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1.
Int J Surg ; 110(1): 202-208, 2024 Jan 01.
Artigo em Inglês | MEDLINE | ID: mdl-38000068

RESUMO

INTRODUCTION: Intraoperative adverse events (iAEs) are increasingly recognized for their impact on patient outcomes. The Kaafarani classification and Surgical Apgar Score (SAS) were developed to assess the intraoperative course; however, both have their drawbacks. ClassIntra was validated for iAEs of any origin. This study compares the Kaafarani and SAS to ClassIntra considering predictive value and interrater reliability in a cohort of abdominal surgery to support implementation of a classification in clinical practice. METHODS: The authors made use of the LAParotomy or LAParoscopy and ADhesiolysis (LAPAD) study database of elective abdominal surgery. Detailed descriptions on iAEs were collected in real-time by a researcher. For the current research aim, all iAEs were graded according ClassIntra, Kaafarani, and SAS (score ≤4). The predictive value was assessed using univariable and multivariable linear regression and the area under the receiver operating curve (AUROC). Two teams graded ClassIntra and Kaafarani to assess the interrater reliability using Cohen's Kappa. RESULTS: A total of 755 surgeries were included, in which 335 (44%) iAEs were graded according to ClassIntra, 228 (30%) to Kaafarani, and 130 (20%) to SAS. All classifications were significantly correlated to postoperative complications, with an AUROC of 0.67 (95% CI: 0.62-0.72), 0.64 (0.59-0.70), and 0.71 (0.56-0.76), respectively. For the secondary endpoint, the interrater reliability of ClassIntra with κ 0.87 (95% CI: 0.84-0.90) and Kaafarani 0.90 (95% CI: 0.87-0.93) was both strong. CONCLUSION: ClassIntra, Kaafarani, and SAS can be used for reporting of iAEs in abdominal surgery with good predictive value for postoperative complications, with strong reliability. ClassIntra, compared with Kaafarani and SAS, included the most iAEs and has the most comprehensive definition suitable for uniform reporting of iAEs in clinical practice and research.


Assuntos
Complicações Intraoperatórias , Complicações Pós-Operatórias , Humanos , Reprodutibilidade dos Testes , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Abdome/cirurgia , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Estudos Retrospectivos
2.
Expert Rev Anticancer Ther ; 23(9): 977-993, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37702571

RESUMO

INTRODUCTION: This study aims to systematically review current evidence on ablative margins and correlation to local tumor progression (LTP) after thermal ablation of hepatocellular carcinoma (HCC) and colorectal liver metastases (CRLM). METHODS: A systematic search was performed in PubMed (MEDLINE) and Web of Science to identify all studies that reported on ablative margins (AM) and related LTP rates. Studies were assessed for risk of bias and synthesized separately per tumor type. Where possible, results were pooled to calculate risk differences (RD) as function of AM. RESULTS: In total, 2910 articles were identified of which 43 articles were eligible for final analysis. There was high variability in AM measurement methodology across studies in terms of measurement technique, imaging modalities, and timing. Most common margin stratification was < 5 mm and > 5 mm, for which data were available in 25/43 studies (58%). Of these, all studies favored AM > 5 mm to reduce the risk of LTP, with absolute RD of 16% points for HCC and 47% points for CRLM as compared to AM < 5 mm. CONCLUSIONS: Current evidence supports AM > 5 mm to reduce the risk of LTP after thermal ablation of HCC and CRLM. However, standardization of AM measurement and reporting is critical to allow future meta-analyses and improved identification of optimal threshold value for clinical use.


Assuntos
Carcinoma Hepatocelular , Ablação por Cateter , Neoplasias Hepáticas , Humanos , Neoplasias Hepáticas/cirurgia , Neoplasias Hepáticas/patologia , Carcinoma Hepatocelular/cirurgia , Carcinoma Hepatocelular/patologia , Ablação por Cateter/métodos , Tomografia Computadorizada por Raios X/métodos , Progressão da Doença , Resultado do Tratamento , Estudos Retrospectivos
4.
Ann Surg ; 277(2): e273-e279, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-34171869

