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1.
Ann Surg ; 279(5): 885-890, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-37698025

RESUMO

OBJECTIVE: To compare costs for 2 days versus 5 days of postoperative antibiotics within the antibiotics after an aPPendectomy In Complex appendicitis trial.Background:Recent studies suggest that restrictive antibiotic use leads to a significant reduction in hospital stays without compromising patient safety. Its potential effect on societal costs remains underexplored. METHODS: This was a pragmatic, open-label, multicenter clinical trial powered for noninferiority. Patients with complex appendicitis (age ≥ 8 years) were randomly allocated to 2 days or 5 days of intravenous antibiotics after appendectomy. Patient inclusion lasted from June 2017 to June 2021 in 15 Dutch hospitals. The final follow-up was on September 1, 2021. The primary trial endpoint was a composite endpoint of infectious complications and mortality within 90 days. In the present study, the main outcome measures were overall societal costs (comprising direct health care costs and costs related to productivity loss) and cost-effectiveness. Direct health care costs were recorded based on data in the electronic patient files, complemented by a telephone follow-up at 90 days. In addition, data on loss of productivity were acquired through the validated Productivity Cost Questionnaire at 4 weeks after surgery. Cost estimates were based on prices for the year 2019. RESULTS: In total, 1005 patients were evaluated in the "intention-to-treat" analysis: 502 patients were allocated to the 2-day group and 503 to the 5-day group. The mean difference in overall societal costs was - €625 (95% CI: -€ 958 to -€ 278) to the advantage of the 2-day group. This difference was largely explained by reduced hospital stay. Productivity losses were similar between the study groups. Restricting postoperative antibiotics to 2 days was cost-effective, with estimated cost savings of €31,117 per additional infectious complication. CONCLUSIONS: Two days of postoperative antibiotics for complex appendicitis results in a statistically significant and relevant cost reduction, as compared with 5 days. Findings apply to laparoscopic appendectomy in a well-resourced health care setting.


Assuntos
Antibacterianos , Apendicite , Humanos , Criança , Antibacterianos/uso terapêutico , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Apendicectomia/métodos , Tempo de Internação , Custos de Cuidados de Saúde , Resultado do Tratamento
2.
Lancet ; 401(10374): 366-376, 2023 02 04.
Artigo em Inglês | MEDLINE | ID: mdl-36669519

RESUMO

BACKGROUND: The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs. METHODS: In this pragmatic, open-label, non-inferiority trial in 15 hospitals in the Netherlands, patients with complex appendicitis (aged ≥8 years) were randomly assigned (1:1) to receive 2 days or 5 days of intravenous antibiotics after appendicectomy. Randomisation was stratified by centre, and treating physicians and patients were not masked to treatment allocation. The primary endpoint was a composite endpoint of infectious complications and mortality within 90 days. The main outcome was the absolute risk difference (95% CI) in the primary endpoint, adjusted for age and severity of appendicitis, with a non-inferiority margin of 7·5%. Outcome assessment was based on electronic patient records and a telephone consultation 90 days after appendicectomy. Efficacy was analysed in the intention-to-treat and per-protocol populations. Safety outcomes were analysed in the intention-to-treat population. This trial was registered with the Netherlands Trial Register, NL5946. FINDINGS: Between April 12, 2017, and June 3, 2021, 13 267 patients were screened and 1066 were randomly assigned, 533 to each group. 31 were excluded from intention-to-treat analysis of the 2-day group and 30 from the 5-day group owing to errors in recruitment or consent. Appendicectomy was done laparoscopically in 955 (95%) of 1005 patients. The telephone follow-up was completed in 664 (66%) of 1005 patients. The primary endpoint occurred in 51 (10%) of 502 patients analysed in the 2-day group and 41 (8%) of 503 patients analysed in the 5-day group (adjusted absolute risk difference 2·0%, 95% CI -1·6 to 5·6). Rates of complications and re-interventions were similar between trial groups. Fewer patients had adverse effects of antibiotics in the 2-day group (45 [9%] of 502 patients) than in the 5-day group (112 [22%] of 503 patients; odds ratio [OR] 0·344, 95% CI 0·237 to 0·498). Re-admission to hospital was more frequent in the 2-day group (58 [12%] of 502 patients) than in the 5-day group (29 [6%] of 503 patients; OR 2·135, 1·342 to 3·396). There were no treatment-related deaths. INTERPRETATION: 2 days of postoperative intravenous antibiotics for complex appendicitis is non-inferior to 5 days in terms of infectious complications and mortality within 90 days, based on a non-inferiority margin of 7·5%. These findings apply to laparoscopic appendicectomy conducted in a well resourced health-care setting. Adopting this strategy will reduce adverse effects of antibiotics and length of hospital stay. FUNDING: The Netherlands Organization for Health Research and Development.


