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BACKGROUND: There is a trend towards laparoscopic sleeve gastrectomy (SG) with same-day discharge (SDD), as an efficient healthcare pathway to alleviate the burden on clinical capacity. This approach seems to be safe, if patients are carefully selected. In our bariatric center, a protocol for Roux-en-Y gastric bypass with SDD has already been successfully implemented. The aim of this study was to evaluate feasibility of applying the same SDD protocol for SG. METHODS: A single-center prospective feasibility study was conducted at a high-volume bariatric center. Low-risk patients who were scheduled for primary SG were included. Strict criteria were used for approval upon SDD. The primary outcome was the rate of successful SDD without readmission within 48 h. Secondary outcomes included short-term complications, emergency department visits, readmissions, and mortality. RESULTS: Fifty patients were included in the study, of whom 45 were successfully discharged on the same day of the surgery. Nausea and vomiting were the most common reasons for overnight hospitalization (three patients). One patient was readmitted within the first 48 h due to a mild complication related to bleeding, resulting in a success rate of 88% for SDD without readmission within 48 h. No severe complications or mortality were reported in the cohort. CONCLUSION: Our SDD protocol for SG has demonstrated feasibility, with a high success rate of SDD and no severe complications. Strict conditions should be met for the safe implementation of a SDD protocol, including careful patient selection and the establishment of a safety net to detect early complications.
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Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Humanos , Alta do Paciente , Obesidade Mórbida/cirurgia , Obesidade Mórbida/complicações , Estudos Prospectivos , Países Baixos , Estudos de Viabilidade , Derivação Gástrica/métodos , Gastrectomia/métodos , Laparoscopia/métodos , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgiaRESUMO
Although widely used in follow-up treatment protocols, the added value of routine radiographs to clinical decision-making in nonoperative treatment of patients with metatarsal fractures is unclear. This retrospective cohort study aimed to determine whether routine follow-up radiographs contributed to changes in treatment strategies in nonoperative treatment of patients with a metatarsal fracture. Adult (aged ≥ 18 years) patients who received nonoperative follow-up treatment for a metatarsal fracture between May first, 2020 and May second, 2022 were included. All relevant data were extracted from patient records. Radiographs without a documented clinical indication were classified as routine. Outcomes included changes in treatment strategies based on routine radiographs during follow-up treatment and secondarily, changes in treatment strategy based on clinically indicated radiographs. A total of 168 patients were included, with 135 single and 33 multiple metatarsal fractures. During follow-up, 223 radiographs were performed, of which 154 (69%) were routine and 69 (31%) were on clinical indication. Of routine radiographs, 9 (6%) led to a change in treatment which only included additional imaging. No switch to operative treatment or prolonging of immobilization was observed based on routine radiographs. Of clinically indicated radiographs, 16 (23%) led to a change of treatment, including prolonged immobilization (n = 2), additional follow-up appointments (n = 1) and additional imaging (n = 12). Our results show routinely performed radiographs seldom affect treatment strategies in nonoperative treatment of metatarsal fractures, indicating minimal added value to clinical decision-making. Omitting routine radiographs from treatment protocols may contribute to the reduction of unnecessary healthcare resource utilization in clinical practice.
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BACKGROUND: The BODY-Q is a patient-reported outcome measure developed for use in bariatric and body contouring surgery. OBJECTIVES: The objective of this study was to examine the validity and reliability of the Dutch version of the BODY-Q. METHODS: The BODY-Q consists of 163 items in 21 independently functioning scales that measure appearance, health-related quality of life, and experience of care. The data used to validate the Dutch BODY-Q were provided by 2 prospective multicenter cohort studies across 3 hospitals in the Netherlands. The BODY-Q was administered before and after surgery at 3 or 4 months and 12 months. Rasch measurement theory (RMT) analysis was used to evaluate the BODY-Q for targeting, category threshold order, Rasch model fit, Person Separation Index, and differential item functioning by language (original English data vs Dutch data). RESULTS: Data were collected between January 2016 and May 2019. The study included 876 participants, who provided 1614 assessments. Validity was supported by 3 RMT findings: most scales showed good targeting, 160 out of 163 items (98.2%) evidenced ordered thresholds, and 142 out of 163 items (87.1%) fitted the RMT model. Reliability was high with Person Separation Index values >0.70 for 19 out of 21 scales. There was negligible influence of differential item functioning by language on person item locations and the scale scoring. CONCLUSIONS: This study provides evidence for the reliability and validity of the Dutch BODY-Q for use in bariatric and body contouring patients in the Netherlands. The Dutch BODY-Q can be used in (inter)national research and clinical practice.