RESUMO

OBJECTIVE AND SUMMARY OF BACKGROUND DATA: Adverse events in surgical patients can occur preoperatively, intraoperatively, and postoperatively. Universally accepted classification systems are not yet available for intraoperative adverse events (iAEs). ClassIntra has recently been developed and validated as a tool for grading iAEs that occur between skin incision and skin closure irrespective of the origin, that is, surgery, anesthesia, or organizational. The aim of this study is to assess the inter-rater agreement of ClassIntra and assess its predictive value for postoperative complications in elective abdominal surgery. METHODS: This study is a secondary use of data from the LAParotomy or LAParoscopy and ADhesiolysis (LAPAD) study, with detailed data on incidence and management of intra-operative and post-operative complications. Data were collected in a cohort of elective abdominal surgeries. Two teams graded all recorded events in the LAPAD study according to ClassIntra. Cohen Kappa coefficient was calculated to determine inter-rater agreement. Uni- and multivariable linear regression was used to assess the predictive value of the ClassIntra grades for postoperative complications. RESULTS: IAEs were rated in 333 of 755 (44%) surgeries by team 1, and in 324 of 755 (43%) surgeries by team 2. Cohen kappa coefficient for ClassIntra grades was 0.87 [95% confidence interval (CI) 0.84-0.90]. Discrepancies in grading were most frequent for intraoperative bleeding and adhesions' associated injuries. At least 1 postoperative complication was observed in 278 (37%) patients. The risk of a postoperative complications increased with every increase in severity grade of ClassIntra. Intraoperative hypotension [mean difference (MD) 23.41, 95% CI 12.93-33.90] and other organ injuries (MD 18.90, 95% CI -4.22 - 42.02) were the strongest predictors for postoperative complications. CONCLUSIONS: ClassIntra has an almost perfect inter-rater agreement for the classification of iAEs. An increasing grade of ClassIntra was associated with a higher incidence of postoperative complications. Discrepancies in grading related to common complications in abdominal procedures mostly consisted of intraoperative bleeding and adhesion-related injuries. Grading of interoperative events in abdominal surgery might further improve by consensus regarding the definitions of a number of frequent events.


Assuntos
Complicações Intraoperatórias , Complicações Pós-Operatórias , Humanos , Complicações Intraoperatórias/diagnóstico , Complicações Intraoperatórias/epidemiologia , Complicações Intraoperatórias/etiologia , Complicações Pós-Operatórias/etiologia , Abdome/cirurgia , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Laparotomia/efeitos adversos , Aderências Teciduais/cirurgia
5.
Trials ; 23(1): 809, 2022 Sep 24.
Artigo em Inglês | MEDLINE | ID: mdl-36153559

RESUMO

BACKGROUND: Prophylactic abdominal drainage is current standard practice after distal pancreatectomy (DP), with the aim to divert pancreatic fluid in case of a postoperative pancreatic fistula (POPF) aimed to prevent further complications as bleeding. Whereas POPF after pancreatoduodenectomy, by definition, involves infection due to anastomotic dehiscence, a POPF after DP is essentially sterile since the bowel is not opened and no anastomoses are created. Routine drainage after DP could potentially be omitted and this could even be beneficial because of the hypothetical prevention of drain-induced infections (Fisher, Surgery 52:205-22, 2018). Abdominal drainage, moreover, should only be performed if it provides additional safety or comfort to the patient. In clinical practice, drains cause clear discomfort. One multicenter randomized controlled trial confirmed the safety of omitting abdominal drainage but did not stratify patients according to their risk of POPF and did not describe a standardized strategy for pancreatic transection. Therefore, a large pragmatic multicenter randomized controlled trial is required, with prespecified POPF risk groups and a homogeneous method of stump closure. The objective of the PANDORINA trial is to evaluate the non-inferiority of omitting routine intra-abdominal drainage after DP on postoperative morbidity (Clavien-Dindo score ≥ 3), and, secondarily, POPF grade B/C. METHODS/DESIGN: Binational multicenter randomized controlled non-inferiority trial, stratifying patients to high and low risk for POPF grade B/C and incorporating a standardized strategy for pancreatic transection. Two groups of 141 patients (282 in total) undergoing elective DP (either open or minimally invasive, with or without splenectomy). Primary outcome is postoperative rate of morbidity (Clavien-Dindo score ≥ 3), and the most relevant secondary outcome is grade B/C POPF. Other secondary outcomes include surgical reintervention, percutaneous catheter drainage, endoscopic catheter drainage, abdominal collections (not requiring drainage), wound infection, delayed gastric emptying, postpancreatectomy hemorrhage as defined by the international study group for pancreatic surgery (ISGPS) (Wente et al., Surgery 142:20-5, 2007), length of stay (LOS), readmission within 90 days, in-hospital mortality, and 90-day mortality. DISCUSSION: PANDORINA is the first binational, multicenter, randomized controlled non-inferiority trial with the primary objective to evaluate the hypothesis that omitting prophylactic abdominal drainage after DP does not worsen the risk of postoperative severe complications (Wente etal., Surgery 142:20-5, 2007; Bassi et al., Surgery 161:584-91, 2017). Most of the published studies on drain placement after pancreatectomy focus on both pancreatoduodenectomy and DP, but these two entities present are associated with different complications and therefore deserve separate evaluation (McMillan et al., Surgery 159:1013-22, 2016; Pratt et al., J Gastrointest Surg 10:1264-78, 2006). The PANDORINA trial is innovative since it takes the preoperative risk on POPF into account based on the D-FRS and it warrants homogenous stump closing by using the same graded compression technique and same stapling device (de Pastena et al., Ann Surg 2022; Asbun and Stauffer, Surg Endosc 25:2643-9, 2011).


