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1.
Surg Oncol ; 53: 102045, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38330805

RESUMO

BACKGROUND: Residual particles of superparamagnetic iron oxide (SPIO) tracer, used for sentinel node biopsy, cause susceptibility artefacts on breast Magnetic Resonance Imaging (MRI). We investigated the impact of these artefacts on the imaging quality of MRI and explored whether contrast-enhanced mammography (CEM) could be an alternative in the follow-up of breast cancer patients. MATERIALS AND METHODS: Data on patients' characteristics, injection site, presence, size (mm) of artefacts on full-field digital mammography (FFDM)/CEM, MRI after 1 ml SPIO was recorded. Image quality scored by two breast radiologists using a 4-point Likert system: 0: no artefacts 1: good diagnostic quality 2: impaired but still readable 3: hampered clinical assessment. Continuous variables reported as means and standard deviations (SD), categorical variables as count and percentage. RESULTS: On FFDM/CEM, performed 13 months postoperatively, no iron SPIO particles were detected, with a Likert score of 0. In all MRI (100%) images, executed at 16.6 months after SPIO injection, susceptibility artefacts at the injection sites i.e., retroareolair and lateral quadrant were observed with a mean size of 41.9 ± 9.8 mm (SD) by observer 1, and 44.8 ± 12.5 mm (SD) by observer 2, independent of the injection site. Both observers scored a Likert score of 2: locally impaired on all MRI images and sequences. CONCLUSIONS: Even 1 ml SPIO tracer used for sentinel node procedure impairs the evaluation of breast MRI at the tracer injection site beyond one year of follow-up. No impairment was observed on FFDM/CEM, suggesting that CEM might be a reliable alternative to breast MRI if required.


Assuntos
Artefatos , Neoplasias da Mama , Compostos Férricos , Humanos , Feminino , Biópsia de Linfonodo Sentinela/métodos , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/cirurgia , Neoplasias da Mama/patologia , Mamografia , Imageamento por Ressonância Magnética/métodos , Nanopartículas Magnéticas de Óxido de Ferro
2.
Clin Breast Cancer ; 24(4): e266-e272, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38395700

RESUMO

INTRODUCTION: Invasive lobular carcinoma (ILC) is known for its diffuse growth pattern and its associated challenges in diagnosing. Magnetic resonance imaging (MRI) is the most accurate imaging modality and might aid in improving preoperative staging compared to full field digital mammography (FFDM) and ultrasound (US), however current literature is inconsistent. The aim of this paper is to evaluate the accuracy of MRI staging compared to FFDM/US and pathology results. METHODS: In this single-centre retrospective study, all patients diagnosed with ILC between 2014 and 2019 who underwent preoperative MRI were included. Specific parameters studied were: (1) the need for second-look targeted biopsies, (2) detection of new tumors (ie, contralateral or multifocal), (3) changes in cTNM-classification, and (4) impact on final treatment plan. Bland-Altman plots were used to compare the tumor sizes measured on MRI and FFDM/US with actual pathological tumor sizes. RESULTS: Ninety-nine patients were included. After performing preoperative MRI, 9 (9.1%) multifocal tumors were diagnosed after additional biopsies. Contralateral tumors were detected twice (2.0%) and cN classification was upgraded in 7 cases (7.1%). Surgical treatment or neoadjuvant treatment plans were changed in 16 patients (16.1%). Compared to histopathological results, FFDM/US underestimated tumor size with a mean of 0.4 cm (Limit of agreement (LoA): -2.8 cm to 2.0 cm) whereas MRI overestimated tumor size with a mean of 0.6 cm (LoA: -1.9 cm to 3.0 cm). CONCLUSIONS: In our study, mean differences in tumor size measurements using FFDM/US and MRI were comparable, with similar random errors. MRI correctly diagnosed multifocal and contralateral tumors more often and provided a better cN staging.


