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PURPOSE: Evaluation of a kidney-adjusted enhanced recovery after surgery (ERAS®) protocol (kERAS) in patients undergoing nephron-sparing surgery (PN). METHODS: The kERAS protocol is a multidimensional protocol focusing on optimized perioperative fluid and nutrition management as well as strict intraoperative and postoperative blood pressure limits. It was applied in a prospective cohort (n = 147) of patients undergoing open or robotic PN. Patients were analyzed for the development of acute postoperative renal failure (AKI), achievement of TRIFECTA criteria, upstaging or new onset of chronic kidney disease (CKD) and length of hospital stay (LOS) and compared to a retrospective cohort (n = 162) without application of the protocol. RESULTS: Cox regression analyses could not confirm a protective effect of kERAS on the development of AKI post-surgery. A positive effect was observed on TRIFECTA achievement (OR 2.2, 95% CI 1.0-4.5, p = 0.0374). Patients treated with the kERAS protocol showed less long-term CKD upstaging compared to those treated with the standard protocol (p = 0.0033). There was no significant effect on LOS and new onset of CKD. CONCLUSION: The implementation of a kERAS protocol can have a positive influence on long-term renal function in patients undergoing PN. It can be used safely without promoting AKI. Furthermore, it can be realized with a manageable amount of additional effort.
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Recuperação Pós-Cirúrgica Melhorada , Neoplasias Renais , Nefrectomia , Complicações Pós-Operatórias , Humanos , Masculino , Feminino , Nefrectomia/métodos , Nefrectomia/efeitos adversos , Pessoa de Meia-Idade , Idoso , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Neoplasias Renais/cirurgia , Estudos Retrospectivos , Tempo de Internação , Injúria Renal Aguda/prevenção & controle , Injúria Renal Aguda/etiologia , Resultado do Tratamento , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Insuficiência Renal Crônica , Tratamentos com Preservação do Órgão/métodosRESUMO
PURPOSE: Despite mobilization is highly recommended in the ERAS® colorectal guideline, studies suggest that more than half of patients don't reach the daily goal of 360 min out of bed. However, data used to quantify mobilization are predominantly based on self-assessments, for which the accuracy is uncertain. This study aims to accurately measure postoperative mobilization in ERAS®-patients by validated motion data from body sensors. METHODS: ERAS®-patients with elective bowel resections were eligible. Self-assessments and motion sensors (movisens: ECG-Move 4 and Move 4; Garmin: Vivosmart4) were used to record mobilization parameter from surgery to postoperative day 3 (POD3): Time out of bed, time on feet and step count. RESULTS: 97 patients were screened and 60 included for study participation. Self-assessment showed a median out of bed duration of 215 min/day (POD1: 135 min, POD2: 225 min, POD3: 225 min). The goal of 360 min was achieved by 16.67% at POD1, 21.28% at POD2 and 20.45% at POD3. Median time on feet objectively measured by Move 4 was 109 min/day. During self-assessment, patients significantly underestimated their "time on feet"-duration with 85 min/day (p = 0.008). Median number of steps was 933/day (Move 4). CONCLUSION: This study confirmed with objectively supported data, that most patients don't reach the daily mobilization goal of 360 min despite being treated by an ERAS®-pathway with ERAS®-nurse. Even considering an empirically approximated underestimation, the ERAS®-target isn't achieved by more than 75% of patients. Therefore, we propose an adjustment of the general ERAS®-goals into more patient-centered, individualized and achievable goals. REGISTRATION: This study is part of the MINT-ERAS-project and was registered prospectively in the German Clinical Trials Register on 25.02.2022. Trial registration number is "DRKS00027863".
