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OBJECTIVE: The aim of this study was to perform an updated Markov analysis to determine the optimal management strategy for patients with an asymptomatic paraesophageal hernia (PEH): elective laparoscopic hernia repair (ELHR) versus watchful waiting (WW). BACKGROUND: Currently, it is recommended that patients with an asymptomatic PEH not undergo repair based on a 20-year-old Markov analysis. The current recommendation might lead to preventable hospitalizations for acute PEH-related complications and compromised survival. METHODS: A Markov model with updated variables was used to compare life-years (L-Ys) gained with ELHR versus WW in patients with a PEH. One-way sensitivity analyses evaluated the robustness of the analysis to alternative data inputs, while probabilistic sensitivity analysis quantified the level of confidence in the results in relation to the uncertainty across all model inputs. RESULTS: At age 40 to 90, ELHR led to greater life expectancy than WW, particularly in women. The gain in L-Ys (2.6) was greatest in a 40-year-old woman and diminished with increasing age. Sensitivity analysis showed that alternative values resulted in modest changes in the difference in L-Ys, but ELHR remained the preferred strategy. Probabilistic analysis showed that ELHR was the preferred strategy in 100% of 10,000 simulations for age 65, 98% for age 80, 90% for age 85, and 59% of simulations in 90-year-old women. CONCLUSIONS: This updated analysis showed that ELHR leads to an increase in L-Ys over WW in healthy patients aged 40 to 90 years with an asymptomatic PEH. In this new paradigm, all patients with a PEH, regardless of symptoms, should be referred for the consideration of elective repair to maximize their life expectancy.
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Hérnia Hiatal , Laparoscopia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Pessoa de Meia-Idade , Adulto Jovem , Hérnia Hiatal/cirurgia , Herniorrafia/métodos , Laparoscopia/métodos , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Conduta ExpectanteRESUMO
OBJECTIVE: To evaluate and characterize outcomes of MSA in patients with IEM. SUMMARY BACKGROUND DATA: MSA improves patients with gastroesophageal reflux and normal motility. However, many patients have IEM, which could impact the outcomes of MSA and discourage use. METHODS: An international, multi-institutional case control study of IEM patients undergoing MSA matched to normal patients was performed. Primary outcomes were new onset dysphagia and need for postoperative interventions. RESULTS: A total of 105 IEM patients underwent MSA with matching controls. At 1 year after MSA: GERD-Health Related Quality of Life was similar; DeMeester scores in IEM patients improved to 15.7 and 8.5 in controls ( P = 0.021); and normalization of the DeMeester score for IEM = 61.7% and controls = 73.1% ( P = 0.079).In IEM patients, 10/12 (83%) with preop dysphagia had resolution; 11/66 (17%) had new onset dysphagia and 55/66 (83%) never had dysphagia. Comparatively, in non-IEM patients, 22/24 (92%) had dysphagia resolve; 2/24 (8%) had persistent dysphagia; 7/69 (10%) had new onset dysphagia, and 62/69 (90%) never had dysphagia.Overall, 19 (18%) IEM patients were dilated after MSA, whereas 12 (11%) non-IEM patients underwent dilation ( P = 0.151). Nine (9%) patients in both groups had their device explanted. CONCLUSIONS: Patients with IEM undergoing MSA demonstrate improved quality of life and reduction in acid exposure. Key differences in IEM patients include lower rates of objective GERD resolution, lower resolution of existing dysphagia, higher rates of new onset dysphagia and need for dilation. GERD patients with IEM should be counselled about these possibilities.