Assuntos
Pancreatectomia , Fístula Pancreática , Abdome/cirurgia , Drenagem/métodos , Humanos , Pâncreas/cirurgia , Pancreatectomia/efeitos adversos , Pancreatectomia/métodos , Fístula Pancreática/etiologia , Fístula Pancreática/prevenção & controle , Fístula Pancreática/cirurgia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos
6.
Br J Surg ; 108(8): 983-990, 2021 08 19.
Artigo em Inglês | MEDLINE | ID: mdl-34195799

RESUMO

BACKGROUND: Based on excellent outcomes from high-volume centres, laparoscopic liver resection is increasingly being adopted into nationwide practice which typically includes low-medium volume centres. It is unknown how the use and outcome of laparoscopic liver resection compare between high-volume centres and low-medium volume centres. This study aimed to compare use and outcome of laparoscopic liver resection in three leading European high-volume centres and nationwide practice in the Netherlands. METHOD: An international, retrospective multicentre cohort study including data from three European high-volume centres (Oslo, Southampton and Milan) and all 20 centres in the Netherlands performing laparoscopic liver resection (low-medium volume practice) from January 2011 to December 2016. A high-volume centre is defined as a centre performing >50 laparoscopic liver resections per year. Patients were retrospectively stratified into low, moderate- and high-risk Southampton difficulty score groups. RESULTS: A total of 2425 patients were included (1540 high-volume; 885 low-medium volume). The median annual proportion of laparoscopic liver resection was 42.9 per cent in high-volume centres and 7.2 per cent in low-medium volume centres. Patients in the high-volume centres had a lower conversion rate (7.4 versus 13.1 per cent; P < 0.001) with less intraoperative incidents (9.3 versus 14.6 per cent; P = 0.002) as compared to low-medium volume centres. Whereas postoperative morbidity and mortality rates were similar in the two groups, a lower reintervention rate (5.1 versus 7.2 per cent; P = 0.034) and a shorter postoperative hospital stay (3 versus 5 days; P < 0.001) were observed in the high-volume centres as compared to the low-medium volume centres. In each Southampton difficulty score group, the conversion rate was lower and hospital stay shorter in high-volume centres. The rate of intraoperative incidents did not differ in the low-risk group, whilst in the moderate-risk and high-risk groups this rate was lower in high-volume centres (absolute difference 6.7 and 14.2 per cent; all P < 0.004). CONCLUSION: High-volume expert centres had a sixfold higher use of laparoscopic liver resection, less conversions, and shorter hospital stay, as compared to a nationwide low-medium volume practice. Stratification into Southampton difficulty score risk groups identified some differences but largely outcomes appeared better for high-volume centres in each risk group.