Assuntos
Neoplasias da Mama , Carcinoma Lobular , Imageamento por Ressonância Magnética , Estadiamento de Neoplasias , Humanos , Feminino , Carcinoma Lobular/diagnóstico por imagem , Carcinoma Lobular/patologia , Carcinoma Lobular/cirurgia , Imageamento por Ressonância Magnética/métodos , Neoplasias da Mama/patologia , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/cirurgia , Neoplasias da Mama/terapia , Estudos Retrospectivos , Pessoa de Meia-Idade , Idoso , Adulto , Mamografia/métodos , Cuidados Pré-Operatórios/métodos , Ultrassonografia Mamária/métodos
3.
J Surg Oncol ; 129(5): 975-980, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38173366

RESUMO

INTRODUCTION: Flap fixation after mastectomy has proven to be one of the most promising solutions to reduce seroma formation. Drain placement remains standard practice in many clinics, even though this may be redundant after flap fixation. METHODS: This is a prospective randomized controlled trial comparing mastectomy and wound closure using flap fixation with or without drain placement. The primary outcome measure was clinically significant seroma (CSS) incidence. The aim of this interim analysis was to assess the assumptions for the sample size calculation and to provide preliminary results. RESULTS: Between July 2020 and January 2023, 112 patients were included. CSS incidence was 9.1% in the drain group and 21% in the no-drain group. In total, 10 patients were lost to follow-up. These numbers are similar to the ones used for the sample size calculation. In the drain group, three patients required interventions for wound complications compared to nine in the no-drain group (odds ratio: 3.612 [95% confidence interval: 0.898-14.537]). CONCLUSION: The sample size calculation seems to be correct and no protocol amendments are necessary. Current preliminary results show no significant differences in CSS incidence. Complete results should be awaited to draw a well-powered conclusion regarding drain policy after mastectomy.


Assuntos
Neoplasias da Mama , Mastectomia , Humanos , Feminino , Mastectomia/efeitos adversos , Seroma/etiologia , Seroma/prevenção & controle , Complicações Pós-Operatórias/etiologia , Estudos Prospectivos , Neoplasias da Mama/cirurgia , Neoplasias da Mama/complicações , Drenagem/efeitos adversos
4.
J Surg Oncol ; 129(6): 1015-1024, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38247263

RESUMO

Flap fixation is the most promising solution to prevent seroma formation after mastectomy. In this systematic review with network meta-analysis (NMA), three different techniques were compared. The NMA included 25 articles, comprising 3423 patients, and revealed that sutures are superior to tissue glue in preventing clinically significant seroma. In addition, running sutures seemed to be superior to interrupted sutures. An RCT comparing these suture techniques seems necessary, given the quality and nature of existing literature.


Assuntos
Neoplasias da Mama , Mastectomia , Seroma , Técnicas de Sutura , Feminino , Humanos , Neoplasias da Mama/cirurgia , Mastectomia/efeitos adversos , Mastectomia/métodos , Metanálise em Rede , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/etiologia , Seroma/etiologia , Seroma/prevenção & controle , Retalhos Cirúrgicos
5.
Ann Surg Oncol ; 31(3): 1643-1652, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38038792

RESUMO

INTRODUCTION: Seroma formation after axillary lymph node dissection (ALND) remains a troublesome complication with significant morbidity. Numerous studies have tried to identify techniques to prevent seroma formation. The aim of this systematic review and network meta-analysis is to use available literature to identify the best intervention for prevention of seroma after standalone ALND. METHODS: A literature search was performed for all comparative articles regarding seroma formation in patients undergoing a standalone ALND or ALND with breast-conserving surgery in the last 25 years. Data regarding seroma formation, clinically significant seroma (CSS), surgical site infections (SSI), and hematomas were collected. The network meta-analysis was performed using a random effects model and the level of inconsistency was evaluated using the Bucher method. RESULTS: A total of 19 articles with 1962 patients were included. Ten different techniques to prevent seroma formation were described. When combining direct and indirect comparisons, axillary drainage until output is less than 50 ml per 24 h for two consecutive days results in significantly less CSS. The use of energy sealing devices, padding, tissue glue, or patches did not significantly reduce the incidence of CSS. When comparing the different techniques with regard to SSIs, no statistically significant differences were seen. CONCLUSIONS: To prevent CSS after ALND, axillary drainage is the most valuable and scientifically proven measure. On the basis of the results of this systematic review with network meta-analysis, removing the drain when output is < 50 ml per 24 h for two consecutive days irrespective of duration seems best. Since drainage policies vary widely, an evidence-based guideline is needed.


