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1.
J Alzheimers Dis ; 2021 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-33843681

RESUMO

BACKGROUND: End of life symptoms and symptom management as well as the quality of dying (QoD) of persons with advanced dementia (PWAD) have not yet been systematically studied in Germany. OBJECTIVE: 1) To investigate symptoms, treatment and care at the end of life, advance care planning, and circumstances of death of recently deceased PWAD; 2) To determine whether there are differences between young and late onset dementia (YOD and LOD). METHODS: The study was performed in the context of the project EPYLOGE (IssuEs in Palliative care for persons in advanced and terminal stages of Young-onset and Late-Onset dementia in Germany). Closest relatives of recently deceased patients with advanced YOD (N = 46) and LOD (N = 54) living at home or in long term care were interviewed. RESULTS: Circumstances of death, symptoms, and treatment appeared to be similar between YOD and LOD, except that persons with LOD had significantly more somatic comorbidities and were admitted to hospital in the last three months of life more often than persons with LOD. At end of life, 60%of PWAD appeared to be "at peace". Difficulty swallowing, gurgling, shortness of breath, and discomfort were observed most frequently. Large interindividual differences in suffering and QoD were present. Determinants of QoD were not identified. CONCLUSION: Our findings suggest that low QoD was caused by inadequate recognition and/or insufficient treatment of burdensome physical and emotional symptoms. PWADs' needs should be assessed regularly, and strategies focusing on treatment and implementing support for both the patient and caregiver must be established.

2.
Dtsch Arztebl Int ; 118(Forthcoming)2021 04 09.
Artigo em Inglês | MEDLINE | ID: mdl-33634785

RESUMO

BACKGROUND: Appendectomy is the gold standard for treatment of acute appendicitis. However, recent studies favor primary antibiotic therapy. The aim of this observational study was to explore changes in the numbers of operations for acute appendicitis in the period 2010-2017, paying special attention to disease severity. METHODS: Data from diagnosis-related group statistics were used to analyze the trends, mortality, and complication rates in the surgical treatment of appendicitis in Germany between 2010 and 2017. All cases of appendectomy after a diagnosis of appendicitis were included. RESULTS: Altogether, 865 688 inpatient cases were analyzed. The number of appendectomies went down by 9,8%, from 113 614 in 2010 to 102 464 in 2017, while the incidence fell from 139/100 000 in 2010 to 123/100 000 in 2017 (standardized by age group). This decrease is due to the lower number of operations for uncomplicated appendicitis (79 906 in 2017 versus 93 135 in 2010). Hospital mortality decreased both in patients who underwent surgical treatment of complicated appendicitis (0.62% in 2010 versus 0.42% in 2017) and in those with a complicated clinical course (5.4% in 2010 versus 3.4% in 2017). CONCLUSION: Decisions on the treatment of acute appendicitis in German hospitals follow the current trend towards non-surgical management in selected patients. At the same time, the care of acute appendicitis has improved with regard to overall hospital morbidity and hospital mortality.

3.
J Alzheimers Dis ; 80(1): 283-297, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33523011

RESUMO

BACKGROUND: Advanced stages of dementia are characterized by severe cognitive and physical impairment. It has not yet been investigated whether persons with young onset dementia (YOD) and late onset dementia (LOD) differ in advanced disease stages. OBJECTIVES: To compare quality of life (QoL) between persons with advanced YOD and LOD; to explore the determinants of QoL; to investigate whether YOD and LOD differ with regard to symptoms and care. METHODS: The study was performed in the context of EPYLOGE (IssuEs in Palliative care for persons in advanced and terminal stages of YOD and LOD in Germany). Persons with advanced dementia (PWAD) were assessed and caregivers were interviewed. QoL was measured with the proxy rating Quality of Life in Late Stage Dementia (QUALID) scale. RESULTS: 93 persons with YOD and 98 with LOD were included. No significant differences in QoL were detected. Determinants of QoL were similar in YOD and LOD. Behavioral and psychological symptoms of dementia (BPSD), suffering and other distressing symptoms were associated with a lower QoL. In YOD but not in LOD antipsychotic treatment was associated with low QoL. The group of persons who were younger than 65 years at the time of the study visit experienced significantly more distressing symptoms than older PWAD. CONCLUSION: Overall, persons with advanced YOD do not appear to be disadvantaged compared to old and oldest PWAD. Special attention, however, must be paid to the group of the very young persons who seem to be particularly vulnerable.

