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BACKGROUND: The Swiss national union of residents and attendings (VSAO) has voiced its desire for a transition from the current 48 h work week to a 42 + 4 h work week, in which 42 h be focused on patient care with the remaining 4 h be dedicated solely to training purposes. This could potentially result in a significant decrease in surgical education time. The current study seeks to address the issues involved in its implementation as well as possible compensatory mechanisms. METHODS: This mixed methods study seeks to clearly underline the challenges associated with the implementation of a 42 + 4 h work week. First, the major stakeholders were identified and analysed via umbrella review. Thereafter, a classic stakeholder analysis was performed. Via morphological matrix, possible models for the implementation of a 42 + 4 h work week were developed and evaluated. Finally, representatives from the identified stakeholder groups were interviewed and given the opportunity to provide feedback. RESULTS: A total of 26 articles were identified by the literature search and were used to identify the major stakeholders and issues involved in the implementation of the desired work hour regulation. Overall, these showed conflicting results with regard to the effect decreased working hours would have on surgical training and patient outcomes. In the end, the morphological matrix produced three feasible and desirable models for the implementation of a 42 + 4 h work week. Each included compensatory mechanisms like auxiliary staff, reduction in administrative tasks, and a switch to EPAs. In their interviews, the stakeholders generally supported these solutions. CONCLUSION: Given the increasing emphasis on the importance of a positive work-life balance, it seems inevitable that the next few years will see the introduction of a 42 + 4 h work week in Switzerland. However, it is imperative that every effort be made to preserve the quality of training and patient care for the next generations. This will require the cooperation of all stakeholders in order to find workable solutions.
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Cirurgia Geral , Internato e Residência , Admissão e Escalonamento de Pessoal , Carga de Trabalho , Internato e Residência/organização & administração , Suíça , Humanos , Admissão e Escalonamento de Pessoal/organização & administração , Cirurgia Geral/educação , Tolerância ao Trabalho Programado , Educação de Pós-Graduação em Medicina , Participação dos InteressadosRESUMO
Chemokines orchestrate many aspects of tumorigenic processes such as angiogenesis, apoptosis and metastatic spread, and related receptors are expressed on tumor cells as well as on inflammatory cells (e.g., tumor-infiltrating T cells, TILs) in the tumor microenvironment. Expressional changes of chemokines and their receptors in solid cancers are common and well known, especially in affecting colorectal cancer patient outcomes. Therefore, the aim of this current systematic review and meta-analysis was to classify chemokines as a prognostic biomarker in colorectal cancer patients. A systematic literature search was conducted in PubMed, CENTRAL and Web of Science. Information on the chemokine expression of 25 chemokines in colorectal cancer tissue and survival data of the patients were investigated. The hazard ratio of overall survival and disease-free survival with chemokine expression was examined. The risk of bias was analyzed using Quality in Prognosis Studies. Random effects meta-analysis was performed to determine the impact on overall respectively disease survival. For this purpose, the pooled hazard ratios (HR) and their 95% confidence intervals (CI) were used for calculation. Twenty-five chemokines were included, and the search revealed 5556 publications. A total of thirty-one publications were included in this systematic review and meta-analysis. Overexpression of chemokine receptor CXCR4 was associated with both a significantly reduced overall survival (HR = 2.70, 95%-CI: 1.57 to 4.66, p = 0.0003) as well as disease-free survival (HR = 2.68, 95%-CI: 1.41 to 5.08, p = 0.0026). All other chemokines showed either heterogeneous results or few studies were available. The overall risk of bias for CXCR4 was rated low. At the current level of evidence, this study demonstrates that CXCR4 overexpression in patients with colorectal cancer is associated with a significantly diminished overall as well as disease-free survival. Summed up, this systematic review and meta-analysis reveals CXCR4 as a promising prognostic biomarker. Nevertheless, more evidence is needed to evaluate CXCR4 and its antagonists serving as new therapeutic targets.