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Transtornos de Deglutição , Refluxo Gastroesofágico , Laparoscopia , Humanos , Estudos de Casos e Controles , Transtornos de Deglutição/etiologia , Transtornos de Deglutição/cirurgia , Esfíncter Esofágico Inferior/cirurgia , Refluxo Gastroesofágico/cirurgia , Fenômenos Magnéticos , Qualidade de Vida , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND & AIMS: The straight leg raise (SLR) maneuver during high-resolution manometry (HRM) can assess esophagogastric junction (EGJ) barrier function by measuring changes in intraesophageal pressure (IEP) when intra-abdominal pressure is increased. We aimed to determine whether increased esophageal pressure during SLR predicts pathologic esophageal acid exposure time (AET). METHODS: Adult patients with persistent gastroesophageal reflux disease (GERD) symptoms undergoing HRM and pH-impedance or wireless pH study off proton pump inhibitor were prospectively studied between July 2021 and March 2022. After the HRM Chicago 4.0 protocol, patients were requested to elevate 1 leg at 45º for 5 seconds while supine. The SLR maneuver was considered effective when intra-abdominal pressure increased by 50%. IEPs were recorded 5 cm above the lower esophageal sphincter at baseline and during SLR. GERD was defined as AET greater than 6%. RESULTS: The SLR was effective in 295 patients (81%), 115 (39%) of whom had an AET greater than 6%. Hiatal hernia (EGJ type 2 or 3) was seen in 135 (46%) patients. Compared with patients with an AET less than 6%, peak IEP during SLR was significantly higher in the GERD group (29.7 vs 13.9 mm Hg; P < .001). Using receiver operating characteristic analysis, an increase of 11 mm Hg of peak IEP from baseline during SLR was the optimal cut-off value to predict an AET greater than 6% (area under the receiver operating characteristic curve, 0.84; sensitivity, 79%; and specificity, 85%), regardless of the presence of hiatal hernia. On multivariable analysis, an IEP pressure increase during the SLR maneuver, EGJ contractile integral, EGJ subtype 2, and EGJ subtype 3, were found to be significant predictors of AET greater than 6% CONCLUSIONS: The SLR maneuver can predict abnormal an AET, thereby increasing the diagnostic value of HRM when GERD is suspected. CLINICALTRIALS: gov ID: NCT04813029.
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Refluxo Gastroesofágico , Hérnia Hiatal , Adulto , Humanos , Perna (Membro)/patologia , Refluxo Gastroesofágico/patologia , Junção Esofagogástrica/patologia , Esfíncter Esofágico Inferior , Manometria/métodosRESUMO
AIMS: There is considerable controversy regarding optimal management of patients with paraesophageal hiatus hernia (pHH). This survey aims at identifying recommended strategies for work-up, surgical therapy, and postoperative follow-up using Delphi methodology. METHODS: We conducted a 2-round, 33-question, web-based Delphi survey on perioperative management (preoperative work-up, surgical procedure and follow-up) of non-revisional, elective pHH among European surgeons with expertise in upper-GI. Responses were graded on a 5-point Likert scale and analyzed using descriptive statistics. Items from the questionnaire were defined as "recommended" or "discouraged" if positive or negative concordance among participants was > 75%. Items with lower concordance levels were labelled "acceptable" (neither recommended nor discouraged). RESULTS: Seventy-two surgeons with a median (IQR) experience of 23 (14-30) years from 17 European countries participated (response rate 60%). The annual median (IQR) individual and institutional caseload was 25 (15-36) and 40 (28-60) pHH-surgeries, respectively. After Delphi round 2, "recommended" strategies were defined for preoperative work-up (endoscopy), indication for surgery (typical symptoms and/or chronic anemia), surgical dissection (hernia sac dissection and resection, preservation of the vagal nerves, crural fascia and pleura, resection of retrocardial lipoma) and reconstruction (posterior crurorrhaphy with single stitches, lower esophageal sphincter augmentation (Nissen or Toupet), and postoperative follow-up (contrast radiography). In addition, we identified "discouraged" strategies for preoperative work-up (endosonography), and surgical reconstruction (crurorrhaphy with running sutures, tension-free hiatus repair with mesh only). In contrast, many items from the questionnaire including most details of mesh augmentation (indication, material, shape, placement, and fixation technique) were "acceptable". CONCLUSIONS: This multinational European Delphi survey represents the first expert-led process to identify recommended strategies for the management of pHH. Our work may be useful in clinical practice to guide the diagnostic process, increase procedural consistency and standardization, and to foster collaborative research.
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Hérnia Hiatal , Laparoscopia , Humanos , Hérnia Hiatal/cirurgia , Técnica Delphi , Fundoplicatura/métodos , Herniorrafia/métodos , Telas Cirúrgicas , Resultado do TratamentoRESUMO
BACKGROUND: Diminished systemic serum butyrylcholinesterase (BChE), a biomarker for chronic inflammation, cachexia, and advanced tumor stage, has shown to play a prognostic role in various malignancies. The aim of this study was to investigate the prognostic value of pretherapeutic BChE levels in patients with resectable adenocarcinoma of the gastroesophageal junction (AEG), treated with or without neoadjuvant therapy. METHODS: Data of a consecutive series of patients with resectable AEG at the Department for General Surgery, Medical University of Vienna, were analyzed. Preoperative serum BChE levels were correlated to clinic-pathological parameters as well as treatment response. The prognostic impact of serum BChE levels on disease-free (DFS) and overall survival (OS) was evaluated by univariate and multivariate cox regression analysis, and Kaplan-Meier curves used for illustration. RESULTS: A total of 319 patients were included in this study, with an overall mean (standard deviation, SD) pretreatment serum BChE level of 6.22 (± 1.91) IU/L. In univariate models, diminished preoperative serum BChE levels were significantly associated with shorter overall (OS, p < 0.003) and disease-free survival (DFS, p < 0.001) in patients who received neoadjuvant treatment and/or primary resection. In multivariated analysis, decreased BChE was significantly associated with shorter DFS (HR: 0.92, 95% CI: 0.84-1.00, p 0.049) and OS (HR: 0.92, 95% CI: 0.85-1.00, p < 0.49) in patients receiving neoadjuvant therapy. Backward regression identified the interaction between preoperative BChE and neoadjuvant chemotherapy as a predictive factor for DFS and OS. CONCLUSION: Diminished serum BChE serves as a strong, independent, and cost-effective prognostic biomarker for worse outcome in patients with resectable AEG who had received neoadjuvant chemotherapy.
