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Importance: Surgical site infections frequently occur after open abdominal surgery. Intraoperative wound irrigation as a preventive measure is a common practice worldwide, although evidence supporting this practice is lacking. Objective: To evaluate the preventive effect of intraoperative wound irrigation with polyhexanide solution. Design, Setting, and Participants: The Intraoperative Wound Irrigation to Prevent Surgical Site Infection After Laparotomy (IOWISI) trial was a multicenter, 3-armed, randomized clinical trial. Patients and outcome assessors were blinded to the intervention. The clinical trial was conducted in 12 university and general hospitals in Germany from September 2017 to December 2021 with 30-day follow-up. Adult patients undergoing laparotomy were eligible for inclusion. The main exclusion criteria were clean laparoscopic procedures and the inability to provide consent. Of 11â¯700 screened, 689 were included and 557 completed the trial; 689 were included in the intention-to-treat and safety analysis. Interventions: Randomization was performed online (3:3:1 allocation) to polyhexanide 0.04%, saline, or no irrigation (control) of the operative wound before closure. Main Outcome and Measures: The primary end point was surgical site infection within 30 postoperative days according to the US Centers for Disease Control and Prevention definition. Results: Among the 689 patients included, 402 were male and 287 were female. The median (range) age was 65.9 (18.5-94.9) years. Participants were randomized to either wound irrigation with polyhexanide (n = 292), saline (n = 295), or no irrigation (n = 102). The procedures were classified as clean contaminated in 92 cases (8%). The surgical site infection incidence was 11.8% overall (81 of 689), 10.6% in the polyhexanide arm (31 of 292), 12.5% in the saline arm (37 of 295), and 12.8% in the no irrigation arm (13 of 102). Irrigation with polyhexanide was not statistically superior to no irrigation or saline irrigation (hazard ratio [HR], 1.23; 95% CI, 0.64-2.36 vs HR, 1.19; 95% CI, 0.74-1.94; P = .47). The incidence of serious adverse events did not differ among the 3 groups. Conclusions and Relevance: In this study, intraoperative wound irrigation with polyhexanide solution did not reduce surgical site infection incidence in clean-contaminated open abdominal surgical procedures compared to saline or no irrigation. More clinical trials are warranted to evaluate the potential benefit in contaminated and septic procedures, including the emergency setting. Trial Registration: drks.de Identifier: DRKS00012251.
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Biguanidas , Laparotomia , Infecção da Ferida Cirúrgica , Irrigação Terapêutica , Humanos , Infecção da Ferida Cirúrgica/prevenção & controle , Masculino , Feminino , Laparotomia/efeitos adversos , Pessoa de Meia-Idade , Biguanidas/uso terapêutico , Biguanidas/administração & dosagem , Idoso , Cuidados Intraoperatórios/métodos , AdultoRESUMO
PURPOSE: Chemotherapy is established as primary treatment in patients with stage IV colorectal cancer and unresectable metastases. Data from nonrandomized clinical trials have fueled persistent uncertainty if primary tumor resection (PTR) before chemotherapy prolongs survival. We investigated the prognostic value of PTR in patients with newly diagnosed stage IV colon cancer who were not amenable to curative treatment. PATIENTS AND METHODS: Patients enrolled in the multicenter, randomized SYNCHRONOUS and CCRe-IV trials were included in the analysis. Patients with colon cancer with synchronous unresectable metastases were randomly assigned at 100 sites in Austria, Germany, and Spain to undergo PTR or up-front chemotherapy (No PTR group). The chemotherapy regimen was left at discretion of the local team. Patients with tumor-related symptoms, inability to tolerate surgery and/or systemic chemotherapy, and history of another cancer were excluded. The primary end point was overall survival (OS), and the analyses were performed with intention-to-treat. RESULTS: A total of 393 patients were randomly assigned to undergo PTR (n = 187) or no PTR (n = 206) between November 2011 and March 2017. Chemotherapy was not administered to 6.4% in the No PTR group and 24.1% in the PTR group. The median follow-up time was 36.7 months (95% CI, 36.6 to 37.3). The median OS was 16.7 months (95% CI, 13.2 to 19.2) in the PTR group and 18.6 months (95% CI, 16.2 to 22.3) in the No PTR group (P = .191). Comparable OS between the study groups was further confirmed on multivariate analysis (hazard ratio, 0.944 [95% CI, 0.738 to 1.209], P = .65) and across all subgroups. Patients with serious adverse events were more common in the No PTR group (10.2% v 18.0%; P = .027). CONCLUSION: Among patients with colon cancer and synchronous unresectable metastases, PTR before systemic chemotherapy was not associated with prolonged OS.