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Procedimentos Clínicos , Deambulação Precoce , Procedimentos Cirúrgicos Eletivos , Recuperação Pós-Cirúrgica Melhorada , Estudos de Viabilidade , Humanos , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Autoavaliação (Psicologia)RESUMO
This study investigated whether adjuvant treatments in stage III cutaneous melanoma (CM) influenced patterns of recurrence. Patients with primary (n = 1033) or relapsed CM (n = 350) who received adjuvant therapies with Nivolumab (N), Pembrolizumab (P), or Dabrafenib and Trametinib (D + T) were extracted from the prospective multicenter real-world skin cancer registry ADOReg. Endpoints were progression-free survival (PFS), distant metastasis-free survival (DMFS), organ-specific DMFS, and overall survival (OS). For primary cases, D + T indicated an improved PFS (1- and 2-year PFS: 90.9%; 82.7%) as compared to P (81.0%, 73.9%; p = .0208), or N (83.8%, 75.2%; p = .0539). BRAF-mutated(mut) CM demonstrated significantly lower PFS (p = .0022) and decreased DMFS (p = .0580) when treated with immune checkpoint inhibitor (ICI) instead of D + T. Besides, NRAS-mut CM tended to perform worse than wt CM upon ICI (PFS: p = .1349; DMFS: p = .0540). OS was similar between the groups. Relapsed cases showed decreased PFS, DMFS, and OS in comparison to primary (all: p < .001), without significant differences between the subgroups. Organ-specific DMFS was significantly altered for primary cases with bone (p = .0367) or brain metastases (p = .0202). In relapsed CM, the frequency of liver (D + T: 1.5%; P: 12%; N: 9%) and LN metastases (D + T: 1.5%; P: 12%; N: 10.2%) was significantly lower with adjuvant D + T than ICI. NRAS-mut CM showed increased recurrence in primary and relapsed cases. These data show that adjuvant D + T is superior to ICI in primary BRAF-mut CM.
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In the context of breast cancer treatment optimization, this study prospectively examines the feasibility and outcomes of utilizing intraoperative radiotherapy (IORT) as a boost in combination with standard external beam radiotherapy (EBRT) for high-risk patients. Different guidelines recommend such a tumor bed boost in addition to whole breast irradiation with EBRT for patients with risk factors for local breast cancer recurrence. The TARGIT BQR (NCT01440010) is a prospective, multicenter registry study aimed at ensuring the quality of clinical outcomes. It provides, for the first time, data from a large cohort with a detailed assessment of acute and long-term toxicity following an IORT boost using low-energy X-rays. Inclusion criteria encompassed tumors up to 3.5 cm in size and preoperative indications for a boost. The IORT boost, administered immediately after tumor resection, delivered a single dose of 20 Gy. EBRT and systemic therapy adhered to local tumor board recommendations. Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs). Between 2011 and 2020, 1133 patients from 10 centers were preoperatively enrolled. The planned IORT boost was conducted in 90%, and EBRT in 97% of cases. Median follow-up was 32 months (range 1-120, 20.4% dropped out), with a median age of 61 years (range 30-90). No acute grade 3 or 4 toxicities were observed. Acute side effects included erythema grade 1 or 2 in 4.4%, palpable seroma in 9.1%, punctured seroma in 0.3%, and wound healing disorders in 2.1%. Overall, chronic teleangiectasia of any grade occurred in 16.2%, fibrosis grade ≥ 2 in 14.3%, pain grade ≥ 2 in 3.4%, and hyperpigmentation in 1.1%. In conclusion, a tumor bed boost through IORT using low-energy X-rays is a swift and feasible method that demonstrates low rates in terms of acute or long-term toxicity profiles in combination with whole breast irradiation.
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INTRODUCTION: Adherence to follow-up (FU) care after bariatric surgery is poor despite strong recommendations. In our pilot Bella trial, we demonstrated that a completely remote follow-up program via smartphone is feasible and safe for patients after bariatric surgery. Building on this, we aim to verify our results in a multicenter, randomized controlled setting. METHODS: This trial plans to enroll 410 participants undergoing primary bariatric surgery in seven German bariatric centers. Participants are randomized into two groups: a control group receiving in-person FU according to the standard in the bariatric centers, and an interventional group monitored using a smartphone application (app). The app sends standardized questionnaires and reminders regarding regular vitamin intake and exercises. The built-in messaging function enables patients to communicate remotely with medical care professionals. After one year, all participants are evaluated at their primary bariatric centers. The primary outcome is weight loss 12 months after surgery. The secondary outcomes include obesity-related comorbidities, quality of life, serum values of vitamins and minerals, body impedance analysis, visits to the emergency department or readmission, patient compliance, and medical staff workload. DISCUSSION: The current study is the first prospective, individually randomized-controlled, multicenter trial where a mobile application completely replaces traditional in-person visits for post-bariatric surgery follow-ups in bariatric centers.