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Butirilcolinesterase , Terapia Neoadjuvante , Humanos , Prognóstico , Biomarcadores , Análise Multivariada , Estudos RetrospectivosRESUMO
OBJECTIVE: The aim of this study was to investigate the prognostic role of plasma platelet count (PLT), mean platelet volume (MPV), and the combined COP-MPV score in patients with resectable adenocarcinomas of the gastroesophageal junction. BACKGROUND: Platelet activation, quantified by PLT and elevated MPV, plays an essential part in the biological process of carcinogenesis and metastasis. An increased preoperative COP-MPV is associated with poor survival in various tumor entities. METHODS: Data of 265 patients undergoing surgical resection for adenocarcinoma of the gastroesophageal junction were abstracted. COP-MPV score was defined for each patient. Utilizing univariate and multivariate Cox proportional hazard analyses, survival was determined. RESULTS: In univariate analysis, elevated PLT (HR 3.58, 95% CI 2.61-4.80, p<0.001) and increased COP-MPV (HR 0.27, 95% CI 0.17-0.42, p<0.001 and HR 0.42, 95% CI 0.29-0.60, p<0.001) significantly correlated with shorter patients' overall and disease-free survival, for all 256 patients, as well as in the subgroups of neoadjuvantly treated (p<0.001) and primarily resected patients (p<0.001). COP-MPV remained a significant prognostic factor in multivariate analysis for OS. However, PLT alone showed significant diminished OS and DFS in all subgroups (p<0.001) in univariate and multivariate analysis. CONCLUSION: PLT is a potent independent prognostic biomarker for survival in a large prospective cohort of patients with resectable adenocarcinoma of the gastroesophageal junction. Additionally, we confirm that the COP-MPV score is significantly associated with worse outcome in these patients, but has no benefit in comparison to PLT.
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Adenocarcinoma , Plaquetas , Humanos , Prognóstico , Estudos Prospectivos , Adenocarcinoma/cirurgia , Junção Esofagogástrica/cirurgiaRESUMO
Up to 30% of patients with gastroesophageal reflux disease (GERD) suffer from laryngopharyngeal reflux (LPR) with symptoms, as chronic cough, laryngitis, or asthma. Besides life-style modifications and medical acid suppression, laparoscopic fundoplication is an established treatment option. Treatment-related side effects after laparoscopic fundoplication have to be weighted against LPR symptom control in 30-85% of patients after surgery. Magnetic sphincter augmentation (MSA) is described as an effective alternative to fundoplication for surgical treatment of GERD. However, evidence on the efficacy of MSA in patients with LPR is very limited. Preliminary data on the results of MSA treating LPR symptoms in patients with acid and weakly acid reflux are promising; showing comparable results to laparoscopic fundoplication by providing the potential of decrease side effects.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Esofagoplastia , Refluxo Laringofaríngeo , Humanos , Refluxo Laringofaríngeo/etiologia , Refluxo Laringofaríngeo/cirurgia , Tosse , Fenômenos MagnéticosRESUMO
BACKGROUND: Various technical modifications of Nissen fundoplication (NF) that aim to improve patients' outcomes have been discussed. This study aims to evaluate the effect of division of the short gastric vessels (SGV) and the addition of a standardized fundophrenicopexia on the postoperative outcome after NF. METHODS: 283 consecutive patients with GERD treated with NF were divided into four groups following consecutive time periods: with division of the SGV and without fundophrenicopexia (group A), with division of the SGV and with fundophrenicopexia (group B), without division of the SGV and with fundophrenicopexia (group C) and without division of the SGV and without fundophrenicopexia (group D). Postoperative contrast swallow, dysphagia scoring, GEDR-HRQL and proton pump inhibitor intake were evaluated. A comparative analysis of patients with division of the SGV and those without (161 A + B vs. 122 C + D), and patients with fundophrenicopexia and those without (78 A vs. 83 B and 49 C vs. 73 D) was performed. RESULTS: Fundophrenicopexia reduced postoperative dysphagia rates (0 group C vs. 5 group D, p = 0.021) in patients where the SGV were preserved and reoperation rates (1 group B vs. 7 group A, p = 0.017) in patients where the SGV were divided. There was no significant difference in the postoperative rates of heartburn relief, dysphagia, gas bloating syndrome, interventions, re-fundoplication and the GERD-HRQL score between groups A + B and C + D, respectively. CONCLUSION: Standardized additional fundophrenicopexia in patients undergoing Nissen fundoplication significantly reduces postoperative dysphagia in patients without division of the SGV and reoperation rates in patients with division of the SGV. Division of the SGV has no influence on the postoperative outcome of NF.