Assuntos
Neoplasias da Mama , Cirurgiões , Humanos , Feminino , Seroma/etiologia , Excisão de Linfonodo/métodos , Mastectomia Segmentar/efeitos adversos , Drenagem/efeitos adversos , Progressão da Doença , Axila , Neoplasias da Mama/complicações
6.
Breast Cancer Res Treat ; 202(2): 245-255, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37495799

RESUMO

PURPOSE: The outcome of the sentinel lymph node in breast cancer patients affects adjuvant treatment. Compared to conventional histopathology, analysis by one-step nucleic acid amplification (OSNA) harvests more micrometastasis, potentially inducing overtreatment. In this study we investigated the impact of OSNA analysis on adjuvant treatment, compared to histopathological analysis. METHODS: Data from T1-3 breast cancer patients with sentinel nodes analysed between January 2016 and December 2019 by OSNA (OSNA group, n = 1086) from Zuyderland Medical Centre, the Netherlands, were compared to concurrent data from the Netherlands Cancer Registry (NKR) where sentinel nodes were examined by histology (histology group, n = 35,143). Primary outcomes were micro- or macrometastasis, axillary treatments (axillary lymph node dissection (ALND) or axillary radiotherapy (ART)), chemotherapy, and endocrine therapy. Statistics with Pearson Chi-square. RESULTS: In the OSNA group more micrometastasis (14.9%) were detected compared to the histology group (7.9%, p < 0.001). No difference in axillary treatment between groups was detected (14.3 vs. 14.4%). In case of mastectomy and macrometastasis, ALND was preferred over ART in the OSNA group (14.9%) compared to the histology group (4.4%, p < 0.001). In cases of micrometastasis, no difference was seen. There was no difference in administration of adjuvant chemotherapy between groups. Endocrine treatment was administrated less often in the OSNA group compared to the histology group (45.8% vs. 50.8%, p < 0.002). CONCLUSION: More micrometastasis were detected by OSNA compared to histopathology, but no subsequent increase in adjuvant axillary and systematic treatment was noticed. When performing mastectomy and OSNA, there was a preference for ALND compared to ART.


Assuntos
Neoplasias da Mama , Ácidos Nucleicos , Linfonodo Sentinela , Humanos , Feminino , Neoplasias da Mama/genética , Neoplasias da Mama/terapia , Neoplasias da Mama/patologia , Linfonodo Sentinela/patologia , Linfonodos/patologia , Biópsia de Linfonodo Sentinela , Micrometástase de Neoplasia/patologia , Mastectomia , Técnicas de Amplificação de Ácido Nucleico , Axila/patologia , Adjuvantes Imunológicos
7.
J Surg Oncol ; 127(5): 776-781, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36598179

RESUMO

BACKGROUND: Localisation techniques for nonpalpable breast cancer lesions and sentinel lymph node biopsy (SLNB) are associated with several drawbacks. A complete magnetic technique using magnetic seeds and superparamagnetic iron oxide tracer could be an interesting alternative. This study describes a clear protocol and the results of a combined magnetic approach. METHODS: From August 2021 to February 2022 40 patients undergoing breast conserving surgery with SLNB were eligible for inclusion. Localisation was performed under ultrasound or stereotactic guidance, 1 week before surgery. Subsequently, 1 ml of tracer was injected at least 4 cm away from the tumour. Technetium-99m (99m Tc) was injected 1 day before surgery as control procedure. Outcomes were SLNB time, a number of nodes detected with magnetic tracer including comparison with 99m Tc, a success rate of malignant lesion detection and pathological margin assessment. RESULTS: In total, 40 procedures were performed on 39 patients. A median of one node was retrieved. Sentinel nodes were retrieved using MagTrace® with a 92.5% detection rate compared to 99m Tc. Wide local excision under magnetic guidance was successful in 35 cases. CONCLUSIONS: This paper describes a combined magnetic approach for breast-conserving surgery and SLNB. An adapted protocol is described and could be used for implementation.


Assuntos
Neoplasias da Mama , Linfonodo Sentinela , Humanos , Feminino , Linfonodo Sentinela/diagnóstico por imagem , Linfonodo Sentinela/cirurgia , Linfonodo Sentinela/patologia , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/cirurgia , Neoplasias da Mama/patologia , Biópsia de Linfonodo Sentinela/métodos , Nanopartículas Magnéticas de Óxido de Ferro , Fenômenos Magnéticos , Linfonodos/diagnóstico por imagem , Linfonodos/cirurgia , Linfonodos/patologia
8.
Surg Oncol ; 46: 101905, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36706578