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Cirurgia Bariátrica , Aplicativos Móveis , Smartphone , Redução de Peso , Adulto , Feminino , Humanos , Masculino , Cirurgia Bariátrica/métodos , Alemanha , Cooperação do Paciente/estatística & dados numéricos , Estudos Prospectivos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como AssuntoRESUMO
BACKGROUND & AIMS: Exploration whether Motivational Interviewing (MI) could be learned and implemented with ease within a surgical in-hospital setting and whether participation in the intervention led to significantly higher compliance with ERAS®-recommended protein intake goals. The individual healing process of many patients is delayed because they fail to cover their calorie requirement, which could be counteracted by a patient-centered conversational intervention that is new in perioperative practice. METHODS: This patient-blinded pilot-RCT included 60 patients (≥18 years) following the certified ERAS® bowel protocol for colorectal surgery between March and August 2022. Five perioperative MI interventions were conducted by two health employees certified to perform MI. Key endpoints were the number of protein shakes drunk, calories of proteins ingested and overall calorie intake. RESULTS: A total of 60 patients (34 men [56.7%]; mean [SD] age, 60.7 [13.3] years) were randomized. MI patient-group had significantly higher protein shake intake on all postoperative days except day 3. For days 0-3 MI group drank significantly more shakes overall (median 5.5 vs. 2.0; P = 0.004) and consumed more calories (median 1650.0 vs. 600.0 kcal; P = 0.004) and proteins (median 110.0 vs. 40.0 g; P = 0.005). Total calorie intake for each day by shakes and dietary intake was significantly higher in the MI-intervention group on day 2 (mean 1772.3 vs. 1358.9 kcal; P = 0.03). CONCLUSIONS: MI may contribute to improve compliance with nutritional goals in the certified ERAS® protocol by increasing protein and calorie intake. The findings suggest further investigation of MI to help patients achieve their perioperative nutrition goals in different clinical settings. TRIAL REGISTRATION: DRKS - Deutsches Register Klinischer Studien; DRKS-ID: DRKS00027863; https://drks.de/search/de/trial/DRKS00027863.
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Procedimentos Cirúrgicos Eletivos , Recuperação Pós-Cirúrgica Melhorada , Entrevista Motivacional , Estado Nutricional , Humanos , Projetos Piloto , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Ingestão de Energia , Período Pós-Operatório , Cuidados Pós-Operatórios/métodos , Proteínas Alimentares/administração & dosagem , ObjetivosRESUMO
Study Design: Very few studies exist regarding the fracture pattern variability of the zygomaticoorbital (ZMO) complex. The retrospective evaluation of a large series of surgically treated unilateral ZMO fractures would in certain circumstances help intraoperative predictability and define sensitive indicators for open reduction and internal fixation. Objective: The aim of this study was to investigate the different fracture patterns after ZMO complex injury regarding the 5 anatomic sutures of the zygoma as well as the concomitance of the paranasal buttress and maxillary sinus wall fracture. Methods: The medical records of all patients with unilateral ZMO fractures who underwent surgical intervention in a single trauma center department between April 2015 and June 2020 were retrospectively reviewed. Demographic and anamnesis data, radiologic findings, and surgical reports were evaluated. According to the preoperative radiologic evaluation, ZMO fractures were classified as unisutural, bisutural, trisutural, tetrasutural, and complete based on the number of zygomatic sutures. The prevalence of various fracture patterns was analyzed. The impact of patient's age and trauma etiology on the fracture pattern was evaluated using descriptive statistical analysis. Results: The study included 492 patients with unilateral ZMO fractures, with a mean age of 49.93 years (SD = 20.66) and a male:female ratio of 2.23:1. The most affected age group was 19-44 years (41.67%) and tripping falls were the most common etiology (27.24%). Trisutural (57.32%) and unisutural fractures (23.17%) were the most common, followed by tetrasutural (8.94%), bisutural (8.54%), and complete fractures (2.03%). A trisutural fracture involving the zygomaticomaxillary suture, the infraorbital rim, and the zygomaticosphenoidal suture was the most common fracture pattern (52.03%). Most fractures were observed in the zygomaticosphenoidal suture (86.99%), followed by the infraorbital rim (74.59%) and the zygomaticomaxillary suture (68.29%). Fractures of the maxillary sinus wall and the paranasal buttress co-existed in 9.55% and 31.30% of all cases, respectively. No correlation was detected between age and fracture pattern (P = .4111). Tripping falls and bicycle accidents significantly influenced the fracture pattern (P < .0001). Conclusions: According to the results, knowledge of the fracture pattern variability of the ZMO complex could in certain circumstances designate CT or CBCT as mandatory before operating on ZMO fractures. Consequently, unnecessary incisions could be avoided. The high concomitance of paranasal buttress fracture also suggests its intraoperative surgical exploration. Further studies should correlate the clinical findings with indication for surgery and postoperative outcome for the different fracture patterns described.
