RESUMEN
BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.
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Gastroplastia , Obesidad Mórbida , Humanos , Adulto , Persona de Mediana Edad , Gastroplastia/métodos , Sobrepeso/cirugía , Sobrepeso/etiología , Resultado del Tratamiento , Obesidad/cirugía , Endoscopía/métodos , Pérdida de Peso , Obesidad Mórbida/cirugíaRESUMEN
BACKGROUND AND AIMS: Opioid-induced esophageal dysfunction (OIED) often presents as spastic esophageal disorders (SEDs) and esophagogastric junction outflow obstruction (EGJOO). The aim of this study was to evaluate and compare clinical outcomes of peroral endoscopic myotomy (POEM) for SEDs and EGJOO among opioid users and nonusers. METHODS: This propensity score (PS) matching study included consecutive opioid users and nonusers who underwent POEM for SEDs and EGJOO between January 2018 and September 2022. The following covariates were used for the PS calculation: age, sex, duration of symptoms, Eckardt score, type of motility disorder, and length of myotomy during POEM. Clinical response was defined as a post-POEM Eckardt score ≤3. RESULTS: A total of 277 consecutive patients underwent POEM during the study period. PS matching resulted in the selection of 64 pairs of patients strictly matched 1:1 (n = 128) with no statistically significant differences in demographic, baseline, or procedural characteristics or in the parameters considered for the PS between the 2 groups. Clinical response to POEM was significantly lower among opioid users (51 of 64 [79.7%]) versus nonusers (60 of 64 [93.8%]) (P = .03) at a median follow-up of 18 months. Among opioid users, higher opioid dose (>60 morphine milligram equivalents per day) was associated with a higher likelihood of failure to respond to POEM (odds ratio, 4.59; 95% confidence interval, 1.31-3.98; P = .02). CONCLUSIONS: Clinical response to POEM for SEDs and EGJOO is significantly lower among opioid users versus nonusers. There was a dose-relationship between opioids and response to POEM, with higher daily opioid usage associated with a higher likelihood of treatment failure.
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Trastornos de la Motilidad Esofágica , Miotomía , Puntaje de Propensión , Humanos , Femenino , Masculino , Persona de Mediana Edad , Adulto , Trastornos de la Motilidad Esofágica/cirugía , Miotomía/métodos , Miotomía/efectos adversos , Analgésicos Opioides/uso terapéutico , Cirugía Endoscópica por Orificios Naturales/métodos , Cirugía Endoscópica por Orificios Naturales/efectos adversos , Anciano , Estudios Retrospectivos , Resultado del Tratamiento , Trastornos Relacionados con Opioides/epidemiología , Esofagoscopía/métodosRESUMEN
BACKGROUND: Endoluminal functional impedance planimetry and panometry assesses secondary peristalsis in response to volumetric distention under sedation. We hypothesize that impedance planimetry and panometry can replace high-resolution manometry in the preoperative assessment prior to anti-reflux surgery. METHODS: Single institution prospective data were collected from patients undergoing anti-reflux surgery between 2021 and 2023. A 16-cm functional luminal imaging probe (FLIP) assessed planimetry and panometry prior to surgery under general anesthesia at the start of each case. Panometry was recorded and esophageal contractile response was classified as normal (NCR), diminished or disordered (DDCR), or absent (ACR) in real time by a single panometry rater, blinded to preoperative HRM results. FLIP results were then compared to preoperative HRM. RESULTS: Data were collected from 120 patients, 70.8% female, with mean age of 63 ± 3 years. There were 105 patients with intraoperative panometry, and 15 with panometry collected during preoperative endoscopy. There were 60 patients (50%) who had peristaltic dysfunction on HRM, of whom 57 had FLIP dysmotility (55 DDCR, 2 ACR) resulting in 95.0% sensitivity. There were 3 patients with normal secondary peristalsis on FLIP with abnormal HRM, all ineffective esophageal motility (IEM). No major motility disorder was missed by FLIP. A negative predictive value of 91.9% was calculated from 34/37 patients with normal FLIP panometry and normal HRM. Patients with normal HRM but abnormal FLIP had larger hernias compared to patients with concordant studies (7.5 ± 2.8 cm vs. 5.4 ± 3.2 cm, p = 0.043) and higher preoperative dysphagia scores (1.5 ± 0.7 vs. 1.1 ± 0.3, p = 0.021). CONCLUSION: Impedance planimetry and panometry can assess motility under general anesthesia or sedation and is highly sensitive to peristaltic dysfunction. Panometry is a novel tool that has potential to streamline and improve patient care and therefore should be considered as an alternative to HRM, especially in patients in which HRM would be inaccessible or poorly tolerated.