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Biomarcadores Tumorais , Quimiocinas , Neoplasias Colorretais , Humanos , Neoplasias Colorretais/patologia , Neoplasias Colorretais/metabolismo , Neoplasias Colorretais/mortalidade , Prognóstico , Biomarcadores Tumorais/metabolismo , Quimiocinas/metabolismo , Receptores CXCR4/metabolismo , Intervalo Livre de DoençaRESUMO
PURPOSE: To systematically review existing evidence on outcomes of endovascular repair of abdominal atherosclerotic penetrating aortic ulcers (PAUs). MATERIAL AND METHODS: Cochrane Central Registry of Registered Trials (CENTRAL), MEDLINE (via PubMed), and Web of Science databases were systematically searched. The systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis protocol (PRISMA-P 2020). The protocol was registered in the international registry of systematic reviews (PROSPERO CRD42022313404). Studies reporting on technical and clinical outcomes of endovascular PAU repair in 3 or more patients were included. Random effects modeling was used to estimate pooled technical success, survival, reinterventions, and type 1 and type 3 endoleaks. Statistical heterogeneity was assessed using the I2 statistic. Pooled results are reported with 95% confidence intervals (CIs). Study quality was assessed using an adapted version of the Modified Coleman Methodology Score. RESULTS: Sixteen studies including 165 patients with a mean/median age ranging from 64 to 78 years receiving endovascular therapy for PAU between 1997 and 2020 were identified. Pooled technical success was 99.0% (CI: 96.0%-100%). In all, 30-day mortality was 1.0% (CI: 0%-6.0%) with an in-hospital mortality of 1.0% (CI: 0.0%-13.0%). There were no reinterventions, type 1, or type 3 endoleaks at 30 days. Median/mean follow-up ranged from 1 to 33 months. Overall, there were 16 deaths (9.7%), 5 reinterventions (3.3%), 3 type 1 (1.8%), and 1 type 3 endoleak (0.6%) during follow-up. The quality of studies was rated low according to the Modified Coleman score at 43.4 (+/- 8.5) of 85 points. CONCLUSION: There is low-level evidence on outcomes of endovascular PAU repair. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. Recommendations with regard to treatment indications and techniques in asymptomatic PAU should be made cautiously. CLINICAL IMPACT: This systematic review demonstrated that evidence on outcomes of endovascular abdominal PAU repair is limited. While in the short-term endovascular repair of abdominal PAU seems safe and effective, mid-term and long-term data are lacking. In the context of a benign prognosis of asymptomatic PAU and lacking standardization in current reporting, recommendations with regard to treatment indications and techniques in asymptomatic PAUs should be made cautiously.
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OBJECTIVE: To systematically review the problem of appetite loss after major abdominal surgery. SUMMARY OF BACKGROUND DATA: Appetite loss is a common problem after major abdominal surgery. Understanding of etiology and treatment options is limited. METHODS: We searched Medline, Cochrane Central Register of Controlled Trials, and Web of Science for studies describing postoperative appetite loss. Data were extracted to clarify definition, etiology, measurement, surgical influence, pharmacological, and nonpharmacological treatment. PROSPERO registration ID: CRD42021224489. RESULTS: Out of 6144 articles, we included 165 studies, 121 of which were also analyzed quantitatively. A total of 19.8% were randomized, controlled trials (n = 24) and 80.2% were nonrandomized studies (n = 97). The studies included 20,506 patients undergoing the following surgeries: esophageal (n = 33 studies), gastric (n = 48), small bowel (n = 6), colon (n = 27), rectal (n = 20), hepatobiliary (n = 6), and pancreatic (n = 13). Appetite was mostly measured with the Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ C30, n = 54). In a meta-analysis of 4 randomized controlled trials gum chewing reduced time to first hunger by 21.2 hours among patients who had bowel surgery. Other reported treatment options with positive effects on appetite but lower levels of evidence include, among others, intravenous ghrelin administration, the oral Japanese herbal medicine Rikkunshito, oral mosapride citrate, multidisciplin-ary-counseling, and watching cooking shows. No studies investigated the effect of well-known appetite stimulants such as cannabinoids, steroids, or megestrol acetate on surgical patients. CONCLUSIONS: Appetite loss after major abdominal surgery is common and associated with increased morbidity and reduced quality of life. Recent studies demonstrate the influence of reduced gastric volume and ghrelin secretion, and increased satiety hormone secretion. There are various treatment options available including level IA evidence for postoperative gum chewing. In the future, surgical trials should include the assessment of appetite loss as a relevant outcome measure.
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Apetite , Procedimentos Cirúrgicos do Sistema Digestório , Abdome/cirurgia , Grelina , Humanos , Qualidade de VidaRESUMO
BACKGROUND: Metabolic syndrome (MetS) is a risk factor in surgery. MetS can progress to metabolic (dysfunction)-associated fatty liver disease (MAFLD), a vast-growing etiology of primary liver tumors which are major indications for liver surgery. The aim of this meta-analysis was to investigate the impact of MetS on complications and long-term outcomes after hepatectomy. METHODS: The protocol for this meta-analysis was registered at PROSPERO prior to data extraction. MEDLINE, Web of Science, and Cochrane Library were searched for publications on liver resections and MetS. Comparative studies were included. Outcomes encompassed postoperative complications, mortality, and long-term oncologic status. Data were pooled as odds ratio (OR) with a random-effects model. Risk of bias was assessed using the Quality in Prognostic Studies tool (QUIPS), and the certainty of the evidence was evaluated with GRADE. Subgroup analyses for patients with histopathologically confirmed non-alcoholic fatty liver disease (NAFLD) versus controls were performed. RESULTS: The meta-analyses included fifteen comparative studies. Patients with MetS suffered significantly more overall complications (OR 1.55; 95% CI [1.05; 2.29]; p=0.03), major complications (OR 1.97 95% CI [1.13; 3.43]; p=0.02; I2=62%), postoperative hemorrhages (OR 1.76; 95% CI [1.23; 2.50]; p=0.01) and infections (OR 1.63; 95% CI [1.03; 2.57]; p=0.04). There were no significant differences in mortality, recurrence, 1- or 5-year overall or recurrence-free survivals. Patients with histologically confirmed NAFLD did not have significantly more overall complications; however, PHLF rates were increased (OR 4.87; 95% CI [1.22; 19.47]; p=0.04). Recurrence and survival outcomes did not differ significantly. The certainty of the evidence for each outcome ranged from low to very low. CONCLUSION: Patients with MetS that undergo liver surgery suffer more complications, such as postoperative hemorrhage and infection but not liver-specific complications-PHLF and biliary leakage. Histologically confirmed NAFLD is associated with significantly higher PHLF rates, yet, survivals of these patients are similar to patients without the MetS. Further studies should focus on identifying the tipping point for increased risk in patients with MetS-associated liver disease, as well as reliable markers of MAFLD stages and early markers of PHLF. TRIAL REGISTRATION: PROSPERO Nr: CRD42021253768.