Assuntos
Carcinoma Hepatocelular/cirurgia , Hepatectomia/métodos , Hospitais com Alto Volume de Atendimentos/estatística & dados numéricos , Laparoscopia/métodos , Neoplasias Hepáticas/cirurgia , Complicações Pós-Operatórias/epidemiologia , Pontuação de Propensão , Idoso , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Estudos Retrospectivos , Fatores de Risco
7.
BMC Health Serv Res ; 21(1): 416, 2021 May 03.
Artigo em Inglês | MEDLINE | ID: mdl-33941181

RESUMO

BACKGROUND: Over the past decades, health care services for pancreatic surgery were reorganized. Volume norms were applied with the result that only a limited number of expert centers perform pancreatic surgery. As a result of this centralization of pancreatic surgery, the patient journey of patients with pancreatic tumors has become multi-institutional. To illustrate, patients are referred to a center of expertise for pancreatic surgery whereas other parts of pancreatic care, such as chemotherapy, take place in local hospitals. This fragmentation of health care services could affect continuity of care (COC). The aim of this study was to assess COC perceived by patients in a pancreatic care network and investigate correlations with patient-and care-related characteristics. METHODS: This is a pilot study in which patients with (pre) malignant pancreatic tumors discussed in a multidisciplinary tumor board in a Dutch tertiary hospital were asked to participate. Patients were asked to fill out the Nijmegen Continuity of Care-questionnaire (NCQ) (5-point Likert scale). Additionally, their patient-and care-related data were retrieved from medical records. Correlations of NCQ score and patient-and care-related characteristics were calculated with Spearman's correlation coefficient. RESULTS: In total, 44 patients were included (92% response rate). Pancreatic cancer was the predominant diagnosis (32%). Forty percent received a repetition of diagnostic investigations in the tertiary hospital. Mean scores for personal continuity were 3.55 ± 0.74 for GP, 3.29 ± 0.91 for the specialist and 3.43 ± 0.65 for collaboration between GPs and specialists. Overall COC was scored with a mean 3.38 ± 0.72. No significant correlations were observed between NCQ score and certain patient-or care-related characteristics. CONCLUSION: Continuity of care perceived by patients with pancreatic tumors was scored as moderate. This outcome supports the need to improve continuity of care within multi-institutional pancreatic care networks.


Assuntos
Continuidade da Assistência ao Paciente , Rede Social , Humanos , Projetos Piloto , Inquéritos e Questionários
8.
Trials ; 22(1): 313, 2021 Apr 29.
Artigo em Inglês | MEDLINE | ID: mdl-33926539

RESUMO

BACKGROUND: Approximately 80% of patients with locally advanced pancreatic cancer (LAPC) are treated with chemotherapy, of whom approximately 10% undergo a resection. Cohort studies investigating local tumor ablation with radiofrequency ablation (RFA) have reported a promising overall survival of 26-34 months when given in a multimodal setting. However, randomized controlled trials (RCTs) investigating the effect of RFA in combination with chemotherapy in patients with LAPC are lacking. METHODS: The "Pancreatic Locally Advanced Unresectable Cancer Ablation" (PELICAN) trial is an international multicenter superiority RCT, initiated by the Dutch Pancreatic Cancer Group (DPCG). All patients with LAPC according to DPCG criteria, who start with FOLFIRINOX or (nab-paclitaxel/)gemcitabine, are screened for eligibility. Restaging is performed after completion of four cycles of FOLFIRINOX or two cycles of (nab-paclitaxel/)gemcitabine (i.e., 2 months of treatment), and the results are assessed within a nationwide online expert panel. Eligible patients with RECIST stable disease or objective response, in whom resection is not feasible, are randomized to RFA followed by chemotherapy or chemotherapy alone. In total, 228 patients will be included in 16 centers in The Netherlands and four other European centers. The primary endpoint is overall survival. Secondary endpoints include progression-free survival, RECIST response, CA 19.9 and CEA response, toxicity, quality of life, pain, costs, and immunomodulatory effects of RFA. DISCUSSION: The PELICAN RCT aims to assess whether the combination of chemotherapy and RFA improves the overall survival when compared to chemotherapy alone, in patients with LAPC with no progression of disease following 2 months of systemic treatment. TRIAL REGISTRATION: Dutch Trial Registry NL4997 . Registered on December 29, 2015. ClinicalTrials.gov NCT03690323 . Retrospectively registered on October 1, 2018.