4.
Vasc Med ; : 1358863X20967091, 2020 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-33256573

RESUMO

We retrospectively analyzed all endovascular procedures of infrapopliteal arterial lesions (n = 383) performed in 270 patients at our institution between December 2008 and January 2018. The overall technical success rate was 97% and yielded 98% for stenoses (n = 214) and 95% for occlusions (n = 169). Trans-Atlantic Inter-Society Consensus (TASC II) classification had no impact on success rates (TASC A + B vs C + D; 96.5% vs 96.9%, p = 0.837). Freedom from clinically driven target lesion revascularization (TLR) after 6 and 12 months was 88.3% and 77.2%. TLR was comparable for TASC A to C lesions and no difference was observed comparing groups of moderately complex TASC A/B lesions and more complex TASC C/D lesions (TASC A + B vs C + D; 78.5% vs 74.2%, p = 0.457). Freedom from TLR was significantly lower in very complex TASC D lesions (TASC A + B + C vs D; 79.7% vs 42.5%, p < 0.001). Multivariate analysis identified TASC D lesions (hazard ratio D/A: 1.5; overall p = 0.002), Fontaine class III and IV (hazard ratio III or IV/IIa or IIb: 2.4; p = 0.041), and occlusive lesions (hazard ratio occlusion/stenosis: 2.4; p = 0.026) as predictors for TLR. In conclusion, endovascular therapy for infrapopliteal artery disease was safe and accompanied with a promising long-term outcome.

5.
Clin Oral Investig ; 2020 Oct 06.
Artigo em Inglês | MEDLINE | ID: mdl-33025147

RESUMO

OBJECTIVES: The purpose of this study was to evaluate the incidence of complications following mandibular reconstruction and to analyse possible contributing factors. MATERIALS AND METHODS: Clinical data and computed tomography scans of all patients who needed a mandibular reconstruction with a reconstruction plate, free fibula flap (FFF) or iliac crest (DCIA) flap between August 2010 and August 2015 were retrospectively analysed. RESULTS: One hundred and ninety patients were enrolled, encompassing 77 reconstructions with reconstruction plate, 89 reconstructions with FFF and 24 reconstructions with DCIA flaps. Cutaneous perforation was most frequently detected in the plate subgroup within the early interval and overall (each p = 0.004). Low body mass index (BMI) and total radiation dosage were the most relevant risk factors for the development of analysed complications. CONCLUSIONS: Microvascular bone flaps have overall less skin perforation than reconstruction plates. BMI and expected total radiation dosage have to be respected in choice of reconstructive technique. CLINICAL RELEVANCE: A treatment algorithm for mandibular reconstructions on the basis of our results is presented.

6.
J Neurooncol ; 2020 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-33094355

RESUMO

INTRODUCTION: Primary malignant spinal astrocytomas present rare oncological entities with limited median survival and rapid neurological deterioration. Evidence on surgical therapy, adjuvant treatment, and neurological outcome is sparse. We aim to describe the treatment algorithm and clinical features on patients with infiltrating intramedullary astrocytomas graded WHO II-IV. METHODS: The following is a multicentered retrospective study of patients treated for spinal malignant glioma WHO II-IV in five high-volume neurosurgical departments from 2008 to 2019. Pilocytic astrocytomas were excluded. We assessed data on surgical technique, perioperative neurological status, adjuvant oncological therapy, and clinical outcome. RESULTS: 40 patients were included (diffuse astrocytoma WHO II n = 11, anaplastic astrocytoma WHO III n = 12, WHO IV n = 17). Only 40% were functionally independent before surgery, most patients presented with moderate disability (47.5%). Most patients underwent a biopsy (n = 18, 45%) or subtotal tumor resection (n = 15, 37.5%), and 49% of the patients deteriorated after surgery. Patients with WHO III and IV tumors were treated with combined radiochemotherapy. Median overall survival (OS) was 46.5 months in WHO II, 25.7 months in WHO III, and 7.4 months in WHO IV astrocytomas. Preoperative clinical status and WHO significantly influenced the OS, and the extent of resection did not. CONCLUSION: Infiltrating intramedullary astrocytomas WHO II-IV present rare entities with dismal prognosis. Due to the high incidence of surgery-related neurological impairment, the aim of the surgical approach should be limited to obtaining the histological tissue via a biopsy or, tumor debulking in cases with rapidly progressive severe preoperative deficits.

7.
J Reconstr Microsurg ; 36(9): 686-693, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32712944

RESUMO

BACKGROUND: Perforator imaging is routinely performed before perforator flap harvest. Hand-held Doppler (hhD) and color duplex ultrasonography (CDU) are currently the most popular radiation-free methods for this purpose that can be applied by the surgeon alone. The aim of this study was to compare the accuracy, reliability, and feasibility of hhD and CDU with indocyanine green angiography (ICGA) in the anterolateral thigh perforator flap (ALTPF). METHODS: All consecutive ALTPF procedures between May 2017 and April 2018 were included in this prospective study. The perforators were visualized by three investigators independently and randomized, applying hhD, CDU, and ICGA. The presence and the distance to the identified perforator were registered. Further, body mass index (BMI), American Society of Anesthesiologists-status, and the patient's history regarding smoking, alcohol use, and diabetes mellitus were registered alongside gender and age to analyze possible confounders. RESULTS: A total of 12 patients were enrolled with a median age of 67 (52-87) years. In total, 30 perforators were detected intraoperatively as well as with the ICGA. The latter visualized the perforators significantly more precisely than hhD and CDU (p < 0.001 and p = 0.001). The sensitivity and positive predictive value were 67 and 62% for hhD, 73 and 64% for CDU, and 100 and 100% for ICGA, respectively. CONCLUSION: According to this study, ICGA visualized perforators more accurately than the standard methods hhD and CDU. Further, it was associated with the highest sensitivity and positive predictive value. ICGA consistently delivered excellent results, whereas hhD and CDU showed variability.