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Bariatria , Contorno Corporal , Humanos , Qualidade de Vida , Reprodutibilidade dos Testes , Estudos Prospectivos , Inquéritos e Questionários , Satisfação do Paciente , Idioma , PsicometriaRESUMO
BACKGROUND: The aim was to evaluate the cost-effectiveness and cost-utility of ursodeoxycholic acid (UDCA) prophylaxis for the prevention of symptomatic gallstone disease after Roux-en-Y gastric bypass (RYGB) in patients without gallstones before surgery. METHODS: Data from a multicentre, double-blind, randomized placebo-controlled superiority trial were used. Patients scheduled for laparoscopic RYGB or sleeve gastrectomy were randomized to receive 900â mg UDCA or placebo for 6 months. Indicated by the clinical report, prophylactic prescription of UDCA was evaluated economically against placebo from a healthcare and societal perspective for the subgroup of patients without gallstones before surgery who underwent RYGB. Volumes and costs of in-hospital care, out-of-hospital care, out-of-pocket expenses, and productivity loss were assessed. Main outcomes were the costs per patient free from symptomatic gallstone disease and the costs per quality-adjusted life-year (QALY). RESULTS: Patients receiving UDCA prophylaxis were more likely to remain free from symptomatic gallstone disease (relative risk 1.06, 95 per cent c.i. 1.02 to 1.11; P = 0.002) compared with patients in the placebo group. The gain in QALYs, corrected for a baseline difference in health utility, was 0.047 (95 per cent bias-corrected and accelerated (Bca) c.i. 0.007 to 0.088) higher (P = 0.022). Differences in costs were -356 (95 per cent Bca c.i. -1573 to 761) from a healthcare perspective and -1392 (-3807 to 917) from a societal perspective including out-of-pocket expenses and productivity loss, both statistically non-significant, in favour of UDCA prophylaxis. The probability of UDCA prophylaxis being cost-effective was at least 0.872. CONCLUSION: UDCA prophylaxis after RYGB in patients without gallstones before surgery was cost-effective.
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Cálculos Biliares , Derivação Gástrica , Obesidade Mórbida , Análise Custo-Benefício , Cálculos Biliares/prevenção & controle , Cálculos Biliares/cirurgia , Gastrectomia , Humanos , Obesidade Mórbida/complicações , Obesidade Mórbida/cirurgia , Ácido Ursodesoxicólico/uso terapêuticoRESUMO
BACKGROUND: This study assessed whether electromagnetic navigation can be of added value during resection of recurrent or post-therapy intra-abdominal/pelvic soft tissue sarcomas (STS) in challenging locations. MATERIALS AND METHODS: Patients were included in a prospective navigation study. A pre-operatively 3D roadmap was made and tracked using electromagnetic reference markers. During the operation, an electromagnetic pointer was used for the localization of the tumor/critical anatomical structures. The primary endpoint was feasibility, secondary outcomes were safety and usability. RESULTS: Nine patients with a total of 12 tumors were included, 7 patients with locally recurrent sarcoma. Three patients received neoadjuvant radiotherapy and three other patients received neoadjuvant systemic treatment. The median tumor size was 4.6 cm (2.4-10.4). The majority of distances from tumor to critical anatomical structures was <0.5 cm. The tumors were localized using the navigation system without technical or safety issues. Despite the challenging nature of these resections, 89% were R0 resections, with a median blood loss of 100 ml (20-1050) and one incident of vascular damage. Based on the survey, surgeons stated navigation resulted in shorter surgery time and made the resections easier. CONCLUSION: Electromagnetic navigation facilitates resections of challenging lower intra-abdominal/pelvic STS and might be of added value.
