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1.
Ann Surg Oncol ; 31(6): 4005-4017, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38526832

RESUMO

BACKGROUND: Unnecessary D2-gastrectomy and associated costs can be prevented after detecting non-curable gastric cancer, but impact of staging on treatment costs is unclear. This study determined the cost impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18FFDG-PET/CT) and staging laparoscopy (SL) in gastric cancer staging. MATERIALS AND METHODS: In this cost analysis, four staging strategies were modeled in a decision tree: (1) 18FFDG-PET/CT first, then SL, (2) SL only, (3) 18FFDG-PET/CT only, and (4) neither SL nor 18FFDG-PET/CT. Costs were assessed on the basis of the prospective PLASTIC-study, which evaluated adding 18FFDG-PET/CT and SL to staging advanced gastric cancer (cT3-4 and/or cN+) in 18 Dutch hospitals. The Dutch Healthcare Authority provided 18FFDG-PET/CT unit costs. SL unit costs were calculated bottom-up. Gastrectomy-associated costs were collected with hospital claim data until 30 days postoperatively. Uncertainty was assessed in a probabilistic sensitivity analysis (1000 iterations). RESULTS: 18FFDG-PET/CT costs were €1104 including biopsy/cytology. Bottom-up calculations totaled €1537 per SL. D2-gastrectomy costs were €19,308. Total costs per patient were €18,137 for strategy 1, €17,079 for strategy 2, and €19,805 for strategy 3. If all patients undergo gastrectomy, total costs were €18,959 per patient (strategy 4). Performing SL only reduced costs by €1880 per patient. Adding 18FFDG-PET/CT to SL increased costs by €1058 per patient; IQR €870-1253 in the sensitivity analysis. CONCLUSIONS: For advanced gastric cancer, performing SL resulted in substantial cost savings by reducing unnecessary gastrectomies. In contrast, routine 18FFDG-PET/CT increased costs without substantially reducing unnecessary gastrectomies, and is not recommended due to limited impact with major costs. TRIAL REGISTRATION: NCT03208621. This trial was registered prospectively on 30-06-2017.


Assuntos
Fluordesoxiglucose F18 , Gastrectomia , Laparoscopia , Estadiamento de Neoplasias , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada , Compostos Radiofarmacêuticos , Neoplasias Gástricas , Neoplasias Gástricas/patologia , Neoplasias Gástricas/cirurgia , Neoplasias Gástricas/diagnóstico por imagem , Neoplasias Gástricas/economia , Humanos , Laparoscopia/economia , Laparoscopia/métodos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/economia , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Estudos Prospectivos , Gastrectomia/economia , Fluordesoxiglucose F18/economia , Compostos Radiofarmacêuticos/economia , Análise Custo-Benefício , Seguimentos , Prognóstico , Custos e Análise de Custo , Masculino , Feminino
2.
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
4.
Int J Surg ; 109(11): 3578-3589, 2023 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-37581636

RESUMO

BACKGROUND: Staging laparoscopy for gastric cancer is recommended to assess the tumor's locoregional extension and exclude peritoneal disease. As there is no consensus on optimizing the procedure's diagnostic accuracy, we aimed to systematically review the literature on operative techniques, followed by peritoneal lavage fluid assessment in gastric cancer patients. Specifically, we sought to indicate the most common characteristics of the procedure and cytological evaluation. METHODS: This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The protocol for this systematic review was registered on PROSPERO database (CRD: 42022306746). On September 2022, a search was carried out using Embase, Medline ALL, Cochrane Central Register of Controlled Trials, and Web of Science Core Collection. RESULTS: The search identified 1632 studies on staging laparoscopy and 2190 studies on peritoneal fluid assessment. Some 212 studies were included. Open Hasson was the method of choice in accessing the peritoneal cavity in 65% of the studies, followed by establishing a pneumoperitoneum at 10-12 mmHg in 52% of reports. Most frequently, the patient was positioned supine (70%), while a 30° scope and three ports were used to assess the peritoneal cavity clockwise (72%, 77%, and 85%, respectively). Right and left upper abdomen quadrants were the predominant area of laparoscopic exploration (both 65%), followed by the primary tumor region (54%), liver and pelvis (both 30%), and small bowel and spleen (19% and 17%, respectively). Regions of peritoneal lavage and aspiration were limited to the pelvis (50%), followed by right and left upper abdomen quadrants (37.5% and 50%, respectively). No studies compared different methods of operative techniques or analysis of ascites/fluid. CONCLUSIONS: This study indicates a high heterogeneity in the technique of staging laparoscopy and peritoneal fluid assessment in gastric cancer patients. Further research and initiatives to reach a consensus on the standardization of the procedure are warranted.