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PURPOSE: Early mobilization is an essential component of the Enhanced Recovery after Surgery (ERAS®)-pathway. However, a large percentage of patients fail to achieve the ERAS® recommended goal (360 min out of bed from post-operative day 1/POD1). Motivational Interviewing (MI) is an evidence-based type of patient-centered consultation to promote intrinsic motivation. This study aims to evaluate if MI can improve postoperative mobilization. METHODS: This two-arm, patient-blinded pilot randomized controlled trial included ERAS®-patients undergoing elective bowel resections. Conversations were validated by MI Treatment Integrity. Two validated motion sensors (movisens) and self-assessments were used to measure mobilization (POD1-POD3: Time out of bed, time on feet and step count). RESULTS: 97 patients were screened, 60 finally included and randomized. Cumulatively across POD1-3, the intervention group (IG) was longer out of bed than the control group (CG) (median: 685 vs. 420 min; p=0.022). The IG achieved the ERAS®-goal of 360 min/day more frequently across POD1-3 (27.4% vs. 10.61%; p=0.013). Time on feet was 131.5 min/day (median per POD) in IG vs. 95.8 min/day in the CG (p=0.212), step count was 1347 in IG vs. 754 steps/day in CG (p=0.298). CONCLUSION: MI could be conducted low threshold and was well accepted by patients. MI can improve mobilization in the context of ERAS®. Despite better performance, it should be noted that only 27.4% of the IG reached the ERAS®-compliance goal of 360 min/day. The findings of this pilot study stipulate to further test the promising perioperative effects of MI within a multicenter superiority trial. REGISTRATION: This study was registered prospectively in the German Clinical Trials Register on 25.02.2022. Trial registration number is "DRKS00027863".
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Deambulação Precoce , Procedimentos Cirúrgicos Eletivos , Recuperação Pós-Cirúrgica Melhorada , Entrevista Motivacional , Humanos , Projetos Piloto , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Método Simples-CegoRESUMO
OBJECTIVE: The present study aims to clarify the prevalence and prognostic impact of anaemia and iron deficiency in patients with heart failure with mildly reduced ejection fraction (HFmrEF). BACKGROUND: The prognostic impact of anaemia and iron deficiency in HFmrEF has not yet been clarified. METHODS: Consecutive patients with HFmrEF were retrospectively included at one institution from 2016 to 2022. Patients with anaemia (i.e. haemoglobin <13 g/dL in males and < 12 g/dL in females) were compared to patients without, respectively patients with or without iron deficiency. The primary endpoint was all-cause mortality at 30 months (median follow-up), secondary endpoints comprised HF-related rehospitalisation. RESULTS: Two thousand one hundred and fifty four patients with HFmrEF with a median haemoglobin level of 12.2 g/dL were included. Anaemia was present in 52% of patients with HFmrEF and associated with a higher risk of all-cause mortality (44% vs. 18%; HR = 3.021; 95% CI 2.552-3.576; p =.001) and HF-related rehospitalisation (18% vs. 8%; HR = 2.351; 95% CI 1.819-3.040; p =.001) at 30 months, which was confirmed after multivariable adjustment. Although iron status was infrequently assessed in anaemics with HFmrEF (27%), the presence of iron deficiency was associated with higher risk of rehospitalisation for worsening HF (25% vs. 15%; HR = 1.746; 95% CI 1.024-2.976; p =.038), but not all-cause mortality (p =.279) at 30 months. CONCLUSION: Anaemia and iron deficiency are very common in atleast half of patients with HFmrEF and independently associated with adverse long-term prognosis.
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Anemia Ferropriva , Anemia , Insuficiência Cardíaca , Deficiências de Ferro , Readmissão do Paciente , Volume Sistólico , Humanos , Feminino , Masculino , Volume Sistólico/fisiologia , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/complicações , Idoso , Estudos Retrospectivos , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Anemia Ferropriva/complicações , Anemia Ferropriva/fisiopatologia , Prognóstico , Hemoglobinas/metabolismo , Causas de Morte , Prevalência , Idoso de 80 Anos ou mais , MortalidadeRESUMO
BACKGROUND: With the widespread use of direct oral anticoagulants (DOACs), there is an urgent need for a rapid assay to exclude clinically relevant plasma levels. Accurate and rapid determination of DOAC levels would guide medical decision-making to (1) determine the potential contribution of the DOAC to spontaneous or trauma-induced hemorrhage; (2) identify appropriate candidates for reversal, or (3) optimize the timing of urgent surgery or intervention. METHODS AND RESULTS: The DOAC Dipstick test uses a disposable strip to identify factor Xa- or thrombin inhibitors in a urine sample. Based on the results of a systematic literature search followed by an analysis of a simple pooling of five retrieved clinical studies, the test strip has a high sensitivity and an acceptably high negative predictive value when compared with levels measured with liquid chromatography tandem mass spectrometry or calibrated chromogenic assays to reliably exclude plasma DOAC concentrations ≥30 ng/mL. CONCLUSION: Based on these data, a simple algorithm is proposed to enhance medical decision-making in acute care indications useful primarily in hospitals not having readily available quantitative tests and 24/7. This algorithm not only determines DOAC exposure but also differentiates between factor Xa and thrombin inhibitors to better guide clinical management.