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Neoplasias Abdominais/cirurgia , Recidiva Local de Neoplasia/cirurgia , Neoplasias Pélvicas/cirurgia , Sarcoma/cirurgia , Neoplasias de Tecidos Moles/cirurgia , Cirurgia Assistida por Computador , Neoplasias Abdominais/diagnóstico por imagem , Idoso , Perda Sanguínea Cirúrgica , Meios de Contraste , Feminino , Humanos , Imageamento Tridimensional , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/diagnóstico por imagem , Duração da Cirurgia , Neoplasias Pélvicas/diagnóstico por imagem , Estudos Prospectivos , Sarcoma/diagnóstico por imagem , Neoplasias de Tecidos Moles/diagnóstico por imagem , Tomografia Computadorizada por Raios XRESUMO
BACKGROUND: Post-operative changes in eating behavior, eating-related distress and eating-related symptoms play an important role in the lives of bariatric surgery patients. However, there are no studies that assess these outcomes using a specifically designed patient-reported outcome measure (PROM) for patients undergoing bariatric surgery. We use our newly developed and validated scales as part of the well-established BODY-Q PROMs to compare laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass patients (LRYGB). METHODS: We analyzed data from an international multi-center prospective cohort study of patients over 18 who underwent bariatric surgery. We used multivariable linear regression models to assess the difference between LRYGB and LSG for the new BODY-Q scales, which include eating behavior, eating-related distress and eating-related symptoms. All analyses were corrected for significant confounding variables. RESULTS: Out of 1420 patients, 920 underwent LRYGB and 500 underwent LSG. The LRYGB group had a higher percentage total weight loss (p < 0.001). There was no significant difference in eating behavior (e.g., stop eating before feeling full, avoiding unhealthy snacks, etc.) or eating-related distress (e.g., feeling ashamed or out of control after eating). Patients who underwent LSG scored significantly better on the post-prandial eating-related symptoms scale (e.g., vomiting, reflux; p < 0.001). Symptoms more prevalent in the LRYGB patients were related to dumping syndrome whereas symptoms more prevalent in LSG patients were related to reflux. CONCLUSION: Patients who underwent LRYGB had a significantly better weight loss after surgery, but they scored worse on post-prandial symptoms in comparison to LSG patients. This information may be relevant for patients in the pre-operative counseling setting, as it may influence their decision for surgical procedure selection.
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Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Comportamento Alimentar , Gastrectomia , Humanos , Obesidade Mórbida/cirurgia , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Resultado do TratamentoRESUMO
PURPOSE: Almost two-thirds of the population undergoing bariatric surgery (BS) suffers from obstructive sleep apnea (OSA). Continuous positive airway pressure (CPAP) is the standard treatment for moderate to severe OSA and is recommended in patients undergoing BS perioperatively. A severe and dreaded complication after BS is anastomotic leakage. There is theoretical concern that perioperative CPAP use may result in increased distension of the gastrointestinal tract and increase the risk of developing an anastomotic leakage. The aim of this study was to evaluate the effect of postoperative CPAP use on the risk of developing anastomotic leakages after BS. METHODS: Retrospectively, all patients from a single bariatric center who underwent BS from November 2007 to August 2019 were included. Presence and severity of OSA were determined using poly(somno)graphy. To evaluate the effect of postoperative CPAP use on anastomotic leakage, a multivariable logistic regression analysis was performed. RESULTS: A total of 4052 patients were included, with OSA being diagnosed in 62%. Overall, 970 patients (24%) used CPAP after BS. Anastomotic leakage occurred in 64 (1.6%) patients after BS. Leakage rate was 1.3% in non-CPAP group versus 2.5% in CPAP group (p = 0.01). CPAP use was associated with anastomotic leakage; however, after adjustment, CPAP use was not an independent predictor (OR = 1.40, 95% CI 0.60-3.28, p = 0.44). CONCLUSION: There is no independent relation between postoperative CPAP use and anastomotic leakage after BS. Only revision surgery was an independent predictor of anastomotic leakage.