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Síndrome Metabólica , Hepatopatia Gordurosa não Alcoólica , Hepatectomia/efeitos adversos , Humanos , Síndrome Metabólica/complicações , Síndrome Metabólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/complicações , Hepatopatia Gordurosa não Alcoólica/epidemiologia , Hepatopatia Gordurosa não Alcoólica/cirurgia , Fatores de RiscoRESUMO
PURPOSE: The objective of this systematic review was to report the cumulative incidence of endograft migration (EM), as well as the morbidity, reintervention rates, and mortality related to EM. This study aimed to provide evidence-based data on patient-relevant sequelae of EM after thoracic endovascular aortic repair (TEVAR) performed using contemporary aortic endografts. MATERIALS AND METHODS: A systematic electronic search of literature in MEDLINE (via PubMed), Web of Science, and Cochrane Central Register of Controlled Trials was performed. The pooled synthesis of outcomes was performed using the inverse variance method. RESULTS: Seven prospective non-randomized and 4 retrospective studies, including a total of 1783 patients presenting 70 EMs, were considered for the quantitative analysis. The pooled rate of EM was 4% (95% CI, 2%-7%; range, 0.2%-11%; I2=82%); pooled morbidity rate was 31% (95% CI, 12%-59%; range, 0%-100%; I2=64%) and pooled reintervention rate was 32% (95% CI, 15%-56%; range, 0%-100%; I2=55%). The pooled mortality rate due to EM was 5% (95% CI, 1%-21%; range, 0%-40%; I2=24%). CONCLUSION: For the first time, this meta-analysis provides pooled reference estimates of EM after TEVAR. Thus, the results hold the potential to further characterize EM after TEVAR. The clinical relevance of EM is underlined by its association with high rates of endoleak-related morbidity, reintervention, and mortality. Close standardized surveillance after TEVAR for early detection of EM and prophylaxis of its sequelae is essential.
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This study aimed to identify cutoff values for donor risk index (DRI), Eurotransplant (ET)-DRI, and balance of risk (BAR) scores that predict the risk of liver graft loss. MEDLINE and Web of Science databases were searched systematically and unrestrictedly. Graft loss odds ratios and 95% confidence intervals were assessed by meta-analyses using Mantel-Haenszel tests with a random-effects model. Cutoff values for predicting graft loss at 3 months, 1 year, and 3 years were analyzed for each of the scores. Measures of calibration and discrimination used in studies validating the DRI and the ET-DRI were summarized. DRI ≥ 1.4 (six studies, n = 35 580 patients) and ET-DRI ≥ 1.4 (four studies, n = 11 666 patients) were associated with the highest risk of graft loss at all time points. BAR > 18 was associated with the highest risk of 3-month and 1-year graft loss (n = 6499 patients). A DRI cutoff of 1.8 and an ET-DRI cutoff of 1.7 were estimated using a summary receiver operator characteristic curve, but the sensitivity and specificity of these cutoff values were low. A DRI and ET-DRI score ≥ 1.4 and a BAR score > 18 have a negative influence on graft survival, but these cutoff values are not well suited for predicting graft loss.
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Transplante de Fígado , Sobrevivência de Enxerto , Humanos , Transplante de Fígado/efeitos adversos , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Doadores de TecidosRESUMO
BACKGROUND: Systematic reviews are an important tool of evidence-based surgery. Surgical systematic reviews and trials, however, require a special methodological approach. PURPOSE: This article provides recommendations for conducting state-of-the-art systematic reviews in surgery with or without meta-analysis. CONCLUSIONS: For systematic reviews in surgery, MEDLINE (via PubMed), Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL) should be searched. Critical appraisal is at the core of every surgical systematic review, with information on blinding, industry involvement, surgical experience, and standardisation of surgical technique holding special importance. Due to clinical heterogeneity among surgical trials, the random-effects model should be used as a default. In the experience of the Study Center of the German Society of Surgery, adherence to these recommendations yields high-quality surgical systematic reviews.