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Trastornos de la Motilidad Esofágica , Esófago , Humanos , Femenino , Persona de Mediana Edad , Anciano , Masculino , Impedancia Eléctrica , Estudios Prospectivos , Endoscopía Gastrointestinal , Manometría/métodosRESUMEN
INTRODUCTION: Zenker's diverticulum (ZD) is a false pulsion diverticulum of the cervical esophagus. It is typically found in older adults and manifests with dysphagia. The purpose of this study is to describe our experience with Per-oral endoscopic myotomy for Zenker's (Z-POEM) and intraoperative impedance planimetry (FLIP). METHODS: We performed a single institution retrospective review of patients undergoing Z-POEM in a prospective database between 2014 and 2022. Upper esophageal sphincter (UES) distensibility index (DI, mm2/mmHg) was measured by FLIP before and after myotomy. The primary outcome was clinical success. Secondary outcomes included technical failure, adverse events, and quality of life as assessed by the gastroesophageal health-related quality of life (GERD-HRQL), reflux severity index (RSI), and dysphagia score. A statistical analysis of DI was done with the paired t-test (p < 0.05). RESULTS: Fifty-four patients underwent Z-POEM, with FLIP measurements available in 30 cases. We achieved technical success and clinical success in 54/54 (100%) patients and 46/54 patients (85%), respectively. Three patients (6%) experienced contained leaks. Three patients were readmitted: one for aforementioned contained leak, one for dysphagia, and one post-operative pneumonia. Three patients with residual dysphagia underwent additional endoscopic procedures, all of whom had diverticula > 4 cm. Following myotomy, mean DI increased by 2.0 ± 1.7 mm2/mmHg (p < 0.001). In those with good clinical success, change in DI averaged + 1.6 ± 1.1 mm2/mmHg. Significant improvement was found in RSI and GERD-HRQL scores, but not dysphagia score. CONCLUSION: Z-POEM is a safe and feasible for treatment of ZD. We saw zero cases of intraoperative abandonment. We propose that large diverticula (> 4 cm) are a risk factor for poor outcomes and may require additional endoscopic procedures. An improvement in DI is expected after myotomy, however, the ideal range is still not known.
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Trastornos de Deglución , Reflujo Gastroesofágico , Miotomía , Cirugía Endoscópica por Orificios Naturales , Divertículo de Zenker , Humanos , Anciano , Divertículo de Zenker/complicaciones , Divertículo de Zenker/cirugía , Trastornos de Deglución/etiología , Impedancia Eléctrica , Calidad de Vida , Esofagoscopía/métodos , Reflujo Gastroesofágico/etiología , Miotomía/métodos , Resultado del Tratamiento , Cirugía Endoscópica por Orificios Naturales/métodosRESUMEN
BACKGROUND: Per-oral plication of the (neo)esophagus (POPE) is an endoscopic procedure used to improve emptying of the defunctionalized esophagus or gastric conduit, with the hope of improving symptoms and quality of life. As this procedure has only been performed in the United States for the past 4 years, safety and efficacy have not been well established. METHODS: This is a retrospective case series for patients who underwent POPE from a single institution between 2019 and 2023. Data collected included demographics, preoperative diagnoses and treatments, imaging, endoscopic data, operative intervention, 90-day complications, and response to treatment. Quality of life and patient satisfaction data were collected by phone survey. RESULTS: Seventeen cases were identified, encompassing 13 primary procedures and 4 repeat POPEs (re-POPE). Eight patients had end-stage achalasia and 5 had impaired gastric emptying after esophagectomy with gastric conduits. Median age was 65 years and median ASA was 3, with 38.5% female patients. POPE was performed with 2-6 plication sutures in an average of 75 min. The majority of patients discharged home the same day. For the 17 procedures, there were 4 complications. Two patients required antibiotics for pneumonia, while 4 required procedural intervention. There were no deaths. Preoperative symptoms improved or resolved at initial follow up in 82.3% of patients. Four patients experienced symptom recurrence and required re-POPE, 1 with achalasia and 3 with gastric conduits. Although all achalasia patients had an "end-stage esophagus," none have required esophagectomy since the introduction of POPE. CONCLUSIONS: POPE is an endoscopic procedure that is efficacious in relieving emptying difficulties for the end-stage esophagus and gastric conduit. It may obviate the need for esophagectomy or conduit replacement. Also, it can be repeated in select patients. While the risk profile of complications is favorable compared to alternative operations, patients with gastric conduits are at higher risk.
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Acalasia del Esófago , Esofagectomía , Complicaciones Posoperatorias , Humanos , Acalasia del Esófago/cirugía , Acalasia del Esófago/fisiopatología , Femenino , Masculino , Estudios Retrospectivos , Anciano , Persona de Mediana Edad , Esofagectomía/métodos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Resultado del Tratamiento , Calidad de Vida , Satisfacción del Paciente/estadística & datos numéricos , Esófago/cirugía , Esófago/fisiopatología , AdultoRESUMEN
INTRODUCTION: Numerous studies comment on quality of life outcomes comparing complete and partial fundoplication with or without a bougie. Society guidelines are moving toward recommending partial fundoplication over complete fundoplication due to improved side effect profile with similar outcomes. Retrospective studies and randomized trials have elucidated that use of a bougie during Nissen fundoplication does impact long-term dysphagia. To date there are no retrospective or prospective data that guide practice for partial fundoplications. OBJECTIVE: The purpose of this project is to investigate the clinical implications of using a bougie for Toupet fundoplication with regard to short-term and long-term dysphagia and need for further therapeutic interventions. METHODS: A retrospective review of a prospectively maintained gastroesophageal database was performed. Demographic, pre-operative quality of life outcomes data, perioperative, and post-operative quality of life outcomes data of 373 patients from 2011 to 2022 undergoing Toupet fundoplication without bougie or with a traditional Savary 56Fr or 58Fr bougie were reviewed. The two groups were compared using student's t-test to identify statically significant differences between the groups. RESULTS: Between 2011 and 2022, 373 patients underwent Toupet fundoplication (276 with traditional bougie, 97 without). Median follow-up in the bougie group was 19 months, versus 9 months in the non bougie group. There was no difference between early (3 weeks) and late dysphagia scores (6 months). In the bougie group there were two mucosal perforations due to the bougie. There were no statistically significant differences in GERD-HRQL, gas bloat, and dysphagia scores between groups at one year. CONCLUSION: There is no difference observed in early or late dysphagia scores, GERD-HRQL, gas bloat or need for dilation in patients undergoing Toupet fundoplication with or without a traditional bougie. It is reasonable to discontinue the use of a traditional bougie during Toupet fundoplication, especially due to risk of esophageal perforation.