RESUMO

BACKGROUNDS: Traditionally, breast conserving surgery for non-palpable breast cancer is guided by wire or radioactive seed and radioactive tracer for sentinel lymph node biopsy (SLNB). Alternatively, a stain-less magnetic seed and superparamagnetic iron oxide tracer (SPIO) can be combined as a radioactive-free technique. The aim of this study was to define the pitfalls we encountered during implementation of this combined technique and provide solutions resulting in an instruction manual for a radio-active free procedure. METHODS: Between January and March 2021, seventeen consecutive patients with cN0 non-palpable breast cancer were included. The magnetic seed was placed to localize the lesion and SPIO was used to identify the sentinel lymph node (SLN). A lymphoscintigraphy with Technetium-99m nano colloid was performed concomitantly in all patients as a control procedure for SPIO. Surgical outcomes are reported, including problems with placing and retrieval of the seed and SPIO and corresponding solutions. RESULTS: Surgical excision was successful with invasive tumor-free margins in all patients. SLN detection was successful in 82% patients when compared to Technetium-99m. The most challenging issue was an overlapping magnetic signal of the seed and SPIO. Solutions are provided in detail. CONCLUSIONS: Combined use of magnetic seed and SPIO for wide local excision and SLNB patients with non-palpable breast lesions appeared challenging due to overlapping magnetic signals. After multiple adaptations, the protocol proved to be feasible with an added advantage of eliminating the use of radioisotopes. We described the pitfalls and solutions resulting in an instruction manual for a totally radioactive-free procedure.


Assuntos
Neoplasias da Mama , Linfonodo Sentinela , Humanos , Feminino , Biópsia de Linfonodo Sentinela/métodos , Projetos Piloto , Mastectomia Segmentar/métodos , Linfonodos/patologia , Tecnécio , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/cirurgia , Linfonodo Sentinela/diagnóstico por imagem , Linfonodo Sentinela/cirurgia , Linfonodo Sentinela/patologia , Fenômenos Magnéticos
9.
J Crohns Colitis ; 17(2): 221-230, 2023 Mar 18.
Artigo em Inglês | MEDLINE | ID: mdl-36094558

RESUMO

BACKGROUND: To prevent recurrence after ileocolonic resection [ICR] in Crohn's disease [CD], postoperative prophylaxis based on risk stratification is recommended in international guidelines. This study aimed to evaluate postoperative CD recurrence after implementation of a clinical management algorithm and to determine the predictive value of clinical and histological risk factors [RFs]. METHODS: In this multicentre, prospective cohort study, CD patients [≥16 years] scheduled for ICR were included. The algorithm advised no postoperative medication for low-risk patients, and treatment with prophylaxis [immunosuppressant/biological] for high-risk patients [≥1 RF: active smoking, penetrating disease, prior ICR]. Clinical and histological RFs [active inflammation, granulomas, plexitis in resection margins] for endoscopic recurrence [Rutgeerts' score ≥i2b at 6 months] were assessed using logistic regression and ROC curves based on predicted probabilities. RESULTS: In total, 213 CD patients after ICR were included [age 34.5 years; 65% women] (93 [44%] low-risk; 120 [56%] high-risk: 45 [38%] smoking; 51 [43%] penetrating disease; 51 [43%] prior ICR). Adherence to the algorithm was 82% in low-risk [no prophylaxis] and 51% in high-risk patients [prophylaxis]. Endoscopic recurrence was higher in patients treated without prophylaxis than with prophylaxis in both low [45% vs 16%, p = 0.012] and high-risk patients [49% vs 26%, p = 0.019]. Clinical risk stratification including the prescription of prophylaxis corresponded to an area under the curve [AUC] of 0.70 (95% confidence interval [CI] 0.61-0.79). Clinical RFs combined with histological RFs increased the AUC to 0.73 [95% CI 0.64-0.81]. CONCLUSION: Adherence to this management algorithm is 65%. Prophylactic medication after ICR prevents endoscopic recurrence in low- and high-risk patients. Clinical risk stratification has an acceptable predictive value, but further refinement is needed.


Assuntos
Doença de Crohn , Humanos , Feminino , Adulto , Masculino , Doença de Crohn/tratamento farmacológico , Doença de Crohn/cirurgia , Doença de Crohn/patologia , Estudos Prospectivos , Colo/cirurgia , Colo/patologia , Fatores de Risco , Medição de Risco , Recidiva , Íleo/patologia
10.
BMC Cancer ; 22(1): 1062, 2022 Oct 14.
Artigo em Inglês | MEDLINE | ID: mdl-36241982