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Neoplasias do Colo , Humanos , Feminino , Masculino , Idoso , Neoplasias do Colo/patologia , Neoplasias do Colo/tratamento farmacológico , Neoplasias do Colo/mortalidade , Pessoa de Meia-Idade , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Estadiamento de Neoplasias , Metástase Neoplásica , Idoso de 80 Anos ou mais , AdultoRESUMO
The limited sensitivity of circulating tumor cell (CTC) detection in pancreatic adenocarcinoma (PDAC) stems from their extremely low concentration in the whole circulating blood, necessitating enhanced detection methodologies. This study sought to amplify assay-sensitivity by employing diagnostic leukapheresis (DLA) to screen large blood volumes. Sixty patients were subjected to DLA, with a median processed blood volume of ~ 2.8 L and approximately 5% of the resulting DLA-product analyzed using CellSearch (CS). Notably, DLA significantly increased CS-CTC detection to 44% in M0-patients and 74% in M1-patients, yielding a 60-fold increase in CS-CTC enumeration. DLA also provided sufficient CS-CTCs for genomic profiling, thereby delivering additional genomic information compared to tissue biopsy samples. DLA CS-CTCs exhibited a pronounced negative prognostic impact on overall survival (OS), evidenced by a reduction in OS from 28.6 to 8.5 months (univariate: p = 0.002; multivariable: p = 0.043). Additionally, a marked enhancement in sensitivity was achieved (by around 3-4-times) compared to peripheral blood (PB) samples, with positive predictive values for OS being preserved at around 90%. Prognostic relevance of CS-CTCs in PDAC was further validated in PB-samples from 228 PDAC patients, consolidating the established association between CTC-presence and reduced OS (8.5 vs. 19.0 months, p < 0.001). In conclusion, DLA-derived CS-CTCs may serve as a viable tool for identifying high-risk PDAC-patients and aiding the optimization of multimodal treatment strategies. Moreover, DLA enables comprehensive diagnostic profiling by providing ample CTC material, reinforcing its utility as a reliable liquid-biopsy approach. This high-volume liquid-biopsy strategy presents a potential pathway for enhancing clinical management in this malignancy.
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Adenocarcinoma , Células Neoplásicas Circulantes , Neoplasias Pancreáticas , Humanos , Neoplasias Pancreáticas/diagnóstico , Adenocarcinoma/diagnóstico , Células Neoplásicas Circulantes/patologia , Biópsia Líquida/métodos , Biomarcadores Tumorais , Volume Sanguíneo , Neoplasias PancreáticasRESUMO
BACKGROUND: Exercise training is beneficial in enhancing physical function and quality of life in cancer patients. Its comprehensive implementation remains challenging, and underlying cardiopulmonary adaptations are poorly investigated. This randomized controlled trial examines the implementation and effects of home-based online training on cardiopulmonary variables and physical activity. METHODS: Of screened post-surgical patients with breast, prostate, or colorectal cancer, 148 were randomly assigned (1:1) to an intervention (2 × 30 min/week of strength-endurance training using video presentations) and a control group. All patients received activity feedback during the 6-month intervention period. Primary endpoint was change in oxygen uptake after 6 months. Secondary endpoints included changes in cardiac output, rate pressure product, quality of life (EORTC QoL-C30), C-reactive protein, and activity behavior. RESULTS: One hundred twenty-two patients (62 intervention and 60 control group) completed the study period. Change in oxygen uptake between intervention and control patients was 1.8 vs. 0.66 ml/kg/min (estimated difference after 6 months: 1.24; 95% CI 0.23 to 2.55; p = 0.017). Rate pressure product was reduced in IG (estimated difference after 6 months: - 1079; 95% CI - 2157 to - 1; p = 0.05). Physical activity per week was not different in IG and CG. There were no significant interaction effects in body composition, cardiac output, C-reactive protein, or quality of life. CONCLUSIONS: Home-based online training among post-surgery cancer patients revealed an increase of oxygen uptake and a decrease of myocardial workload during exercise. The implementation of area-wide home-based training and activity feedback as an integral component in cancer care and studies investigating long-term effects are needed. TRIAL REGISTRATION: DRKS-ID: DRKS00020499 ; Registered 17 March 2020.
