia superior. Además, hubo un bolo alimentario impactado y una red esofágica. El paciente fue tratado con dilatación con balón e inhibidores de la bomba de protones. Como resultado, los síntomas desaparecieron por completo. La pseudodiverticulosis intramural esofágica es una causa rara de impactación del bolo alimentario y su tratamiento se dirige a las condiciones asociadas subyacentes, así como a la resolución de complicaciones.

Torsade de pointes secondary to long QT syndrome after intragastric balloon placement. A rare but severe complication

The obesity pandemic is becoming one of the most prevalent diseases nowadays. There is a wide spectrum of treatment, ranging from hygienic-dietary measures to bariatric surgery. Endoscopic intragastric balloon placement is becoming increasingly more frequent, due to its technical simplicity, safety and short-term success(1). Although complications are rare some can be severe, so pre-endoscopic evaluation must be carried out carefully. A 43-year-old woman with a history of grade I obesity (BMI 32.7) had an Orbera® intragastric balloon implanted successfully. After the procedure she presented frequent nausea and vomiting, partially controlled with antiemetics. She attended the Emergency Department(ED) with a persistent emetic syndrome - oral intolerance and short-term loss of consciousness(syncope), for which she was admitted. Lab tests showed metabolic alkalosis with severe hypokalemia(K+ 1.8mmol/L), so fluid therapy was initiated for hydroelectrolytic replacement. During the patient’s stay in the ED, two episodes of polymorphic ventricular tachychardia “Torsades de Pointes” (PVT-TDP) occurred, leading to cardiac arrest and requiring electrical cardioversion to restore sinus rhythm, in addition to a temporary pacemaker placement. Telemetry showed a corrected QT interval of >500ms, compatible with Long QT Syndrome(LQTS). Once the patient was hemodynamically stabilized a gastroscopy was performed. The intragastric balloon located in the fundus was removed using an extraction kit, puncturing and aspirating 500ml of saline solution, and extracting the collapsed balloon without any complications. The patient achieved an adequate oral intake afterwards, and no recurrence of emetic episodes were noticed. Previous ECGs revealed a prolonged QT interval and a genetic study confirmed a congenital type 1 LQTS. Treatment was initiated with beta-blockers and a bicameral automatic defibrillator was implanted in order to prevent recurrences. ... (AU)

Nuevo balón intragástrico ingerible (Elipse(R)). ¿Café para todos? Posicionamiento de GETTEMO / A new swallowable intragastric balloon (Elipse(R)). Coffee for everybody? The position of GETTEMO

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Perforación gástrica por balón intragástrico en paciente con funduplicatura de Nissen / Gastric perforation by intragastric balloon in patient with Nissen fundoplication

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