Assuntos
Neoplasias Pancreáticas , Ablação por Radiofrequência , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Humanos , Estudos Multicêntricos como Assunto , Países Baixos , Neoplasias Pancreáticas/tratamento farmacológico , Neoplasias Pancreáticas/cirurgia , Intervalo Livre de Progressão , Ablação por Radiofrequência/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
Br J Surg ; 108(7): 826-833, 2021 07 23.
Artigo em Inglês | MEDLINE | ID: mdl-33738473

RESUMO

BACKGROUND: Centralization of pancreatic surgery in the Netherlands has been ongoing since 2011. The aim of this study was to assess how centralization has affected the likelihood of resection and survival of patients with non-metastatic pancreatic head and periampullary cancer, diagnosed in hospitals with and without pancreatic surgery services. METHODS: An observational cohort study was performed on nationwide data from the Netherlands Cancer Registry (2009-2017), including patients diagnosed with non-metastatic pancreatic head or periampullary cancer. The period of diagnosis was divided into three time intervals: 2009-2011, 2012-2014 and 2015-2017. Hospital of diagnosis was classified as a pancreatic or non-pancreatic surgery centre. Analyses were performed using multivariable logistic and Cox regression models. RESULTS: In total, 10 079 patients were included, of whom 3114 (30.9 per cent) were diagnosed in pancreatic surgery centres. Between 2009-2011 and 2015-2017, the number of patients undergoing resection increased from 1267 of 3169 (40.0 per cent) to 1705 of 3566 (47.8 per cent) (P for trend < 0.001). In multivariable analysis, in 2015-2017, unlike the previous periods, patients diagnosed in pancreatic and non-pancreatic surgery centres had a similar likelihood of resection (odds ratio 1.08, 95 per cent c.i. 0.90 to 1.28; P = 0.422). In this period, however, overall survival was higher in patients diagnosed in pancreatic surgery than in those diagnosed in non-pancreatic surgery centres (hazard ratio 0.92, 95 per cent c.i. 0.85 to 0.99; P = 0.047). CONCLUSION: After centralization of pancreatic surgery, the resection rate for patients with pancreatic head and periampullary cancer diagnosed in non-pancreatic surgery centres increased and became similar to that in pancreatic surgery centres. Overall survival remained higher in patients diagnosed in pancreatic surgery centres.


Assuntos
Cirurgia Geral/organização & administração , Pancreatectomia/estatística & dados numéricos , Neoplasias Pancreáticas/mortalidade , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Países Baixos/epidemiologia , Pancreatectomia/mortalidade , Neoplasias Pancreáticas/diagnóstico , Neoplasias Pancreáticas/cirurgia , Estudos Prospectivos , Taxa de Sobrevida/tendências
11.
Eur J Surg Oncol ; 47(3 Pt B): 708-716, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33323293

RESUMO

INTRODUCTION: First, this study aimed to assess the prognostic value of different definitions for resection margin status on disease-free survival (DFS) and overall survival (OS) in pancreatic ductal adenocarcinoma (PDAC). Second, preoperative predictors of direct margin involvement were identified. MATERIALS AND METHODS: This nationwide observational cohort study included all patients who underwent upfront PDAC resection (2014-2016), as registered in the prospective Dutch Pancreatic Cancer Audit. Patients were subdivided into three groups: R0 (≥1 mm margin clearance), R1 (<1 mm margin clearance) or R1 (direct margin involvement). Survival was compared using multivariable Cox regression analysis. Logistic regression with baseline variables was performed to identify preoperative predictors of R1 (direct). RESULTS: 595 patients with a median OS of 18 months (IQR 10-32 months) months were analysed. R0 (≥1 mm) was achieved in 277 patients (47%), R1 (<1 mm) in 146 patients (24%) and R1 (direct) in 172 patients (29%). R1 (direct) was associated with a worse OS, as compared with both R0 (≥1 mm) (hazard ratio (HR) 1.35 [95% and confidence interval (CI) 1.08-1.70); P < 0.01) and R1 (<1 mm) (HR 1.29 [95%CI 1.01-1.67]; P < 0.05). No OS difference was found between R0 (≥1 mm) and R1 (<1 mm) (HR 1.05 [95% CI 0.82-1.34]; P = 0.71). Preoperative predictors associated with an increased risk of R1 (direct) included age, male sex, performance score 2-4, and venous or arterial tumour involvement. CONCLUSION: Resection margin clearance of <1 mm, but without direct margin involvement, does not affect survival, as compared with a margin clearance of ≥1 mm. Given that any vascular tumour involvement on preoperative imaging was associated with an increased risk of R1 (direct) resection with upfront surgery, neoadjuvant therapy might be considered in these patients.