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Transtornos de Deglutição , Refluxo Gastroesofágico , Laparoscopia , Transtornos de Deglutição/etiologia , Transtornos de Deglutição/prevenção & controle , Transtornos de Deglutição/cirurgia , Seguimentos , Fundoplicatura/efeitos adversos , Refluxo Gastroesofágico/etiologia , Refluxo Gastroesofágico/cirurgia , Humanos , Reoperação , Resultado do TratamentoRESUMO
BACKGROUND: Dysphagia remains the most significant concern after anti-reflux surgery, including magnetic sphincter augmentation (MSA). The aim of this study was to evaluate postoperative dysphagia rates, its risk factors, and management after MSA. METHODS: From a prospectively collected database of all 357 patients that underwent MSA at our institution, a total of 268 patients were included in our retrospective study. Postoperative dysphagia score, gastrointestinal symptoms, proton pump inhibitor intake, GERD-HRQL, Alimentary Satisfaction, and serial contrast swallow imaging were evaluated within standardized follow-up appointments. To determine patients' characteristics and surgical factors associated with postoperative dysphagia, a multivariable logistic regression analysis was performed. RESULTS: At a median follow-up of 23 months, none of the patients presented with severe dysphagia, defined as the inability to swallow solids or/and liquids. 1% of the patients underwent endoscopic dilatation, and 1% had been treated conservatively for dysphagia. 2% of the patients needed re-operation, most commonly due to recurrent hiatal hernia. Two patients underwent device removal due to unspecific discomfort and pain. No migration of the device or erosion by the device was seen. The LINX® device size ≤ 13 was found to be the only factor associated with postoperative dysphagia (OR 5.90 (95% CI 1.4-24.8)). The postoperative total GERD-HRQL score was significantly lower than preoperative total score (2 vs. 19; p = 0.001), and daily heartburn, regurgitations, and respiratory complains improved in 228/241 (95%), 131/138 (95%) and 92/97 (95%) of patients, respectively. CONCLUSIONS: Dysphagia requiring endoscopic or surgical intervention was rare after MSA in a large case series. LINX® devices with a size < 13 were shown to be an independent risk factor for developing postoperative dysphagia.
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Transtornos de Deglutição , Refluxo Gastroesofágico , Laparoscopia , Transtornos de Deglutição/etiologia , Transtornos de Deglutição/cirurgia , Esfíncter Esofágico Inferior/cirurgia , Fundoplicatura/métodos , Refluxo Gastroesofágico/complicações , Refluxo Gastroesofágico/cirurgia , Humanos , Laparoscopia/métodos , Fenômenos Magnéticos , Qualidade de Vida , Estudos Retrospectivos , Resultado do TratamentoRESUMO
The symptoms of gastroesophageal reflux disease (GERD) are very common, but cannot be reliably controlled with medication, as more than 40% of patients suffer troublesome symptoms more than twice a week even when taking maximum doses of proton pump inhibitors (PPI). Until recently, the only surgical option was anti-reflux surgery, usually performed as a hiatal hernia repair and some form of fundoplication. While this is still the gold standard, some centers note high recurrence rates and/or high rates of side effects such as dysphagia, bloating, and post-prandial discomfort. This paper describes a new surgical procedure that controls reflux symptoms through hiatal hernia repair in combination with the implantation of a silicone cube. The cube is implanted near the left side of the esophagus above the lower esophageal sphincter (LES). The details of the procedure, the indications for this new approach, the initial results, and the rate of side effects compared to Nissen fundoplication are described. Implantation of the CE-certified RefluxStop™ (Implantica, Zug, Switzerland) has been used for 3 years and the initial studies show encouraging success rates. In addition, side effects are significantly reduced. These results must be evaluated in further studies.