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Trastornos de Deglución , Fundoplicación , Reflujo Gastroesofágico , Complicaciones Posoperatorias , Calidad de Vida , Humanos , Fundoplicación/métodos , Fundoplicación/efectos adversos , Trastornos de Deglución/etiología , Masculino , Estudios Retrospectivos , Femenino , Persona de Mediana Edad , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Reflujo Gastroesofágico/cirugía , Anciano , AdultoRESUMEN
BACKGROUND: Laparoscopic cholecystectomy with common bile duct exploration (LCBDE) is equivalent in safety and efficacy to endoscopic retrograde cholangiopancreatography (ERCP) plus laparoscopic cholecystectomy (LC) while decreasing number of procedures and length of stay (LOS). Despite these advantages LCBDE is infrequently utilized. We hypothesized that formal, simulation-based training in LCBDE would result in increased utilization and improve patient outcomes across participating institutions. METHODS: Data was obtained from an on-going multi-center study in which simulator-based transcystic LCBDE training curricula were instituted for attending surgeons and residents. A 2-year retrospective review of LCBDE utilization prior to LCBDE training was compared to utilization up to 2 years after initiation of training. Patient outcomes were analyzed between LCBDE strategy and ERCP strategy groups using χ2, t tests, and Wilcoxon rank tests. RESULTS: A total of 50 attendings and 70 residents trained in LCBDE since November 2020. Initial LCBDE utilization rate ranged from 0.74 to 4.5%, and increased among all institutions after training, ranging from 9.3 to 41.4% of cases. There were 393 choledocholithiasis patients analyzed using LCBDE (N = 129) and ERCP (N = 264) strategies. The LCBDE group had shorter median LOS (3 days vs. 4 days, p < 0.0001). No significant differences in readmission rates between LCBDE and ERCP groups (4.7% vs. 7.2%, p = 0.33), or in post-procedure pancreatitis (0.8% v 0.8%, p > 0.98). In comparison to LCBDE, the ERCP group had higher rates of bile duct injury (0% v 3.8%, p = 0.034) and fluid collections requiring intervention (0.8% v 6.8%, p < 0.009) secondary to cholecystectomy complications. Laparoscopic antegrade balloon sphincteroplasty had the highest technical success rate (87%), followed by choledochoscopic techniques (64%). CONCLUSION: Simulator-based training in LCBDE results in higher utilization rates, shorter LOS, and comparable safety to ERCP plus cholecystectomy. Therefore, implementation of LCBDE training is strongly recommended to optimize healthcare utilization and management of patients with choledocholithiasis.
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Colecistectomía Laparoscópica , Coledocolitiasis , Laparoscopía , Humanos , Coledocolitiasis/cirugía , Conducto Colédoco/cirugía , Colangiopancreatografia Retrógrada Endoscópica/métodos , Colecistectomía Laparoscópica/métodos , Estudios Retrospectivos , Tiempo de InternaciónRESUMEN
BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone. METHODS: We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21-65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks. FINDINGS: Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery. INTERPRETATION: ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975. FUNDING: Apollo Endosurgery, Mayo Clinic.
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Gastroplastia , Gastroplastia/efectos adversos , Gastroplastia/métodos , Humanos , Obesidad/etiología , Obesidad/cirugía , Estudios Prospectivos , Resultado del Tratamiento , Pérdida de PesoRESUMEN
BACKGROUND: Zenker's diverticulum peroral endoscopic myotomy (zPOEM) is a minimally invasive treatment strategy for Zenker's diverticulum, with excellent results for management of small-to-moderate Zenker's diverticulum. We evaluated its use in the management of large Zenker's diverticulum. METHODS: This was a retrospective multicenter cohort study across 11 international centers including adult patients with large Zenker's diverticulum ≥â40âmm treated by zPOEM between March 2017 and March 2022.âThe primary outcome was clinical success (dysphagia score ≤â1 without need for further intervention). Secondary outcomes included technical success (complete myotomy as intended), adverse events (AEs), and rate of recurrence. RESULTS: 83 patients (male 62.7â%, mean age 72.6 [SD 11.5] years) underwent zPOEM for treatment of large Zenker's diverticulum (median size 50âmm, interquartile range [IQR] 41-55âmm, range 40-80âmm). The zPOEM procedure was technically successful in 82 patients (98.8â%), with a mean procedure time of 48.7 (SD 23.2) minutes. Clinical success was achieved in 71 patients (85.5â%). Median (IQR) symptom scores improved significantly from baseline for dysphagia (2 2 3 vs. 0 [0-2]; Pâ<â0.001), regurgitation (3 2 3 4 vs. 0 [0-0]; Pâ<â0.001), and respiratory symptoms (2 [0-3] vs. 0 [0-0]; Pâ<â0.001). Among patients achieving clinical success, only one recurrence (1.4â%) was recorded during a median follow-up of 12.2 months (IQR 3-28). Post-procedure AEs, all mild to moderate, occurred in four patients (4.8â%). CONCLUSION: This study demonstrated safe and effective use of zPOEM in the management of large Zenker's diverticulum.