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Fístula Anastomótica/epidemiologia , Cirurgia Bariátrica/efeitos adversos , Pressão Positiva Contínua nas Vias Aéreas , Complicações Pós-Operatórias/epidemiologia , Grampeamento Cirúrgico/efeitos adversos , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Estudos Retrospectivos , Apneia Obstrutiva do Sono/terapia , Resultado do TratamentoRESUMO
PURPOSE: To describe and validate a new methodology for visualizing and quantifying 3-dimensional (3D) displacement of the stent frames of the Nellix endosystem after endovascular aneurysm sealing (EVAS). METHODS: The 3D positions of the stent frames were registered to 5 fixed anatomical landmarks on the post-EVAS computed tomography (CT) scans, facilitating comparison of the position and shape of the stent frames between consecutive follow-up scans. Displacement of the proximal and distal ends of the stent frames, the entire stent frame trajectories, as well as changes in distance between the stent frames were determined for 6 patients with >5-mm displacement and 6 patients with <5-mm displacement at 1-year follow-up. The measurements were performed by 2 independent observers; the intraclass correlation coefficient (ICC) was used to determine interobserver variability. RESULTS: Three types of displacement were identified: displacement of the proximal and/or distal end of the stent frames, lateral displacement of one or both stent frames, and stent frame buckling. The ICC ranged from good (0.750) to excellent (0.958). No endoleak or migration was detected in the 12 patients on conventional CT angiography at 1 year. However, of the 6 patients with >5-mm displacement on the 1-year CT as determined by the new methodology, 2 went on to develop a type Ia endoleak in longer follow-up, and displacement progressed to >15 mm for 2 other patients. No endoleak or progressive displacement was appreciated for the patients with <5-mm displacement. CONCLUSION: The sac anchoring principle of the Nellix endosystem may result in several types of displacement that have not been observed during surveillance of regular endovascular aneurysm repairs. The presented methodology allows precise 3D determination of the Nellix endosystems and can detect subtle displacement better than standard CT angiography. Displacement >5 mm on the 1-year CT scans reconstructed with the new methodology may forecast impaired sealing and anchoring of the Nellix endosystem.
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Aneurisma da Aorta Abdominal/cirurgia , Aortografia/métodos , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Angiografia por Tomografia Computadorizada , Endoleak/diagnóstico por imagem , Procedimentos Endovasculares/instrumentação , Migração de Corpo Estranho/diagnóstico por imagem , Tomografia Computadorizada Multidetectores , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Implante de Prótese Vascular/efeitos adversos , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Migração de Corpo Estranho/etiologia , Humanos , Imageamento Tridimensional , Masculino , Variações Dependentes do Observador , Valor Preditivo dos Testes , Desenho de Prótese , Interpretação de Imagem Radiográfica Assistida por Computador , Reprodutibilidade dos Testes , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: To describe the added value of determining changes in position and apposition on computed tomography angiography (CTA) after endovascular aneurysm repair (EVAR) to detect early caudal displacement of the device and to prevent type Ia endoleak. METHODS: Four groups of elective EVAR patients were selected from a dataset purposely enriched with type Ia endoleak and migration (>10 mm) cases. The groups included cases of late type Ia endoleak (n=36), migration (n=9), a type II endoleak (n=16), and controls without post-EVAR complications (n=37). Apposition of the endograft fabric with the aortic neck, shortest distance between the fabric and the renal arteries, expansion of the main body (or dilatation of the aorta in the infrarenal sealing zone), and tilt of the endograft toward the aortic axis were determined on the first postoperative and the last available CTA scan without type Ia endoleak or migration. Differences in these endograft dimensions were compared between the first vs last scan and among the 4 groups. RESULTS: No significant differences in endograft configurations were observed among the groups on the first postoperative CTA scan. On the last CTA scan before a complication arose, the position of the fabric relative to the renal arteries, expansion of the main body, and apposition of the fabric with the aortic neck were significantly different between the type Ia endoleak (median follow-up 15 months) and migration groups (median follow-up 23 months) compared with the control group (median follow-up 19 months). Most endograft dimensions had changed significantly compared with the first postoperative CTA scan for all groups. Apposition had increased in the control group but had decreased significantly in the type Ia endoleak and migration groups. CONCLUSION: Progressive changes in dimensions of the endograft within the infrarenal neck could be detected on regular CTA scans before the complication became urgent in many patients.