8.
BMC Psychiatry ; 20(1): 177, 2020 04 19.
Artigo em Inglês | MEDLINE | ID: mdl-32306925

RESUMO

BACKGROUND: Patients with mental illnesses often have massive difficulties returning to work after inpatient treatment at a psychiatric clinic and are often at risk of losing their jobs. The psychosocial support for this patient group at the interface of clinic/outpatient care is often insufficient. METHODS/DESIGN: The RETURN-study prospectively assesses and surveys 200 patients with mental disorders in a cluster randomized intervention study, i.e. treatment teams and patients from intervention wards receive a return-to-work (RTW) intervention. Patients in control wards obtain treatment as usual (TAU). Pairs of comparable wards (similar patient population, similar staff density) have been identified and then randomized for control and intervention (n = 14 for each condition). On intervention wards return-to-work experts (RTW experts) who focus treatment on the workplace-related needs of patients with mental illnesses have been established. These RTW experts ensure the use of available resources within the framework of work-related discharge management and should lead to a more successful return to the workplace. The days at work in the year after release will be evaluated in a mixed methods approach as well as the return rate in the year after release, disability days in the year after return, relapse rate after 12 months, cost-benefit ratio of the intervention, analysis of the predictors / barriers for a successful return to the workplace (e.g. psychopathology, cognition, stigma, social-psychiatric support, company support, etc.), possibilities to implement the concept of RTW experts in standard psychiatric care (TAU - treatment as usual), the impact of the RTW experts' approach on the treatment process in standard psychiatric care. DISCUSSION: This approach is already internationally established in the field of somatic rehabilitation and supported employment [Am J Psychiatry 171:1183-90, 2014; Lancet 370:1146-52, 2007; Cochrane Database Syst Rev, doi:10.1002/14651858.CD006237.pub3, 2014]; the innovative aspect of this project is to implement and evaluate it in standard psychiatric care in Germany. This project requires no new interventions to be developed and tested, as the techniques of the case manager/job coach is applied to the field of return to work. TRIAL REGISTRATION: The study was registered in Deutsches Register Klinische Studien searchable via its Meta-registry (http://apps.who.int/trialsearch/), Trial registration number: DRKS00016037, Date of registration: 21/12/2018, URL of trial registry record.

9.
Eur Radiol ; 29(7): 3424-3430, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31062134

RESUMO

OBJECTIVE: To evaluate contrast-enhanced T1-weighted magnetic resonance (MR) images in histologically proven fibrous dysplasia (FD) for the prevalence of "milk cloud appearance" and its association with ground-glass appearance (GGA) on radiography or computed tomography (CT). METHODS: For this retrospective cohort study, 37 patients with histologically proven FD imaged preoperatively with contrast-enhanced MR imaging and radiography or CT were identified at our institution. Three radiologists independently evaluated MR images for the presence of milk cloud appearance on T1-weighted contrast-enhanced images, sites of skeletal involvement, type of bone involved, uni- vs. multifocality, mono- vs. polyostotic disease, maximum diameter, proportion of bone involved, expansile remodeling, and T2 homogeneity. The presence or absence of GGA on radiography or CT was determined in consensus. Inter-reader agreement was evaluated for milk cloud appearance using Cohen's kappa, and associations between milk cloud appearance and other imaging parameters were tested using Spearman's rho. RESULTS: Among the 37 histologically proven FD lesions, GGA was identified in 70% of the lesions, while milk cloud appearance was found in 82% of the lesions. Inter-reader agreement for milk cloud appearance on MR imaging was good to excellent (κ 0.65, 0.82, and 0.8). A significant correlation was found between milk cloud appearance and GGA (ρ = 0.31, p < 0.001). CONCLUSION: Milk cloud appearance is a characteristic sign of FD on contrast-enhanced T1-weighted MR images. Recognition of this feature may be helpful when radiographs are equivocal or unremarkable or when MR imaging is performed as the primary imaging modality in cases of FD. KEY POINTS: • Fibrous dysplasia displays a characteristic feature on contrast-enhanced T1-weighted MR imaging: milk cloud appearance. • Milk cloud appearance correlates well with the radiographic or CT finding of ground-glass appearance. • Recognition of milk cloud appearance on contrast-enhanced MR imaging may be helpful when radiographs are equivocal or unremarkable or when MR imaging is performed as the primary imaging modality in cases of fibrous dysplasia.