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OBJECTIVE: The aim of this study was to determine the clinical role of the systemic immune-inflammation index in patients with resectable adenocarcinoma of the gastroesophageal junction treated with or without neoadjuvant therapy. BACKGROUND: Adenocarcinoma of the gastroesophageal junction is an aggressive disease, with less than 20% of overall patients surviving more than 5 years after diagnosis, while currently available clinical staging for esophageal cancer is lacking necessary accuracy. The systemic immune-inflammation index (SII) based on peripheral neutrophil, lymphocyte, and platelet counts has shown a prognostic impact in various malignancies. METHODS: Data of consecutive patients undergoing esophagectomy (n = 320, 1992 to 2016) were abstracted. The cut point for high and low SII before neoadjuvant treatment and before surgery was calculated for illustration of the Kaplan-Meier curves. SII was used for the correlation with patients' clinicopathological characteristics as a continuous variable. Survival was analyzed with Cox proportional hazards models using clinical or pathological staging, adjusting for other known survival predictors. RESULTS: In both neoadjuvantly treated and primarily resected patients, high SII was significantly associated with diminished overall [hazard ratio (HR) 1.3, 95% confidence interval (95% CI) 1.2-1.4; HR 1.2, 95% CI 1.2-1.3, respectively] and disease-free survival (HR 1.3, 95% CI 1.2-1.3; HR 1.2, 95% CI 1.2-1.3, respectively). In multivariable survival analysis, SII remained an independent prognostic factor for overall survival (HR 1.3, 95% CI 1.2-1.4; HR 1.2, 95% CI 1.2-1.3, respectively) and disease-free survival (HR 1.3, 95% CI 1.2-1.3; HR 1.2, 95% CI 1.2-1.3, respectively) in primarily resected and neoadjuvantly treated patients. CONCLUSION: Elevated SII is an independent adverse prognostic factor in patients with resectable gastroesophageal adenocarcinomas with and without neoadjuvant treatment.
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Adenocarcinoma/imunologia , Neoplasias Esofágicas/imunologia , Inflamação/imunologia , Neoplasias Gástricas/imunologia , Adenocarcinoma/mortalidade , Adenocarcinoma/cirurgia , Adulto , Idoso , Áustria , Neoplasias Esofágicas/mortalidade , Neoplasias Esofágicas/cirurgia , Esofagectomia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Terapia Neoadjuvante , Prognóstico , Estudos Prospectivos , Neoplasias Gástricas/mortalidade , Neoplasias Gástricas/cirurgia , Taxa de SobrevidaRESUMO
PURPOSE OF REVIEW: Magnetic sphincter augmentation (MSA) has been designed as a less disruptive and more standardized laparoscopic surgical procedure than fundoplication for patients with early stage gastroesophageal reflux disease (GERD). We analyzed the more recent literature in search of updates regarding indications, technique, perioperative management, and long-term outcomes. RECENT FINDINGS: Over the years, the procedure of MSA has evolved to including full hiatus repair rather than relying on the preservation of the phreno-esophageal ligament. Restoring the mechanical synergy between the lower esophageal sphincter and the crural diaphragm has the potential to further enhance the antireflux barrier. The adoption of this approach has led to expand the indications from early stage disease to different scenarios including patients with high esophageal acid exposure, atypical symptoms, large hiatal hernias, Barrett's esophagus, postbariatric surgery, and previously failed fundoplication. SUMMARY: MSA has a favorable side-effect profile and is highly effective in reducing typical reflux symptoms, medication dependency, and esophageal acid exposure. Excellent outcomes have been confirmed over a 12-year follow-up, indicating that the operation has the potential to prevent GERD progression. Further studies are needed to confirm the cost-effectiveness of this procedure in patients with more advanced disease-stage and prior gastric surgery. A randomized control trial comparing MSA with fundoplication could raise the level of evidence and the strength of recommendation.