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Algoritmos , Consenso , Inibidores do Fator Xa , Humanos , Inibidores do Fator Xa/sangue , Inibidores do Fator Xa/uso terapêutico , Administração Oral , Hemorragia , Valor Preditivo dos Testes , Monitoramento de Medicamentos/métodos , Anticoagulantes/uso terapêutico , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Tomada de Decisão Clínica , Antitrombinas , Fitas Reagentes , Espectrometria de Massas em Tandem , Reprodutibilidade dos TestesRESUMO
Manipulation of the subcellular localization of transcription factors by preventing their shuttling via the nuclear pore complex (NPC) emerges as a novel therapeutic strategy against cancer. One transmembrane component of the NPC is POM121, encoded by a tandem gene locus POM121A/C on chromosome 7. Overexpression of POM121 is associated with metabolic diseases (e.g., diabetes) and unfavorable clinical outcome in patients with colorectal cancer (CRC). Peroxisome proliferator-activated receptor-gamma (PPARγ) is a transcription factor with anti-diabetic and anti-tumoral efficacy. It is inhibited by export from the nucleus to the cytosol via the RAS-RAF-MEK1/2-ERK1/2 signaling pathway, a major oncogenic driver of CRC. We therefore hypothesized that POM121 participates in the transport of PPARγ across the NPC to regulate its transcriptional activity on genes involved in metabolic and tumor control. We found that POM121A/C mRNA was enriched and POM121 protein co-expressed with PPARγ in tissues from CRC patients conferring poor prognosis. Its interactome was predicted to include proteins responsible for tumor metabolism and immunity, and in-silico modeling provided insights into potential 3D structures of POM121. A peptide region downstream of the nuclear localization sequence (NLS) of POM121 was identified as a cytoplasmic interactor of PPARγ. POM121 positivity correlated with the cytoplasmic localization of PPARγ in patients with KRAS mutant CRC. In contrast, POM121A/C silencing by CRISPR/Cas9 sgRNA or siRNA enforced nuclear accumulation of PPARγ and activated PPARγ target genes promoting lipid metabolism and cell cycle arrest resulting in reduced proliferation of human CRC cells. Our data suggest the POM121-PPARγ axis as a potential drugable target in CRC.
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Neoplasias , Poro Nuclear , Humanos , Poro Nuclear/metabolismo , PPAR gama/genética , PPAR gama/metabolismo , RNA Guia de Sistemas CRISPR-Cas , Complexo de Proteínas Formadoras de Poros Nucleares/metabolismo , Fatores de Transcrição/metabolismo , Neoplasias/metabolismo , Glicoproteínas de Membrana/metabolismoRESUMO
PURPOSE: The primary aim was to compare the prevalence of acute and delayed intracranial haemorrhage (ICH) following mild traumatic brain injury (mTBI) in patients on antithrombotic medication referred to a clinic for oral and plastic maxillofacial surgery. The secondary aim was to evaluate the need for short-term hospitalisation based on initial radiological and clinical findings. METHODS: This was an observational retrospective single-centre study of all patients on antithrombotic medication who were admitted to our department of oral and plastic maxillofacial surgery with mTBI over a 5 year period. Demographic and anamnesis data, injury characteristics, antithrombotic medication, radiological findings, treatment, and outcome were analysed. Patients were divided into the following four groups based on their antithrombotic medication: (1) single antiplatelet users, (2) vitamin K antagonist users, (3) direct oral anticoagulant users, and (4) double antithrombotic users. All patients underwent an emergency cranial CT (CT0) at admission. Based on clinical and radiological evaluation, different treatment protocols were applied. Patients with positive CT0 findings and patients with secondary neurological deterioration received a control CT (CT1) before discharge. Acute and delayed ICH and patient's outcome during hospitalisation were evaluated using descriptive statistical analysis. RESULTS: A total of 696 patients (mean age, 71.6 years) on antithrombotic medication who presented at our department with mTBI were included in the analysis. Most injuries were caused by a ground-level fall (76.9%). Thirty-six patients (5.1%) developed an acute traumatic ICH, and 47 intracerebral lesions were detected by radiology-most of these in patients taking acetylsalicylic acid. No association was detected between ICH and antithrombotic medication (p = 0.4353). In total, 258 (37.1%) patients were admitted for 48 h in-hospital observation. The prevalence of delayed ICH was 0.1%, and the mortality rate was 0.1%. Multivariable analysis identified a Glasgow Coma Scale (GCS) of < 15, loss of consciousness, amnesia, headache, dizziness, and nausea as clinical characteristics significantly associated with an increased risk of acute ICH, whereas age, sex, and trauma mechanism were not associated with ICH prevalence. Of the 39 patients who underwent a control CT1, most had a decreasing or at least constant intracranial lesion; in three patients, intracranial bleeding increased but was not clinically relevant. CONCLUSION: According to our experience, antithrombotic therapy does not increase the rate of ICH after mTBI. A GCS of < 15, loss of consciousness, amnesia, headache, dizziness, and nausea are indicators of higher ICH risk. A second CT scan is more effective in patients with secondary neurological deterioration. Initial CT findings were not clinically relevant and should not indicate in-hospital observation.