Assuntos
Osso e Ossos/patologia , Meios de Contraste/farmacologia , Displasia Fibrosa Óssea/diagnóstico , Imagem por Ressonância Magnética/métodos , Adolescente , Adulto , Criança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
10.
Int J Cancer ; 145(8): 2292-2303, 2019 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-30882891

RESUMO

This prospective trial aimed to investigate whether tumor-specific cKIT and PDGFRA mutations can be detected and quantified in circulating tumor (ct)DNA in patients with active GIST, and whether detection indicates disease activity. We included 25 patients with active disease and cKIT or PDGFRA mutations detected in tissue. Mutant ctDNA was detected in the peripheral blood plasma using allele-specific ligation (L-)PCR and droplet digital (d)PCR. CtDNA harboring tumor-specific cKIT or PDGFRA mutations was detected at least once in 16 out of 25 patients using L-PCR (64%) and in 20 out of 25 patients with dPCR (80%). Using dPCR, the absolute numbers of ctDNA fragments (DNA copies/ml) and the mutant allele frequency (MAF; in percent of wild-type control) strongly correlated with tumor size expressed as RECIST1.1 sum of diameter (SOD) in mm (ρ = 0.3719 and 0.408, respectively, p < 0.0001) and response status (ρ = 0.3939 and 0.392, respectively, p < 0.0001 and p < 0.001). Specificity of dPCR for detection of progression was 79.2% with a sensitivity of 55.2% and dPCR discriminated CR from active disease with a specificity of 96% and s sensitivity of 44.7%. With L-PCR, correlations of MAF with tumor size and response status were less prominent. Serial ctDNA measurement reflected individual disease courses over time. Targeted panel sequencing of four patients detected additional driver mutations in all cases and secondary resistance mutations in two cases. Thus, ctDNA indicates disease activity in patients with GIST and should be incorporated as companion biomarker in future prospective trials.


Assuntos
DNA Tumoral Circulante/genética , DNA de Neoplasias/genética , Tumores do Estroma Gastrointestinal/genética , Mutação , Proteínas Proto-Oncogênicas c-kit/genética , Receptor alfa de Fator de Crescimento Derivado de Plaquetas/genética , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores Tumorais/sangue , Biomarcadores Tumorais/genética , DNA Tumoral Circulante/sangue , DNA de Neoplasias/sangue , Feminino , Tumores do Estroma Gastrointestinal/tratamento farmacológico , Tumores do Estroma Gastrointestinal/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/métodos , Reação em Cadeia da Polimerase/métodos , Estudos Prospectivos , Inibidores de Proteínas Quinases/uso terapêutico
11.
BMC Psychiatry ; 18(1): 271, 2018 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-30170575

RESUMO

BACKGROUND: Scientific research on palliative care in dementia is still underdeveloped. In particular, there are no research studies at all on palliative care issues in young onset dementia (YOD), although significant differences compared to late onset dementia (LOD) are expected. Most studies have focused on persons with dementia in long term care (LTC) facilities but have neglected persons that are cared for at home. We hypothesize that unmet care needs exist in advanced and terminal stages of YOD and LOD and that they differ between YOD and LOD. METHODS/DESIGN: The EPYLOGE-study (IssuEs in Palliative care for people in advanced and terminal stages of Young-onset and Late-Onset dementia in GErmany) aims to prospectively assess and survey 200 persons with YOD and LOD in advanced stages who are cared for in LTC facilities and at home. Furthermore, EPYLOGE aims to investigate the circumstances of death of 100 persons with YOD and LOD. This includes 1) describing symptoms and management, health care utilization, palliative care provision, quality of life and death, elements of advance care planning, family caregivers' needs and satisfaction; 2) comparing YOD and LOD regarding these factors; 3) developing expert-consensus recommendations derived from the study results for the improvement and implementation of strategies and interventions for palliative care provision; 4) and communicating the recommendations nationally and internationally in order to improve and adapt guidelines, to change current practice and to give a basis and perspectives for future research projects. The results will also be communicated to patients and their families in order to counsel and support them in their decision making processes and their dialogue with professional caregivers and physicians. DISCUSSION: EPYLOGE is the first study in Germany that assesses palliative care and end-of-life issues in dementia. Furthermore, it is the first study internationally that focuses on the specific palliative care situation of persons with YOD and their families. EPYLOGE serves as a basis for the improvement of palliative care in dementia. TRIAL REGISTRATION: The study is registered in ClinicalTrials.gov ( NCT03364179 ; Registered: 6. December 2017.


