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1.
Surg Endosc ; 38(2): 872-879, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38082016

RESUMEN

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.


Asunto(s)
Derivación Gástrica , Laparoscopía , Obesidad Mórbida , Humanos , Alta del Paciente , Obesidad Mórbida/cirugía , Obesidad Mórbida/complicaciones , Estudios Prospectivos , Países Bajos , Estudios de Factibilidad , Derivación Gástrica/métodos , Gastrectomía/métodos , Laparoscopía/métodos , Estudios Retrospectivos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/cirugía
2.
Aesthet Surg J ; 43(5): 569-579, 2023 04 10.
Artículo en Inglés | MEDLINE | ID: mdl-36478151

RESUMEN

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.


Asunto(s)
Bariatria , Contorneado Corporal , Humanos , Calidad de Vida , Reproducibilidad de los Resultados , Estudios Prospectivos , Encuestas y Cuestionarios , Satisfacción del Paciente , Lenguaje , Psicometría
3.
Br J Surg ; 109(11): 1116-1123, 2022 10 14.
Artículo en Inglés | MEDLINE | ID: mdl-35979609

RESUMEN

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 900 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.


Asunto(s)
Cálculos Biliares , Derivación Gástrica , Obesidad Mórbida , Análisis Costo-Beneficio , Cálculos Biliares/prevención & control , Cálculos Biliares/cirugía , Gastrectomía , Humanos , Obesidad Mórbida/complicaciones , Obesidad Mórbida/cirugía , Ácido Ursodesoxicólico/uso terapéutico
4.
J Surg Oncol ; 124(7): 1173-1181, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34320228

RESUMEN

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.


Asunto(s)
Neoplasias Abdominales/cirugía , Recurrencia Local de Neoplasia/cirugía , Neoplasias Pélvicas/cirugía , Sarcoma/cirugía , Neoplasias de los Tejidos Blandos/cirugía , Cirugía Asistida por Computador , Neoplasias Abdominales/diagnóstico por imagen , Anciano , Pérdida de Sangre Quirúrgica , Medios de Contraste , Femenino , Humanos , Imagenología Tridimensional , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/diagnóstico por imagen , Tempo Operativo , Neoplasias Pélvicas/diagnóstico por imagen , Estudios Prospectivos , Sarcoma/diagnóstico por imagen , Neoplasias de los Tejidos Blandos/diagnóstico por imagen , Tomografía Computarizada por Rayos X
5.
Surg Endosc ; 35(8): 4609-4617, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-32815020

RESUMEN

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.


Asunto(s)
Derivación Gástrica , Laparoscopía , Obesidad Mórbida , Conducta Alimentaria , Gastrectomía , Humanos , Obesidad Mórbida/cirugía , Medición de Resultados Informados por el Paciente , Estudios Prospectivos , Resultado del Tratamiento
6.
Sleep Breath ; 25(2): 1037-1043, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-32986151

RESUMEN

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.


Asunto(s)
Fuga Anastomótica/epidemiología , Cirugía Bariátrica/efectos adversos , Presión de las Vías Aéreas Positiva Contínua , Complicaciones Posoperatorias/epidemiología , Grapado Quirúrgico/efectos adversos , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Estudios Retrospectivos , Apnea Obstructiva del Sueño/terapia , Resultado del Tratamiento
7.
J Endovasc Ther ; 25(1): 52-61, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-29219029

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Aortografía/métodos , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Angiografía por Tomografía Computarizada , Endofuga/diagnóstico por imagen , Procedimientos Endovasculares/instrumentación , Migración de Cuerpo Extraño/diagnóstico por imagen , Tomografía Computarizada Multidetector , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Migración de Cuerpo Extraño/etiología , Humanos , Imagenología Tridimensional , Masculino , Variaciones Dependientes del Observador , Valor Predictivo de las Pruebas , Diseño de Prótesis , Interpretación de Imagen Radiográfica Asistida por Computador , Reproducibilidad de los Resultados , Factores de Tiempo , Resultado del Tratamiento
8.
J Endovasc Ther ; 25(4): 428-434, 2018 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-29785859

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Procedimientos Endovasculares/instrumentación , Stents , Anciano , Anciano de 80 o más Años , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Angiografía por Tomografía Computarizada , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Femenino , Migración de Cuerpo Extraño/etiología , Humanos , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
9.
J Endovasc Ther ; 25(3): 366-375, 2018 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-29575993

RESUMEN

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.


Asunto(s)
Aorta Abdominal/cirugía , Aneurisma de la Aorta Abdominal/cirugía , Aortografía/métodos , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Angiografía por Tomografía Computarizada , Endofuga/diagnóstico por imagen , Procedimientos Endovasculares/instrumentación , Migración de Cuerpo Extraño/diagnóstico por imagen , Stents , Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Bases de Datos Factuales , Diagnóstico Precoz , Endofuga/etiología , Procedimientos Endovasculares/efectos adversos , Migración de Cuerpo Extraño/etiología , Humanos , Imagenología Tridimensional , Valor Predictivo de las Pruebas , Interpretación de Imagen Radiográfica Asistida por Computador , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
10.
Vascular ; 26(4): 393-399, 2018 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-29212423

RESUMEN

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.


Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Aortografía/métodos , Implantación de Prótesis Vascular/efectos adversos , Angiografía por Tomografía Computarizada/métodos , Endofuga/diagnóstico por imagen , Procedimientos Endovasculares/efectos adversos , Interpretación de Imagen Radiográfica Asistida por Computador/métodos , Técnica de Sustracción , Anciano , Anciano de 80 o más Años , Algoritmos , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Diagnóstico Precoz , Endofuga/etiología , Femenino , Humanos , Masculino , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Programas Informáticos , Factores de Tiempo , Resultado del Tratamiento
11.
BMC Gastroenterol ; 17(1): 164, 2017 Dec 20.
Artículo en Inglés | MEDLINE | ID: mdl-29262795

RESUMEN

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.


Asunto(s)
Colagogos y Coleréticos/uso terapéutico , Cálculos Biliares/prevención & control , Derivación Gástrica/efectos adversos , Complicaciones Posoperatorias/prevención & control , Ácido Ursodesoxicólico/uso terapéutico , Colagogos y Coleréticos/efectos adversos , Colagogos y Coleréticos/economía , Protocolos Clínicos , Análisis Costo-Beneficio , Método Doble Ciego , Estudios de Seguimiento , Cálculos Biliares/etiología , Humanos , Obesidad Mórbida/cirugía , Complicaciones Posoperatorias/etiología , Calidad de Vida , Ácido Ursodesoxicólico/efectos adversos , Ácido Ursodesoxicólico/economía
13.
JAMA ; 318(24): 2438-2445, 2017 12 26.
Artículo en Inglés | MEDLINE | ID: mdl-29279933

RESUMEN

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.


Asunto(s)
Antibacterianos/administración & dosificación , Profilaxis Antibiótica , Cefazolina/administración & dosificación , Remoción de Dispositivos/efectos adversos , Fracturas Óseas/cirugía , Extremidad Inferior/lesiones , Infección de la Herida Quirúrgica/prevención & control , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Incidencia , Infusiones Intravenosas , Análisis de Intención de Tratar , Fijadores Internos , Masculino , Persona de Mediana Edad , Prótesis e Implantes/efectos adversos , Calidad de Vida , Infección de la Herida Quirúrgica/epidemiología , Adulto Joven
14.
BMC Surg ; 15: 12, 2015 Feb 06.
Artículo en Inglés | MEDLINE | ID: mdl-25972101

RESUMEN

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.


Asunto(s)
Antibacterianos/uso terapéutico , Profilaxis Antibiótica , Cefazolina/uso terapéutico , Remoción de Dispositivos , Fijación Interna de Fracturas/instrumentación , Cuidados Preoperatorios/métodos , Infección de la Herida Quirúrgica/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Protocolos Clínicos , Método Doble Ciego , Esquema de Medicación , Femenino , Estudios de Seguimiento , Pie/cirugía , Humanos , Inyecciones Intravenosas , Pierna/cirugía , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Adulto Joven
15.
BMJ Open ; 14(2): e076040, 2024 Feb 21.
Artículo en Inglés | MEDLINE | ID: mdl-38387990

RESUMEN

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.


Asunto(s)
Cuidados Posteriores , Servicio de Urgencia en Hospital , Fracturas Óseas , Telemedicina , Centros Traumatológicos , Humanos , Tratamiento de Urgencia , Hospitalización , Investigación Cualitativa , Fracturas Óseas/terapia , Población Urbana , Satisfacción del Paciente
16.
Clin Obes ; 14(2): e12633, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38124342

RESUMEN

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.


Asunto(s)
Cirugía Bariátrica , Derivación Gástrica , Laparoscopía , Obesidad Mórbida , Humanos , Obesidad Mórbida/cirugía , Calidad de Vida , Laparoscopía/métodos , Cirugía Bariátrica/efectos adversos , Cirugía Bariátrica/métodos , Derivación Gástrica/métodos , Emociones , Gastrectomía/efectos adversos , Gastrectomía/métodos , Pérdida de Peso , Estudios Retrospectivos , Resultado del Tratamiento
17.
J Hand Surg Eur Vol ; 49(3): 341-349, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-37458134

RESUMEN

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.