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Neoplasias , Qualidade de Vida , Masculino , Humanos , Proteína C-Reativa , Retroalimentação , Exercício Físico , Terapia por Exercício , Neoplasias/cirurgia , OxigênioRESUMO
BACKGROUND: The detrimental impact of malnutrition and cachexia in cancer patients subjected to surgical resection is well established. However, how systemic and local metabolic alterations in cancer patients impact the serum metabolite signature, thereby leading to cancer-specific differences, is poorly defined. In order to implement metabolomics as a potential tool in clinical diagnostics and disease follow-up, targeted metabolite profiling based on quantitative measurements is essential. We hypothesized that the quantitative metabolic profile assessed by 1 H nuclear magnetic resonance (NMR) spectroscopy can be used to identify cancer-induced catabolism and potentially distinguish between specific tumour entities. Importantly, to prove tumour dependency and assess metabolic normalization, we additionally analysed the metabolome of patients' sera longitudinally post-surgery in order to assess metabolic normalization. METHODS: Forty two metabolites in sera of patients with tumour entities known to cause malnutrition and cachexia, namely, upper gastrointestinal cancer and pancreatic cancer, as well as sera of healthy controls, were quantified by 1 H NMR spectroscopy. RESULTS: Comparing serum metabolites of patients with gastrointestinal cancer with healthy controls and pancreatic cancer patients, we identified at least 15 significantly changed metabolites in each comparison. Principal component and pathway analysis tools showed a catabolic signature in preoperative upper gastrointestinal cancer patients. The most specifically upregulated metabolite group in gastrointestinal cancer patients was ketone bodies (3-hydroxybutyrate, P < 0.0001; acetoacetate, P < 0.0001; acetone, P < 0.0001; false discovery rate [FDR] adjusted). Increased glycerol levels (P < 0.0001), increased concentration of the ketogenic amino acid lysine (P = 0.03) and a significant correlation of 3-hydroxybutyrate levels with branched-chained amino acids (leucine, P = 0.02; isoleucine, P = 0.04 [FDR adjusted]) suggested that ketone body synthesis was driven by lipolysis and amino acid breakdown. Interestingly, the catabolic signature was independent of the body mass index, clinically assessed malnutrition using the nutritional risk screening score, and systemic inflammation assessed by CRP and leukocyte count. Longitudinal measurements and principal component analyses revealed a quick normalization of key metabolic alterations seven days post-surgery, including ketosis. CONCLUSIONS: Together, the quantitative metabolic profile obtained by 1 H NMR spectroscopy identified a tumour-induced catabolic signature specific to upper gastrointestinal cancer patients and enabled monitoring restoration of metabolic homeostasis after surgery. This approach was critical to identify the obtained metabolic profile as an upper gastrointestinal cancer-specific signature independent of malnutrition and inflammation.
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Neoplasias Gastrointestinais , Desnutrição , Neoplasias Pancreáticas , Humanos , Ácido 3-Hidroxibutírico , Caquexia/etiologia , Caquexia/metabolismo , Neoplasias Gastrointestinais/complicações , Neoplasias Gastrointestinais/metabolismo , Inflamação/metabolismo , Leucina , Desnutrição/etiologia , Desnutrição/metabolismo , Neoplasias Pancreáticas/metabolismo , MetabolômicaRESUMO
INTRODUCTION: It has been shown that cytoreductive surgery (CRS) in combination with hyperthermic intraperitoneal chemotherapy (HIPEC) is an effective treatment for patients suffering from peritoneal malignancies. Despite good results, there is an ongoing debate about this treatment due to perioperative morbidity. The aim of this study is to identify relevant risk factors for an unfavorable postoperative outcome after CRS and HIPEC. MATERIALS AND METHODS: A retrospective analysis of a prospectively recorded database of all patients undergoing CRS and HIPEC between 2013 and 2020 in the Department of Surgery of the University Hospital Dresden was performed with a special focus on certain surgical steps of multivisceral resection, one- or 2- stage CRS/HIPEC and underlying diagnosis as possible risk factors for worse postoperative course. RESULTS: N = 173 CRS and HIPEC procedures were performed for various diagnoses. Relevant postoperative morbidity was 24% and 30d-mortality 1.2%. Simultaneous liver resections, preoperative hypalbuminemia and 2-staged CRS/HIPEC were significant risk factors for a worse postoperative course in multivariable analysis. Assessment of the association of simultaneous anastomoses and morbidity and mortality was inconclusive. CONCLUSION: CRS and HIPEC is a safe treatment without relevant intraoperative morbidity and mortality and acceptable postoperative outcome. One-stage CRS/HIPEC should be preferred.