Assuntos
Cuidadores/psicologia , Demência/psicologia , Pesquisas sobre Serviços de Saúde/métodos , Cuidados Paliativos/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Adulto , Idade de Início , Idoso , Tomada de Decisões , Demência/terapia , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Cuidados Paliativos/métodos , Estudos Prospectivos , Qualidade de Vida , Projetos de Pesquisa
12.
J Neurosurg Spine ; 28(6): 654-662, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29521579

RESUMO

OBJECTIVE Spinal ependymomas are rare glial neoplasms. Because their incidence is low, only a few larger studies have investigated this condition. There are no clear data concerning prognosis and therapy. The aim of the study was to describe the natural history, perioperative clinical course, and local tumor control of adult patients with spinal ependymomas who were surgically treated under modern treatment standards. METHODS The authors performed a multicenter retrospective study. They identified 158 adult patients with spinal ependymomas who had received surgical treatment between January 2006 and June 2013. The authors analyzed the clinical and histological aspects of these cases to identify the predictive factors for postoperative morbidity, tumor resectability, and recurrence. RESULTS Gross-total resection (GTR) was achieved in 80% of cases. At discharge, 37% of the patients showed a neurological decline. During follow-up the majority recovered, whereas 76% showed at least preoperative status. Permanent functional deterioration remained in 2% of the patients. Transient deficits were more frequent in patients with cervically located ependymomas (p = 0.004) and in older patients (p = 0.002). Permanent deficits were independently predicted only by older age (p = 0.026). Tumor progression was observed in 15 cases. The 5-year progression-free survival (PFS) rate was 80%, and GTR (p = 0.037), WHO grade II (p = 0.009), and low Ki-67 index (p = 0.005) were independent prognostic factors for PFS. Adjuvant radiation therapy was performed in 15 cases. No statistically relevant effects of radiation therapy were observed among patients with incompletely resected ependymomas (p = 0.079). CONCLUSIONS Due to its beneficial value for PFS, GTR is important in the treatment of spinal ependymoma. Gross-total resection is feasible in the majority of cases, with acceptable rates of permanent deficits. Also, Ki-67 appears to be an important prognostic factor and should be included in a grading scheme for spinal ependymomas.


Assuntos
Ependimoma/cirurgia , Neoplasias da Medula Espinal/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores Tumorais/metabolismo , Ependimoma/diagnóstico , Ependimoma/epidemiologia , Ependimoma/radioterapia , Feminino , Seguimentos , Humanos , Antígeno Ki-67/metabolismo , Masculino , Microcirurgia , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/diagnóstico , Recidiva Local de Neoplasia/epidemiologia , Prognóstico , Intervalo Livre de Progressão , Radioterapia Adjuvante , Estudos Retrospectivos , Neoplasias da Medula Espinal/diagnóstico , Neoplasias da Medula Espinal/epidemiologia , Neoplasias da Medula Espinal/radioterapia , Adulto Jovem
13.
Trials ; 18(1): 621, 2017 Dec 28.
Artigo em Inglês | MEDLINE | ID: mdl-29282145

RESUMO

BACKGROUND: The majority of patients with gastric or esophago-gastric cancer are at risk for malnutrition. Preoperative malnutrition was shown to increase the incidence of postoperative complications following abdominal surgery. However, it remains unclear if preoperative parenteral nutritional support during neoadjuvant chemotherapy (NACT) may be effective to reduce the rate of postoperative complications in these patients. METHODS/DESIGN: The PERCOG trial is a randomized controlled multicenter observer-blinded trial, investigating if the improvement of the general condition of patients with non-metastasized gastric cancer or cancer of the esophago-gastric junction during NACT by supplemental parenteral nutrition can decrease the postoperative Comprehensive Complication Index (CCI). Statistical analysis of the primary endpoint measure (CCI on postoperative day 30) will be based on the intention-to-treat population. The global level of significance is set at 5% and the sample size (n = 150) is determined to assure a power of 80%. DISCUSSION: The results of the PERCOG trial will provide high-level evidence for clinical recommendations regarding the administration of preoperative supportive parenteral nutrition and provide all participating patients the opportunity of an improved treatment. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00009451 . Registered on 3 July 2017.


Assuntos
Neoplasias Esofágicas/tratamento farmacológico , Junção Esofagogástrica , Nutrição Parenteral , Complicações Pós-Operatórias/prevenção & controle , Cuidados Pré-Operatórios , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias Gástricas/tratamento farmacológico , Coleta de Dados , Humanos , Morbidade , Estudos Multicêntricos como Assunto , Terapia Neoadjuvante , Avaliação de Resultados em Cuidados de Saúde , Tamanho da Amostra
14.
Trials ; 18(1): 410, 2017 09 04.
Artigo em Inglês | MEDLINE | ID: mdl-28870242