Assuntos
Antibacterianos , Apendicite , Humanos , Apendicite/tratamento farmacológico , Apendicite/cirurgia , Encaminhamento e Consulta , Resultado do Tratamento , Telefone
3.
Ann Surg Oncol ; 30(9): 5472-5485, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37340200

RESUMO

BACKGROUND: Involved lateral lymph nodes (LLNs) have been associated with increased local recurrence (LR) and ipsi-lateral LR (LLR) rates. However, consensus regarding the indication and type of surgical treatment for suspicious LLNs is lacking. This study evaluated the surgical treatment of LLNs in an untrained setting at a national level. METHODS: Patients who underwent additional LLN surgery were selected from a national cross-sectional cohort study regarding patients undergoing rectal cancer surgery in 69 Dutch hospitals in 2016. LLN surgery consisted of either 'node-picking' (the removal of an individual LLN) or 'partial regional node dissection' (PRND; an incomplete resection of the LLN area). For all patients with primarily enlarged (≥7 mm) LLNs, those undergoing rectal surgery with an additional LLN procedure were compared to those  undergoing only rectal resection. RESULTS: Out of 3057 patients, 64 underwent additional LLN surgery, with 4-year LR and LLR rates of 26% and 15%, respectively. Forty-eight patients (75%) had enlarged LLNs, with corresponding recurrence rates of 26% and 19%, respectively. Node-picking (n = 40) resulted in a 20% 4-year LLR, and a 14% LLR after PRND (n = 8; p = 0.677). Multivariable analysis of 158 patients with enlarged LLNs undergoing additional LLN surgery (n = 48) or rectal resection alone (n = 110) showed no significant association of LLN surgery with 4-year LR or LLR, but suggested higher recurrence risks after LLN surgery (LR: hazard ratio [HR] 1.5, 95% confidence interval [CI] 0.7-3.2, p = 0.264; LLR: HR 1.9, 95% CI 0.2-2.5, p = 0.874). CONCLUSION: Evaluation of Dutch practice in 2016 revealed that approximately one-third of patients with primarily enlarged LLNs underwent surgical treatment, mostly consisting of node-picking. Recurrence rates were not significantly affected by LLN surgery, but did suggest worse outcomes. Outcomes of LLN surgery after adequate training requires further research.


Assuntos
Excisão de Linfonodo , Neoplasias Retais , Humanos , Excisão de Linfonodo/métodos , Estudos Transversais , Linfonodos/cirurgia , Linfonodos/patologia , Neoplasias Retais/patologia , Reto/patologia , Estudos Retrospectivos , Recidiva Local de Neoplasia/cirurgia , Recidiva Local de Neoplasia/patologia , Estadiamento de Neoplasias
4.
Int J Colorectal Dis ; 37(5): 1087-1095, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35415811

RESUMO

PURPOSE: Current studies have demonstrated conflicting results regarding surgical care for acute appendicitis during the COVID-19 pandemic. This study aimed to assess trends in diagnosis as well as treatment of acute appendicitis in the Netherlands during the first and second COVID-19 infection wave. METHODS: All consecutive patients that had an appendectomy for acute appendicitis in nine hospitals from January 2019 to December 2020 were included. The primary outcome was the number of appendectomies for acute appendicitis. Secondary outcomes included time between onset of symptoms and hospital admission, proportion of complex appendicitis, postoperative length of stay and postoperative infectious complications. Outcomes were compared between the pre-COVID group and COVID group. RESULTS: A total of 4401 patients were included. The mean weekly rate of appendectomies during the COVID period was 44.0, compared to 40.9 in the pre-COVID period. The proportion of patients with complex appendicitis and mean postoperative length of stay in days were similar in the pre-COVID and COVID group (respectively 35.5% vs 36.8%, p = 0.36 and 2.0 ± 2.2 vs 2.0 ± 2.6, p = 0.93). There were no differences in postoperative infectious complications. A computed tomography scan was used more frequently as a diagnostic tool after the onset of COVID-19 compared to pre-COVID (13.8% vs 9.8%, p < 0.001, respectively). CONCLUSION: No differences were observed in number of appendectomies, proportion of complex appendicitis, postoperative length of stay or postoperative infectious complications before and during the COVID-19 pandemic. A CT scan was used more frequently during the COVID-19 pandemic.