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Procedimentos Cirúrgicos de Citorredução , Hipertermia Induzida , Humanos , Procedimentos Cirúrgicos de Citorredução/efeitos adversos , Quimioterapia Intraperitoneal Hipertérmica/efeitos adversos , Estudos Retrospectivos , Hipertermia Induzida/efeitos adversos , Terapia Combinada , Morbidade , Taxa de Sobrevida , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêuticoRESUMO
Purpose: Clinical abundance of artificial intelligence has increased significantly in the last decade. This survey aims to provide an overview of the current state of knowledge and acceptance of AI applications among surgeons in Germany. Methods: A total of 357 surgeons from German university hospitals, academic teaching hospitals and private practices were contacted by e-mail and asked to participate in the anonymous survey. Results: A total of 147 physicians completed the survey. The majority of respondents (n = 85, 52.8%) stated that they were familiar with AI applications in medicine. Personal knowledge was self-rated as average (n = 67, 41.6%) or rudimentary (n = 60, 37.3%) by the majority of participants. On the basis of various application scenarios, it became apparent that the respondents have different demands on AI applications in the area of "diagnosis confirmation" as compared to the area of "therapy decision." For the latter category, the requirements in terms of the error level are significantly higher and more respondents view their application in medical practice rather critically. Accordingly, most of the participants hope that AI systems will primarily improve diagnosis confirmation, while they see their ethical and legal problems with regard to liability as the main obstacle to extensive clinical application. Conclusion: German surgeons are in principle positively disposed toward AI applications. However, many surgeons see a deficit in their own knowledge and in the implementation of AI applications in their own professional environment. Accordingly, medical education programs targeting both medical students and healthcare professionals should convey basic knowledge about the development and clinical implementation process of AI applications in different medical fields, including surgery.
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Estudantes de Medicina , Cirurgiões , Humanos , Inteligência Artificial , Inquéritos e Questionários , AlemanhaRESUMO
The skills, knowledge and resources to search for, find, understand, evaluate and apply health information is defined as health literacy (HL). If individuals want to use health information from the Internet, they need Digital Health Literacy (eHL), which in addition to HL also includes, for example, media literacy. If information cannot be found or understood by patients due to low (e)HL, patients will not have the opportunity to make informed decisions. In addition, many health apps for self-management or prevention also require (e)HL. Thus, it follows that active participation in healthcare, in terms of Person-Centered Care (PCC) is only possible through (e)HL. Currently, there is a great need to strengthen these competencies in society to achieve increased empowerment of patients and their health. However, at the same time, there is a need to train and improve competencies in the field of healthcare professionals so that they can counsel and guide patients. This article provides an overview with a focus on HL and eHL in healthcare, shows the opportunities to adapt services and describes the possible handling of patients with low (e)HL. In addition, the opportunities for patients and healthcare professionals to improve (e)HL are highlighted.
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Letramento em Saúde , Telemedicina , Atenção à Saúde , Humanos , Assistência Centrada no Paciente , AutocuidadoRESUMO
BACKGROUND: This survey study investigates surgical patients' use and perception of digital health technologies in Germany in the pre-COVID-19 era. OBJECTIVE: The objective of this study was to relate surgical patients' characteristics to the use and perception of several digital health technologies. METHODS: In this single-center, cross-sectional survey study in the outpatient department of a university hospital in Germany, 406 patients completed a questionnaire with the following three domains: general information and use of the internet, smartphones, and general digital health aspects. Analyses were stratified by age group and highest education level achieved. RESULTS: We found significant age-based differences in most of the evaluated aspects. Younger patients were more open to using new technologies in private and medical settings but had more security concerns. Although searching for information on illnesses on the web was common, the overall acceptance of and trust in web-based consultations were rather low, with <50% of patients in each age group reporting acceptance and trust. More people with academic qualifications than without academic qualifications searched for information on the web before visiting physicians (73/121, 60.3% and 100/240, 41.7%, respectively). Patients with academic degrees were also more engaged in health-related information and communication technology use. CONCLUSIONS: These results support the need for eHealth literacy, health literacy, and available digital devices and internet access to support the active, meaningful use of information and communication technologies in health care. Uncertainties and a lack of knowledge exist, especially regarding telemedicine and the use of medical and health apps. This is especially pronounced among older patients and patients with a low education status.
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PURPOSE: Anastomotic leakage (AL) and surgical site infection (SSI) account for most postoperative complications in colorectal surgery. The aim of this retrospective trial was to investigate whether perioperative selective decontamination of the digestive tract (SDD) reduces these complications and to provide a cost-effectiveness model for elective colorectal surgery. METHODS: All patients operated between November 2016 and March 2020 were included in our analysis. Patients in the primary cohort (PC) received SDD and those in the historical control cohort (CC) did not receive SDD. In the case of rectal/sigmoid resection, SDD was also applied via a transanally placed Foley catheter (TAFC) for 48 h postoperatively. A propensity score-matched analysis was performed to identify risk factors for AL and SSI. Costs were calculated based on German diagnosis-related group (DRG) fees per case. RESULTS: A total of 308 patients (154 per cohort) with a median age of 62.6 years (IQR 52.5-70.8) were analyzed. AL was observed in ten patients (6.5%) in the PC and 23 patients (14.9%) in the CC (OR 0.380, 95% CI 0.174-0.833; P = 0.016). SSI occurred in 14 patients (9.1%) in the PC and 30 patients in the CC (19.5%), representing a significant reduction in our SSI rate (P = 0.009). The cost-effectiveness analysis showed that SDD is highly effective in saving costs with a number needed to treat of 12 for AL and 10 for SSI. CONCLUSION: SDD significantly reduces the incidence of AL and SSI and saves costs for the general healthcare system.