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Procedimentos Cirúrgicos Operatórios , Revisões Sistemáticas como Assunto , Humanos , Guias de Prática Clínica como Assunto , Sociedades MédicasRESUMO
OBJECTIVE: To compare perioperative outcomes of laparoscopic pancreaticoduodenectomy (LPD) to open pancreaticoduodenectomy (OPD) using evidence from randomized controlled trials (RCTs). BACKGROUND: LPD is used more commonly, but this surge is mostly based on observational data. METHODS: We searched CENTRAL, Medline and Web of Science for RCTs comparing minimally invasive to OPD for adults with benign or malignant disease requiring elective pancreaticoduodenectomy. Main outcomes were 90-day mortality, Clavien-Dindo ≥3 complications, and length of hospital stay (LOS). Secondary outcomes were postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), postpancreatectomy hemorrhage (PPH), bile leak, blood loss, reoperation, readmission, oncologic outcomes (R0-resection, lymph nodes harvested), and operative times. Data were pooled as odds ratio (OR) or mean difference (MD) with a random-effects model. Risk of bias was assessed using the Cochrane Tool and the GRADE approach (Prospero registration ID: CRD42019120363). RESULTS: Three RCTs with a total of 224 patients were included. Meta-analysis showed there were no significant differences regarding 90-day mortality, Clavien-Dindo ≥3 complications, LOS, POPF, DGE, PPH, bile leak, reoperation, readmission, or oncologic outcomes between LPD and OPD. Operative times were significantly longer for LPD {MD [95% confidence interval (CI)] 95.44âminutes (24.06-166.81âminutes)}, whereas blood loss was lower for LPD [MD (CI) -150.99âmL (-168.54 to -133.44âmL)]. Certainty of evidence was moderate to very low. CONCLUSIONS: At current level of evidence, LPD shows no advantage over OPD. Limitations include high risk of bias and moderate to very low certainty of evidence. Further studies should focus on patient safety during LPD learning curves and the potential role of robotic surgery.
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Laparoscopia/métodos , Neoplasias Pancreáticas/cirurgia , Pancreaticoduodenectomia/métodos , Complicações Pós-Operatórias/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Saúde Global , Humanos , IncidênciaRESUMO
INTRODUCTION: The present study evaluated the potential benefit of adding cetuximab to neoadjuvant, adjuvant, or palliative standard therapy for pancreatic cancer. METHODS: A systematic literature search was performed in MEDLINE, Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL). Only randomised controlled trials (RCTs) investigating the effect of adding cetuximab to standard chemotherapy in pancreatic cancer were included. Evaluated outcomes were overall survival, progression-free survival, objective response, and toxicity. For overall survival and progression-free survival, hazard ratios (HR) with 95% confidence intervals (CI) were chosen as effect measure. For objective response, odds ratios (OR) with 95% CI were used. Analysis was based on a random effects model. RESULTS: After screening 568 publications, a total of 4 RCTs with 924 patients were included. In all trials, patients were adequately randomised with balanced intervention and control groups. There was no significant difference in overall survival (HR 1.04; 95% CI: 0.90-1.19; p = 0.60), progression-free survival (HR 1.06; 95% CI: 0.93-1.22; p = 0.36), or objective response (OR 0.99; 95% CI: 0.66 -1.49; p = 0.96) when adding cetuximab to a standard therapy. Toxicity was the same or higher in each of the included trials. According to GRADE, the certainty of the evidence is high. Therefore, adding cetuximab to pancreatic cancer therapy has no clinically relevant benefit. CONCLUSION: In the presence of no survival benefit, increased toxicity, and higher costs, a decreased cost-benefit ratio compared to the standard care must be suggested. Conducting further RCTs in unselected pancreatic cancer populations is unlikely to change this conclusion.
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Antineoplásicos Imunológicos/uso terapêutico , Cetuximab/uso terapêutico , Neoplasias Pancreáticas/tratamento farmacológico , Antineoplásicos Imunológicos/administração & dosagem , Antineoplásicos Imunológicos/efeitos adversos , Cetuximab/administração & dosagem , Cetuximab/efeitos adversos , Humanos , Neoplasias Pancreáticas/diagnóstico , Neoplasias Pancreáticas/mortalidade , Prognóstico , Resultado do TratamentoRESUMO
BACKGROUND: Postoperative pancreatic fistulas remain a driver of major complications after partial pancreatectomy. It is unclear whether coverage of the anastomosis or pancreatic remnant can reduce the incidence of postoperative pancreatic fistulas. The aim of this study was to evaluate the effect of autologous or artificial coverage of the pancreatic remnant or anastomosis on outcomes after partial pancreatectomy. METHODS: A systematic literature search was performed using MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) up to March 2024. All RCTs analysing a coverage method in patients undergoing partial pancreatoduodenectomy or distal pancreatectomy were included. The primary outcome was postoperative pancreatic fistula development. Subgroup analyses for pancreatoduodenectomy or distal pancreatectomy and artificial or autologous coverage were conducted. RESULTS: A total of 18 RCTs with 2326 patients were included. In the overall analysis, coverage decreased the incidence of postoperative pancreatic fistulas by 29% (OR 0.71, 95% c.i. 0.54 to 0.93, P < 0.01). This decrease was also seen in the 12 RCTs covering the remnant after distal pancreatectomy (OR 0.69, 95% c.i. 0.51 to 0.94, P < 0.02) and the 4 RCTs applying autologous coverage after pancreatoduodenectomy and distal pancreatectomy (OR 0.53, 95% c.i. 0.29 to 0.96, P < 0.04). Other subgroup analyses (artificial coverage or pancreatoduodenectomy) showed no statistically significant differences. The secondary endpoints of mortality, reoperations, and re-interventions were each affected positively by the use of coverage techniques. The certainty of evidence was very low to moderate. CONCLUSION: The implementation of coverage, whether artificial or autologous, is beneficial after partial pancreatectomy, especially in patients undergoing distal pancreatectomy with autologous coverage.