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Concussão Encefálica , Humanos , Idoso , Concussão Encefálica/complicações , Fibrinolíticos/efeitos adversos , Estudos Retrospectivos , Tontura/induzido quimicamente , Tontura/complicações , Tontura/tratamento farmacológico , Hemorragias Intracranianas/induzido quimicamente , Hemorragias Intracranianas/diagnóstico por imagem , Hemorragias Intracranianas/epidemiologia , Anticoagulantes/efeitos adversos , Hospitalização , Tomografia Computadorizada por Raios X/efeitos adversos , Inconsciência/induzido quimicamente , Inconsciência/complicações , Inconsciência/tratamento farmacológico , Cefaleia/induzido quimicamente , Cefaleia/complicações , Cefaleia/tratamento farmacológico , Amnésia/induzido quimicamente , Amnésia/complicações , Amnésia/tratamento farmacológico , Náusea/induzido quimicamente , Náusea/complicações , Náusea/tratamento farmacológicoRESUMO
PURPOSE: The aim of this study is to identify pre- and intraoperative factors indicating the feasibility of intraoperative radiotherapy (IORT) during breast-conserving surgery (BCS). MATERIALS AND METHODS: From January 2018 to December 2019, a total of 128 women undergoing BCS due to early breast cancer were included in this prospective observational study, independent of whether IORT was planned or not. Patient and tumor characteristics as well as surgical parameters that could potentially influence the feasibility of IORT were recorded for the entire collective. In addition, a preoperative senological assessment was performed and analyzed to assess the feasibility of IORT. Logistic regression was then used to identify relevant preoperative parameters and to generate a formula predicting the feasibility of IORT. RESULTS: Of the 128 included women undergoing BCS, 46 were preoperatively rated to be feasible, 20 to be questionably feasible for IORT. Ultimately, IORT was realized in 30 patients. The most frequent reasons for omission of IORT were insufficient tumor-to-skin distance and/or an excessively large tumor cavity. Small clinical tumor size and large tumor-to-skin distance according to preoperative ultrasound were significantly related to accomplishment of IORT. CONCLUSION: We observed that preoperative ultrasound-based tumor-skin distance is a significant factor in addition to already known parameters to predict feasibility of IORT. Based on our findings we developed a formula to optimize IORT planning which might serve as an additional tool to improve patient selection for IORT in early breast cancer.
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Neoplasias da Mama , Feminino , Humanos , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/radioterapia , Neoplasias da Mama/cirurgia , Mastectomia Segmentar , Raios X , Estudos Prospectivos , Estudos de Viabilidade , Cuidados IntraoperatóriosRESUMO
Inhibitors of anti-apoptotic BCL-2 family proteins in combination with chemotherapy and hypomethylating agents (HMAs) are promising therapeutic approaches in acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). Alvocidib, a cyclin-dependent kinase 9 (CDK9) inhibitor and indirect transcriptional repressor of the anti-apoptotic factor MCL-1, has previously shown clinical activity in AML. Availability of biomarkers for response to the alvocidib + 5- AZA could also extend the rationale of this treatment concept to high-risk MDS. In this study, we performed a comprehensive in vitro assessment of alvocidib and 5-AZA effects in n=45 high-risk MDS patients. Our data revealed additive cytotoxic effects of the combination treatment. Mutational profiling of MDS samples identified ASXL1 mutations as predictors of response. Further, increased response rates were associated with higher gene-expression of the pro-apoptotic factor NOXA in ASXL1 mutated samples. The higher sensitivity of ASXL1 mutant cells to the combination treatment was confirmed in vivo in ASXL1Y588X transgenic mice. Overall, our study demonstrated augmented activity for the alvocidib + 5-AZA combination in higher-risk MDS and identified ASXL1 mutations as a biomarker of response for potential stratification studies.