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Trastornos de Deglución , Miotomía , Divertículo de Zenker , Adulto , Humanos , Masculino , Anciano , Divertículo de Zenker/cirugía , Trastornos de Deglución/etiología , Trastornos de Deglución/cirugía , Estudios de Cohortes , Tiempo de Internación , Miotomía/efectos adversos , Resultado del Tratamiento , Estudios Retrospectivos , Esofagoscopía/efectos adversos , Esofagoscopía/métodosRESUMEN
BACKGROUND: Peroral endoscopic myotomy (POEM) is a mainstay of treatment for achalasia. Tailored myotomy based on compliance, as measured with impedance planimetry (FLIP), has yet to be described. In this study we describe the associations between Eckardt score, postoperative GERD, and compliance. METHODS: A retrospective review of a prospectively maintained database was performed, evaluating patients who underwent POEM and intraoperative FLIP between January 2019 and November 2021. Group comparisons were made using two-tailed Wilcoxon rank-sum and Fisher's exact tests. Spearman's correlation coefficients (r) were used to assess the relationship between compliance and outcomes, all with two-tailed statistical significance of p < 0.05. RESULTS: Thirty five patients underwent POEM with intraoperative FLIP. At a 30 mL and 40 mL fill, respectively, compliance increased by 80% (180 ± 152%) and 77% (177 ± 131%) from pre to post myotomy. Mean Eckardt score improved from 5.5 ± 2.6 preoperatively to 1.3 ± 1.6 and 1.8 ± 1.9 at first and second follow up, respectively. Median times to first and second follow up were 22 days (IQR 16-23) and 65 days (IQR 58-142). A higher compliance at 40 mL fill was moderately associated with lower Eckardt score at first (r = -0.49, p = 0.012) and second (r = -0.64, p = 0.014) follow up. Post myotomy compliance ≥ 125 mm3/mmHg at 40 mL fill was associated with lower Eckardt scores, < 3, at first (0.4 ± 0.5 vs 1.8 ± 1.3, p = 0.008) and second (0.4 ± 0.5, vs 2.0 ± 1.4, p = 0.027) follow up. Compliance ≥ 125 mm3/mmHg performed better than previously defined ideal ranges of DI and CSA in predicting postoperative Eckardt scores. Compliance was not significantly associated with development of postoperative GERD. CONCLUSIONS: A target post myotomy compliance of ≥ 125 mm3/mmHg at a 40 mL fill is associated with normal Eckardt scores at first and second postoperative visits, and performs better than previously defined ideal ranges of DI and CSA in predicting post-operative Eckardt scores. Compliance is a poor predictor of developing GERD after POEM.
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Acalasia del Esófago , Reflujo Gastroesofágico , Miotomía , Cirugía Endoscópica por Orificios Naturales , Humanos , Impedancia Eléctrica , Resultado del Tratamiento , Unión Esofagogástrica/cirugía , Acalasia del Esófago/cirugía , Esfínter Esofágico Inferior/cirugía , EsofagoscopíaRESUMEN
BACKGROUND: Mesh reinforced cruroplasty during laparoscopic paraesophageal hernia repair remains controversial due to wide variation in surgical technique and mesh composition. This study aims to review outcomes and rates of recurrence following laparoscopic paraesophageal hernia repair (LPEHR) with mesh reinforced cruroplasty utilizing absorbable mesh at a single institution. METHODS: A retrospective review of all patients who underwent LPEHR with mesh was performed. Medical records were reviewed for patient reported, radiographic or endoscopic evidence of recurrence, defined as > 2 cm of vertical intrathoracic stomach. If no studies were available for review, patients were considered to have no recurrence. Outcomes and mesh-related complications were also reviewed. RESULTS: Between 10/2008 and 9/2021, 473 patients underwent LPEHR with absorbable mesh; 1.3% type 2 hernias, 86.0% type 3 hernias, 12.7% type 4 hernias. Three types of mesh were used: initially biologic mesh (n = 83), then heavyweight synthetic bioabsorbable mesh (n = 261), and finally lightweight synthetic bioabsorbable mesh (n = 111). There were no significant differences in age, ASA, BMI, gender, smoking status, chronic steroid use, preoperative acid suppression, hernia type, or recurrent hernia between groups. There were no significant differences in 30-day postoperative outcomes. Reflux Symptom Index, GERD-HRQL, and Dysphagia Scores at 1- and 2-year postoperative timepoints were not significantly different. The overall recurrence rate was 16.7%, with no significant differences in recurrence rates between biologic, heavyweight or lightweight biosynthetic absorbable mesh through 2 years after surgery. A shorter median time to recurrence (10 months, p = 0.016) was seen in the lightweight group. CONCLUSION: LPEHR with absorbable mesh reinforced cruroplasty is feasible and safe, with equivalent patient-reported outcomes, including dysphagia, up to 2-years postop regardless of mesh choice. No significant differences in recurrence rates between biologic, heavyweight, or lightweight synthetic bioabsorbable mesh were seen up to 2 years after LPEHR.