RESUMO

BACKGROUND: Current pre-operative Sentinel Lymph Node (SLN) mapping using dual tracing is associated with drawbacks (radiation exposure, logistic challenges). Superparamagnetic iron oxide (SPIO) is a non-inferior alternative for SLN mapping in breast cancer patients. Limited research has been performed on SPIO use and pre-operative MRI in melanoma patients to identify SLNs.  METHODS: Healthy participants underwent MRI-scanning pre- and post SPIO-injection during 20 min. Workflow protocols varied in dosage, massage duration, route of administration and injection sites. The first lymph node showing a susceptibility artefact caused by SPIO accumulation was considered as SLN. RESULTS: Artefacts were identified in 5/6 participants. Two participants received a 0.5 ml subcutaneous injection and 30-s massage, of which one showed an artefact after one hour. Four participants received a 1.0 ml intracutaneous injection and two-minute massage, leading to artefacts in all participants. All SLNs were observed within five minutes, except after lower limb injection (30 min). CONCLUSION: SPIO and pre-operative MRI-scanning seems to be a promising alternative for SLN visualization in melanoma patients. An intracutaneous injection of 1.0 ml SPIO tracer, followed by a two-minute massage seems to be the most effective technique, simplifying the pre-operative pathway. Result will be used in a larger prospective study with melanoma patients. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05054062) - September 9, 2021.


Assuntos
Melanoma , Linfonodo Sentinela , Humanos , Compostos Férricos , Voluntários Saudáveis , Linfonodos/patologia , Nanopartículas Magnéticas de Óxido de Ferro , Imageamento por Ressonância Magnética , Melanoma/diagnóstico por imagem , Melanoma/patologia , Projetos Piloto , Estudos Prospectivos , Linfonodo Sentinela/diagnóstico por imagem , Linfonodo Sentinela/patologia , Biópsia de Linfonodo Sentinela/métodos , Fluxo de Trabalho
11.
J Surg Oncol ; 126(3): 443-449, 2022 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-35532101

RESUMO

BACKGROUND: In patients with cT1-T3N0 breast cancer, postmastectomy radiation therapy (PMRT) is considered a contraindication for immediate breast reconstruction (IBR) due to a high risk of complications. The sentinel node biopsy (SNB) is an important determinant for PMRT. In this study, we evaluated the impact of SNB outcome on the planning of IBR after mastectomy. METHODS: Data of patients undergoing mastectomy and SNB in Zuyderland Medical Centre between 2016 and 2019 were retrospectively analysed. Perioperative factors influencing the planning of IBR and SNB results assessed by the intraoperative one-step nucleic acid amplification (OSNA) were registered. RESULTS: Of 397 patients, 169 opted for IBR. One hundred and seven IBRs were performed: 101 tissue expanders, 5 deep inferior epigastric perforator flaps and 1 latissimus dorsi flap.  Eighteen patients (18/107) had macrometastases in the SNB, in six of them IBR was cancelled due to the indication for PMRT (33%). In the other 12 patients IBR was executed as planned.  A delayed reconstruction was performed in 59 patients. CONCLUSION: In breast cancer patients undergoing mastectomy with macrometastases in the SNB, IBR was postponed in 33% due to risk on PMRT. To predict this risk, we advise to acknowledge the SNB outcome by using OSNA before proceeding to IBR.


Assuntos
Neoplasias da Mama , Mamoplastia , Ácidos Nucleicos , Retalho Perfurante , Neoplasias da Mama/genética , Neoplasias da Mama/radioterapia , Neoplasias da Mama/cirurgia , Feminino , Humanos , Mamoplastia/métodos , Mastectomia , Retalho Perfurante/cirurgia , Radioterapia Adjuvante , Estudos Retrospectivos
12.
Breast Care (Basel) ; 17(6): 567-572, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36590141

RESUMO

Purpose: Axillary lymph node dissection (ALND) is performed to treat locoregional metastatic disease in breast cancer and melanoma patients. However, it is notorious for its complications, most commonly seroma formation and its sequelae. Ample research has been done to evaluate seroma formation after ALND; these results, however, have not been conclusive. Hence, this pilot study aimed to evaluate a readily available haemostatic patch, Hemopatch®, to assess its effect on seroma formation following ALND. Methods: In this pilot study, a prospective cohort of 20 patients receiving Hemopatch® following ALND was compared to a retrospective cohort of patients who underwent ALND between 2014 and 2019. The primary outcome measure was the number of patients developing clinically significant seroma (CSS) after ALND. Additionally, the number of wound complications, subsequent interventions, additional outpatient clinic visits, and drain output was assessed. Differences between groups were deemed clinically relevant if the proportions differed >50% between groups. Results: In total, 20 prospective and 42 retrospective patients were included. In the Hemopatch® group, 30% of the patients developed CSS, compared to 43% in the control group. Three patients in both groups developed a surgical site infection. Thirty-five percent of patients in the Hemopatch® group required additional unscheduled visits versus 62% of patients in the control group. Conclusion: The application of Hemopatch® after ALND did not lead to a clinically relevant reduction of CSS and wound complications. However, fewer Hemopatch® patients required additional outpatient clinic visits. Due to the limited amount of participants, the true value of Hemopatch® in ALND remains unclear.