Assuntos
Carcinoma Ductal Pancreático/cirurgia , Margens de Excisão , Neoplasias Pancreáticas/cirurgia , Idoso , Carcinoma Ductal Pancreático/patologia , Estudos de Coortes , Intervalo Livre de Doença , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Países Baixos , Neoplasias Pancreáticas/patologia , Prognóstico , Modelos de Riscos Proporcionais , Taxa de Sobrevida
12.
Pancreatology ; 21(1): 163-169, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33309624

RESUMO

BACKGROUND: The treatment options for patients with locally advanced pancreatic cancer (LAPC) have improved in recent years and consequently survival has increased. It is unknown, however, if elderly patients benefit from these improvements in therapy. With the ongoing aging of the patient population and an increasing incidence of pancreatic cancer, this patient group becomes more relevant. This study aims to clarify the association between increasing age, treatment and overall survival in patients with LAPC. METHODS: Post-hoc analysis of a multicenter registry including consecutive patients with LAPC, who were registered in 14 centers of the Dutch Pancreatic Cancer Group (April 2015-December 2017). Patients were divided in three groups according to age (<65, 65-74 and ≥75 years). Primary outcome was overall survival stratified by primary treatment strategy. Multivariable regression analyses were performed to adjust for possible confounders. RESULTS: Overall, 422 patients with LAPC were included; 162 patients (38%) aged <65 years, 182 patients (43%) aged 65-74 and 78 patients (19%) aged ≥75 years. Chemotherapy was administered in 86%, 81% and 50% of the patients in the different age groups (p<0.01). Median overall survival was 12, 11 and 7 months for the different age groups (p<0.01).Patients treated with chemotherapy showed comparable median overall survival of 13, 14 and 10 months for the different age groups (p=0.11). When adjusted for confounders, age was not associated with overall survival. CONCLUSION: Elderly patients are less likely to be treated with chemotherapy, but when treated with chemotherapy, their survival is comparable to younger patients.


Assuntos
Neoplasias Pancreáticas/mortalidade , Neoplasias Pancreáticas/terapia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Quimiorradioterapia , Tratamento Farmacológico , Feminino , Humanos , Quimioterapia de Indução , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Análise de Sobrevida , Adulto Jovem
13.
Trials ; 21(1): 334, 2020 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-32299515

RESUMO

BACKGROUND: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. METHODS/DESIGN: PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients nationwide. DISCUSSION: The PACAP-1 trial is designed to evaluate whether a nationwide program for enhanced implementation of best practices in pancreatic cancer care can improve 1-year overall survival and quality of life. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03513705. Trial opened for accrual on 22th May 2018.


Assuntos
Carcinoma Ductal Pancreático/mortalidade , Carcinoma Ductal Pancreático/terapia , Implementação de Plano de Saúde , Neoplasias Pancreáticas/mortalidade , Neoplasias Pancreáticas/terapia , Qualidade de Vida , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos do Sistema Biliar , Carcinoma Ductal Pancreático/epidemiologia , Criança , Pré-Escolar , Análise por Conglomerados , Drenagem , Terapia de Reposição de Enzimas , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Terapia Neoadjuvante , Países Baixos/epidemiologia , Cuidados Paliativos , Neoplasias Pancreáticas/epidemiologia , Pancreaticoduodenectomia , Cooperação do Paciente , Ensaios Clínicos Controlados Aleatórios como Assunto , Stents , Resultado do Tratamento , Adulto Jovem
14.
Eur J Surg Oncol ; 46(3): 429-432, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31668976

RESUMO

Colorectal cancer is a common disease and patient follow-up can overwhelm outpatient services. Cancer patients are followed to provide (psychological) support, and to identify and treat disease recurrence and complications. This article describes our thoughts on, and first experience with the development and implementation of an alternative, remote follow-up plan for colorectal cancer patients. Within remote follow-up, patients have access to test results, and are supported with self-management information. They have access to telemedicine applications such as video-consultation, text messaging, and telephone services to contact their physician and nurse practitioner. Routine outpatient clinical visits are abandoned. Currently, 66 patients are being followed remotely. Application of telemedicine within cancer follow-up has several advantages. Patients do not have to travel back and forth, sparing time, costs and efforts. Second, telemedicine applications increase patient empowerment. If applied safely, remote follow-up may become a viable alternative to clinical follow-up.