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Productos Biológicos , Trastornos de Deglución , Hernia Hiatal , Laparoscopía , Humanos , Hernia Hiatal/cirugía , Hernia Hiatal/complicaciones , Trastornos de Deglución/etiología , Mallas Quirúrgicas/efectos adversos , Estudios Retrospectivos , Herniorrafia/métodos , Laparoscopía/efectos adversos , Resultado del TratamientoRESUMEN
INTRODUCTION: Impedance planimetry (FLIP) provides objective feedback to optimize fundoplication outcomes. Ideal FLIP ranges for differing wraps and bougies have not yet been established. We report FLIP measurements during fundoplication grouped by choice of wrap and bougie with associated outcomes. METHODS: A retrospective review of a prospective gastroesophageal database was performed for all Nissen or Toupet fundoplication with intraoperative FLIP using an 8-cm catheter, 30-mL and/or 40-mL fill and/or 16-cm catheter, 60-mL fill. Surgeons used no bougie, the FLIP balloon as bougie, or a hard bougie. Outcomes included perioperative data, Reflux Symptom Index, GERD-HRQL, Dysphagia scores, need for dilation, postoperative EGD findings, and hernia recurrence. Group comparisons were made using two-tailed Kruskal-Wallis and Fisher's exact tests. RESULTS: Between 2016 and 2022, 333 patients underwent fundoplication and intraoperative FLIP. Procedures included Toupet with hard bougie (TFHB, N = 147), Toupet with FLIP bougie (TFFB, N = 69), Toupet without bougie (TFNB, N = 78), Nissen with hard bougie (NFHB, n = 20), or Nissen with FLIP bougie (NFFB, N = 19). FLIP measurements at 30-mL/40-mL fills varied significantly between groups, notably distensibility index at crural closure (CCDI) and post-fundoplication (FDI). No significant differences in FLIP measurements were seen between those who developed poor postoperative outcomes and those who did not, including when grouping by choice of wrap and bougie. At a 40-mL fill, abnormal motility patients with CCDI > 3.5 mm2/mmHg developed zero postoperative dysphagia. TFFB abnormal motility patients with CCDI > 3.5 mm2/mmHg or FDI > 3.6 mm2/mmHg developed zero postoperative dysphagia. CONCLUSION: Intraoperative FLIP measurements vary by fundoplication and bougie choice. A CCDI > 3.5 mm2/mmHg (40 mL fill) should be sought in abnormal motility patients, regardless of wrap or bougie, to avoid postoperative dysphagia. TFFB abnormal motility patients with FDI > 3.6 mm2/mmHg (40 mL fill) also developed zero postoperative dysphagia. FDI > 6.2 mm2/mmHg (40 mL fill) was seen in all postoperative hernia recurrences.
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Trastornos de Deglución , Laparoscopía , Humanos , Fundoplicación/métodos , Estudios Prospectivos , Impedancia Eléctrica , Dilatación , Laparoscopía/métodosRESUMEN
BACKGROUND: As flexible endoscopy becomes an increasingly valuable minimally invasive approach to surgical challenges, an efficient and comprehensive training curriculum is needed to train surgeons in therapeutic endoscopy. We developed a modular curriculum utilizing a simulation-based, "into the fire" approach to endoscopic foreign body removal for practicing physicians with task performance pre- and post-testing. METHODS: From 2020 to 2021, two sessions of our advanced flexible endoscopy course were taught by two expert surgical endoscopists using ex-vivo porcine models. The course focused on safe removal techniques for various foreign bodies as part of an overall endoscopy curriculum that uses hands-on simulation-based pre-testing, didactics, and mentored practice sessions, followed by post-course examination. Pre- and post-course assessments and surveys were used to evaluate knowledge, performance, and confidence of participants, and subsequently analyzed using the Wilcoxon-signed rank test. RESULTS: Of the 16 practicing physicians who participated in the course, 43.8% were certified in Fundamentals of Endoscopic Surgery, and 62.5% had completed > 200 prior upper endoscopies. Upon course completion, scoring on knowledge-based written examinations improved from 3.4 ± 1.9 to 5.8 ± 2.0 (p < 0.001). Technical facility of each participant demonstrated significant overall improvement with post-course score increased from 15.8 ± 2.5 to 23.6 ± 1.6 (p < 0.001), with skill refinement noted in technical subcategories of appropriate instrument use (p < 0.001), foreign body manipulation (p < 0.001), and successful foreign body removal (p < 0.001). Confidence surveys likewise demonstrated significant increase in confidence after completion of the curriculum 11.6 ± 3.4 to 23.0 ± 5.5 (p < 0.001). CONCLUSIONS: The "into the fire" approach to teaching endoscopic foreign body removal utilizing our simulation module provides an effective curriculum to improve knowledge, confidence, and overall technical performance. Our methodology utilizes hands-on, simulation-based pre-testing prior to instruction. This introduces clinical scenarios and technical challenges, while accounting for and tailoring to provider-specific variation in knowledge and experience, facilitating training efficiency.