13.
Stroke ; 51(12): 3664-3672, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33040703

RESUMO

BACKGROUND AND PURPOSE: Quality indicators (QI) are an accepted tool to measure performance of hospitals in routine care. We investigated the association between quality of acute stroke care defined by overall adherence to evidence-based QI and early outcome in German acute care hospitals. METHODS: Patients with ischemic stroke admitted to one of the hospitals cooperating within the ADSR (German Stroke Register Study Group) were analyzed. The ADSR is a voluntary network of 9 regional stroke registers monitoring quality of acute stroke care across 736 hospitals in Germany. Quality of stroke care was defined by adherence to 11 evidence-based indicators of early processes of stroke care. The correlation between overall adherence to QI with outcome was investigated by assessing the association between 7-day in-hospital mortality with the proportion of QI fulfilled from the total number of QI the individual patient was eligible for. Generalized linear mixed model analysis was performed adjusted for the variables age, sex, National Institutes of Health Stroke Scale and living will and as random effect for the variable hospital. RESULTS: Between 2015 and 2016, 388 012 patients with ischemic stroke were reported (median age 76 years, 52.4% male). Adherence to distinct QI ranged between 41.0% (thrombolysis in eligible patients) and 95.2% (early physiotherapy). Seven-day in-hospital mortality was 3.4%. The overall proportion of QI fulfilled was median 90% (interquartile range, 75%-100%). In multivariable analysis, a linear association between overall adherence to QI and 7-day in-hospital-mortality was observed (odds ratio adherence <50% versus 100%, 12.7 [95% CI, 11.8-13.7]; P<0.001). CONCLUSIONS: Higher quality of care measured by adherence to a set of evidence-based process QI for the early phase of stroke treatment was associated with lower in-hospital mortality.


Assuntos
Mortalidade Hospitalar , AVC Isquêmico/terapia , Neuroimagem/estatística & dados numéricos , Reabilitação do Acidente Vascular Cerebral/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Angiografia Cerebral/estatística & dados numéricos , Transtornos de Deglutição/diagnóstico , Deambulação Precoce/estatística & dados numéricos , Feminino , Alemanha , Humanos , AVC Isquêmico/diagnóstico por imagem , AVC Isquêmico/reabilitação , Masculino , Programas de Rastreamento/estatística & dados numéricos , Pessoa de Meia-Idade , Terapia Ocupacional/estatística & dados numéricos , Modalidades de Fisioterapia/estatística & dados numéricos , Inibidores da Agregação Plaquetária/uso terapêutico , Avaliação de Processos em Cuidados de Saúde , Indicadores de Qualidade em Assistência à Saúde , Qualidade da Assistência à Saúde , Fonoterapia/estatística & dados numéricos , Terapia Trombolítica/estatística & dados numéricos , Tempo para o Tratamento/estatística & dados numéricos , Adulto Jovem
14.
BMC Cancer ; 20(1): 735, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32767988

RESUMO

BACKGROUND: Seroma formation is a common complication after breast cancer surgery and can lead to delayed wound healing, infection, patient discomfort and repeated visits to the outpatient clinic. Mastectomy combined with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. There is evidence showing that closed-suction drainage may be insufficient in preventing seroma formation. There is reasonable doubt whether there is still place for closed-suction drainage after mastectomy when flap fixation is performed. We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone. Furthermore, we expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections. METHODS: This is a randomized controlled trial in female breast cancer patients undergoing mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB). Patients will be eligible for inclusion if they are older than 18 years, have an indication for mastectomy with or without sentinel procedure. Exclusion criteria are modified radical mastectomy, direct breast reconstruction, previous history of radiation therapy of the unilateral breast, breast conserving therapy and inability to give informed consent. A total of 250 patients will be randomly allocated to one of two groups: mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage. Follow-up will be conducted up to six months postoperatively. The primary outcome is the proportion of patients undergoing one or more seroma aspirations. Secondary outcome measures consist of the number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits. DISCUSSION: To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome. This study could result in finding evidence that supports performing mastectomy without closed-suction drainage. TRIAL REGISTRATION: This trial was approved by the medical ethical committee of Zuyderland Medical Center METC-Z on 20 March 2019 (METCZ20190023). The SARA Trial was registered at ClinicalTrials.gov as per July 2019, Identifier: NCT04035590 .