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Aorta Abdominal/cirurgia , Aneurisma da Aorta Abdominal/cirurgia , Aortografia/métodos , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Angiografia por Tomografia Computadorizada , Endoleak/diagnóstico por imagem , Procedimentos Endovasculares/instrumentação , Migração de Corpo Estranho/diagnóstico por imagem , Stents , Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Implante de Prótese Vascular/efeitos adversos , Bases de Dados Factuais , Diagnóstico Precoce , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Migração de Corpo Estranho/etiologia , Humanos , Imageamento Tridimensional , Valor Preditivo dos Testes , Interpretação de Imagem Radiográfica Assistida por Computador , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
PURPOSE: To investigate the initial proximal position and seal of the Nellix EndoVascular Aneurysm Sealing (EVAS) system in the aortic neck using a novel methodology. METHODS: Forty-six consecutive patients who underwent elective EVAS for an abdominal aortic aneurysm were retrospectively selected and dichotomized into an early (n=23) and a late (n=23) group. The aortic neck morphology and aortic neck surface (ANS) were determined on preoperative computed tomography (CT) scans; the endograft position and nonapposition surface (NAS) were determined on the 1-month CT scans. The position of the proximal endobag boundary was measured by 2 experienced observers to analyze the interobserver variability for the EVAS NAS measurements. The shortest distance from the lowest renal artery to the endobag (shortest fabric distance) and the shortest distance from the endobag to the end of the infrarenal neck (shortest sealing distance) were determined. The intraclass correlation coefficients (ICCs) are presented with the 95% confidence interval (CI). Continuous data are presented as the median and interquartile range (IQR: Q3 - Q1). RESULTS: There were no differences between the early and late EVAS groups regarding aortic neck morphology except for the neck calcification circumference [41° (IQR 33°) vs 87° (IQR 60°), respectively; p=0.043]. Perfect agreement was observed for the NAS (ICC 0.897, 95% CI 0.780 to 0.956). The NAS as a percentage of the preoperative ANS was 47% (IQR 43) vs 49% (IQR 49) for the early vs late groups, respectively (p=0.214). The shortest fabric distances were 5 mm (IQR 5) and 4 mm (IQR 7) for the early and late groups, respectively (p=0.604); the shortest sealing distances were 9 mm (IQR 13) and 16 mm (IQR 17), respectively (p=0.066). CONCLUSION: Accurate positioning of the Nellix EVAS system in the aortic neck may be challenging. Despite considerable experience with the system, still around half of the potential seal in the aortic neck was missed in the current series, without improvement over time. This should be considered during preoperative planning and may be a cause of a higher than expected complication rate. Detailed post-EVAS nonapposition surface can be determined with the described novel methodology that takes into account the sometimes irregularly shaped top of the sealing endobags.
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Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/instrumentação , Prótese Vascular , Procedimentos Endovasculares/instrumentação , Stents , Idoso , Idoso de 80 Anos ou mais , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Angiografia por Tomografia Computadorizada , Endoleak/etiologia , Procedimentos Endovasculares/efeitos adversos , Feminino , Migração de Corpo Estranho/etiologia , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
Background Early detection of small type I endoleaks after endovascular aneurysm sealing is mandatory because they can rapidly progress and lead to severe complications. Recognition of endoleaks can be challenging due to the appearances on computed tomography unique to endovascular aneurysm sealing. We aimed to validate the accuracy and added value of subtraction computed tomography imaging using a post-processing software algorithm to improve detection of endovascular aneurysm sealing-associated endoleaks on postoperative surveillance imaging. Methods The computed tomography scans of 17 patients (16 males; median age: 78, range: 72-84) who underwent a post-endovascular aneurysm sealing computed tomography including both non-contrast and arterial phase series were used to validate the post processing software algorithm. Subtraction images are produced after segmentation and alignment. Initial alignment of the stent segmentations is automatically performed by registering the geometric centers of the 3D coordinates of both computed tomography series. Accurate alignment is then performed by translation with an iterative closest point algorithm. Accuracy of alignment was determined by calculating the root mean square error between matched 3D coordinates of stent segmentations. Results The median root mean square error after initial center of gravity alignment was 0.62 mm (IQR: 0.55-0.80 mm), which improved to 0.53 mm (IQR: 0.47-0.69 mm) after the ICP alignment. Visual inspection showed good alignment and no manual adjustment was necessary. Conclusions The possible merit of subtraction computed tomography imaging for the detection of small endoleaks during surveillance after endovascular aneurysm sealing was illustrated. Alignment of different computed tomography phases using a software algorithm was very accurate. Further studies are needed to establish the exact role of this technique during surveillance after endovascular aneurysm sealing compared to less invasive techniques like contrast-enhanced ultrasound.