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Anastomose Cirúrgica , Pancreatectomia , Fístula Pancreática , Pancreaticoduodenectomia , Complicações Pós-Operatórias , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Fístula Pancreática/prevenção & controle , Fístula Pancreática/etiologia , Fístula Pancreática/epidemiologia , Pancreatectomia/efeitos adversos , Pancreatectomia/métodos , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Anastomose Cirúrgica/efeitos adversos , Anastomose Cirúrgica/métodos , Pancreaticoduodenectomia/efeitos adversos , Pancreaticoduodenectomia/métodos , Pâncreas/cirurgiaRESUMO
Background: The impact of neoadjuvant chemotherapy (nCTX) on survival and tumor response in patients with esophagogastric signet ring cell carcinoma (SRCC) is still controversial. Methods: Two independent reviewers performed a systematic literature search in Medline, CENTRAL, and Web of Science including prospective and retrospective two-arm non-randomized and randomized controlled studies (RCTs). Data was extracted on overall survival (OS) and tumor regression in resected esophagogastric SRCC patients with or without nCTX. Survival data was analyzed using published hazard ratios (HR) if available or determined it from other survival data or survival curves. OS and histopathological response rates by type of tumor (SRCC vs. non-SRCC) were also investigated. Results: Out of 559 studies, ten (1 RCT, 9 non-RCTs) were included in this meta-analysis (PROSPERO CRD42022298743) investigating 3,653 patients in total. The four studies investigating survival in SRCC patients treated with nCTX + surgery vs. surgery alone showed no survival benefit for neither intervention, but heterogeneity was considerable (HR, 1.01; 95% CI, 0.61-1.67; p = 0.98; I2 = 89%). In patients treated by nCTX + surgery SRCC patients showed worse survival (HR, 1.45; 95% CI, 1.21-1.74; p < 0.01) and lower rate of major histopathological response than non-SRCC patients (OR, 2.47; 95% CI, 1.78-3.44; p < 0.01). Conclusion: The current meta-analysis could not demonstrate beneficial effects of nCTX for SRCC patients. Histopathological response to and survival benefits of non-taxane-based nCTX seem to be lower in comparison to non-SRC esophagogastric cancer. However, certainty of evidence is low due to the scarcity of high-quality trials. Further research is necessary to determine optimal treatment for SRCC patients. Systematic Review Registration: https://www.crd.york.ac.uk/, PROSPERO (CRD42022298743).
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Background: Open partial pancreatoduodenectomy (OPD) represents the current gold standard of surgical treatment of a wide range of diseases of the pancreatic head but is associated with morbidity in around 40% of cases. Robotic partial pancreatoduodenectomy (RPD) is being used increasingly, yet, no randomised controlled trials (RCTs) of RPD versus OPD have been published, leaving a low level of evidence to support this practice. Methods: This investigator-initiated, exploratory RCT with two parallel study arms was conducted at a high-volume pancreatic centre in line with IDEAL recommendations (stage 2b). Patients scheduled for elective partial pancreatoduodenectomy (PD) for any indication were randomised (1:1) to RPD or OPD with a centralised web-based tool. The primary endpoint was postoperative cumulative morbidity within 90 days, assessed via the Comprehensive Complication Index (CCI). Biometricians were blinded to the intervention, but patients and surgeons were not. The trial was registered prospectively (DRKS00020407). Findings: Between June 3, 2020 and February 14, 2022, 81 patients were randomly assigned to RPD (n = 41) or OPD (n = 40), of whom 62 patients (RPD: n = 29, OPD: n = 33) were analysed in the modified intention to treat analysis. Four patients in the OPD group were randomised, but did not undergo surgery in our department and one patient was excluded in the RPD group due to other reason. Nine patients in the RPD group and 3 patients in the OPD were excluded from the primary analysis because they did not undergo PD, but rather underwent other types of surgery. The CCI after 90 days was comparable between groups (RPD: 34.02 ± 23.48 versus OPD: 36.45 ± 27.65, difference in means [95% CI]: -2.42 [-15.55; 10.71], p = 0.713). The RPD group had a higher incidence of grade B/C pancreas-specific complications compared to the OPD group (17 (58.6%) versus 11 (33.3%); difference in rates [95% CI]: 25.3% [1.2%; 49.4%], p = 0.046). The only complication that occurred significantly more often in the RPD than in the OPD group was clinically relevant delayed gastric emptying. Procedure-related and overall hospital costs were significantly higher and duration of surgery was longer in the RPD group. Blood loss did not differ significantly between groups. The intraoperative conversion rate of RPD was 23%. Overall 90-day mortality was 4.8% without significant differences between RPD and OPD. Interpretation: In the setting of a very high-volume centre, both RPD and OPD can be considered safe techniques. Further confirmatory multicentre RCTs are warranted to uncover potential advantages of RPD in terms of perioperative and long-term outcomes. Funding: Federal Ministry of Education and Research (BMBF: 01KG2010).