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Fístula Anastomótica , Cirurgia Colorretal , Idoso , Fístula Anastomótica/etiologia , Fístula Anastomótica/prevenção & controle , Antibacterianos/uso terapêutico , Descontaminação , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Trato Gastrointestinal , Humanos , Pessoa de Meia-Idade , Pontuação de Propensão , Estudos Retrospectivos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/prevenção & controleRESUMO
BACKGROUND: Digital innovations in medicine are disruptive technologies that can change the way diagnostic procedures and treatments are delivered. Such innovations are typically designed in teams with different disciplinary backgrounds. This paper concentrates on 2 interdisciplinary research teams with 20 members from the medicine and engineering sciences working jointly on digital health solutions. OBJECTIVE: The aim of this paper was to identify factors on the individual, team, and organizational levels that influence the implementation of interdisciplinary research projects elaborating on digital applications for medicine and, based on the results, to draw conclusions for the proactive design of the interdisciplinary research process to make these projects successful. METHODS: To achieve this aim, 2 interdisciplinary research teams were observed, and a small case study (response rate: 15/20, 75%) was conducted using a web-based questionnaire containing both closed and open self-report questions. The Spearman rank correlation coefficient was calculated to analyze the quantitative data. The answers to the open-ended questions were subjected to qualitative content analysis. RESULTS: With regard to the interdisciplinary research projects investigated, the influencing factors of the three levels presented (individual, team, and organization) have proven to be relevant for interdisciplinary research cooperation. CONCLUSIONS: With regard to recommendations for the future design of interdisciplinary cooperation, management aspects are addressed, that is, the installation of a coordinator, systematic definition of goals, required resources, and necessary efforts on the part of the involved interdisciplinary research partners. As only small groups were investigated, further research in this field is necessary to derive more general recommendations for interdisciplinary research teams. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00023909, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023909â; German Clinical Trials Register, DRKS00025077, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00025077.
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Background: Cinacalcet is a calcimimetic drug that has increasingly been used as a bridging therapy for primary hyperparathyroidism (pHPT), especially during the COVID-19 pandemic. The aim of our study was to investigate if preoperative cinacalcet therapy affects intraoperative parathyroid hormone (IOPTH) monitoring during parathyroidectomy, which is an important indicator for the success of surgery. Methods: In this single-center retrospective analysis, we studied the outcomes of 72 patients who underwent surgery for pHPT. We evaluated two groups: those with cinacalcet therapy before operationthe cinacalcet group (CG)and those without medical therapy preoperatively (non-CG). In order to perform a between-group comparison of time trends, we fit a linear mixed-effects model with PTH as the response variable and predictors PTH levels preoperatively, group (cinacalcet yes/no), time, the group-by-time interaction, and a random intercept (per subject). Results: Our cohort included 51 (71%) women and 21 (29%) men, who were operated upon for pHPT in the period from January 2018 until August 2021. All patients were diagnosed with pHPT and 54% of the cohort were symptomatic for hypercalcemia. Moreover, 30% of the patients were treated with cinacalcet as a bridging therapy preoperatively, and this increased during the COVID-19 pandemic, as 64% of this group were treated in the last two years. Calcium values were significantly different before (p < 0.001) and after (p = 0.0089) surgery, but calcium level change did not differ significantly between the CG and non-CG. Parathyroid hormone (PTH) levels dropped significantly in both groups during 10 min IOPTH monitoring (p < 0.001), but there was no significant difference between the two groups (p = 0.212). Conclusions: In the examined patient cohort, the use of cinacalcet did not affect the value of IOPTH monitoring during surgery for pHPT.
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BACKGROUND: There is a strong interaction between hepatic hemodynamics and perfusion in the splanchnic system. However, little is known about differences in perfusion in different splanchnic compartments and their changes after hepatectomy. METHODS: Perfusion in various splanchnic compartments (ie, stomach, small intestine, right and left colon, liver) was assessed pre- and post-hepatectomy by intraoperative laser Doppler flowmetry. Differences of splanchnic perfusion between compartments were evaluated by ANOVA, and risk factors of postoperative complications (graded by the comprehensive complication index [CCI]) were analyzed by univariate and multivariate analyses. A prediction model of postoperative complications was developed. RESULTS: A total of 50 and 29 patients with major and minor hepatectomy were enrolled. Splanchnic perfusion at baseline varied significantly across different splanchnic compartments with highest values in the small bowel and right colon (P < .001). Major hepatectomy induced a significant perfusion decrease in the stomach (P = .006), right colon (P < .001) and small bowel (P = .035). A postresection perfusion deficit in the right colon with values below 254 perfusion units (PU) was identified as an independent predictor of clinically relevant complications after major hepatectomy (concordance index: 0.79, 95% CI 0.66-0.87, P = .002). Bootstrap validation confirmed internal validity and excellent calibration. CONCLUSIONS: Major hepatectomy causes significant reduction of splanchnic perfusion. An intraoperative posthepatectomy microcirculatory perfusion deficit of the right colon is a strong and independent predictor of clinically relevant postoperative complications after major hepatectomy.