Assuntos
Laparoscopia , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/cirurgia , Neoplasias Gástricas/patologia , Líquido Ascítico/patologia , Estadiamento de Neoplasias , Laparoscopia/métodos , Lavagem Peritoneal
5.
JAMA Surg ; 158(2): 120-128, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36576822

RESUMO

Importance: Laparoscopic gastrectomy is rapidly being adopted worldwide as an alternative to open gastrectomy to treat gastric cancer. However, laparoscopic gastrectomy might be more expensive as a result of longer operating times and more expensive surgical materials. To date, the cost-effectiveness of both procedures has not been prospectively evaluated in a randomized clinical trial. Objective: To evaluate the cost-effectiveness of laparoscopic compared with open gastrectomy. Design, Setting, and Participants: In this multicenter randomized clinical trial of patients undergoing total or distal gastrectomy in 10 Dutch tertiary referral centers, cost-effectiveness data were collected alongside a multicenter randomized clinical trial on laparoscopic vs open gastrectomy for resectable gastric adenocarcinoma (cT1-4aN0-3bM0). A modified societal perspective and 1-year time horizon were used. Costs were calculated on the individual patient level by using hospital registry data and medical consumption and productivity loss questionnaires. The unit costs of laparoscopic and open gastrectomy were calculated bottom-up. Quality-adjusted life-years (QALYs) were calculated with the EuroQol 5-dimension questionnaire, in which a value of 0 indicates death and 1 indicates perfect health. Missing questionnaire data were imputed with multiple imputation. Bootstrapping was performed to estimate the uncertainty surrounding the cost-effectiveness. The study was conducted from March 17, 2015, to August 20, 2018. Data analyses were performed between September 1, 2020, and November 17, 2021. Interventions: Laparoscopic vs open gastrectomy. Main Outcomes and Measures: Evaluations in this cost-effectiveness analysis included total costs and QALYs. Results: Between 2015 and 2018, 227 patients were included. Mean (SD) age was 67.5 (11.7) years, and 140 were male (61.7%). Unit costs for initial surgery were calculated to be €8124 (US $8087) for laparoscopic total gastrectomy, €7353 (US $7320) for laparoscopic distal gastrectomy, €6584 (US $6554) for open total gastrectomy, and €5893 (US $5866) for open distal gastrectomy. Mean total costs after 1-year follow-up were €26 084 (US $25 965) in the laparoscopic group and €25 332 (US $25 216) in the open group (difference, €752 [US $749; 3.0%]). Mean (SD) QALY contributions during 1 year were 0.665 (0.298) in the laparoscopic group and 0.686 (0.288) in the open group (difference, -0.021). Bootstrapping showed that these differences between treatment groups were relatively small compared with the uncertainty of the analysis. Conclusions and Relevance: Although the laparoscopic gastrectomy itself was more expensive, after 1-year follow-up, results suggest that differences in both total costs and effectiveness were limited between laparoscopic and open gastrectomy. These results support centers' choosing, based on their own preference, whether to (de)implement laparoscopic gastrectomy as an alternative to open gastrectomy.