Assuntos
Apendicite , COVID-19 , Doença Aguda , Apendicectomia/efeitos adversos , Apendicectomia/métodos , Apendicite/diagnóstico , Apendicite/epidemiologia , Apendicite/cirurgia , COVID-19/epidemiologia , Estudos de Coortes , Humanos , Tempo de Internação , Pandemias , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos
5.
Breast Cancer Res ; 20(1): 34, 2018 04 18.
Artigo em Inglês | MEDLINE | ID: mdl-29669584

RESUMO

BACKGROUND: The main purpose was to investigate the correlation between magnetic resonance imaging (MRI)-based response patterns halfway through neoadjuvant chemotherapy and immunotherapy (NAC) and pathological tumor response in patients with breast cancer. Secondary purposes were to compare the predictive value of MRI-based response patterns measured halfway through NAC and after NAC and to measure interobserver variability. METHODS: All consecutive patients treated with NAC for primary invasive breast cancer from 2012 to 2015 and who underwent breast MRI before, halfway through (and after) NAC were included. All breast tumors were reassessed on MRI by two experienced breast radiologists and classified into six patterns: type 0 (complete radiologic response); type 1 (concentric shrinkage); type 2 (crumbling); type 3 (diffuse enhancement); type 4 (stable disease); type 5 (progressive disease). Percentages of tumors showing pathological complete response (pCR), > 50% tumor reduction and > 50% tumor diameter reduction per MRI-based response pattern were calculated. Correlation between MRI-based response patterns and pathological tumor reduction was studied with Pearson's correlation coefficient, and interobserver agreement was tested with Cohen's Kappa. RESULTS: Patients (n = 76; mean age 53, range 29-72 years) with 80 tumors (4 bilateral) were included. There was significant correlation between these MRI-based response patterns halfway through NAC and tumor reduction on pathology assessment (reader 1 r = 0.33; p = 0.003 and reader 2 r = 0.45; p < 0.001). Type-0, type-1 or type-2 patterns halfway through NAC showed highest tumor reduction rates on pathology assessment, with > 50% tumor reduction in 90%, 78% and 65% of cases, respectively. In 83% of tumors with type 0 halfway through NAC, pathology assessment showed pCR. There was no significant correlation between MRI-based response patterns after NAC and tumor reduction rates on pathology assessment (reader 1 r = - 0.17; p = 0.145 and reader 2 r = - 0.17; p = 0.146). In 41% of tumors with type 0 after NAC, pathology assessment showed pCR. CONCLUSION: MRI-based response patterns halfway through NAC can predict pathologic response more accurately than MRI-based response patterns after NAC. Complete radiological response halfway NAC is associated with 83% pCR, while complete radiological response after NAC seems to be correct in only 41% of cases.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Mama/diagnóstico por imagem , Carcinoma Ductal de Mama/tratamento farmacológico , Terapia Neoadjuvante/métodos , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Mama/efeitos dos fármacos , Mama/patologia , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/diagnóstico por imagem , Carcinoma Ductal de Mama/patologia , Meios de Contraste/administração & dosagem , Feminino , Humanos , Imageamento por Ressonância Magnética , Pessoa de Meia-Idade
7.
Obes Surg ; 34(4): 1286-1294, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38393455

RESUMO

INTRODUCTION: Several studies have shown the positive effect on weight loss of the banded Roux-en-Y gastric bypass (BRYGB). Thus far, studies describing the 10-year post-operative results are scarce. Therefore, the aim of this study was to describe the weight loss results, effect on associated medical problems, and complication rates during 10 years of follow-up after BRYGB. METHOD: Data were collected from patients who underwent laparoscopic BRYGB with a non-adjustable silicone gastric ring between January 2011 and March 2013. All patients were included when found to be eligible according to the IFSO criteria. RESULTS: One hundred forty-nine patients were included, 110 received a primary BRYGB and 39 received a conversional BRYGB. The primary BRYGB group consisted of 68% female patients with a mean BMI of 44.5 kg/m2 and a mean age of 46 years old. The conversional group consisted of 77% females and had a mean BMI of 34.8 kg/m2 and a mean age of 48 years. At 10-year follow-up, 67.1% of the data was available. Ten-year post-operative 30% total weight loss was seen in the primary group, and 7% in the conversional group. In 10 years, 23% of the patients had complications of which half were ring-related. CONCLUSION: The addition of a silicon ring to the Roux-en-Y gastric bypass may result in substantial and stable weight loss maintenance 10 years post-operative. Furthermore, the number of patients with long-term complications was low and the number of associated medical problems was significantly reduced.


Assuntos
Derivação Gástrica , Laparoscopia , Obesidade Mórbida , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Derivação Gástrica/métodos , Obesidade Mórbida/cirurgia , Seguimentos , Estômago/cirurgia , Redução de Peso , Laparoscopia/métodos , Resultado do Tratamento , Estudos Retrospectivos
8.
BMJ Open ; 14(5): e078853, 2024 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-38719323

RESUMO

INTRODUCTION: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery. METHOD AND ANALYSIS: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05464394.