RESUMO

BACKGROUND: Postoperative surgical site infection (SSI) is one of the most common hospital infections and contributes substantially to postoperative morbidity and mortality. In addition, SSIs dramatically increase the treatment cost and length of hospital stay. Following visceral surgery by laparotomy, SSI rates are especially high (14-25%). Therefore, measures to prevent SSI in this field are urgently needed. Prophylactic intraoperative wound irrigation (IOWI) of the subcutaneous soft tissue before skin closure hypothetically represents an easy and economical option to reduce SSI rates and is already frequently used in clinical practice. However, there are currently no definite recommendations on the use of IOWI since high-level evidence supporting its use is lacking. Consequently, clinical practice varies widely. Antiseptic polyhexanide (PHX)-based solutions are approved for soft-tissue wound irrigation in surgery but have not been specifically evaluated in randomized clinical trials for the prevention of SSI following laparotomy for visceral surgery. METHODS/DESIGN: The IOWISI trial is a multicentre, randomized, observer- and patient-blinded clinical trial with three parallel treatment groups, comparing IOWI with a 0.04% PHX solution to no irrigation (test 1) or saline (test 2) before skin closure after laparotomy for visceral surgery (contamination level II-IV). The primary endpoint of the trial is the SSI rate within 30 days postoperatively. Statistical analysis of the primary endpoint measure will be based on the intention-to-treat population. The global level of significance is set at 2.5% for test 1 and 5% for test 2 and the sample size (n = 540) is determined to assure a power of 94% (test 1) and 85% (test 2). DISCUSSION: The IOWISI trial will provide high-level evidence as a basis for clinical recommendations regarding the use of IOWI with PHX or saline and will potentially impact on future clinical guidelines and practice. The pragmatic trial design guarantees high external validity. TRIAL REGISTRATION: Registered at the German Clinical Trials Register, DRKS00012251 . Registered on 3 July 2017.


Assuntos
Anti-Infecciosos Locais/administração & dosagem , Biguanidas/administração & dosagem , Laparotomia , Infecção da Ferida Cirúrgica/prevenção & controle , Irrigação Terapêutica/métodos , Anti-Infecciosos Locais/efeitos adversos , Biguanidas/efeitos adversos , Protocolos Clínicos , Método Duplo-Cego , Alemanha , Humanos , Análise de Intenção de Tratamento , Cuidados Intraoperatórios , Laparotomia/efeitos adversos , Projetos de Pesquisa , Fatores de Risco , Infecção da Ferida Cirúrgica/diagnóstico , Infecção da Ferida Cirúrgica/microbiologia , Irrigação Terapêutica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
15.
Diabetes Metab Syndr Obes ; 10: 235-245, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28684917

RESUMO

OBJECTIVE: Overweight and obesity are globally increasing risk factors for diseases in the context of metabolic syndrome. A randomized controlled trial was conducted to investigate whether there are any existing differences between two lifestyle intervention strategies with respect to weight reduction after 1 year. SUBJECTS AND METHODS: A total of 166 subjects with a body mass index of 28-35 kg/m2 were enrolled in this trial at seven study centers; 109 were randomly allocated to the intervention group (comprehensive lifestyle modification program: web-based Individual Health Management [IHM]) with 3-month reduction phase plus 9-month maintenance phase, and 57 were allocated to the control group (written information with advice for healthy food habits: usual care [UC]). Body weight, waist circumference, blood pressure, laboratory findings, and bioimpedance analysis used to determine body composition were measured at baseline and after 3, 6, 9, and 12 months. The primary outcome parameter was body weight at month 12 compared to baseline. RESULTS: With respect to baseline status there were no statistically significant differences between the groups. Based on the intent-to-treat population, body weight showed a mean decrease of 8.7 kg (SD 6.1) in the intervention group (IHM) and 4.2 kg (SD 5) in the control group (UC) at month 12. This statistically significant difference (P<0.001) was confirmed by various sensitivity analyses. Body mass index, waist circumference, high-density lipid cholesterol, body fat, and the ratio of fat and body cell mass improved to a significantly higher degree in the IHM group. CONCLUSION: IHM proved to be superior to UC in weight reduction after 1 year. With a mean loss of about 10% of the baseline weight, a clinically high relevant risk reduction for cardio-metabolic diseases is achievable.

16.
Radiat Oncol ; 12(1): 45, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-28249612

RESUMO

BACKGROUND: Standard of care primary treatment of carcinoma of locally advanced squamous cell head and neck cancer (LAHNSCC) consists of platinum-based concomitant chemo-irradiation. Despite progress in the treatment of LAHNSCC using modern radiotherapy techniques the outcome remains still poor. Using IMRT with SIB the escalation of total dose to the GTV is possible with the aim to improve clinical outcome. This study tests the hypothesis if radiation dose escalation to the GTV improves 2-year-LRC and -OS after concomitant chemo-irradiation. METHODS: The ESCALOX trial is a prospective randomized phase III study using cisplatin chemo-irradiation and the SIB-IMRT concept in patients with LAHNSCC of the oral cavity, oropharynx or hypopharynx to escalate the total dose to the GTV up to 80.5 Gy. Chemotherapy is planned either in the 1st and 5th week (cisplatin 20 mg/m2/d d 1-5 and d 29-33) or weekly (cisplatin 40 mg/m2/d) during RT. RT is delivered as SIB with total doses of 80.5 Gy/70.0 Gy/56.0 Gy with 2.3 Gy/2.0 Gy and 1.6 Gy in the experimental arm and in the control arm with 70.0 Gy/56.0 Gy with 2.0 Gy and 1.6 Gy. A pre-study with dose escalation up to 77.0 Gy/70.0 Gy/56.0 Gy with 2.2 Gy/2.0 Gy and 1.6 Gy is demanded by the German federal office of radiation protection (BfS). In the translational part of the trial 100 of the randomised patients will be investigated by 18-F-FMiso-PET-CT for the presence and behaviour of tumor hypoxia twice in the week before treatment start. DISCUSSION: The primary endpoint of the pre-study is acute radiation induced toxicity. Primary endpoint of the main trial is 2-year-LRC. By using the dose escalation up to 80.5 Gy to the GTV of the primary tumor and lymph nodes > 2 cm a LRC benefit of 15% at 2 years should be expected. The ESCALOX trial is supported by Deutsche Forschungsgemeinschaft (DFG); Grant No.: MO-363/4-1. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT 01212354 , EudraCT-No.: 2010-021139-15.