Assuntos
Laparoscopia , Neoplasias Gástricas , Humanos , Masculino , Idoso , Feminino , Análise Custo-Benefício , Neoplasias Gástricas/cirurgia , Neoplasias Gástricas/patologia , Análise de Custo-Efetividade , Laparoscopia/métodos , Gastrectomia/métodos
7.
PLoS One ; 16(6): e0252771, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34115771

RESUMO

INTRODUCTION: Given clinicians' frequent concerns about unfavourable outcomes, Intensive Care Unit (ICU) triage decisions in acutely ill cancer patients can be difficult, as clinicians may have doubts about the appropriateness of an ICU admission. To aid to this decision making, we studied the survival and performance status of cancer patients 2 years following an unplanned ICU admission. MATERIALS AND METHODS: This was a retrospective cohort study in a large tertiary referral university hospital in the Netherlands. We categorized all adult patients with an unplanned ICU admission in 2017 into two groups: patients with or without an active malignancy. Descriptive statistics, Pearson's Chi-square tests and the Mann-Whitney U tests were used to evaluate the primary objective 2-year mortality and performance status. A good performance status was defined as ECOG performance status 0 (fully active) or 1 (restricted in physically strenuous activity but ambulatory and able to carry out light work). A multivariable binary logistic regression analysis was used to identify factors associated with 2-year mortality within cancer patients. RESULTS: Of the 1046 unplanned ICU admissions, 125 (12%) patients had cancer. The 2-year mortality in patients with cancer was significantly higher than in patients without cancer (72% and 42.5%, P <0.001). The median performance status at 2 years in cancer patients was 1 (IQR 0-2). Only an ECOG performance status of 2 (OR 8.94; 95% CI 1.21-65.89) was independently associated with 2-year mortality. CONCLUSIONS: In our study, the majority of the survivors have a good performance status 2 years after ICU admission. However, at that point, three-quarter of these cancer patients had died, and mortality in cancer patients was significantly higher than in patients without cancer. ICU admission decisions in acutely ill cancer patients should be based on performance status, severity of illness and long-term prognosis, and this should be communicated in the shared decision making. An ICU admission decision should not solely be based on the presence of a malignancy.


Assuntos
Unidades de Terapia Intensiva/estatística & dados numéricos , Mortalidade/tendências , Neoplasias/epidemiologia , Idoso , Tomada de Decisão Clínica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/mortalidade , Neoplasias/patologia , Admissão do Paciente/estatística & dados numéricos , Análise de Sobrevida , Triagem/normas , Triagem/estatística & dados numéricos
9.
Am J Gastroenterol ; 115(7): 1026-1035, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32618653

RESUMO

INTRODUCTION: Clinical guidelines recommend surveillance of patients with Barrett's esophagus (BE). However, the surveillance intervals in practice are shorter than policy recommendations. We aimed to determine how this policy-practice gap affects the costs and benefits of BE surveillance. METHODS: We used the Netherlands as an exemplary Western country and simulated a cohort of 60-year-old patients with BE using the Microsimulation Screening Analysis model-esophageal adenocarcinoma (EAC) microsimulation model. We evaluated surveillance according to the Dutch guideline and more intensive surveillance of patients without dysplastic BE and low-grade dysplasia. For each strategy, we computed the quality-adjusted life years (QALYs) gained and costs compared with no surveillance. We also performed a budget impact analysis to estimate the increased costs of BE management in the Netherlands for 2017. RESULTS: Compared with no surveillance, the Dutch guideline incurred an additional &OV0556;5.0 ($5.7) million per 1,000 patients with BE for surveillance and treatment, whereas 57 esophageal adenocarcinoma (EAC) cases (>T1a) were prevented. With intensive and very intensive surveillance strategies for both nondysplastic BE and low-grade dysplasia, the net costs increased by another &OV0556;2.5-5.6 ($2.8-6.5) million while preventing 10-19 more EAC cases and gaining 33-60 more QALYs. On a population level, this amounted to &OV0556;21-47 ($24-54) million (+32%-70%) higher healthcare costs in 2017. DISCUSSION: The policy-practice gap in BE surveillance intervals results in 50%-114% higher net costs for BE management for only 10%-18% increase in QALYs gained, depending on actual intensity of surveillance. Incentives to eliminate this policy-practice gap should be developed to reduce the burden of BE management on patients and healthcare resources.