Assuntos
Antifibrinolíticos , Derivação Gástrica , Obesidade Mórbida , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/uso terapêutico , Derivação Gástrica/efeitos adversos , Derivação Gástrica/métodos , Obesidade Mórbida/cirurgia , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/uso terapêutico , Método Duplo-Cego , Hemorragia Pós-Operatória/prevenção & controle , Hemorragia Pós-Operatória/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Feminino , Estudos Multicêntricos como Assunto , Adulto , Países Baixos , Ensaios Clínicos Fase III como Assunto , Masculino
9.
Blood ; 117(8): 2319-31, 2011 Feb 24.
Artigo em Inglês | MEDLINE | ID: mdl-21119107

RESUMO

In many B-cell lymphomas, chromosomal translocations are biologic and diagnostic hallmarks of disease. An intriguing subset is formed by the so-called double- hit (DH) lymphomas that are defined by a chromosomal breakpoint affecting the MYC/8q24 locus in combination with another recurrent breakpoint, mainly a t(14;18)(q32;q21) involving BCL2. Recently, these lymphomas have received increased attention, which contributed to the introduction of a novel category of lymphomas in the 2008 WHO classification, "B cell lymphoma unclassifiable with features intermediate between DLBCL and BL." In this review we explore the existing literature for the most recurrent types of DH B-cell lymphomas and the involved genes with their functions, as well as their pathology and clinical aspects including therapy and prognosis. The incidence of aggressive B-cell lymphomas other than Burkitt lymphoma with a MYC breakpoint and in particular a double hit is difficult to assess, because screening by methods like FISH has not been applied on large, unselected series, and the published cytogenetic data may be biased to specific categories of lymphomas. DH lymphomas have been classified heterogeneously but mostly as DLBCL, the majority having a germinal center phenotype and expression of BCL2. Patients with DH lymphomas often present with poor prognostic parameters, including elevated LDH, bone marrow and CNS involvement, and a high IPI score. All studies on larger series of patients suggest a poor prognosis, also if treated with RCHOP or high-intensity treatment modalities. Importantly, this poor outcome cannot be accounted for by the mere presence of a MYC/8q24 breakpoint. Likely, the combination of MYC and BCL2 expression and/or a related high genomic complexity are more important. Compared to these DH lymphomas, BCL6(+)/MYC(+) DH lymphomas are far less common, and in fact most of these cases represent BCL2(+)/BCL6(+)/MYC(+) triple-hit lymphomas with involvement of BCL2 as well. CCND1(+)/MYC(+) DH lymphomas with involvement of 11q13 may also be relatively frequent, the great majority being classified as aggressive variants of mantle cell lymphoma. This suggests that activation of MYC might be an important progression pathway in mantle cell lymphoma as well. Based on clinical significance and the fact that no other solid diagnostic tools are available to identify DH lymphomas, it seems advisable to test all diffuse large B-cell and related lymphomas for MYC and other breakpoints.


Assuntos
Pontos de Quebra do Cromossomo , Linfoma de Células B/classificação , Linfoma de Células B/genética , Genes myc , Humanos , Prognóstico
10.
Obes Surg ; 33(6): 1746-1753, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37043139

RESUMO

BACKGROUND: Vertical banded gastroplasty (VBG) has a relatively high failure rate in the long run, requiring revisional surgery in 30-65%. A common conversion option is to Roux-en-Y gastric bypass (RYGB), which can be performed laparoscopically or open. Current literature contains small cohorts and inconclusive results. Therefore, we set out to compare our series of open and laparoscopic VBG to RYGB conversions. METHODS: All conversions performed between 1996 and 2020 were included. Patients were divided into 3 groups based on conversion indication: weight recurrence (group 1), excessive weight loss (group 2), and eating/pouch difficulties (group 3). The primary outcome was postoperative complications according to the Clavien-Dindo (CD) classification. Secondary outcome was %total weight loss (%TWL) 1 to 5 years after revisional surgery. RESULTS: We included 205 patients (84.9% female) of whom 105 underwent laparoscopic and 100 open VBG to RYGB conversion. Twenty-three short-term complications occurred in the laparoscopic group, with 16 > CD3a. In the open group, 33 complications occurred with 12 > CD3a. Overall complications were 33.3% in laparoscopic and 64% in open patients. There were no significant differences between the laparoscopic and open group in BMI (p = 0.76) and %TWL (p = 0.694) after 5 years. After 5 years, lost to follow-up was 97% in the open group. Twenty-eight percent of patients who reached follow-up in the laparoscopic group had available data. CONCLUSIONS: We demonstrate that the overall complication rate is lower in the laparoscopic group compared to the open group. Regarding BMI, an improvement was achieved in both groups after 5 years.