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Cuerpos Extraños , Internado y Residencia , Entrenamiento Simulado , Cirujanos , Humanos , Animales , Porcinos , Endoscopía Gastrointestinal , Curriculum , Simulación por Computador , Entrenamiento Simulado/métodos , Competencia ClínicaRESUMEN
BACKGROUND: Despite the advantages of laparoscopic cholecystectomy, major bile duct injury (BDI) rates during this operation remain unacceptably high. In October 2018, SAGES released the Safe Cholecystectomy modules, which define specific strategies to minimize the risk of BDI. This study aims to investigate whether this curriculum can change the knowledge and behaviors of surgeons in practice. METHODS: Practicing surgeons were recruited from the membership of SAGES and the American College of Surgeons Advisory Council for Rural Surgery. All participants completed a baseline assessment (pre-test) that involved interpreting cholangiograms, troubleshooting difficult cases, and managing BDI. Participants' dissection strategies during cholecystectomy were also compared to the strategies of a panel of 15 experts based on accuracy scores using the Think Like a Surgeon validated web-based platform. Participants were then randomized to complete the Safe Cholecystectomy modules (Safe Chole module group) or participate in usually scheduled CME activities (control group). Both groups completed repeat assessments (post-tests) one month after randomization. RESULTS: Overall, 41 participants were eligible for analysis, including 18 Safe Chole module participants and 23 controls. The two groups had no significant differences in pre-test scores. However, at post-test, Safe Chole module participants made significantly fewer errors managing BDI and interpreting cholangiograms. Safe Chole module participants were less likely to convert to an open operation on the post-test than controls when facing challenging dissections. However, Safe Chole module participants displayed a similar incidence of errors when evaluating adequate critical views of safety. CONCLUSIONS: In this randomized-controlled trial, the SAGES Safe Cholecystectomy modules improved surgeons' abilities to interpret cholangiograms and safely manage BDI. Additionally, surgeons who studied the modules were less likely to convert to open during difficult dissections. These data show the power of the Safe Cholecystectomy modules to affect practicing surgeons' behaviors in a measurable and meaningful way.
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Traumatismos Abdominales , Enfermedades de los Conductos Biliares , Colecistectomía Laparoscópica , Cirujanos , Humanos , Conductos Biliares/lesiones , Juicio , Complicaciones Intraoperatorias/epidemiología , Colecistectomía , Colecistectomía Laparoscópica/métodosRESUMEN
BACKGROUND: Criteria to diagnose gastroesophageal reflux disease (GERD) vary. The American Gastroenterology Association (AGA) 2022 Expert Review on GERD focuses on acid exposure time (AET) rather than DeMeester score from ambulatory pH testing (BRAVO). We aim to review outcomes following anti-reflux surgery (ARS) at our institution, grouped by differing criteria for the diagnosis of GERD. METHODS: A retrospective review of a prospective gastroesophageal quality database was performed for all patients undergoing evaluation for ARS with preoperative BRAVO ≥ 48 h. Group comparisons were made using two-tailed Wilcoxon rank-sum and Fisher's exact tests and two-tailed statistical significance of p < 0.05. RESULTS: Between 2010 and 2022, 253 patients underwent an evaluation for ARS with BRAVO testing. Most patients (86.9%) met our institution's historical criteria: LA C/D esophagitis, Barrett's, or DeMeester ≥ 14.72 on 1+ days. Fewer patients (67.2%) met new AGA criteria: LA B/C/D esophagitis, Barrett's, or AET ≥ 6% on 2+ days. Sixty-one patients (24%) met historical criteria only, with significantly lower BMI, ASA, less hiatal hernias, and less DeMeester and AET-positive days, a less severe GERD phenotype. There were no differences between groups in perioperative outcomes or % symptom resolution. Objective GERD outcomes (need for dilation, esophagitis, and postop BRAVO) were equivalent between groups. Patient-reported quality of life scores, including GERD-HRQL, RSI, and Dysphagia Score did not differ between groups from preop through 1 year postop. Those who met our historical criteria only reported significantly worse RSI scores (p = 0.03) and worse GERD-HRQL scores at 2 years postop, though not statistically significant (p = 0.07). CONCLUSION: Updated AGA GERD guidelines exclude a portion of patients who historically would have been diagnosed with and surgically treated for GERD. This cohort appears to have a less severe GERD phenotype but equivalent outcomes up to 1 year, with more atypical GERD symptoms at 2 years postop. AET may better define who should be offered ARS than DeMeester score.