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BACKGROUND: Optimal pain management is one of the core elements of Enhanced Recovery After Surgery (ERAS®) protocols and remains a challenge. Acupuncture (AC) is an effective treatment for various pain conditions. Systematic and personalized allocation of acupoints may be decisive for efficacy. METHODS: Based on the predominant pressure sensitivity of six gastrointestinal (GI) checkpoints (G1-G6), we devised a method to detect personalized patterns of pain and a corresponding set of acupoints. We performed a single AC treatment with semi-permanent needles and assessed the visual analogue scale (VAS) score, pain threshold based on pressure algometry (PA), and temperature changes on abdominal skin areas before and 5 min after AC. RESULTS: Between April and June 2021, thirty-eight patients were prospectively included in this pilot study. The mean reduction in subjective pain sensation as assessed by VAS was 86%, paralleled by an augmentation of the pain threshold as measured by PA by 64%. A small but significant increase in the skin temperature was observed above the abdominal surface. These effects were independent of the type of surgery. CONCLUSION: Checkpoint acupuncture may be a complementary tool for postoperative pain management. Further investigations are needed to explore this analgesic effect.
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Terapia por Acupuntura , Humanos , Projetos Piloto , Dor Pós-Operatória/prevenção & controle , Manejo da Dor , Medição da DorRESUMO
BACKGROUND/AIM: The aim of this study was to evaluate patient preferences regarding cervical dysplasia clinics. Specifically, preferences in terms of diagnostic and therapeutic pathways as well as logistical and structural aspects were addressed to recognize unmet needs and improve existing structures of cervical dysplasia care. PATIENTS AND METHODS: This questionnaire-based study was conducted between June and December 2022 at an academic medical center in Southwestern Germany. A total of 226 patients who had an appointment at the certified dysplasia clinic were included. RESULTS: The vast majority of patients (74.8%) preferred counseling at the certified dysplasia clinic in the case of an abnormal finding of the cervix or labia. A prompt appointment (within a maximum of 4 weeks), a timely notification about test results (within a maximum of 2 weeks), a travel time <60 minutes and seeing the same doctor during follow-up appointments were recognized as important aspects. While about half of the patients (53.5%) were indifferent to the sex of the gynecologist, almost all of the remaining patients stated they would prefer to be seen by a female doctor (44.3% female doctor vs. 2.2% male doctor). CONCLUSION: Most women expect very timely appointments and result notifications. Moreover, they favor short travel times and continuity of care. The identified patient preferences should be considered to increase patient satisfaction and quality of care when developing and optimizing management at specialized dysplasia clinics.
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Displasia do Colo do Útero , Neoplasias Vulvares , Humanos , Masculino , Feminino , Preferência do Paciente , Colo do Útero , Satisfação do Paciente , Displasia do Colo do Útero/diagnóstico , HiperplasiaRESUMO
The primary aim of this study was to assess the incidence of a difficult airway and emergency tracheostomy in patients with orofacial infections originating in the mandible, and a secondary aim was to determine the potential predictors of difficult intubation. This retrospective single-center study included all patients who were referred between 2015 and 2022 with an orofacial infection originating in the mandible and who were surgically drained under intubation anesthesia. The incidence of a difficult airway regarding ventilation, laryngoscopy, and intubation was analyzed descriptively. Associations between potential influencing factors and difficult intubation were examined via multivariable analysis. A total of 361 patients (mean age: 47.7 years) were included in the analysis. A difficult airway was present in 121/361 (33.5%) patients. Difficult intubation was most common in patients with infections of the massetericomandibular space (42.6%), followed by infections of the mouth floor (40%) and pterygomandibular space (23.5%). Dyspnea and stridor were not associated with the localization of infection (p = 0.6486/p = 0.4418). Multivariable analysis revealed increased age, restricted mouth opening, higher Mallampati scores, and higher Cormack-Lehane classification grades as significant predictors of difficult intubation. Higher BMI, dysphagia, dyspnea, stridor and a non-palpable mandibular rim did not influence the airway management. Patients with a difficult airway were more likely to be admitted to the ICU after surgery than patients with regular airway were (p = 0.0001). To conclude, the incidence of a difficult airway was high in patients with orofacial infections originating in the mandible. Older age, limited mouth opening, a higher Mallampati score, and a higher Cormack-Lehane grade were reliable predictors of difficult intubation.