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Hepatectomia , Complicações Pós-Operatórias , Colo/cirurgia , Hepatectomia/efeitos adversos , Humanos , Microcirculação , Perfusão , Complicações Pós-Operatórias/etiologiaRESUMO
BACKGROUND: Postpancreatectomy haemorrhage (PPH) is a rare but potentially fatal complication after pancreatoduodenectomy. Preventive strategies are lacking with scarce data for support. The aim of this study was to investigate whether a prophylactic falciform ligament wrap around the hepatic and gastroduodenal artery can prevent PPH from these vessels. METHODS: In a randomized, controlled, multicentre trial, patients who were scheduled for elective open partial pancreatoduodenectomy with pancreatojejunostomy between 5 November 2015 and 2 April 2020 were randomly allocated in a 1 : 1 ratio to undergo pancreatoduodenectomy with (intervention) or without (control) a falciform ligament wrap around the hepatic artery. The primary endpoint was the rate of clinically relevant PPH from the hepatic artery or gastroduodenal artery stump within 3 months after pancreatoduodenectomy. Secondary endpoints were the rates of associated postoperative complications, for example postoperative pancreatic fistula (POPF) and PPH. RESULTS: Altogether, 445 patients were randomized with 222 and 223 in each group. Among the patients included in modified intention-to-treat analysis (207 in the intervention group and 210 in the control group), the primary endpoint was observed in six of 207 in the intervention group compared with 15 of 210 in the control group (2.9 versus 7.1 per cent respectively; odds ratio 0.39 (95 per cent c.i. 0.15 to 1.02); P = 0.071). Per protocol analysis showed a significant reduction in the intervention group (odds ratio 0.26 (95 per cent c.i. 0.09 to 0.80); P = 0.017). A soft pancreas texture (43 per cent) and the rate of a clinically relevant POPF were evenly (20 per cent) distributed between the groups. The rate of any clinically relevant PPH including the primary endpoint and other bleeding sites was not significantly different between intervention and control groups (9.7 versus 14.8 per cent respectively). CONCLUSION: A falciform ligament wrap may reduce PPH from the hepatic artery or gastroduodenal artery stump and should be considered during pancreatoduodenectomy. REGISTRATION NUMBER: NCT02588066 (http://www.clinicaltrials.gov).
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Hemostasia Cirúrgica/métodos , Artéria Hepática/cirurgia , Ligamentos/cirurgia , Pancreaticoduodenectomia/métodos , Hemorragia Pós-Operatória/prevenção & controle , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pancreaticoduodenectomia/efeitos adversosRESUMO
BACKGROUND: Pelvic exenteration (PE) is the only option for long-term cure of advanced cancer originating from different types of tumor or recurrent disease in the lower pelvis. The aim was to show differences between colorectal and non-colorectal cancer in survival and postoperative morbidity. METHODS: Retrospective data of 63 patients treated with total pelvic exenteration between 2013 and 2018 are reported. Pre-, intra-, and postoperative parameters, survival data, and risk factors for complications were analyzed. RESULTS: A total of 57.2% (n = 37) of the patients had colorectal cancer, 22.3% had gynecological malignancies (vulvar (n = 6) or cervical (n = 8) cancer), 11.1% (n = 7) had anal cancer, and 9.5% had other primary tumors. A total of 30.2% (n = 19) underwent PE for a primary tumor and 69.8% (n = 44) for recurrent cancer. The 30-day in-hospital mortality was 0%. Neoadjuvant treatment was administered to 65.1% (n = 41) of the patients and correlated significantly with postoperative complications (odds ratio 4.441; 95% CI: 1.375-14.342, P > 0.05). R0, R1, R2, and Rx resections were achieved in 65.1%, 19%, 1.6%, and 14.3% of the patients, respectively. In patients undergoing R0 resection, 2-year OS and RFS were 73.2% and 52.4%, respectively. Resection status was a significant risk factor for recurrence-free and overall survival (OS) in univariate analysis. Multivariate analysis revealed age (P = 0.021), ASA ≥ 3 (P = 0.005), high blood loss (P = 0.028), low preoperative hemoglobin level (P < 0.001), nodal positivity (P < 0.001), and surgical complications (P = 0.003) as independent risk factors for OS. CONCLUSION: Pelvic exenteration is a procedure with high morbidity rates but remains the only curative option for advanced or recurrent colorectal and non-colorectal cancer in the pelvis.