Assuntos
Esôfago de Barrett/economia , Esôfago de Barrett/terapia , Análise Custo-Benefício , Fidelidade a Diretrizes/economia , Lacunas da Prática Profissional/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos , Guias de Prática Clínica como Assunto
10.
Surg Endosc ; 34(1): 116-125, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-30919056

RESUMO

BACKGROUND: Few large-scale epidemiologic studies evaluate the clinical and economic burden of appendicitis. These data may impact future research and treatment strategies. In this study, the objective was to determine the burden of appendectomy for appendicitis in terms of incidence rates, length of hospital stay (LOS) and hospital costs on a national level. In addition, outcomes were compared for subgroups based on surgical treatment, age and hospital setting. METHODS: Observational retrospective population-based cohort study using the national Dutch healthcare reimbursement registry, which covers hospital registration and reimbursement for 17 million inhabitants. Patients with a diagnosis of appendicitis who underwent appendectomy between 2006 and 2016 were included. Primary outcomes were incidence rates, LOS and hospital costs. RESULTS: A total of 135,025 patients were included. Some 53% of patients was male, and 64% was treated in a general hospital. The overall incidence rate of appendectomy was 81 per 100,000 inhabitants and showed a significant decreasing trend across time and age. Mean ± SD LOS per patient was 3.66 ± 3.5 days. LOS showed a significant increase with age and was significantly longer for open versus minimally invasive appendectomy. Mean ± SD hospital costs per patient were €3700 ± 1284. Costs were initially lower for open compared to minimally invasive appendectomy, but were similar from 2012 onward. Compared to non-university hospitals, patients treated in university hospitals had a significantly longer LOS and higher costs. CONCLUSIONS: Appendectomy for appendicitis represents a substantial clinical and economic burden in the Netherlands. A preference for minimally invasive technique seems justified.


Assuntos
Apendicectomia , Apendicite , Efeitos Psicossociais da Doença , Adulto , Apendicectomia/economia , Apendicectomia/métodos , Apendicite/epidemiologia , Apendicite/cirurgia , Estudos de Coortes , Feminino , Custos Hospitalares , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Estudos Retrospectivos
11.
Trials ; 19(1): 263, 2018 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-29720238

RESUMO

BACKGROUND: Acute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days. METHODS: Patients of 8 years and older undergoing appendectomy for acute complex appendicitis - defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess - are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ɑ 0.025). Both per-protocol and intention-to-treat analyses will be performed. DISCUSSION: This trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly. TRIAL REGISTRATION: Dutch Trial Register, NTR6128 . Registered on 20 December 2016.


Assuntos
Abscesso Abdominal/prevenção & controle , Antibacterianos/administração & dosagem , Apendicectomia , Apendicite/cirurgia , Infecção da Ferida Cirúrgica/prevenção & controle , Abscesso Abdominal/economia , Abscesso Abdominal/microbiologia , Abscesso Abdominal/mortalidade , Administração Intravenosa , Antibacterianos/efeitos adversos , Antibacterianos/economia , Apendicectomia/efeitos adversos , Apendicectomia/economia , Apendicectomia/mortalidade , Apendicite/economia , Apendicite/microbiologia , Apendicite/mortalidade , Ensaios Clínicos Fase IV como Assunto , Análise Custo-Benefício , Esquema de Medicação , Custos de Medicamentos , Estudos de Equivalência como Asunto , Feminino , Custos Hospitalares , Humanos , Tempo de Internação , Masculino , Estudos Multicêntricos como Assunto , Países Baixos , Estudos Prospectivos , Fatores de Risco , Infecção da Ferida Cirúrgica/economia , Infecção da Ferida Cirúrgica/microbiologia , Infecção da Ferida Cirúrgica/mortalidade , Fatores de Tempo , Resultado do Tratamento
12.
BMC Cancer ; 18(1): 142, 2018 02 06.
Artigo em Inglês | MEDLINE | ID: mdl-29409469