RESUMO
The primary aim was to evaluate the compliance of cranial CT indication with the national guideline-based decision rules in patients after mTBI. The secondary aim was to determine the incidence of CT pathologies among justified and unjustified CT scans and to investigate the diagnostic value of these decision rules. This is a retrospective, single-center study on 1837 patients (mean age = 70.7 years) referred to a clinic of oral and maxillofacial surgery following mTBI over a five-year period. The current national clinical decision rules and recommendations for mTBI were retrospectively applied to calculate the incidence of unjustified CT imaging. The intracranial pathologies among the justified and unjustified CT scans were presented using descriptive statistical analysis. The performance of the decision rules was ascertained by calculating the sensitivity, specificity, and predictive values. A total of 123 intracerebral lesions were radiologically detected in 102 (5.5%) of the study patients. Most (62.1%) of the CT scans strictly complied with the guideline recommendations, and 37.8% were not justified and likely avoidable. A significantly higher incidence of intracranial pathology was observed in patients with justified CT scans compared with patients with unjustified CT scans (7.9% vs. 2.5%, p < 0.0001). Patients with loss of consciousness, amnesia, seizures, cephalgia, somnolence, dizziness, nausea, and clinical signs of cranial fractures presented pathologic CT findings more frequently (p < 0.05). The decision rules identified CT pathologies with 92.28% sensitivity and 39.08% specificity. To conclude, compliance with the national decision rules for mTBI was low, and more than a third of the CT scans performed were identified as "likely avoidable". A higher incidence of pathologic CT findings was detected in patients with justified cranial CT imaging. The investigated decision rules showed a high sensitivity but low specificity for predicting CT pathologies.
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The aim of the study was to determine the factors influencing the development of recurrence after the surgical treatment of odontogenic maxillary sinusitis in an oral and maxillofacial surgery clinic over a 7-year period. Demographic and anamnesis data, clinical and radiological findings, treatment and outcome were analyzed. A multivariable analysis was performed to find associations between patient age, causative focus, surgical access for sinus revision, multilayer closure with a buccal fat pad, inferior meatal antrostomy (IMA) for temporary sinus drainage and sinusitis recurrence. A total of 164 patients with a mean age of 51.7 years were included. Sinusitis recurrence was observed in nine patients (5.48%) within 6 months after primary surgery. No significant correlation was detected between patient age, causative focus, surgical access for sinus revision, multilayer closure with a buccal fat pad, IMA for sinus drainage and the development of recurrence (p > 0.05). Patients with a history of antiresorptive-related osteonecrosis of the jaw showed a significant tendency toward disease recurrence (p = 0.0375). In conclusion, except for antiresorptive administration, none of the investigated variables were related to a higher risk of sinusitis recurrence. We encourage a combined approach of intraoral removal of the infective focus and sinus drainage via FESS, as well as an individual treatment decision in a multidisciplinary setting with collaboration between dentistry, maxillofacial surgery and otorhinolaryngology to avoid sinusitis recurrence.
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The achievement of major molecular response (MMR, BCR::ABL1 ≤ 0.1% IS) within the first year of treatment with tyrosine kinase inhibitors (TKI) is a milestone in the therapeutic management of patients with newly diagnosed chronic myeloid leukemia (CML). We analyzed the predictive value of gene expression levels of ESPL1/Separase, PTTG1/Securin and PTTG1IP/Securin interacting protein for MMR achievement within 12 months. Relative expression levels (normalized to GUSB) of ESPL1, PTTG1 and PTTG1IP in white blood cells of patients (responders n = 46, non-responders n = 51) at the time of diagnosis were comparatively analyzed by qRT-PCR. 3D scatter plot analysis combined with a distance analysis performed with respect to a commonly calculated centroid center resulted in a trend to larger distances for non-responders compared to the responder cohort (p = 0.0187). Logistic regression and analysis of maximum likelihood estimates revealed a positive correlation of distance (cut-off) with non-achieving MMR within 12 months (p = 0.0388, odds ratio 1.479, 95%CI: 1.020 to 2.143). Thus, 10% of the tested non-responders (cut-off ≥ 5.9) could have been predicted already at the time of diagnosis. Future scoring of ESPL1, PTTG1 and PTTG1IP transcript levels may be a helpful tool in risk stratification of CML patients before initiation of TKI first = line treatment.