Assuntos
Derivação Gástrica , Gastroplastia , Laparoscopia , Obesidade Mórbida , Humanos , Feminino , Masculino , Derivação Gástrica/métodos , Gastroplastia/efeitos adversos , Gastroplastia/métodos , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Reoperação/métodos , Laparoscopia/métodos , Redução de Peso , Resultado do Tratamento
11.
Obes Surg ; 33(6): 1668-1675, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37012502

RESUMO

BACKGROUND: Some patients with overweight or obesity are not eligible for surgery according to international guidelines or do not wish a surgical intervention. For these patients, different treatment options are being explored. In this study, we examined the effectiveness of the swallowable intragastric balloon (IB) combined with lifestyle coaching, in patients living with overweight and obesity. METHOD: A retrospective data study was conducted on patients with a swallowable IB placement between December 2018 and July 2021, combined with a 12-month coaching program. Before balloon placement, patients underwent multidisciplinary screening. The IB was swallowed and filled with fluid once in the stomach and naturally excreted around 16 weeks. RESULTS: A total of 336 patients, 71.7% female, were included with a mean age of 45.7 (±11.7) years. Mean baseline weight and BMI were 107.54 (±19.16) kg and 36.1 (±5.02) kg/m2. After 1 year, the mean total weight loss was 11.0% (±8.4). The mean placement duration was 13.1 (±2.82) min, and in 43.7%, a stylet was used to facilitate placement. The most common symptoms were nausea (80.4%) and gastric pain (80.3%). In the majority of patients, complaints were resolved within a week. The early deflation of the balloon occurred in 8 patients (2.4%) of which one showed symptoms suggesting a gastric outlet obstruction. CONCLUSION: Given the low rate of long-term complaints while providing a positive effect on weight loss, we conclude that the swallowable intragastric balloon, combined with lifestyle coaching, is a safe and effective treatment option for patients living with overweight and obesity.


Assuntos
Balão Gástrico , Tutoria , Obesidade Mórbida , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Sobrepeso/etiologia , Obesidade Mórbida/cirurgia , Balão Gástrico/efeitos adversos , Estudos Retrospectivos , Obesidade/complicações , Obesidade/cirurgia , Resultado do Tratamento , Redução de Peso , Estilo de Vida , Índice de Massa Corporal
12.
BMJ Open ; 13(7): e067981, 2023 07 04.
Artigo em Inglês | MEDLINE | ID: mdl-37407040

RESUMO

INTRODUCTION: Oesophageal cancer (EC) and gastric cancer (GC) are among the top 10 cancers worldwide. Both diseases impact the nutritional status of patients and their Quality of Life (QoL). Preoperative malnutrition is reported in 42%-80%. However, studies investigating postoperative nutritional status are limited, and postoperative identification and treatment of micronutrient and macronutrient deficiencies are currently lacking in (inter-)national guidelines. The aim of this study is to identify and target micronutrient deficiencies after surgery for oesophagogastric neoplasms. METHODS: This is a single-centre prospective intervention trial performed in Zuyderland Medical Centre. 248 patients who underwent oesophagectomy (n=124) or (sub)total gastrectomy (n=124) from 2011 until 2022 will be included. Both groups will receive Calcium Soft Chew D3 and a multivitamin supplement (MVS) specifically developed according to the type of operation patients underwent; the oesophagectomy group will receive Multi-E and the gastrectomy group will receive Multi-G. The MVSs will be taken once daily and Calcium Soft Chew D3 two times per day. Supplementation will start after baseline measurements. At baseline (T0), blood withdrawal for micronutrient analysis and faecal elastase-1 analysis for exocrine pancreatic insufficiency (EPI) will be performed. Additionally, patients will receive questionnaires regarding QoL and dietary behaviour. After 180 days of supplementation (T1), baseline measurements will be repeated, and the supplement tolerance questionnaire will be completed. Measurements will also be conducted after 360 days (T2) and after 720 days (T3) of supplementation. The main study parameter is micronutrient deficiency (yes/no) for all measurements. Secondary parameters include occurrence of EPI (n, %), diarrhoea (n, %), steatorrhoea (n, %) or bloating (n, %), time between surgery and start of supplementation (mean in months), and QoL at all time points. ETHICS AND DISSEMINATION: The study was approved by the Zuyderland Medical Centre Ethics Committee, Heerlen, the Netherlands. The findings will be disseminated through scientific congresses and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05281380.