Assuntos
Mastectomia/métodos , Complicações Pós-Operatórias/terapia , Seroma/terapia , Retalhos Cirúrgicos/transplante , Adulto , Feminino , Humanos , Mastectomia/efeitos adversos , Países Baixos , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/etiologia , Tamanho da Amostra , Biópsia de Linfonodo Sentinela , Seroma/etiologia , Sucção , Técnicas de Sutura
15.
Breast ; 46: 81-86, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31103811

RESUMO

OBJECTIVE: The main objective of this double-blind randomized controlled trial (RCT) was to assess seroma formation and its sequelae in patients undergoing mastectomy. Patients were randomized into one of three groups in which different wound closure techniques were applied: 1) conventional wound closure without flap fixation (CON) 2) flap fixation using sutures (FF-S) and 3) flap fixation using an adhesive tissue glue (FF-G). BACKGROUND: Seroma formation is still a bothersome complication after mastectomy. Flap fixation seems promising in reducing seroma formation. Various flap fixation techniques remain to be analyzed, including long-term outcome measures. METHODS: This trial was conducted in three different hospitals between June 2014 and November 2016. Patients were allocated to one of three groups. The primary outcome was the number of seroma needle aspirations. Secondary outcomes were (surgical site) infections, number of outpatient clinic visits, shoulder function, postoperative pain, patient-reported cosmesis and skin dimpling. RESULTS: A total of 187 patients were randomly assigned to CON (n = 61), FF-S (n = 64) and FF-G (n = 62). The number of seroma aspirations was significantly higher in CON when compared to both flap fixation groups (p = 0.032), with no difference between FF-S and FF-G. Secondary outcomes showed no statistical differences between all groups. The higher number of outpatient clinic visits in CON was considered to be of clinical importance (CON = 27 (44.3%), FF-S = 19 (30.6%) and FF-G = 21 (34.4%)). CONCLUSIONS: Mastectomy followed by flap fixation with either sutures or adhesive tissue glue reduces the number of seroma aspirations when compared to simple wound closure.


Assuntos
Neoplasias da Mama/cirurgia , Mastectomia/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Seroma/prevenção & controle , Retalhos Cirúrgicos , Adesivos , Adulto , Método Duplo-Cego , Drenagem/estatística & dados numéricos , Feminino , Humanos , Mastectomia/métodos , Pessoa de Meia-Idade , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/terapia , Espaço Morto Respiratório , Seroma/epidemiologia , Seroma/terapia , Técnicas de Sutura , Resultado do Tratamento
16.
BMC Neurol ; 17(1): 49, 2017 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-28279162

RESUMO

BACKGROUND: Factors influencing access to stroke unit (SU) care and data on quality of SU care in Germany are scarce. We investigated characteristics of patients directly admitted to a SU as well as patient-related and structural factors influencing adherence to predefined indicators of quality of acute stroke care across hospitals providing SU care. METHODS: Data were derived from the German Stroke Registers Study Group (ADSR), a voluntary network of 9 regional registers for monitoring quality of acute stroke care in Germany. Multivariable logistic regression analyses were performed to investigate characteristics influencing direct admission to SU. Generalized Linear Mixed Models (GLMM) were used to estimate the influence of structural hospital characteristics (percentage of patients admitted to SU, year of SU-certification, and number of stroke and TIA patients treated per year) on adherence to predefined quality indicators. RESULTS: In 2012 180,887 patients were treated in 255 hospitals providing certified SU care participating within the ADSR were included in the analysis; of those 82.4% were directly admitted to a SU. Ischemic stroke patients without disturbances of consciousness (p < .0001), an interval onset to admission time ≤3 h (p < .0001), and weekend admission (p < .0001) were more likely to be directly admitted to a SU. A higher proportion of quality indicators within predefined target ranges were achieved in hospitals with a higher proportion of SU admission (p = 0.0002). Quality of stroke care could be maintained even if certification was several years ago. CONCLUSIONS: Differences in demographical and clinical characteristics regarding the probability of SU admission were observed. The influence of structural characteristics on adherence to evidence-based quality indicators was low.