Assuntos
Neoplasias Colorretais/terapia , Estadiamento de Neoplasias/métodos , Satisfação do Paciente , Avaliação de Programas e Projetos de Saúde/métodos , Medição de Risco/métodos , Telemedicina/métodos , Idoso , Neoplasias Colorretais/diagnóstico , Feminino , Seguimentos , Humanos , Masculino
15.
Eur J Surg Oncol ; 45(10): 1770-1777, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31204168

RESUMO

BACKGROUND: The aim of this study is to collect the best available evidence for diagnostic modalities, frequency, and duration of surveillance after resection for pancreatic ductal adenocarcinoma (PDAC). METHODS: PDAC guidelines published after 2015 were collected. Furthermore, a systematic search of the literature on postoperative surveillance was performed in PubMed and Embase from 2000 to 2019. Articles comparing different diagnostic modalities and frequencies of postoperative surveillance in PDAC patients with regard to survival, quality of life, morbidity and cost-effectiveness were selected. RESULTS: The literature search resulted in 570 articles. A total of seven guidelines and twelve original clinical studies were eventually evaluated. PDAC guidelines increasingly recommend a combination of tumor marker testing and computed tomography (CT) imaging every three to six months during the first two years after resection. These guidelines are, however, based on expert opinion and other low-level evidence. Prospective studies comparing different surveillance strategies are lacking. According to recent studies, surveillance with tumor markers and imaging at regular intervals results in the detection of PDAC recurrence before the onset of symptoms and more frequent administration of further therapy, such as chemotherapy or radiotherapy. CONCLUSION: Current evidence for recurrence-focused surveillance after PDAC resection is limited and contradictory. Consequently, recommendations on surveillance are conflicting. To define the clinical merit of recurrence-focused surveillance, patients who are most likely to benefit from early detection and treatment of PDAC recurrence need to be identified. To this purpose, well-designed prospective studies are needed, accounting for both economical and psychosocial implications of surveillance.


Assuntos
Carcinoma Ductal Pancreático/cirurgia , Pancreatectomia , Neoplasias Pancreáticas/cirurgia , Qualidade de Vida , Carcinoma Ductal Pancreático/diagnóstico , Carcinoma Ductal Pancreático/epidemiologia , Saúde Global , Humanos , Morbidade/tendências , Neoplasias Pancreáticas/diagnóstico , Neoplasias Pancreáticas/epidemiologia , Período Pós-Operatório , Taxa de Sobrevida/tendências
16.
Int J Obes (Lond) ; 37(3): 461-7, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-22546777

RESUMO

OBJECTIVES: To investigate temporal changes in the bias associated with self-reported (as opposed to measured) body mass index (BMI) and explore the relationship of such bias to changing social attitudes towards obesity. METHODS: Using data from the National Health and Nutrition Examination Survey covering two time periods, 1988-1994 and 2005-2008, discrepancy scores between self-reported vs measured BMI were generated. Changes in the sensitivity of BMI categories based on self-reports were examined for six weight groups, both for the US adult population as a whole and major demographic groups. Linear regression models were used to examine temporal changes in average bias, as well as attitudes about weight within each weight category and by demographic group. RESULTS: Between 2005-2008 and 1988-1994, the bias towards underestimation of a person's BMI based on interview responses has declined among obese individuals, a trend evident in virtually all demographic subgroups explored. Conversely, most demographic groups showed little change in the extent of bias among underweight and normal-weight individuals. Although the 2005-2008 survey respondents underestimated their measured BMI more than the 1988-1994 respondents, this shift can be entirely explained by the increased prevalence of obesity in more recent years. In fact, obese individuals in 2005-2008 were less likely to overreport their height and underreport their weight than their counterparts in the 1988-1994. Evidence from responses to questions about ideal weight and desire to lose weight point in the direction of a shift in social attitudes, which may make it easier to 'admit' to greater weight in surveys. CONCLUSION: Over the past 20 years, the bias in self-reported height and weight has declined leading to more accurate BMI categorizations based on self-report. This change is likely to affect efforts to find correction factors to adjust BMI scores based on self-reported height and weight.