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Neoplasias do Ânus , Exenteração Pélvica , Neoplasias Retais , Humanos , Recidiva Local de Neoplasia/cirurgia , Exenteração Pélvica/efeitos adversos , Neoplasias Retais/cirurgia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Physical training is recommended in various national and international guidelines for patients with cancer. Observational studies have shown that physical activity leads to reduced recurrence and mortality rates by 20-40% in colorectal, breast, and prostate cancer. Despite existing evidence, a systematic care structure is still lacking. The primary aim of this study is to implement and evaluate an online training platform to strengthen physical performance and patient empowerment after cancer surgery. METHODS: The evaluation will be conducted as a prospective multicenter randomized controlled trial with three subgroups (colorectal-, breast-, and prostate cancer). Each group will include 100 patients (total 300 patients including dropouts; clinical stages T1-3 and/or N+; M0 after surgery intervention) and the primary endpoint (13% increase in the maximal oxygen consumption during exercise) will be examined. The intervention group will receive a 6-month home-based online training (2-3 times per week strength-endurance training using video presentations), bidirectional activity feedback information, online communication, and online counseling. The control group (usual care) will be advised lifestyle improvement. In-hospital testing will be performed before, during, and after the intervention. In addition to cardiopulmonary capacity, tumor specific diagnostics (liquid biopsy, depression and fatigue assessment, metabolic and endothelial screening) will be applied. DISCUSSION: Due to the increasing incidence of cancer, associated with considerable mortality, morbidity and impaired quality of life, there is an imperative requirement for improved cancer care, of which structured physical training may become an integral component. TRIAL REGISTRATION: DRKS-ID: DRKS00020499 ; Registered 17 March 2020.
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BACKGROUND: Electronic medical records (EMRs) offer key advantages over analog documentation in healthcare. In addition to providing details about current and past treatments, EMRs enable clear and traceable documentation regardless of the location. This supports evidence-based, multi-professional treatment and leads to more efficient healthcare. However, there are still several challenges regarding the use of EMRs. Understanding these challenges is essential to improve healthcare. The aim of this article is to provide an overview of the current state of EMRs in the field of visceral medicine, to describe the future prospects in this field, and to highlight some of the challenges that need to be faced. SUMMARY: The benefits of EMRs are manifold and particularly pronounced in the area of quality assurance and improvement of communication not only between different healthcare professionals but also between physicians and patients. Besides the danger of medical errors, the health consequences for the users (cognitive load) arise from poor usability or a system that does not fit into the real world. Involving users in the development of EMRs in the sense of participatory design can be helpful here. The use of EMRs in practice together with patients should be accompanied by training to ensure optimal outcomes in terms of shared decision-making. KEY MESSAGE: EMRs offer a variety of benefits. However, it is critical to consider user involvement, setting specificity, and user training during development, implementation, and use in order to minimize unintended consequences.
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Importance: Tumor relapse after partial hepatectomy for colorectal liver metastasis (CRLM) remains an unsolved issue. Intraoperative manipulation of the liver during conventional hepatectomy might enhance hematogenous tumor cell spread. The anterior approach is an alternative approach that may reduce intraoperative tumor cell dissemination. Objective: To determine the efficacy and safety of the anterior approach compared with conventional hepatectomy in patients undergoing resection for CRLM. Design, Setting, and Participants: This randomized clinical study evaluated the efficacy and safety of the anterior approach compared with conventional hepatectomy in adult patients with CRLM who were scheduled for hepatectomy from February 1, 2003, to March 31, 2012, at a tertiary-care hospital. A total of 80 patients with CRLM were randomized to the anterior approach and conventional hepatectomy groups in a 1:1 ratio. Bone marrow and blood samples were analyzed for disseminated tumor cells and circulating tumor cells (CTC) using cytokeratin 20 reverse transcriptase-polymerase chain reaction analysis. Data were analyzed from April 1 to December 1, 2018, using intention to treat. Interventions: Anterior approach vs conventional hepatectomy. Main Outcomes and Measures: The primary end point was intraoperative CTC detection in central blood samples after liver resection. Secondary end points included postoperative morbidity, mortality, and long-term survival. Results: Among the 80 patients included in the analysis (48 men [60%]; mean [SD] age, 61 [10] years), baseline characteristics, including preoperative CTC detection, were comparable between both groups. There was no statistically significant difference in intraoperative CTC detection between patients in the conventional hepatectomy (5 of 21 [24%]) and anterior approach (6 of 22 [27%]) groups (P = .54). Except for a longer operating time in the anterior approach group (mean [SD], 171 [53] vs 221 [53] minutes; P < .001), there were no significant differences in intraoperative and postoperative outcomes between both study groups. Although detection of CTC was associated with poor overall (median, 46 [95% CI, 40-52] vs 81 [95% CI, 54-107] months; P = .03) and disease-free (median, 40 [95% CI, 34-46] vs 60 [95% CI, 46-74] months; P = .04) survival, there was no significant difference in overall (median, 73 [95% CI, 42-104] vs 55 [95% CI, 35-75] months; P = .43) and disease-free (median, 48 [95% CI, 40-56] vs 40 [95% CI, 28-52] months; P = .88) survival between the conventional hepatectomy and anterior approach groups. Also, there was no significant difference in patterns of recurrence between both groups. Conclusions and Relevance: This randomized clinical trial found that the anterior approach was not superior to conventional hepatectomy in reducing intraoperative tumor cell dissemination in patients undergoing resection of CRLM. Trial Registration: isrctn.org Identifier: ISRCTN45066244.