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BACKGROUND: To compare proximal gastrectomy with double-tract reconstruction and total gastrectomy in patients with gastroesophageal junction (AEG II-III) and gastric cancer. METHODS: We conducted systematic searches in Medline, Web of Science, and Cochrane Library until December 20, 2021 (PROSPERO registration number: CRD42021291500). Risk of bias was assessed using the revised Cochrane risk of bias tool and the ROBINS-I tool, as applicable. Evidence was rated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: One randomized controlled trial (RCT) and 13 non-RCTs with 1,317 patients (715 patients with total gastrectomy and 602 patients with proximal gastrectomy with double-tract reconstruction) were included. Patients treated by total gastrectomy had a significantly higher proportion of advanced cancer stages International Union Against Cancer IB-III (odds ratio: 0.68, 95% confidence interval: 0.51-0.91, P = .01). This heterogeneity biases the observed improved overall survival of patients after proximal gastrectomy with double-tract reconstruction (odds ratio: 0.67, 95% confidence interval: 0.44-1.01, P = .05). Both procedures were comparably efficient regarding perioperative parameters. Postoperative/preoperative bodyweight ratio (mean difference: 3.56, 95% confidence interval: 1.32-5.79, P = .002), postoperative/preoperative serum-hemoglobin ratio (mean difference 3.73, 95% confidence interval: 1.59-5.88, P < .001), and postoperative serum vitamin B12 levels (mean difference 42.46, 95% confidence interval: 6.37-78.55, P = .02) were superior after proximal gastrectomy with double-tract reconstruction, while postoperative/preoperative serum-albumin ratio (mean difference 1.24, 95% confidence interval: -4.76 to 7.24, P = .69) and postoperative/preoperative serum total protein ratio (mean difference 1.12, 95% confidence interval: -2.77 to 5.00, P = .57) were not different. Health-related quality of life data were reported in only 2 studies, which found no significant advantages for proximal gastrectomy with double-tract reconstruction. CONCLUSION: Proximal gastrectomy with double-tract reconstruction offers advantages in postoperative nutritional parameters compared to total gastrectomy (GRADE: moderate quality of evidence). Oncological effectiveness of proximal gastrectomy with double-tract reconstruction cannot be assessed (GRADE: very low quality of evidence). Further thoroughly planned randomized controlled trials in Western patient cohorts are necessary to improve treatment for gastric cancer patients.
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Neoplasias Gástricas , Humanos , Neoplasias Gástricas/cirurgia , Resultado do Tratamento , Gastrectomia/métodos , Junção Esofagogástrica , Estudos Retrospectivos , Complicações Pós-Operatórias/etiologia , Tomada de Decisão ClínicaRESUMO
INTRODUCTION: Pancreatic resections for malignant or benign diseases are associated with major morbidity and changes in physiology. To reduce perioperative complications and enhance recovery, many types of perioperative medical management have been introduced. The aim of this study was to provide an evidence-based overview on the best perioperative drug treatment. METHODS: The electronic bibliographic databases Medline, Embase, CENTRAL, and Web of Science were systematically searched for randomized controlled trials (RCT) evaluating perioperative drug treatments in pancreatic surgery. The investigated drugs were somatostatin analogues, steroids, pancreatic enzyme replacement therapy (PERT), prokinetic therapy, antidiabetic drugs, and proton pump inhibitors (PPI). Targeted outcomes in each drug category were meta-analyzed. RESULTS: A total of 49 RCT were included. The analysis of somatostatin analogues showed a significantly lower incidence of postoperative pancreatic fistula (POPF) in the somatostatin group compared to the control group (OR 0.58, 95% CI: 0.45 to 0.74). The comparison of glucocorticoids versus placebo showed significantly less POPF in the glucocorticoid group (OR 0.22, 95% CI: 0.07 to 0.77). There was no significant difference in DGE when erythromycin was compared to placebo (OR 0.33, 95% CI: 0.08 to 1.30). The other investigated drug regimens could only be analyzed qualitatively. CONCLUSION: This systematic review provides a comprehensive overview on perioperative drug treatment in pancreatic surgery. Some often-prescribed perioperative drug treatments lack high quality evidence and further research is needed.