Assuntos
Carcinoma de Células Escamosas/radioterapia , Neoplasias de Cabeça e Pescoço/radioterapia , Recidiva Local de Neoplasia/prevenção & controle , Hipóxia Tumoral , Adolescente , Adulto , Idoso , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/patologia , Quimiorradioterapia , Feminino , Seguimentos , Neoplasias de Cabeça e Pescoço/tratamento farmacológico , Neoplasias de Cabeça e Pescoço/patologia , Humanos , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Prognóstico , Estudos Prospectivos , Dosagem Radioterapêutica , Taxa de Sobrevida , Adulto Jovem
17.
Radiology ; 283(2): 499-507, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28234549

RESUMO

Purpose To analyze if fractional anisotropy (FA) in nonenhancing peritumoral regions (NEPTRs) at baseline is associated with later tumor recurrence in glioblastoma. Materials and Methods Ethical approval was obtained for this retrospective, HIPAA-compliant study. FA was measured in 70 patients with glioblastoma in five regions of interest (ROIs) per patient in the NEPTR at preoperative magnetic resonance (MR) imaging with (166 regions) or without (184 regions) local contrast-enhancing tumor recurrence at follow-up MR imaging (median, 7.3 months; range, 0.9-46.6 months). ROIs were classified according to their location (white matter, cortex, fiber tracts, basal ganglia). Ratio of FA in the ROI of the NEPTR to that in the contralateral side (FAcontra) and to that in the internal capsule (FAint) was calculated. A generalized linear mixed model was performed. Ten-fold cross-validation was used for the receiver operating characteristics (ROC) analysis. Results FAcontra and FAint were significantly lower in regions with later tumor recurrence than in regions without (median FAcontra: 0.29 [interquartile range {IR}, 0.22-0.36] vs 0.46 [IR, 0.38-0.57]; median FAint: 0.20 [IR, 0.16-0.24] vs 0.29 [IR, 0.22-0.36], respectively). ROC analysis revealed an area under the ROC curve of 0.893 for FAcontra and of 0.815 for FAint, resulting in respective sensitivity and specificity of 85.5% and 84.2% for FAcontra and 86.7% and 66.8% for FAint. Conclusion Local tumor recurrence in the NEPTR may be predicted by FA metrics at baseline in patients with glioblastoma. This might be important for surgery or radiation planning. © RSNA, 2016 Online supplemental material is available for this article.


Assuntos
Neoplasias Encefálicas/diagnóstico por imagem , Neoplasias Encefálicas/cirurgia , Imagem de Difusão por Ressonância Magnética/métodos , Glioblastoma/diagnóstico por imagem , Glioblastoma/cirurgia , Recidiva Local de Neoplasia/diagnóstico por imagem , Idoso , Anisotropia , Feminino , Humanos , Interpretação de Imagem Assistida por Computador/métodos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/prevenção & controle , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade , Resultado do Tratamento
18.
Ann Thorac Surg ; 103(2): 573-579, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27623272

RESUMO

BACKGROUND: Mitral valve (MV) repair through a right minithoracotomy (RT) is technically more demanding than through a median sternotomy (MS) and has been cited for a higher rate of reoperation, increased postoperative bleeding, thromboembolic events, poor visualization, and longer operative times. Randomized studies are not available, however, and specific characteristics of patients who undergo operation with either technique are usually highly different. Therefore, a propensity matching study was performed to reduce selection bias. METHODS: A retrospective analysis was made of 745 patients, 501 in group RT (67%) and 244 in group MS (33%), who underwent isolated MV repair between 2000 and 2010. Propensity matching identified 97 matched patient pairs for comparison of functional outcome, survival, incidence of reoperation, and quality of life after MV repair. RESULTS: Propensity matched patients in group RT had longer cardiopulmonary bypass time (120 ± 28 versus 99 ± 30 minutes, p < 0.001) and cross-clamp time (86 ± 23.5 versus 74 ± 25 minutes, p < 0.001). Thirty-day mortality was similar for both groups (RT, 0%; MS, 1%; p = 0.13). There were no significant differences in other outcomes such as amount of red blood cell transfusion, ventilation time, and hospital stay. Five-year survival in group RT (93.5% ± 3.7%) versus group MS (87.4% ± 3.6%, p = 0.556) and freedom from MV reoperation (93.3% ± 2.9% versus 97.9% ± 1.5%, respectively; p = 0.157) were not different. Functional outcome and quality of life variables were similar. CONCLUSIONS: Mitral valve surgery through a right minithoracotomy is a safe procedure associated with a very low operative mortality comparable to the standard sternotomy approach. In addition to improved cosmetics, minimally invasive MV surgery provides equally durable results as the standard sternotomy approach.