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Aneurisma da Aorta Abdominal/cirurgia , Aortografia/métodos , Implante de Prótese Vascular/efeitos adversos , Angiografia por Tomografia Computadorizada/métodos , Endoleak/diagnóstico por imagem , Procedimentos Endovasculares/efeitos adversos , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Técnica de Subtração , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Diagnóstico Precoce , Endoleak/etiologia , Feminino , Humanos , Masculino , Valor Preditivo dos Testes , Reprodutibilidade dos Testes , Software , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The number of bariatric interventions for morbid obesity is increasing worldwide. Rapid weight loss is a major risk factor for gallstone development. Approximately 11 % of patients who underwent Roux-en-Y gastric bypass develop symptomatic gallstone disease. Gallstone disease can lead to severe complications and often requires hospitalization and surgery. Ursodeoxycholic acid (UDCA) prevents the formation of gallstones after bariatric surgery. However, randomized controlled trials with symptomatic gallstone disease as primary endpoint have not been conducted. Currently, major guidelines make no definite statement about postoperative UDCA prophylaxis and most bariatric centers do not prescribe UDCA. METHODS: A randomized, placebo-controlled, double-blind multicenter trial will be performed for which 980 patients will be included. The study population consists of consecutive patients scheduled to undergo Roux-en-Y gastric bypass or sleeve gastrectomy in three bariatric centers in the Netherlands. Patients will undergo a preoperative ultrasound and randomization will be stratified for pre-existing gallstones and for type of surgery. The intervention group will receive UDCA 900 mg once daily for six months. The placebo group will receive similar-looking placebo tablets. The primary endpoint is symptomatic gallstone disease after 24 months, defined as admission or hospital visit for symptomatic gallstone disease. Secondary endpoints consist of the development of gallstones on ultrasound at 24 months, number of cholecystectomies, side-effects of UDCA and quality of life. Furthermore, cost-effectiveness, cost-utility and budget impact analyses will be performed. DISCUSSION: The UPGRADE trial will answer the question whether UDCA reduces the incidence of symptomatic gallstone disease after Roux-en-Y gastric bypass or sleeve gastrectomy. Furthermore it will determine if treatment with UDCA is cost-effective. TRIAL REGISTRATION: Netherlands Trial Register (trialregister.nl) 6135 . Date registered: 21-Nov-2016.
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Colagogos e Coleréticos/uso terapêutico , Cálculos Biliares/prevenção & controle , Derivação Gástrica/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Ácido Ursodesoxicólico/uso terapêutico , Colagogos e Coleréticos/efeitos adversos , Colagogos e Coleréticos/economia , Protocolos Clínicos , Análise Custo-Benefício , Método Duplo-Cego , Seguimentos , Cálculos Biliares/etiologia , Humanos , Obesidade Mórbida/cirurgia , Complicações Pós-Operatórias/etiologia , Qualidade de Vida , Ácido Ursodesoxicólico/efeitos adversos , Ácido Ursodesoxicólico/economiaRESUMO
Importance: Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. Objective: To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Design, Setting, and Participants: Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. Interventions: A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Main Outcomes and Measures: Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Results: Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Conclusions and Relevance: Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. Trial Registration: clinicaltrials.gov Identifier: NCT02225821.