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BACKGROUND: Widespread implementation of the minimally invasive technique in pancreatic surgery has proven to be challenging. The aim of this study was to compare the perioperative outcomes of minimally invasive (laparoscopic and robotic) pancreatic surgery with open pancreatic surgery using data obtained from RCTs. METHODS: A literature search was done using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Web of Science; all available RCTs comparing minimally invasive pancreatic surgery and open pancreatic surgery in adults requiring elective distal pancreatectomy or partial pancreatoduodenectomy were included. Outcomes were mortality rate, general and pancreatic surgery specific morbidity rate, and length of hospital stay. RESULTS: Six RCTs with 984 patients were included; 99.0 per cent (486) of minimally invasive procedures were performed laparoscopically and 1.0 per cent (five) robotically. In minimally invasive pancreatic surgery, length of hospital stay (-1.3 days, -2 to -0.5, P = 0.001) and intraoperative blood loss (-137â ml, -182 to -92, P < 0.001) were reduced. In the subgroup analysis, reduction in length of hospital stay was only present for minimally invasive distal pancreatectomy (-2 days, -2.3 to -1.7, P < 0.001). A minimally invasive approach showed reductions in surgical site infections (OR 0.4, 0.1 to 0.96, P = 0.040) and intraoperative blood loss (-131â ml, -173 to -89, P < 0.001) with a 75â min longer duration of surgery (42 to 108â min, P < 0.001) only in partial pancreatoduodenectomy. No significant differences were found with regards to mortality rate and postoperative complications. CONCLUSION: This meta-analysis presents level 1 evidence of reduced length of hospital stay and intraoperative blood loss in minimally invasive pancreatic surgery compared with open pancreatic surgery. Morbidity rate and mortality rate were comparable, but longer duration of surgery in minimally invasive partial pancreatoduodenectomy hints that this technique in partial pancreatoduodenectomy is technically more challenging than in distal pancreatectomy.
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Perda Sanguínea Cirúrgica , Robótica , Adulto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Pancreatectomia/métodos , Pâncreas/cirurgiaRESUMO
INTRODUCTION: Low-grade myofibroblastic sarcoma (LGMS) is a rare tumor entity which occurs in the subcutaneous and deep soft tissues; it is less common in the bone with a predilection for the extremities and the head and neck region. As confirming the diagnosis is difficult and treatment strategies are not standardized, we aimed to identify patient and tumor characteristics, and to summarize treatment strategies and their clinical outcomes to guide surgeons. METHODS: Included were full articles reporting patients with histology of LGMS in the extremities, excluding tumors of the trunk. All patients underwent surgery but with different extend, from marginal to wide resection. Included studies should inform about local recurrence, metastasis, or evidence of disease, depending on the surgical treatment. We conducted a structured search using MEDLINE (via PubMed), Web of Science, EMBASE and Cochrane Central Register of Controlled Trials (CENTRAL) to identify studies on low-grade myofibroblastic sarcoma of the extremities. Study designs like randomized controlled trials, systematic reviews, prospective trials, retrospective studies, and case reports were included. Prospective studies and comparative studies were not available at all. Therefore, meta-analysis was not possible and statistical analysis was purely descriptive. RESULTS: Of the 789 studies identified from our initial search, 17 studies including 59 cases reported LGMS of the extremities with the surgical treatment and clinical outcome and were therefore analyzed. In addition, we present the rare case and surgical management of a 28-year-old male patient with residual LGMS of the thumb after an initial incomplete resection. The current literature suggests that a wide excision with R0 margins should be considered the standard treatment for LGMS. In cases where surgery leads to significant functional impairment, individual options like free tissue transfer from a donor site have to be considered. Therefore, we also present an illustrative case. For all selected case series and case reports, a high risk of confounding, selection bias, information bias, and reporting bias must be anticipated. Nevertheless, this systematic review provides a comprehensive overview on surgical treatment and clinical outcomes in LGMS surgery of the extremities.
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BACKGROUND: Patient centeredness is an integral part of the quality of care. Patient-reported experience measures (PREMs) are assumed to be an appropriate tool to assess patient-centredness. An evaluation of German-speaking PREMs is lacking. OBJECTIVE: To perform a systematic review and qualitative analysis of psychometric measurement qualities of German-language PREMs using for the first time a comprehensive framework of patient centredness. METHODS: A systematic literature search was performed in Medline, PsycInfo, CINHAL, Embase, Cochrane database (last search 9th November 2021) for studies describing generic, surgery- or cancer care-specific PREMs. All questionnaires that were developed in or translated into German were included. The content of the included PREMs was evaluated using a comprehensive framework of patient centredness covering 16 domains. Baseline data of all PREM studies were extracted by two independent reviewers. Psychometric measurement qualities of the PREMs were assessed using current COSMIN guidelines. RESULTS: After removal of duplicates 3,457 abstracts were screened, of which 3,345 were excluded. The remaining 112 articles contained 51 PREMs, of which 12 were either developed in (4 PREMs) or translated into German (8 PREMs). Eight PREMs were generic (NORPEQ, PPE-15, PEACS, HCAHPS, QPPS, DUQUE, PEQ-G, Schoenfelder et al.), 4 cancer care-specific (EORTC IN-PATSAT32, PSCC-G, Danish National Cancer Questionnaire, SCCC) and none was surgery-specific. None of the PREMs covered all domains of patient-centeredness. Overall rating of structural validity was adequate only for PEACS and HCAHPS. High ratings for internal consistency were given for NORPEQ, Schoenfelder et al., PSCC-G and the SCCC. Cross-cultural validity for translated questionnaires was adequate only for the PSCC-G, while reliability was adequately assessed only for the EORTC IN-PATSAT32. Due to a lack of measurement gold standard and minimal important change, criterion validity and measurement invariance could not be assessed for any of the PREMs. CONCLUSION: This is the first systematic review using a comprehensive framework of patient centredness and shows that none of the included PREMs, even those translated from other languages into German, cover all aspects of patient centredness. Furthermore, all included PREMS show deficits in the results or evaluation of psychometric measurement properties. Nonetheless, based on the results, the EORTC IN-PATSAT32 and PSCC-G can be recommended for use in cancer patients in the German-language region, while the German versions of the HCAHPS, NORPEQ, PPE-15 and PEACS can be recommended as generic PREMs. TRIAL REGISTRATION: Registration. PROSPERO CRD42021276827.