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Refluxo Gastroesofágico , Laparoscopia , Esfíncter Esofágico Inferior/cirurgia , Fundoplicatura , Refluxo Gastroesofágico/cirurgia , Humanos , Fenômenos Magnéticos , Resultado do TratamentoRESUMO
OBJECTIVES: To evaluate image quality by first use of LumiVision® in dynamic MR swallowing, a contrast medium consisting of biological substances versus a gadolinium-buttermilk mixture in patients who underwent Nissen fundoplication due to gastroesophageal reflux disease (GERD). METHODS: The protocol of this retrospective study was approved by the local Institutional Review Board. A hundred twenty-nine patients (146 examinations) underwent a dynamic MR swallowing study (at 1.5 T or 3.0 T) and received an oral contrast agent. Two readers evaluated the distention of the esophagus, contrast, and traceability of the bolus in a 3-point scale. A steady-state coherent sequence (B-FFE, TrueFISP) was used. The patients were divided into 3 different groups: 53 patients received gadolinium chelate (Dotarem®)-buttermilk mixture (GBM) in a dilution of 1:40 as an oral contrast agent; 44 patients received LumiVision® water mixture (LWM) in a dilution of 1:1 and 49 patients received LumiVision® (L) undiluted. RESULTS: GBM showed significantly better results in overall evaluation for both readers in contrast to LWM (p = .003, p = .002). L also reached significantly better results in overall evaluation than LWM in both readers (p = .004, p = .042). There was no significant difference in the overall evaluation between L and GBM (p = .914, p = .376).According to Landis and Koch, interobserver agreement was "substantial" (Cohen's kappa = 0.738) between both readers. CONCLUSION: LumiVision® undiluted showed equal image quality compared to gadolinium-buttermilk mixture. The constellation of LumiVision® water mixture led to a clearly negative result in relation to the image quality compared to LumiVision® undiluted. Therefore, oral ingestion of LumiVision® undiluted is recommended for MR swallowing examinations. KEY POINTS: ⢠LumiVision® undiluted shows significantly better image quality in comparison to LumiVision® diluted in oral application in swallowing MRI. ⢠LumiVision® undiluted shows equal image quality in comparison to gadolinium-buttermilk mixture in oral application. ⢠Oral ingestion of LumiVision® undiluted can replace gadolinium-buttermilk mixture in oral MR examinations.
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Meios de Contraste , Deglutição , Gadolínio DTPA , Humanos , Imageamento por Ressonância Magnética , Estudos RetrospectivosRESUMO
BACKGROUND: Magnetic sphincter augmentation (MSA) is a surgical intervention for gastroesophageal reflux disease (GERD) which has been evaluated in numerous studies and has shown beneficial effects. Long-term effectiveness data for MSA as well as laparoscopic fundoplication (LF) in patients with GERD are needed. OBJECTIVE: The objective of this study was to evaluate the 3-year outcomes for MSA and LF in patients with GERD. METHODS: This prospective, multi-center, observational registry study evaluated MSA and LF in clinical practice over 3 years (ClinicalTrials.gov identifier: NCT01624506). Data collection included baseline characteristics, reflux symptoms, medication use, satisfaction and complications. Post-surgical evaluations were collected at yearly intervals. RESULTS: Between December 2009 and December 2014, 631 patients (465 MSA and 166 LF) were enrolled in the registry. Both MSA and LF resulted in improvements in total GERD-HRQL score (mean reduction in GERD-HRQL from baseline to 3 years post-surgery: MSA 22.0 to 4.6 and LF 23.6 to 4.9) and in satisfaction (GERD-HRQL satisfaction increase from baseline to 3 years: MSA 4.6% to 78.2% and LF 3.7% to 76.5%). Most patients were able to belch as needed with both therapies (MSA 97.6% and LF 91.7% at 3 years). MSA allowed a higher percentage of patients the ability to vomit as needed (MSA 91.2% and LF 68.0% at 3 years). PPI usage declined from baseline to 3 years for both groups after surgery (MSA 97.8% to 24.2% and LF 95.8% to 19.5%). The mean procedure time was shorter for MSA than for LF. Intraoperative and procedure-related complication rates (≤ 2%) were low for both therapies. CONCLUSIONS: This 3-year prospective observational registry study contributes to the mounting evidence for the effectiveness of MSA and LF. Despite the more severe nature of GERD in the LF group, the clinical outcomes for MSA and LF were favorable from an effectiveness and safety standpoint.
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Fundoplicatura , Laparoscopia , Esfíncter Esofágico Inferior/cirurgia , Humanos , Fenômenos Magnéticos , Estudos Prospectivos , Qualidade de Vida , Resultado do TratamentoRESUMO
BACKGROUND: Electrical stimulation therapy (EST) of the lower esophageal sphincter (LES) is a novel technique in antireflux surgery. Due to the minimal alteration at the LES during surgery, LES-EST is meant to be ideal for patients with gastroesophageal reflux disease (GERD) and ineffective esophageal motility (IEM). The aim of this prospective trial (NCT03476265) is to evaluate health-related quality of life and esophageal acid exposure after LES-EST in patients with GERD and IEM. METHODS: This is a prospective non-randomized open-label study. Patients with GERD and IEM undergoing LES-EST were included. Follow-up (FUP) at 12 months after surgery included health-related quality of life (HRQL) assessment with standardized questionnaires (GERD-HRQL) and esophageal functional testing. RESULTS: According to the study protocol, 17 patients fulfilled eligibility criteria. HRQL score for heartburn and regurgitation improved from 21 (interquartile range (IQR) 15-27) to 7.5 (1.25-19), p = 0.001 and from 17 (11-23.5) to 4 (0-12), p = 0.003, respectively. There was neither significant improvement of esophageal acid exposure nor reduction of number of reflux events in pH impedance measurement. Distal contractile integral improved from 64 (11.5-301) to 115 (IQR 10-363) mmHg s cm, p = 0.249. None of the patients showed any sign of dysphagia after LES-EST. One patient needed re-do surgery and re-implantation of the LES-EST due to breaking of the lead after one year. CONCLUSION: Although patient satisfaction improved significantly after surgery, this study fails to demonstrate normalization or significant improvement of acid exposure in the distal esophagus after LES-EST.