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Esofagitis , Reflujo Gastroesofágico , Humanos , Calidad de Vida , Estudios Prospectivos , Reflujo Gastroesofágico/diagnóstico , Reflujo Gastroesofágico/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
INTRODUCTION: Genetic contributions to hernia development are incompletely understood. This study performed the first comprehensive genome-wide association study (GWAS) for diaphragmatic hernia using a large population-based cohort in the UK Biobank (UKB). METHODS AND PROCEDURES: Two-stage GWAS (discovery and confirmation) was performed for diaphragmatic hernia in the UKB. Briefly, 275,549 and 91,850 subjects were randomly selected for association tests in Stages 1 and 2, respectively. Association tests between 8,568,156 SNPs (genotyped or imputed with MAF > 0.01) in the autosomal genome and diaphragmatic hernia were performed in Stage 1. SNPs with P < 1 × 10-5 were selected for confirmation in Stage 2, and those with P < 0.05 and the same direction of association as Stage 1 were selected for combined association testing; SNPs with combined P < 5 × 10-8 were considered GWAS-significant. LD clumping analysis identified genetically independent chromosomal regions (loci). A genetic risk score (GRS) measured the cumulative risk of independent SNPs in 91,849 additional subjects using odds ratios (ORs) from Stages 1 and 2. RESULTS: 36,351 patients were identified with diaphragmatic hernia (ICD-10 K44). In Stage 1 analysis, 2654 SNPs were associated (P < 1 × 10-5) with diaphragmatic hernia. Stage 2 analysis confirmed 338 SNPs (P < 0.05). In combined analysis, 245 SNPs reached GWAS significance (P < 5 × 10-8). LD clumping analysis revealed 14 independent loci associated with diaphragmatic hernia. Two loci have been previously associated with inguinal hernia at 2p16 (rs181661155) and 11p13 (rs5030123). eQTL analysis suggested genes CRLF1, UBA52, and CALD1 are also significantly associated with these loci. GRS showed significant increase in cases compared to controls (P < 1 × 10-16) and is associated with increased risk of diaphragmatic hernia (P < 1 × 10-7). CONCLUSIONS: We identified 245 SNPs at 14 susceptibility loci associated with diaphragmatic hernia in a large population-based cohort. These results offer insight into pathogenetic mechanisms of diaphragmatic hernia development and may be used in genetic risk scores for pre-operative risk-stratification and clinical prediction models.
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Estudio de Asociación del Genoma Completo , Hernia Diafragmática , Bancos de Muestras Biológicas , Predisposición Genética a la Enfermedad , Estudio de Asociación del Genoma Completo/métodos , Humanos , Polimorfismo de Nucleótido Simple , Reino UnidoRESUMEN
BACKGROUND: The endoluminal functional lumen imaging probe (FLIP) can be used to obtain real-time measurements of the diameter (Dmin), cross-sectional area (CSA), and distensibility of the pylorus before and after peroral pyloromyotomy (POP), an emerging endoscopic treatment for delayed gastric emptying. Our study aims to report our single-center experience in performing POP with FLIP measurements before and after pyloromyotomy. METHODS: A retrospective review of a prospectively maintained gastroesophageal database was performed. Demographic and perioperative data, including intraoperative FLIP measurements of the pylorus before and after POP, were analyzed. Measurements were compared using paired t tests. RESULTS: Thirty-four patients underwent POP between February 2017 and July 2020. Twenty-three (67.7%) patients were male and the average age was 59 years. The etiology of delayed gastric emptying was post-vagotomy in 22 patients, idiopathic gastroparesis in 7 patients, and diabetic gastroparesis in 5 patients. There were no significant differences in pre-myotomy or post-myotomy FLIP measurements when comparing the post-vagotomy versus the gastroparesis groups. There were significant increases in Dmin, CSA, and distensibility index when comparing pre-myotomy and post-myotomy readings for all patients (all p < 0.001). At follow-up, 64.7% of patients reported resolution of all symptoms. CONCLUSION: POP is an effective intervention in patients with delayed gastric emptying. Significant changes in FLIP measurements before and after POP suggest that FLIP may be a useful adjunct in guiding the management of delayed gastric emptying.
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Gastroparesia , Miotomía , Piloromiotomia , Impedancia Eléctrica , Vaciamiento Gástrico , Gastroparesia/diagnóstico por imagen , Gastroparesia/etiología , Humanos , Masculino , Persona de Mediana Edad , Miotomía/efectos adversos , Piloromiotomia/métodos , Píloro/cirugía , Resultado del TratamientoRESUMEN
INTRODUCTION: The esophagogastric junction (EGJ) is a complex anti-reflux barrier whose integrity relies on both the intrinsic lower esophageal sphincter (LES) and extrinsic crural diaphragm. During hiatal hernia repair, it is unclear whether the crural closure or the fundoplication is more important to restore the anti-reflux barrier. The objective of this study is to analyze changes in LES minimum diameter (Dmin) and distensibility index (DI) using the endoluminal functional lumen imaging probe (FLIP) during hiatal hernia repair. METHODS: Following implementation of a standardized operative FLIP protocol, all data were collected prospectively and entered into a quality database. This data were reviewed retrospectively for all patients undergoing hiatal hernia repair. FLIP measurements were collected prior to hernia dissection, after hernia reduction, after cruroplasty, and after fundoplication. Additionally, subjective assessment of the tightness of crural closure was rated by the primary surgeon on a scale of 1 to 5, 1 being the loosest and 5 being the tightest. RESULTS: Between August 2018 and February 2020, 97 hiatal hernia repairs were performed by a single surgeon. FLIP measurements collected using a 40-mL volume fill without pneumoperitoneum demonstrated a significant decrease in LES Dmin (13.84 ± 2.59 to 10.27 ± 2.09) and DI (6.81 ± 3.03 to 2.85 ± 1.23 mm2/mmHg) after crural closure (both p < 0.0001). Following fundoplication, there was a small, but also statistically significant, increase in both Dmin and DI (both p < 0.0001). Additionally, subjective assessment of crural tightness after cruroplasty correlated well with DI (r = - 0.466, p < 0.001) and all patients with a crural tightness rating ≥ 4.5 (N = 13) had a DI < 2.0 mm2/mmHg. CONCLUSION: Cruroplasty results in a significant decrease in LES distensibility and may be more important than fundoplication in restoring EGJ competency. Additionally, subjective estimation of crural tightness correlates well with objective FLIP evaluation, suggesting surgeon assessment of cruroplasty is reliable.