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Medicamentos Genéricos , Idioma , Humanos , Reprodutibilidade dos Testes , Psicometria , Bases de Dados Factuais , Medidas de Resultados Relatados pelo PacienteRESUMO
BACKGROUND: Pancreatic surgery is regarded as the only curative treatment for pancreatic cancer (PC). As the neoadjuvant therapy is applied widely nowadays, the proportion of patients with PC undergoing surgery also with locally advanced tumour findings has increased accordingly. Especially in these situations, a radical resection of all tumour tissues is challenging. A novel surgical strategy has been introduced recently to achieve this aim, namely the TRIANGLE operation which comprises the radical resection of all nerve and lymphatic tissue between coeliac artery, superior mesenteric artery and mesenteric-portal axis without including extended lymphadenectomy outside this area. Due to currently published studies, Triangle Operation is a safe and feasible procedure. However, this has not been systematically analysed to date. This systematic review and meta-analysis aim to evaluate surgical and postoperative outcomes of Triangle Operation in pancreatic surgery. METHODS AND ANALYSIS: Pubmed, Web of Science and Cochrane Central Register of Controlled Trials in the Cochrane Library will be searched from inception until 31 December 2022. This study will include all articles comparing Triangle Operation versus non-Triangle Operation in pancreatic surgery to assess outcomes. The primary endpoints will be R0 resection rate and 1-year overall survival. The secondary endpoints will be delayed gastric emptying, postoperative pancreatic fistula, post pancreatectomy haemorrhages and reoperation incidence, overall complications, mortality and 3-year overall survival. The study selection, study quality assessment, data extraction and critical appraisal will be carried out by two reviewers. Inter-reviewer disagreements will be evaluated by discussion with a third reviewer. Besides, a subgroup analysis will be conducted focused on robotic surgery, laparoscopic surgery and open surgery in detail. Additionally, the Grading of Recommendations, Assessment, Development and Evaluations framework will be performed to evaluate the strength of evidence. ETHICS AND DISSEMINATION: This systematic review and meta-analysis will not require ethical approval. Results will be published in a peer-reviewed scientific journal. PROSPERO REGISTRATION NUMBER: CRD42021234721.
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Neoplasias Pancreáticas , Humanos , Neoplasias Pancreáticas/complicações , Pâncreas/cirurgia , Pancreatectomia/efeitos adversos , Abdome/cirurgia , Complicações Pós-Operatórias/epidemiologia , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Neoplasias PancreáticasRESUMO
Background: Non-alcoholic steatohepatitis (NASH) comprises a major healthcare problem affecting up to 30% of patients with obesity and the associated risk for cardiovascular and liver-related mortality. Several new drugs for NASH-treatment are currently investigated. No study thus far directly compared surgical and non-surgical therapies for NASH. This network meta-analysis compares for the first time the effectiveness of different therapies for NASH using a novel statistical approach. Methods: The study was conducted according to the PRISMA guidelines for network meta-analysis. PubMed, CENTRAL and Web of Science were searched without restriction of time or language using a validated search strategy. Studies investigating therapies for NASH in adults with liver biopsies at baseline and after at least 12 months were selected. Patients with liver cirrhosis were excluded. Risk of bias was assessed with ROB-2 and ROBINS-I-tools. A novel method for population-adjusted indirect comparison to include and compare single-arm trials was applied. Main outcomes were NASH-resolution and improvement of fibrosis. Results: Out of 7,913 studies, twelve randomized non-surgical studies and twelve non-randomized surgical trials were included. NASH-resolution after non-surgical intervention was 29% [95% confidence interval (CI): 23-40%] and 79% (95% CI: 72-88%) after surgery. The network meta-analysis showed that surgery had a higher chance of NASH-resolution than medication [odds ratio (OR) =2.68; 95% CI: 1.44-4.97] while drug treatment was superior to placebo (OR =2.24; 95% CI: 1.55-3.24). Surgery (OR =2.18; 95% CI: 1.34-3.56) and medication (OR =1.79; 95% CI: 1.39-2.31) were equally effective to treat fibrosis compared to placebo without difference between them. The results did not change when only new drugs specifically developed for the treatment of NASH were included. Conclusions: Metabolic surgery has a higher effectiveness for NASH-therapy than medical therapy while both were equally effective regarding improvement of fibrosis. Trials directly comparing surgery with medication must be urgently conducted. Patients with NASH should be informed about surgical treatment options.