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Terapia por Estimulação Elétrica , Refluxo Gastroesofágico , Esfíncter Esofágico Inferior/cirurgia , Refluxo Gastroesofágico/etiologia , Refluxo Gastroesofágico/terapia , Humanos , Estudos Prospectivos , Qualidade de VidaRESUMO
Surgery for benign esophageal diseases may be complex, requiring specialist training, but currently, unlike oncologic surgery, it is not centralized. The aim of the study was to explore the opinion of European surgeons on the centralization of surgery for benign esophageal diseases. A web-based questionnaire, developed through a modified Delphi process, was administered to general and thoracic surgeons of 33 European surgical societies. There were 791 complete responses (98.5%), in 59.2% of respondents, the age ranged between 41 and 60 years, 60.3% of respondents worked in tertiary centers. In 2017, the number of major surgical procedures performed for any esophageal disease by respondents was <10 for 56.5% and >100 for 4.5%; in responder's hospitals procedures number was <10 in 27% and >100 in 15%. Centralization of surgery for benign esophageal diseases was advocated by 83.4%, in centers located according to geographic/population criteria (69.3%), in tertiary hospitals (74.5%), with availability of advanced diagnostic and interventional technologies (88.4%), in at least 10 beds units (70.5%). For national and international centers accreditation/certification, criteria approved included in-hospital mortality and morbidity (95%), quality of life oriented follow-up after surgery (88.9%), quality audits (82.6%), academic research (58.2%), and collaboration with national and international centers (76.6%); indications on surgical procedures volumes were variable. The present study strongly supports the centralization of surgery for benign esophageal diseases, in large part modeled on the principles that have underpinned the centralization of cancer surgery internationally, with emphasis on structure, process, volumes, quality audit, and clinical research.
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Doenças do Esôfago , Neoplasias Esofágicas , Adulto , Consenso , Doenças do Esôfago/cirurgia , Neoplasias Esofágicas/cirurgia , Humanos , Pessoa de Meia-Idade , Qualidade de VidaRESUMO
Patient satisfaction when treated with acid-suppressing medication for chronic GERD disease is less than 70%. Surgical standardisation, centralisation, improved awareness of patient selection and new surgical methods have stimulated interest in surgical reflux therapy in recent years. Magnetic sphincter augmentation (MSA) seems to be a safe alternative to laparoscopic fundoplication, with reported complication rates of 0.1% and reoperation rates of 3.4% and is also effective (GERD-HRQL improvement from 19.9 to 4.1, p = 0.001 as well PPI cessation and pH normalisation in 79 and 89% of patients, respectively). Electric sphincter augmentation shows promising short-term results in small patient cohorts (92% symptomatic improvement). However, randomised controlled studies comparing these new techniques to the "gold standard" of laparoscopic fundoplication are still missing.
Assuntos
Refluxo Gastroesofágico , Laparoscopia , Esfíncter Esofágico Inferior/cirurgia , Fundoplicatura , Refluxo Gastroesofágico/cirurgia , Humanos , Qualidade de Vida , Resultado do TratamentoRESUMO
BACKGROUND: The hernia recurrence rate after surgical treatment of large hiatal hernias is still very high. The optimal technique to reduce the recurrence rate is still under debate. The aim of this work is to clarify whether pledgeted reinforced sutures or a resorbable mesh can reduce the recurrence rate compared to hiatus closure with only sutures. MATERIALS AND METHODS: An Austria-wide, multi-centre, prospective, randomised study was planned. The study protocol was prepared by the main test centre (University Clinic for General, Visceral and Thoracic Surgery, Paracelsus Medical University Salzburg). The study includes patients who are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia. A large hiatal hernia is defined as > 5 cm in manometry or gastroscopy or at least â of the stomach lying intrathoracically. The primary study endpoint is defined as the hernia recurrence rate, objectively assessed by gastroscopy. After inclusion in the study, patients will be followed up for 6 months, 1 year, 3 years and 5 years after the operation, using standardised questionnaires and gastroscopy. The power calculation showed a requirement of 55 patients per group. Preoperative randomisation and data management are software-based. RESULTS: The study approval by the leading ethics committee is currently pending and the study itself has been registered on ClinicalTrials.gov since October 2020. The Clinical Trials Registration Number is NCT04591860. Five clinics are participating in the study at the moment and all centres are actively enrolling patients. The duration of the study is set until January 2027. CONCLUSION: This study is the world's first prospective randomised study that examines the value of pledgets and resorbable mesh to reduce the recurrence rate after treatment of large hiatal hernias. The results will help to find the optimal technique to close the hiatus of large hiatal hernias.