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Neoplasias Colorretais/patologia , Hepatectomia/métodos , Neoplasias Hepáticas/secundário , Neoplasias Hepáticas/cirurgia , Complicações Pós-Operatórias/epidemiologia , Idoso , Neoplasias Colorretais/mortalidade , Neoplasias Colorretais/terapia , Feminino , Hepatectomia/efeitos adversos , Humanos , Neoplasias Hepáticas/mortalidade , Masculino , Pessoa de Meia-Idade , Células Neoplásicas Circulantes , Duração da Cirurgia , Estudos Prospectivos , Taxa de Sobrevida , Resultado do TratamentoRESUMO
BACKGROUND: Digitalization is a disruptive technology that changes the way we deliver diagnostic procedures and treatments in medicine. Different stakeholders have varying interests in and expectations of the digitalization of modern medicine. Many recent digital advances in the medical field, such as the implementation of electronic health records, telemedical services, and mobile health apps, are increasingly used by medical professionals and patients. During the current pandemic outbreak of a novel coronavirus-caused respiratory disease (COVID-19), many modern information and communication technologies (ICT) have been used to overcome the physical barriers and limitations caused by government-issued curfews and workforce shortages. Therefore, the COVID-19 pandemic has led to a surge in the usage of modern ICT in medicine. At the same time, the eHealth literacy of physicians working with these technologies has probably not improved since our study. OBJECTIVE: This paper describes a representative cohort of German physicians before the COVID-19 pandemic and their eHealth literacy and attitude towards modern ICT. METHODS: A structured, self-developed questionnaire about user behavior and attitudes towards eHealth applications was administered to a representative cohort of 93 German physicians. RESULTS: Of the 93 German physicians who participated in the study, 97% (90/93) use a mobile phone. Medical apps are used by 42% (39/93). Half of the surveyed physicians (47/93, 50%) use their private mobile phones for official purposes on a daily basis. Telemedicine is part of the daily routine for more than one-third (31/93, 33%) of all participants. More than 80% (76/93, 82%) of the trial participants state that their knowledge regarding the legal aspects and data safety of medical apps and cloud computing is insufficient. CONCLUSIONS: Modern ICT is frequently used and mostly welcomed by German physicians. However, there is a tremendous lack of eHealth literacy and knowledge about the safe and secure implementation of these technologies in routine clinical practice.
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Atitude do Pessoal de Saúde , Letramento em Saúde , Médicos/psicologia , Telemedicina , Adulto , COVID-19 , Estudos de Coortes , Infecções por Coronavirus/epidemiologia , Feminino , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Médicos/estatística & dados numéricos , Pneumonia Viral/epidemiologia , Inquéritos e QuestionáriosRESUMO
The COVID-19 pandemic has tremendously changed private and professional interactions and behaviors worldwide. The effects of this pandemic and the actions taken have changed our healthcare systems, which consequently has affected medical education and surgical training. In the face of constant disruptions of surgical education and training during this pandemic outbreak, structured and innovative concepts and adapted educational curricula are important to ensure a high quality of medical treatment. While efforts were undertaken to prevent viral spreading, it is important to analyze and assess the effects of this crisis on medical education, surgical training and teaching at large and certainly in the field of surgical oncology. Against this background, in this paper we introduce practical and creative recommendations for the continuity of students' and residents' medical and surgical training and teaching. This includes virtual educational curricula, skills development classes, video-based feedback and simulation in the specialty field of surgical oncology. In conclusion, the effects of COVID 19 on Surgical Training and Teaching, certainly in the field of Surgical Oncology, are challenging.