Assuntos
Neoplasias Esofágicas , Vitaminas , Humanos , Vitaminas/uso terapêutico , Qualidade de Vida , Estudos Prospectivos , Cálcio , Cálcio da Dieta , Neoplasias Esofágicas/cirurgia
13.
Obes Surg ; 33(12): 3746-3754, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37922062

RESUMO

INTRODUCTION: Weight loss prior to bariatric-metabolic surgery (BMS) is recommended in most bariatric centers. However, there is limited high-quality evidence to support mandatory preoperative weight loss. In this study, we will evaluate whether weight gain prior to primary BMS is related to lower postoperative weight loss. METHODS: A retrospective analysis of prospectively collected data was performed. Preoperative weight loss (weight loss from start of program to day of surgery), postoperative weight loss (weight loss from day of surgery to follow-up), and total weight loss (weight loss from start of program to follow-up) were calculated. Five groups were defined based on patients' preoperative weight change: preoperative weight loss of >5 kg (group I), 3-5 kg (group II), 1-3 kg (group III), preoperative stable weight (group IV), and preoperative weight gain >1 kg (group V). Linear mixed models were used to compare the postoperative weight loss between group V and the other four groups (I-IV). RESULTS: A total of 1928 patients were included. Mean age was 44 years, 78.6% were female, and preoperative BMI was 43.7 kg/m2. Analysis showed significantly higher postoperative weight loss in group V, compared to all other groups at 12, 24, and 36 months follow-up. Up to three years follow-up, highest total weight loss was observed in group I. CONCLUSION: Weight gain before surgery should not be a reason to withhold a bariatric-metabolic operation. However, patients with higher preoperative weight loss have higher total weight loss. Therefore, preoperative weight loss should be encouraged prior to bariatric surgery.


Assuntos
Cirurgia Bariátrica , Obesidade Mórbida , Humanos , Feminino , Adulto , Masculino , Estudos Retrospectivos , Obesidade Mórbida/cirurgia , Aumento de Peso , Redução de Peso , Resultado do Tratamento
14.
Obes Surg ; 32(6): 1856-1863, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35366739

RESUMO

BACKGROUND: Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for obesity with excellent long-term results, even though weight regain can occur. A method to improve the results of RYGB and minimize chance of weight regain is banded RYGB. Better sustained weight loss is also related to higher remission of comorbidities. The aim of this study was to evaluate the effect of banded and non-banded RYGB on long-term weight loss results and comorbidities. METHOD: A retrospective comparative data study was performed. Patients who underwent a primary RYGB between July 2013 and December 2014 and followed a 5-year follow-up program in the Dutch Obesity Clinic were included. Comorbidities were assessed during screening and follow-up. RESULTS: The study included 375 patients with mean weight and body mass index (BMI) of 128.9 (± 21.2) kg and 44.50 (± 5.72) kg/m2. Of this group, 184 patients underwent RYGB and 191 banded RYGB. During follow-up (3 months, 1-5 years) % Total Weight Loss (%TWL) was superior in the banded group (32.6% vs 27.6% at 5 years post-operative, p < 0.001). Complication rates in both groups were similar. Comorbidity improvement or remission did not significantly differ between the two groups (p = 0.14-1.00). After 5 years of follow-up, 79 patients (20.5%) were lost to follow-up. CONCLUSION: Banded RYGB does show superior weight loss compared to non-banded RYGB. No difference in effect on comorbidity improvement or remission was observed. Since complication rates are similar, while weight loss is significantly greater, we recommend performing banded RYGB over non-banded RYGB.


Assuntos
Derivação Gástrica , Obesidade Mórbida , Índice de Massa Corporal , Derivação Gástrica/métodos , Humanos , Obesidade Mórbida/cirurgia , Reoperação/métodos , Estudos Retrospectivos , Resultado do Tratamento , Aumento de Peso , Redução de Peso
15.
Obes Surg ; 32(9): 2860-2868, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35788954