Assuntos
Hérnia Hiatal , Laparoscopia , Áustria , Hérnia Hiatal/cirurgia , Herniorrafia , Humanos , Estudos Prospectivos , Recidiva , Telas Cirúrgicas , Suturas , Resultado do TratamentoRESUMO
PURPOSE: Neoadjuvant radiochemotherapy (RCTH) is proven to be highly effective in the treatment of esophageal cancer (EC). We investigated oncological outcome and morbidity in patients treated with a modified CROSS protocol followed by esophagectomy at our institution. METHODS: Patients with EC receiving neoadjuvant RCTH with paclitaxel and carboplatin and concurrent radiotherapy (46â¯Gy) followed by esophagectomy were included in this retrospective analysis. Histopathological response, overall survival (OS) and recurrence-free interval (RFI) as well as perioperative morbidity were investigated. RESULTS: Thirty-six patients (86.1% male, mean age 61.3 years, standard deviation 11.52) received neoadjuvant RCTH before surgery. Sixteen patients (44.4%) were treated for squamous cell cancer, whereas 20 patients (55.6%) had adenocarcinoma. The majority (75%) underwent abdominothoracic esophageal resection. Major complications occurred in 7 patients (19.5%) including anastomotic leakage in 4 patients (11.1%). A R0 resection was achieved in 97.2%. A complete pathological remission was seen in 13 patients (36.1%). Major response, classified as Mandard tumor regression grade 1 and 2, was found in 26 patients (72.2%). Median OS and RFI were not reached. CONCLUSIONS: Neoadjuvant radiotherapy with 46â¯Gy and concomitant chemotherapy with paclitaxel and carboplatin for the treatment of locally advanced esophageal carcinoma is safe and effective. The results of this modified radiotherapy protocol are encouraging and should be considered in future patient treatment and study designs.
Assuntos
Adenocarcinoma/terapia , Carcinoma de Células Escamosas/terapia , Quimiorradioterapia , Neoplasias Esofágicas/terapia , Adenocarcinoma/cirurgia , Idoso , Antineoplásicos/uso terapêutico , Carboplatina/uso terapêutico , Carcinoma de Células Escamosas/cirurgia , Quimiorradioterapia/métodos , Neoplasias Esofágicas/cirurgia , Esofagectomia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Terapia Neoadjuvante/métodos , Paclitaxel/uso terapêutico , Cuidados Pré-Operatórios/métodos , Estudos Retrospectivos , Análise de Sobrevida , Resultado do TratamentoRESUMO
BACKGROUND: Patients with preoperative ineffective esophageal motility (IEM) are thought to be at increased risk for postoperative dysphagia leading to the recommendations for tailoring or avoiding anti-reflux surgery in these patients. The aim of this study was to evaluate if IEM has an influence on postoperative outcome after laparoscopic Nissen fundoplication (LNF). METHODS: Seventy-two consecutive patients with IEM underwent LNF and were case-matched with 72 patients without IEM based on sex, age, BMI, HH size, total pH percentage time, total number of reflux episodes and the presence of BE. Standardized interview assessing postoperative gastrointestinal symptoms, proton pump inhibitor intake, GERD-health-related-quality-of-life (GERD-HRQL), alimentary satisfaction and patients' overall satisfaction was evaluated. RESULTS: Although a higher rate of preoperative dysphagia was observed in patients with IEM (29% IEM vs. 11% no IEM, p = 0.007), there was no significant difference in rates of dysphagia postoperatively (2 IEM vs. 1 no IEM, p = 0.559). Furthermore, no distinction was found in the postoperative outcome regarding symptom relief, quality of life, gas bloating syndrome, ability to belch and/or vomit or revision surgery between the two groups. CONCLUSION: Although preoperative IEM has an influence on GERD presentation, it has no effect on postoperative outcome after LNF. IEM should not be a cause for avoiding LNF, as is has been shown as the most effective and safe anti-reflux treatment.