Asunto(s)
Fijación Interna de Fracturas , Fracturas del Radio , Adulto , Humanos , Estudios Retrospectivos , Fracturas del Radio/cirugía
18.
Obes Surg ; 34(8): 2862-2871, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38795202

RESUMEN

INTRODUCTION: Same-day discharge (SDD) after laparoscopic Roux-en-Y gastric bypass (RYGB) is a safe and effective healthcare pathway. However, there is limited understanding of the patient perspective on SDD. The aim of this study was to explore patient satisfaction and experience with SDD after RYGB. METHODS: A mixed-methods study with a concurrent design was conducted in a Dutch teaching hospital, using questionnaires and interviews. Patients who underwent RYGB and were discharged on the day of the surgery completed four questionnaires of the BODY-Q (satisfaction with the surgeon, satisfaction with the medical team, satisfaction with the office staff, and satisfaction with information provision) ± 4 months postoperative. The results of the questionnaires were compared with pre-existing data from a cohort of patients who stayed overnight after surgery (i.e., control group). A subset of patients was individually interviewed for an in-depth understanding of the patient perspective on SDD. RESULTS: In the questionnaires, median scores for the control group (n = 158) versus the present group of patients (n = 51) were as follows: 92/100 vs. 92/100 (p = 0.331) for the surgeon, 100/100 vs. 92/100 (p = 0.775) for the medical team, 100/100 vs. 100/100 (p = 0.616) for the office staff, and 90/100 vs. 73/100 (p = 0.015) for information provision. Interviews with 14 patients revealed seven themes, describing high satisfaction, along with several points of interest. CONCLUSIONS: Patient satisfaction with SDD after RYGB is high, although information provision regarding the day of surgery could be improved. However, not every medically eligible patient might be suitable for this healthcare pathway, as responsibilities are shifted.


Asunto(s)
Derivación Gástrica , Laparoscopía , Obesidad Mórbida , Alta del Paciente , Satisfacción del Paciente , Humanos , Femenino , Masculino , Adulto , Encuestas y Cuestionarios , Obesidad Mórbida/cirugía , Obesidad Mórbida/psicología , Persona de Mediana Edad , Países Bajos , Procedimientos Quirúrgicos Ambulatorios
19.
Clin Obes ; : e12675, 2024 May 22.
Artículo en Inglés | MEDLINE | ID: mdl-38777325

RESUMEN

BODY-Q is a patient-reported outcome measure for comprehensive assessment of outcomes specific to patients undergoing bariatric surgery. The clinical utility of BODY-Q is hampered by the lack of guidance on score interpretation. This study aimed to determine minimal important difference (MID) for assessment of BODY-Q. Prospective BODY-Q data from Denmark and the Netherlands pre- and post-bariatric surgery were collected. Two distribution-based methods were used to estimate MID by 0.2 standard deviations of baseline scores and the mean standardized response change of scores from baseline to 3-years postoperatively. In total, 5476 assessments from 2253 participants were included of which 1628 (72.3%) underwent Roux-en-Y gastric bypass, 586 (26.0%) sleeve gastrectomy, 33 (1.5%) gastric banding, and 6 (0.03%) other surgeries. The mean age was 45.1 ± 10.9 with a mean BMI of 46.6 ± 9.6. Baseline MID ranged from 1 to 4 in health-related quality of life (HRQL) and from 2 to 8 in appearance scales. The mean change of scores ranged from 4 to 5 in HRQL and from 4 to 7 in the appearance scales. The estimated MID for the change in BODY-Q HRQL and appearance scales ranged from 3 to 8 and is recommended for use to interpret BODY-Q scores and assess treatment effects in bariatric surgery.

20.
Obes Surg ; 33(3): 807-812, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36598709

RESUMEN

INTRODUCTION: Same-day discharge after bariatric surgery is increasingly being performed. In current practice, patients with only minor comorbidities are considered eligible for same-day discharge after laparoscopic Roux-en-Y gastric bypass (RYGB). Obstructive sleep apnea (OSA) is a common comorbidity in patients with morbid obesity, with a prevalence of around 70-80% among patients undergoing bariatric surgery. Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. We aimed to investigate whether same-day discharge after RYGB is feasible for patients with compliant use of CPAP. METHODS: In this single-center prospective feasibility study, patients were selected who were scheduled for RYGB and were adequately treated for OSA. Compliance on the use of CPAP had to be proved (> 4 h per night for 14 consecutive nights). There were strict criteria on approval upon same-day discharge. The primary outcome was the rate of successful same-day discharge. Secondary outcomes included short-term complications, emergency department presentations, readmissions, and mortality. RESULTS: Forty-nine patients underwent RYGB with intended same-day discharge, of whom 45 (92%) were successfully discharged. Three patients had an overnight stay because of divergent vital signs and one patient due to a delayed start of the surgery. Two patients (4%) were readmitted in the first 48 h postoperatively, both due to intraluminal bleeding which was managed conservatively (Clavien-Dindo 2). There were no severe complications in the first 48 h after surgery. CONCLUSION: Same-day discharge after RYGB can be considered feasible for selected patients with well-regulated OSA.


Asunto(s)
Derivación Gástrica , Laparoscopía , Obesidad Mórbida , Apnea Obstructiva del Sueño , Humanos , Derivación Gástrica/efectos adversos , Obesidad Mórbida/cirugía , Alta del Paciente , Estudios Prospectivos , Estudios de Factibilidad , Apnea Obstructiva del Sueño/cirugía , Apnea Obstructiva del Sueño/complicaciones , Laparoscopía/efectos adversos , Estudios Retrospectivos , Resultado del Tratamiento
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