RESUMO

BACKGROUND: Prior research suggested presurgical weight loss is associated with greater total weight loss, resulting in a more effective bariatric intervention. We aimed to assess whether preoperative weight loss is a predictor for total weight loss, and which patient factors are associated with successful weight loss. METHODS: All patients (N = 773) that underwent primary bariatric surgery between June 2017 and August 2019 were included in this single-center retrospective study. Outcome measures were preoperative weight loss (%preopWL) and total weight loss (%TWL) up to 1 year postoperatively. Patients were divided into 4 groups based on quartiles of %preopWL. RESULTS: Total weight loss after 1, 6, and 12 months for the upper quartile was 16.9%, 33.4%, and 37.8%, and for the lower quartile 11.8%, 28.9%, and 35.2%, respectively (p < 0.001). Seven hundred fourteen patients (92.4%) were available for the 1-year follow-up. Preoperative weight loss was not associated with the incidence of complications. Independent factors predicting increased %preopWL were mandated preoperative weight loss program (MWP) (p < 0.001), older age (p = 0.005), weight measurement in the week before surgery (p = 0.031), and non-diabetic status (p = 0.010). Predictors for superior %TWL were MWP (p = 0.014), younger age (p = 0.001), non-diabetic status (p = 0.005), female gender (p = 0.001), higher Body Mass Index (p = 0.006), and banded gastric bypass (p = 0.001). CONCLUSION: Higher preoperative weight loss is associated with persisting greater weight loss up to at least 12 months post-surgery. In order to optimize preoperative weight loss, we recommend extra preoperative support to younger and diabetic patients. We advise nutritional counseling and additional weight measurement in the week before surgery.


Assuntos
Cirurgia Bariátrica , Derivação Gástrica , Obesidade Mórbida , Índice de Massa Corporal , Feminino , Humanos , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Redução de Peso
16.
Obes Surg ; 31(10): 4607-4611, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34283377

RESUMO

Prevailing recommendations on reporting weight loss after bariatric and metabolic surgery are not evidence-based. They promote the outcome metric percentage excess weight loss (%EWL), sometimes indicated as percentage excess body mass index loss (%EBMIL). Many studies proved that this popular outcome measure, in contrast to other weight loss metrics, is inaccurate and error-sensitive when comparing weight loss within and between studies. It is inappropriate for assessing poor weight loss response and weight regain as well. The percentage (total) weight loss metric is the best alternative. The Dutch Society for Metabolic and Bariatric Surgery (DSMBS) recommends to stop using the %EWL (or %EBMIL) metric as primary outcome measure in all cases and calls on the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) to propagate this evidence-based recommendation.


Assuntos
Cirurgia Bariátrica , Derivação Gástrica , Obesidade Mórbida , Índice de Massa Corporal , Humanos , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Redução de Peso
17.
Nutrients ; 13(10)2021 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-34684494

RESUMO

Prehabilitation has been postulated as an effective preventive intervention to reduce postoperative complications, particularly for elderly patients with a relatively high risk of complications. To date, it remains to be determined whether prehabilitation increases physical capacity and reduces postoperative complications. The aim of this study was to assess the feasibility of a 4-week multimodal prehabilitation program consisting of a personalized, supervised training program and nutritional intervention with daily fresh protein-rich food for colorectal cancer patients aged over 64 years prior to surgery. The primary outcome was the feasibility of this prehabilitation program defined as ≥80% compliance with the exercise training program and nutritional intervention. The secondary outcomes were the organizational feasibility and acceptability of the prehabilitation program. A compliance rate of ≥80% to both the exercise and nutritional intervention was accomplished by 6 patients (66.7%). Attendance of ≥80% at all 12 training sessions was achieved by 7 patients (77.8%); all patients (100%) attended ≥80% of the available training sessions. Overall, compliance with the training was 91.7%. Six patients (66.7%) accomplished compliance of ≥80% with the nutritional program. The median protein intake was 1.2 (g/kg/d). No adverse events occurred. This multimodal prehabilitation program was feasible for the majority of patients.


Assuntos
Neoplasias Colorretais/cirurgia , Terapia por Exercício/métodos , Terapia Nutricional/métodos , Complicações Pós-Operatórias/prevenção & controle , Exercício Pré-Operatório , Idoso , Dieta Rica em Proteínas/métodos , Estudos de Viabilidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Aceitação pelo Paciente de Cuidados de Saúde , Avaliação de Programas e Projetos de Saúde , Estudos Prospectivos , Resultado do Tratamento
18.
Eur J Surg Oncol ; 47(6): 1292-1298, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33349525

RESUMO

BACKGROUND: Regional recurrence (RR), also known as lymph node recurrence, is an endpoint in several trials concerning reducing axillary treatment in cT1-2N0 breast cancer patients. The risk of RR may decrease with each subsequent event-free year, affecting the yield and consequently usefulness of long (er) follow-up. The aim of this study is to determine the risk of RR as a first event within five years after diagnosis in subtypes of breast cancer, conditional to being event-free for one, two, three and four years. METHODS: From the Netherlands Cancer Registry, cT1-2N0 breast cancer patients diagnosed from 2005 to 2008 were analyzed. Subgroup analysis was performed for pT1-2N+(sn) patients. RR risk was calculated with Kaplan-Meier analysis. Conditional RR (assuming x event-free years) was determined by selecting patients without an event at x years, and calculating the remaining risk for RR within five years after diagnosis. RESULTS: A total of 18,009 cT1-2N0 (all pN stages) breast cancer patients were included. RR occurred in 1.3% of cT1-2N0 and 1.5% of pT1-2N+(sn) patients. The risk of RR varied between subtypes; it was highest for triple negative tumors and lowest for ER + PR + Her2-and ER + Her2+ tumors. After event-free years, the risk of RR decreased subsequently in both groups and in all subtypes. After two event-free years, the risk of RR was 0.8%. CONCLUSION: The absolute yield of follow-up to detect RR beyond two years is low; for every 125 event-free patients, one RR can be expected until five years. This suggests that follow-up longer than two years is of limited value for detecting RR in both clinical and research setting.