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Reflujo Gastroesofágico , Hernia Hiatal , Esfínter Esofágico Inferior/cirugía , Unión Esofagogástrica/cirugía , Fundoplicación/métodos , Reflujo Gastroesofágico/cirugía , Hernia , Hernia Hiatal/cirugía , Humanos , Estudios RetrospectivosRESUMEN
BACKGROUND: Simulation using virtual reality (VR) simulators is an important tool in surgical training. VR laparoscopic simulators can provide immediate objective performance assessment without observer evaluation. This study aims to explore the correlation between subjective observer evaluation and VR laparoscopic simulator performance metrics in a laparoscopic cholecystectomy (LC) simulation module. METHODS: A LC simulation module using a VR laparoscopic simulator was completed by PGY2-3 general surgery residents at a single institution. Simulation performance was recorded and evaluated by a trained evaluator using the validated Global Operative Assessment of Laparoscopic Skills (GOALS) form, the Objective Structured Assessment of Technical Skills (OSATS) form, and a LC-specific simulation assessment form (LC-SIM). Objective performance metrics were also obtained from the simulator system. Performance before the curriculum (pre-test) and after the curriculum (post-test) were compared. RESULTS: Fourteen residents were included in the study. There were significant improvements from pre-test to post-test on each component of GOALS, OSATS, and LC-SIM scores (all p values < 0.05). In terms of objective simulator metrics, significant improvements were noted in time to extract gallbladder (481 ± 221 vs 909 ± 366 min, p = 0.019), total number of movements (475 ± 264 vs 839 ± 324 min, p = 0.012), and total path length (955 ± 475 vs 1775 ± 632 cm, p = 0.012) from pre-test to post-test. While number of movements and total path lengths of both hands decreased, speed of right instrument also decreased from 4.1 + 2.7 to 3.0 ± 0.7 cm/sec (p = 0.007). Average speed of left instrument was associated with respect for tissue (r = 0.60, p < 0.05) and depth perception (r = 0.68, p < 0.05) on post-test evaluations. CONCLUSION: Our study demonstrated significant improvement in technical skills based on subjective evaluator assessment as well as objective simulator metrics after simulation. The few correlations identified between the subjective evaluator and the objective simulator assessments suggest the two evaluation modalities were measuring different aspects of the technical skills and should both be considered in the evaluation process.
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Colecistectomía Laparoscópica , Laparoscopía , Entrenamiento Simulado , Realidad Virtual , Colecistectomía Laparoscópica/educación , Competencia Clínica , Simulación por Computador , Curriculum , Humanos , Entrenamiento Simulado/métodos , Interfaz Usuario-ComputadorRESUMEN
BACKGROUND: Numerous studies show changes in functional lumen imaging probe (FLIP) measurements after myotomy during peroral endoscopic myotomy (POEM), but few report on FLIP measurements at follow-up esophagogastroduodenoscopy (EGD). The purpose of this study was to compare perioperative FLIP measurements to those at follow-up EGD. METHODS: Patients who underwent POEM with FLIP in the operating room and POEM patients who had EGD with FLIP at follow-up were included. FLIP measurements, including diameter (Dmin), pressure, cross-sectional area (CSA), and distensibility index (DI), were analyzed at a 30-mL balloon fill. Differences between measurements at different timepoints were assessed using a two-tailed Wilcoxon signed-rank test. RESULTS: A total of 97 patients who underwent POEM and 28 who underwent EGD with FLIP were analyzed. The average age was 63 ± 18 years and 46.4% of the patients were male. Mean preoperative Eckardt score was 6.5 ± 4.8, decreasing to 1.6 ± 2.0 at follow-up. EGDs were performed at a median of 15 months after surgery. When compared to mean measurements obtained post-myotomy, at the time of EGD, pressure was found to be significantly lower (p = 0.007) and DI significantly higher (p = 0.045). Of the patients who underwent EGD, 70.8% had an increase in DI, 55.6% had evidence of reflux esophagitis, and 81.0% met diagnostic criteria for reflux on esophageal pH monitoring. However, there was no correlation with the development of esophagitis or reflux and increase or decrease in DI at follow-up. CONCLUSIONS: There are significant changes in FLIP measurements between the time of surgery and at follow-up EGD. These results suggest that esophageal remodeling may cause changes in lower esophageal sphincter geometry after POEM and postoperative FLIP targets immediately post-myotomy may need to be adjusted to account for these changes.