Assuntos
Isquemia Encefálica/terapia , Atenção à Saúde/estatística & dados numéricos , Hospitais Especializados/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Acidente Vascular Cerebral/terapia , Isquemia Encefálica/epidemiologia , Alemanha/epidemiologia , Humanos , Acidente Vascular Cerebral/epidemiologia
17.
Dtsch Arztebl Int ; 111(45): 759-65, 2014 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-25467052

RESUMO

BACKGROUND: Stroke patients should be cared for in accordance with evidence-based guidelines. The extent of implementation of guidelines for the acute care of stroke patients in Germany has been unclear to date. METHODS: The regional quality assurance projects that cooperate in the framework of the German Stroke Registers Study Group (Arbeitsgemeinschaft Deutscher Schlaganfall-Register, ADSR) collected data on the care of stroke patients in 627 hospitals in 2012. The quality of the acute hospital care of patients with stroke or transient ischemic attack (TIA) was assessed on the basis of 15 standardized, evidence-based quality indicators and compared across the nine participating regional quality assurance projects. RESULTS: Data were obtained on more than 260 000 patients nationwide. Intravenous thrombolysis was performed in 59.7% of eligible ischemic stroke patients patients (range among participating projects, 49.7-63.6%). Dysphagia screening was documented in 86.2% (range, 74.8-93.1%). For the following indicators, the defined targets were not reached for all of Germany: anti-aggregation within 48 hours, 93.4% (range, 86.6-96.4%); anticoagulation for atrial fibrillation, 77.6% (range, 72.4-80.1%); standardized dysphagia screening, 86.2% (range, 74.8-93.1%); oral and written information of the patients or their relatives, 86.1% (range, 75.4-91.5%). The rate of patients examined or treated by a speech therapist was in the target range. CONCLUSION: The defined targets were reached for most of the quality indicators. Some indicators, however, varied widely across regional quality assurance projects. This implies that the standardization of care for stroke patients in Germany has not yet been fully achieved.


Assuntos
Fidelidade a Diretrizes/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Garantia da Qualidade dos Cuidados de Saúde/estatística & dados numéricos , Sistema de Registros , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/terapia , Distribuição por Idade , Idoso , Prática Clínica Baseada em Evidências , Feminino , Alemanha/epidemiologia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Prevalência , Distribuição por Sexo , Acidente Vascular Cerebral/diagnóstico , Resultado do Tratamento
18.
Int J Surg Case Rep ; 5(8): 441-3, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24973522

RESUMO

INTRODUCTION: Stenosis of the subclavian artery is uncommon and it rarely causes symptoms. Only symptomatic patients should be treated. PRESENTATION OF CASE: We report a case of chronic left upper limb ischemia caused by subclavian artery stenosis after repetitive clavicular fixation. The stenosis was first treated with carotid-subclavian bypass and soon followed by angioplasty and stenting of the subclavian artery because of occlusion of the bypass. Finally, failure of these procedures necessitated a subclavian-axillary crossover bypass. DISCUSSION: Both extra-anatomic bypass and percutaneous transluminal angioplasty are safe and effective. If feasible, many authors use endovascular treatment. According to literature, extra-anatomic bypass still remains the first choice of treatment for symptomatic patients. However, the introduction of routine stent implantation is equalling these results. Because of its lower long-term patency rate, endovascular treatment is favorable for patients at high risk. CONCLUSION: Our case is a good example of difficulties involved in choosing the best treatment option for subclavian artery stenosis.

20.
Ophthalmologica ; 217(1): 58-61, 2003.
Artigo em Inglês | MEDLINE | ID: mdl-12566875

RESUMO

To evaluate the efficacy of internal drainage of a lacrimal abscess, we treated 10 patients with pyocele of the lacrimal sac, who did not want to undergo operative intervention. A temporary nasolacrimal stent was placed in the nasolacrimal duct, and the pussy material was collected for microbiological examination to adjust the preliminary antibiotic treatment which was given systemically and locally. The stents were removed after the infection had subsided clinically. Three years later, there was a recurrence of the infection in only 1 patient. This internal drainage of the lacrimal sac, combined with systemic and local antibiotics, was successful in 90% of the patients.


Assuntos
Abscesso/terapia , Dacriocistite/terapia , Drenagem/métodos , Ducto Nasolacrimal , Stents , Abscesso/microbiologia , Idoso , Idoso de 80 Anos ou mais , Bactérias/isolamento & purificação , Doença Crônica , Terapia Combinada , Dacriocistite/microbiologia , Dexametasona/uso terapêutico , Doxiciclina/uso terapêutico , Quimioterapia Combinada/uso terapêutico , Feminino , Gentamicinas/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade
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