RESUMO

BACKGROUND: Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. METHODS: This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4-6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6-8 weeks after CRE-I. CRE-II will include 18F-FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not undergo surgery, quality of life, clinical irresectability (cT4b) rate, radical resection rate, postoperative complications, progression-free survival, distant dissemination rate, and cost-effectiveness. We hypothesise that active surveillance leads to non-inferior survival, improved quality of life and a reduction in costs, compared to standard oesophagectomy. DISCUSSION: If active surveillance and surgery as needed after nCRT leads to non-inferior survival compared to standard oesophagectomy, this organ-sparing approach can be implemented as a standard of care.


Assuntos
Ensaios Clínicos Fase III como Assunto/métodos , Neoplasias Esofágicas/terapia , Estudos Multicêntricos como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Quimiorradioterapia/métodos , Análise Custo-Benefício , Intervalo Livre de Doença , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/métodos , Neoplasias Esofágicas/diagnóstico por imagem , Esofagectomia/métodos , Humanos , Terapia Neoadjuvante , Avaliação de Resultados em Cuidados de Saúde/economia , Avaliação de Resultados em Cuidados de Saúde/métodos , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos
13.
BMC Cancer ; 15: 556, 2015 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-26219670

RESUMO

BACKGROUND: For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. METHODS: The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. DISCUSSION: In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient. TRIAL REGISTRATION: NCT02248519.


Assuntos
Adenocarcinoma/cirurgia , Gastrectomia/métodos , Laparoscopia/métodos , Neoplasias Gástricas/cirurgia , Adenocarcinoma/economia , Adenocarcinoma/patologia , Análise Custo-Benefício , Gastrectomia/economia , Humanos , Laparoscopia/economia , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Países Baixos , Complicações Pós-Operatórias/economia , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Qualidade de Vida , Neoplasias Gástricas/economia , Neoplasias Gástricas/patologia , Análise de Sobrevida , Resultado do Tratamento
14.
Ann Surg ; 260(2): 267-73, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25350650

RESUMO

OBJECTIVE: To describe causes of death in the first year after esophagectomy and determine the time frame that should be used for measurement of quality of surgery. A case-mix adjustment model was developed for the comparison between hospitals. BACKGROUND: The time period in which postoperative mortality should be measured as a performance indicator is debated. METHODS: Cause of death was identified for patients in a tertiary referral hospital who died within 1 year after surgery and classified as surgery related or not surgery related. Sensitivity and specificity for detecting deaths related to surgery were calculated for different periods of follow-up. Case-mix adjustment models for 30-day mortality (30DM), in-hospital mortality, and 90-day mortality (90DM) were developed. RESULTS: In total, 1282 patients underwent esophagectomy. 30DM was 2.9%, the in-hospital mortality rate was 5.1% and 90DM was 7%. Beyond 30 days, a substantial number of deaths were related to the operation, especially due to anastomotic leakage. Postdischarge nononcological mortality was most frequently caused by sudden death. One in 5 patients died because of recurrent disease, being the most important threat in the first year after surgery. The 30DM had a sensitivity for detecting surgery-related deaths of 33% and a specificity of 100%. The 90DM had a sensitivity of 74% and a specificity of 96%. CONCLUSIONS: A period of postoperative follow-up longer than 30 days needs to be considered when comparing surgical performance between institutes. In the case-mix adjustment model for 90DM, no other variables have to be taken into account compared to those involved in 30DM.