Assuntos
Estatura , Índice de Massa Corporal , Peso Corporal , Obesidade/epidemiologia , Autorrelato , Adulto , Idoso , Viés , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos Nutricionais , Reprodutibilidade dos Testes , Fatores de Tempo , Estados Unidos/epidemiologia
18.
Dig Surg ; 28(5-6): 412-6, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-22189058

RESUMO

INTRODUCTION: Transanal endoscopic microsurgery (TEM) is widely used for the excision of both benign and malignant rectal tumours. It is relatively expensive and can be a challenging technique. A recent development in laparoscopic surgery is the single-port technique (single-incision laparoscopic surgery, SILS). The SILS port is a flexible multichannel port for transumbilical laparoscopic surgery. Even though not developed for transanal use the port could be ideal because of its shape and texture. METHODS: 12 patients underwent transanal resection using an SILS port and normal laparoscopic instruments. RESULTS: 10 out of 12 patients were treated successfully with the SILS port. Two polyps were resected using an open transanal technique because the distance between the SILS port and the polyp was too small. The average operative time was 55 min (range 40-80 min). All patients could be discharged on the first postoperative day. There were no major complications. CONCLUSION: Our current data show that transanal surgery using a single port is a relatively easy procedure with operative times comparable to TEM. More surgeons will therefore be able to perform transanal endoscopic surgery.


Assuntos
Pólipos Intestinais/cirurgia , Cirurgia Endoscópica por Orifício Natural/métodos , Reto/cirurgia , Idoso , Idoso de 80 Anos ou mais , Canal Anal , Feminino , Humanos , Pólipos Intestinais/patologia , Masculino , Pessoa de Meia-Idade , Cirurgia Endoscópica por Orifício Natural/instrumentação , Fatores de Tempo
20.
J Gastrointest Surg ; 13(4): 676-86, 2009 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-19132451

RESUMO

BACKGROUND: For patients with acute colitis, the decision when and how to operate is difficult in most cases. It was the aim of this systematic review to analyze early mortality and morbidity of colectomy for severe acute colitis in order to identify opportunities to improve perioperative treatment and outcome. METHODS: A systematic review of the available literature in the Medline and PubMed databases from 1975 to 2007 was performed. All articles were assessed methodologically; the articles of poor methodological quality were excluded. Articles on laparoscopic colectomy for acute colitis were analyzed separately. RESULTS: In total, 29 studies met the criteria for the systematic review, describing a total of 2,714 patients, 1,257 of whom were operated on in an acute setting, i.e., urgent or emergency colectomy. Reported in-hospital mortality was 8.0%; the 30-day mortality was 5.2%. Morbidity was 50.8%. The majority of complications were of infectious and thromboembolic nature. Over the last three decades, there was a shift in indications from toxic megacolon, from 71.1% in 1975-1984 to 21.6% in 1995-2005, to severe acute colitis not responding to conservative treatment, from 16.5% in 1975-1984 to 58.1% in 1995-2007. Mortality decreased from 10.0% to 1.8%. Morbidity remained high, exceeding 40% in the last decade. Mortality after laparoscopic surgery was 0.6%. Complication rate varies from 16-37%. CONCLUSION: Colectomy for acute colitis is complicated by considerable morbidity. The incidence of adverse outcome has substantially decreased over the last three decades, but further improvements are still required. The retrospective nature of the included studies allows for a considerable degree of selection bias that limits robust and clinically sound conclusions about both conventional and laparoscopic surgery.


Assuntos
Colectomia , Colite/cirurgia , Doença Aguda , Colectomia/efeitos adversos , Colite/mortalidade , Mortalidade Hospitalar , Humanos , Megacolo Tóxico/cirurgia , Complicações Pós-Operatórias/epidemiologia , Resultado do Tratamento
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