Assuntos
Neoplasias da Mama/epidemiologia , Neoplasias da Mama/patologia , Linfonodos/patologia , Recidiva Local de Neoplasia/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/metabolismo , Feminino , Humanos , Estimativa de Kaplan-Meier , Metástase Linfática , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Países Baixos/epidemiologia , Receptor ErbB-2/metabolismo , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Neoplasias de Mama Triplo Negativas/epidemiologia , Neoplasias de Mama Triplo Negativas/patologia , Adulto Jovem
19.
BMJ Case Rep ; 13(6)2020 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-32499294

RESUMO

Neurofibromatosis type 1 (NF1, Von Recklinghausen disease) is an autosomal dominant disease with a birth incidence of 1/2500-3000. The most common presentations of NF1 are cutaneous presentations like café-au-lait spots and neurofibromas. 5%-25% of patients with NF1 have gastrointestinal manifestations of the disease. Appendiceal neurofibroma are extremely rare and only a few cases are described in literature. An appendectomy is indicated because of high risk of appendicitis and malignant transformation. We report the case of a 74-year-old male patient with a history of NF1 with chronic right lower quadrant pain. Successive imaging scans showed suspicion of chronic appendicitis. A diagnostic laparoscopy, resulting in a laparoscopic appendectomy was performed without complications. Histopathology showed appendiceal neurofibroma and diverticula. The postoperative course was uneventful. In patients with NF1 with right lower quadrant pain benign appendiceal neurofibroma should be included in the differential diagnosis. A diagnostic laparoscopy should be performed followed by an appendectomy.


Assuntos
Dor Abdominal/diagnóstico , Apendicectomia/métodos , Apêndice/patologia , Divertículo , Neurofibromatose 1 , Dor Abdominal/etiologia , Idoso , Neoplasias do Apêndice/prevenção & controle , Apendicite/diagnóstico , Apendicite/prevenção & controle , Biópsia/métodos , Dor Crônica , Diagnóstico Diferencial , Divertículo/patologia , Divertículo/cirurgia , Humanos , Laparoscopia/métodos , Masculino , Neurofibromatose 1/diagnóstico , Neurofibromatose 1/fisiopatologia , Neurofibromatose 1/cirurgia , Tomografia Computadorizada por Raios X/métodos , Resultado do Tratamento
20.
BMJ Case Rep ; 13(12)2020 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-33298482

RESUMO

A 26-year-old multigravida, 30+3 weeks pregnant woman, was referred to our tertiary referral centre with acute abdominal pain and vomiting suspected for internal herniation. She had a history of a primary banded Roux-en-Y gastric bypass (B-RYGB). The MRI scan showed a clustered small bowel package with possible mesenteric swirl diagnosed as internal herniation. A diagnostic laparoscopy was converted to laparotomy showing an internal herniation of the alimentary limb through the silicone ring. The internal herniation was reduced by cutting the silicone ring. Postoperative recovery, remaining pregnancy and labour were uneventful. During pregnancy after B-RYGB, small bowel obstruction can in rare cases occur due to internal herniation through the silicone ring. Education regarding this complication should be provided before bariatric surgery. Treatment of women, 24 to 32 weeks pregnant, in a specialised centre for bariatric complications with a neonatal intensive care unit is advised to improve maternal and neonatal outcome.


Assuntos
Derivação Gástrica/efeitos adversos , Hérnia Interna/etiologia , Obstrução Intestinal/etiologia , Complicações na Gravidez/etiologia , Adulto , Feminino , Idade Gestacional , Humanos , Hérnia Interna/diagnóstico por imagem , Hérnia Interna/cirurgia , Obstrução Intestinal/diagnóstico por imagem , Obstrução Intestinal/cirurgia , Laparoscopia , Laparotomia , Imageamento por Ressonância Magnética , Mesentério/cirurgia , Gravidez , Complicações na Gravidez/diagnóstico por imagem , Complicações na Gravidez/cirurgia
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