Assuntos
Neoplasias Esofágicas/cirurgia , Esofagectomia/mortalidade , Esofagectomia/normas , Mortalidade Hospitalar/tendências , Indicadores de Qualidade em Assistência à Saúde , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Causas de Morte , Grupos Diagnósticos Relacionados , Neoplasias Esofágicas/mortalidade , Neoplasias Esofágicas/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Estudos Prospectivos , Medição de Risco , Fatores de Risco
15.
Surgery ; 156(5): 1078-88, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25231747

RESUMO

BACKGROUND: With the implementation of competency-based curricula, Objective Structured Assessment of Technical Skills (OSATS) increasingly is being used for the assessment of operative skills. Although evidence for its usefulness has been demonstrated in experimental study designs, data supporting OSATS application in the operating room are limited. This study evaluates the validity and reliability of the OSATS instrument to assess the operative skills of surgery residents in the operating theater. METHODS: Twenty-four residents were recruited from seven hospitals within a general surgical training region and classified equally into three groups according to postgraduate training year (PGY). Each resident had to perform five different types of operations. Surgical performance was measured using a modified OSATS consisting of three scales: Global Rating Scale, Overall Performance Scale, and Alphabetic Summary Scale. Validity and reliability metrics included construct validity (Kruskal-Wallis test) and internal consistency reliability (Cronbach's α coefficient). Spearman's correlation coefficients were calculated to determine correlations between the different scales. RESULTS: Eighteen residents (PGY 1-2 [n = 7]; PGY 3-4 [n = 8]; PGY 5-6 [n = 3]) performed 249 operations. Comparisons of the performance scores revealed that evidence for construct validity depended on the difficulty level of the selected procedures. For individual operations, internal consistency reliability of the Global Rating Scale ranged from 0.93 to 0.95. Scores on the different scales correlated strongly (r = 0.62-0.76, P < .001). CONCLUSION: Assessment of operative skills in the operating theater using this modified OSATS instrument has the potential to establish learning curves, allowing adequate monitoring of residents' progress in achieving operative competence. The Alphabetic Summary Scale seems to be of additional value. Use of the Overall Performance Scale should be reconsidered.


Assuntos
Competência Clínica , Avaliação Educacional/métodos , Cirurgia Geral/educação , Neoplasias da Mama/cirurgia , Colecistectomia Laparoscópica/normas , Cirurgia Geral/normas , Herniorrafia/normas , Fraturas do Quadril/cirurgia , Humanos , Internato e Residência , Estudos Prospectivos
16.
World J Surg ; 37(1): 147-55, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23015224

RESUMO

BACKGROUND: In esophageal cancer patients preoperative staging will determine the type of surgical procedure and use of neoadjuvant therapy. Tumor location and lymph node status play a pivotal role in this tailored strategy. The aim of the present study was to prospectively evaluate the accuracy of preoperative assessment of tumor location according to the Siewert classification and lymph node status per station with endoscopy/endoscopic ultrasound (EUS) and computed tomography (CT). METHODS: In 50 esophagectomy patients with adenocarcinoma of the gastroesophageal junction (GEJ), tumor location according to Siewert and N-stage per nodal station as determined preoperatively by endoscopy/EUS and CT were compared with the histopathologic findings in the resection specimen. RESULTS: Overall accuracy in predicting tumor location according to the Siewert classification was 70 % for endoscopy/EUS and 72 % for CT. Preoperative data could not be compared with the pathologic assessment in 11 patients (22 %), as large tumors obscured the landmark of the gastric folds. The overall accuracy for predicting the N-stage in 250 lymph node stations was 66 % for EUS and 68 % for CT. The accuracy was good for those stations located high in the thorax, but poor for celiac trunk nodes. CONCLUSIONS: Given the frequent discrepancy between the endoscopic and pathologic location of the GEJ and the common problem of advanced tumors obscuring the landmarks used in the assessment of the Siewert classification, its usefulness is limited. The overall accuracy for EUS and CT in predicting the N-stage per station was moderate.