Assuntos
Implante de Prótese de Valva Cardíaca/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Insuficiência da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Esternotomia/métodos , Toracotomia/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Alemanha/epidemiologia , Mortalidade Hospitalar/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência da Valva Mitral/mortalidade , Duração da Cirurgia , Pontuação de Propensão , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
19.
World Neurosurg ; 99: 726-734.e7, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27840205

RESUMO

BACKGROUND: The diagnostic value of computed tomography (CT)-guided spinal biopsy in patients with suspected spondylodiscitis is reported inconsistently in the literature. Our aim was to evaluate associations between procedural, clinical, and imaging parameters and the diagnostic yield of CT-guided spinal biopsy. METHODS: One hundred and two procedures performed in 87 patients with clinically suggested spondylodiscitis were analyzed retrospectively. Preprocedural magnetic resonance (MR) and CT images were evaluated regarding signal alterations, vertebral destruction, and soft-tissue involvement. The position of the biopsy needle in correlation with MR imaging findings was assessed. Patient characteristics and clinical details were noted. Parameters were compared in patients with positive and negative microbiological and histologic results. RESULTS: Following microbiologic and histologic analysis, infectious spondylodiscitis was diagnosed in 29 and 23 biopsies, respectively. Microbiology results were significantly higher in biopsy specimens with central needle positioning within contrast enhancing tissue in correlation with the MR images (36% vs. 7%; P = 0.005). Biopsy specimens positioned in fluid-equivalent hyperintense discs in T2-weighted sequences yielded significantly lower microbiology results (6% vs. 33%; P = 0.036). Purely lytic endplate destruction and mixed vertebral density as shown by CT increased microbiology results (60% vs. 24%; P = 0.028). Previous antibiotic treatment for any cause did not influence microbiology yields significantly (P = 0.232). CONCLUSIONS: MR imaging is mandatory to determine the optimal biopsy position. No clinical or imaging parameter could rule out a positive biopsy result and thus omit an unnecessary procedure. Biopsy should not be avoided if antibiotic treatment has previously been administered.


Assuntos
Infecções Bacterianas/patologia , Biópsia por Agulha/métodos , Discite/patologia , Biópsia Guiada por Imagem/métodos , Disco Intervertebral/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Infecções Bacterianas/diagnóstico , Infecções Bacterianas/diagnóstico por imagem , Infecções Bacterianas/microbiologia , Discite/diagnóstico , Discite/diagnóstico por imagem , Discite/microbiologia , Feminino , Humanos , Disco Intervertebral/diagnóstico por imagem , Disco Intervertebral/microbiologia , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Tomografia Computadorizada por Raios X
20.
Int Orthop ; 40(4): 673-80, 2016 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-26728611

RESUMO

PURPOSE: This study investigated whether etoricoxib (COX-II blocker) has a superior efficacy of preventing heterotopic ossification (HO) after total hip arthroplasty (THA) compared to diclofenac (non-selective NSAID). METHODS: One hundred patients were included (50 in each group) in this single centre, prospective, double-blinded, randomized, controlled trial. Etoricoxib (90 mg) was administered once and diclofenac (75 mg) twice per day for a perioperative period of nine days. The incidence of HO was evaluated on radiographs of the pelvis six months after surgery. RESULTS: Eighty nine of 100 (89 %) patients could be analysed. The overall HO incidence was 37.8 %. There was no significant difference between both study groups. Twelve patients (27.3 %) of the DIC group and 13 patients (28.9 %) of the ETO group showed Brooker grade I ossifications. Five patients (11.4 %) of the DIC and four patients of the ETO (8.9 %) group showed grade II HO formations. No class III or IV HO formations occured in both groups. Ad hoc analysis detected a negative correlation between HO incidence and limited abduction and internal rotation of the hip. CONCLUSIONS: Etoricoxib and diclofenac are equally effective for oral HO prophylaxis after primary cementless THA when given for nine peri-operative days to ensure a full recovery and high patient satisfaction.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Artroplastia de Quadril/efeitos adversos , Inibidores de Ciclo-Oxigenase 2/uso terapêutico , Diclofenaco/uso terapêutico , Ossificação Heterotópica/prevenção & controle , Piridinas/uso terapêutico , Sulfonas/uso terapêutico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios não Esteroides/efeitos adversos , Inibidores de Ciclo-Oxigenase 2/efeitos adversos , Diclofenaco/efeitos adversos , Método Duplo-Cego , Etoricoxib , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Ossificação Heterotópica/etiologia , Pelve/diagnóstico por imagem , Pelve/patologia , Período Perioperatório , Estudos Prospectivos , Piridinas/efeitos adversos , Sulfonas/efeitos adversos
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