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Antibacterianos/administração & dosagem , Antibioticoprofilaxia , Cefazolina/administração & dosagem , Remoção de Dispositivo/efeitos adversos , Fraturas Ósseas/cirurgia , Extremidade Inferior/lesões , Infecção da Ferida Cirúrgica/prevenção & controle , Adulto , Idoso , Método Duplo-Cego , Feminino , Humanos , Incidência , Infusões Intravenosas , Análise de Intenção de Tratamento , Fixadores Internos , Masculino , Pessoa de Meia-Idade , Próteses e Implantes/efeitos adversos , Qualidade de Vida , Infecção da Ferida Cirúrgica/epidemiologia , Adulto JovemRESUMO
BACKGROUND: In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures. METHODS: This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up). DISCUSSION: If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of 3.5 million per year. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.
Assuntos
Antibacterianos/uso terapêutico , Antibioticoprofilaxia , Cefazolina/uso terapêutico , Remoção de Dispositivo , Fixação Interna de Fraturas/instrumentação , Cuidados Pré-Operatórios/métodos , Infecção da Ferida Cirúrgica/prevenção & controle , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos Clínicos , Método Duplo-Cego , Esquema de Medicação , Feminino , Seguimentos , Pé/cirurgia , Humanos , Injeções Intravenosas , Perna (Membro)/cirurgia , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto JovemRESUMO
It is assumed that the individuals who undergo bariatric surgery will experience significant improvements in their health and overall well-being. However, it is yet to be examined whether these individuals may also experience subsequent decision regret. The level of regret regarding the choice to undergo bariatric surgery was assessed 1 year after bariatric surgery using the Decision Regret Scale (DRS). Associations of regret with patient characteristics, complications, weight loss and quality of life (BODY-Q) were investigated using linear regression analyses. In total, 115 patients completed the DRS (92% underwent Roux-en-Y gastric bypass Roux-en-Y gastric bypass and 8% underwent sleeve gastrectomy (SG)). Two out of 115 patients indicated absolute regret about their decision to undergo bariatric surgery because of insufficient weight loss and complications. The median decision regret score was zero (range 0-80). Most patients experienced no decision regret (50.4%), followed by mild regret (34.8%) and moderate to strong regret (14.8%). Higher levels of regret were associated with having osteo-articular disorders, gastro-oesophageal reflux disease or a history of psychiatric disorders at baseline. Patients with mild regret demonstrated significantly more weight loss and better psychological function. Major surgical complications were not associated with increased decision regret. Only two out of 115 patients (1.7%) indicated absolute regret about their decision to undergo bariatric surgery, and 15% reported moderate-to-strong regret according to the results of the DRS. These findings should be considered when providing pre-operative counselling and could assist patients in their decision-making process.
Assuntos
Cirurgia Bariátrica , Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Humanos , Obesidade Mórbida/cirurgia , Qualidade de Vida , Laparoscopia/métodos , Cirurgia Bariátrica/efeitos adversos , Cirurgia Bariátrica/métodos , Derivação Gástrica/métodos , Emoções , Gastrectomia/efeitos adversos , Gastrectomia/métodos , Redução de Peso , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVES: This study aimed to identify factors influencing orthopaedic trauma patients' experiences and satisfaction with emergency department (ED) care and follow-up through Virtual Fracture Care (VFC) review workflow. DESIGN: This study employed an explorative, descriptive, qualitative design using individual, semistructured interviews. SETTING: An urban level 2 trauma centre and teaching hospital in Amsterdam, the Netherlands. PARTICIPANTS: Eligible patients were Dutch-speaking or English-speaking orthopaedic trauma patients, aged 18 years or above, who visited the hospital's ED between June and September 2022, and were treated through VFC review workflow. Exclusion criteria were: reason for follow-up other than injury, eye/motor/verbal score <15 at ED admission, follow-up treatment in another hospital, treatment initiated in another hospital, acute hospital admission (<24 hours). Twenty-three patients were invited for participation, of whom 15 participated and were interviewed. RESULTS: Several influential factors contributed to seven generic themes: (1) waiting times, (2) information provision, (3) healthcare professional communication, (4) care expectations, (5) care coordination, (6) care environment and (7) patient condition. Overall, participants were satisfied with received care. Interpersonal skills of healthcare professionals, and timing and content of provided information were specifically valued. Additionally, patients stated that their needs in the ED differed from those after ED discharge, and appreciated the way the VFC review workflow addressed this. Points of improvement included more active involvement of patients in the care process and prevention of inconsistent instructions by different healthcare professionals. CONCLUSIONS: Patient experiences with ED care and VFC review follow-up are influenced by factors categorised into seven themes. The VFC review workflow effectively addresses these factors, leading to positive feedback. Recommendations for healthcare professionals include anticipating evolving post-ED information needs, engaging patients early to provide clarity about the care process, involving them in treatment decisions and expanding information provision across the entire care pathway.