Assuntos
Adenocarcinoma/patologia , Adenocarcinoma/secundário , Neoplasias Esofágicas/patologia , Junção Esofagogástrica/patologia , Neoplasias Gástricas/patologia , Adenocarcinoma/cirurgia , Idoso , Idoso de 80 Anos ou mais , Neoplasias Esofágicas/cirurgia , Feminino , Humanos , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios , Estudos Prospectivos , Neoplasias Gástricas/cirurgia
17.
J Surg Oncol ; 101(3): 270-8, 2010 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-20082349

RESUMO

In this review the preoperative risk assessment and prevention of complications in patients undergoing esophagectomy for cancer is discussed. Age, pulmonary and cardiovascular condition, nutritional status, and neoadjuvant chemo(radio)therapy are known predictive factors. None of these factors is a valid exclusion criterion for esophagectomy, but may help in careful patient selection. Both anesthetists and surgeons play an important role in intraoperative risk reduction by means of appropriate fluid management and application of optimal surgical techniques.


Assuntos
Neoplasias Esofágicas/cirurgia , Esofagectomia/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Medição de Risco , Adulto , Idoso , Humanos , Desnutrição/complicações , Pessoa de Meia-Idade , Terapia Neoadjuvante , Estado Nutricional , Obesidade/complicações , Fatores de Risco
18.
N Engl J Med ; 347(21): 1662-9, 2002 Nov 21.
Artigo em Inglês | MEDLINE | ID: mdl-12444180

RESUMO

BACKGROUND: Controversy exists about the best surgical treatment for esophageal carcinoma. METHODS: We randomly assigned 220 patients with adenocarcinoma of the mid-to-distal esophagus or adenocarcinoma of the gastric cardia involving the distal esophagus either to transhiatal esophagectomy or to transthoracic esophagectomy with extended en bloc lymphadenectomy. Principal end points were overall survival and disease-free survival. Early morbidity and mortality, the number of quality-adjusted life-years gained, and cost effectiveness were also determined. RESULTS: A total of 106 patients were assigned to undergo transhiatal esophagectomy, and 114 to undergo transthoracic esophagectomy. Demographic characteristics and characteristics of the tumor were similar in the two groups. Perioperative morbidity was higher after transthoracic esophagectomy, but there was no significant difference in in-hospital mortality (P=0.45). After a median follow-up of 4.7 years, 142 patients had died--74 (70 percent) after transhiatal resection and 68 (60 percent) after transthoracic resection (P=0.12). Although the difference in survival was not statistically significant, there was a trend toward a survival benefit with the extended approach at five years: disease-free survival was 27 percent in the transhiatal-esophagectomy group, as compared with 39 percent in the transthoracic-esophagectomy group (95 percent confidence interval for the difference, -1 to 24 percent [the negative value indicates better survival with transhiatal resection]), whereas overall survival was 29 percent as compared with 39 percent (95 percent confidence interval for the difference, -3 to 23 percent). CONCLUSIONS: Transhiatal esophagectomy was associated with lower morbidity than transthoracic esophagectomy with extended en bloc lymphadenectomy. Although median overall, disease-free, and quality-adjusted survival did not differ statistically between the groups, there was a trend toward improved long-term survival at five years with the extended transthoracic approach.


Assuntos
Adenocarcinoma/cirurgia , Neoplasias Esofágicas/cirurgia , Esofagectomia/métodos , Adenocarcinoma/mortalidade , Adulto , Idoso , Análise Custo-Benefício , Intervalo Livre de Doença , Neoplasias Esofágicas/mortalidade , Esofagectomia/economia , Feminino , Seguimentos , Custos de Cuidados de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/epidemiologia , Anos de Vida Ajustados por Qualidade de Vida , Análise de Sobrevida
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