Assuntos
Assistência ao Convalescente , Serviço Hospitalar de Emergência , Fraturas Ósseas , Telemedicina , Centros de Traumatologia , Humanos , Tratamento de Emergência , Hospitalização , Pesquisa Qualitativa , Fraturas Ósseas/terapia , População Urbana , Satisfação do PacienteRESUMO
The aim of this before-and-after study was to evaluate the implementation of a virtual fracture clinic (VFC) on the time between injury and surgery in patients presenting with a phalangeal or metacarpal fracture and in need of semi-acute surgical treatment. Between 1 January and 30 September 2018 (pre-VFC) and in the same period in 2022 (VFC), 101 and 113 patients were included, respectively. Before VCF implementation, the time between injury and surgery was 8.9 days (95% confidence interval [CI]: 8.1 to 9.6), while after VCF implementation it was 7.6 days (95% CI: 7.0 to 8.3). In 2018, 7% of operations were unacceptably delayed beyond 14 days from injury, which was reduced to 5% in 2022, despite patient-presentation delays of up to 10 days. VFC implementation was associated with a reduction in time until semi-acute surgery for phalangeal or metacarpal fractures and improved the quality of semi-acute surgery planning.Level of evidence: Level III.
RESUMO
This study aimed to determine the effects of virtual fracture care (VFC) on secondary healthcare utilization in non-operative treatment of adult patients with a distal radial fracture. A retrospective cohort study was performed, including those who received non-operative treatment without VFC (pre-VFC) and with VFC (VFC). Outcomes included secondary healthcare utilization, calculated treatment costs, emergency department (ED) reattendances and complication rates. In total, 88 pre-VFC and 99 VFC patients were included. Pre-VFC patients had more follow-up appointments, with a median of 4 (IQR: 3) versus a median of 4 (IQR: 1) in VFC patients. In addition, 3% of follow-up appointments for pre-VFC patients were performed remotely compared to 18% for VFC patients. Complications and ED reattendances were comparable between groups. In this study, non-operative treatment of adult patients with a distal radial fracture through VFC reduced secondary healthcare utilization, with similar reported complication and ED reattendance rates compared with treatment without VFC.Level of evidence: III.
Assuntos
Fixação Interna de Fraturas , Fraturas do Rádio , Adulto , Humanos , Estudos Retrospectivos , Fraturas do Rádio/cirurgiaRESUMO
BACKGROUND: Bariatric surgery with same-day discharge (SDD) is becoming increasingly common. Nevertheless, there is limited data available comparing gastric bypass patients with SDD to those with overnight hospitalization. OBJECTIVE: The aim of this study was to investigate the short-term outcomes of gastric bypass with SDD compared to overnight hospitalization in The Netherlands. SETTING: Retrospective database study with the use of the Dutch national registry. METHODS: Patients who underwent gastric bypass surgery in 2022 were included and propensity score matching was performed to compare SDD with patients discharged on postoperative days (POD) 1-4. The primary outcome was the occurrence of severe complications within 30 days postoperative. RESULTS: A total of 775 SDD patients were matched with 1550 patients discharged on POD 1-4. The occurrence of severe complications was .9% in both groups (P = 1.000), and there were no significant differences in reoperations or mortality. A significant difference was observed in the readmission rate, with 3.9% in the SDD group compared to 1.6% in the other group (P = .001). A proportionally small, yet statistically significant difference favored the control group regarding anastomotic leakages (.6% versus 0%, P = .004) and unspecified surgical complications (1.4% versus .5%, P = .028). CONCLUSION: Gastric bypass with SDD is safe, with no increased risk of short-term severe complications, reoperations, or mortality. However, SDD is associated with a higher 30-day readmission rate compared to patients who stay overnight in the hospital after surgery.