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OBJECTIVE: To provide improved guidance for the consistent application of the Clavien-Dindo classification (CDC) and Comprehensive Complication Index (CCI®) in challenging clinical scenarios. BACKGROUND: Standardized outcome reporting is key for proper assessment of surgical procedures. A recent consensus conference recommended the CDC and the CCI® for assessing postoperative morbidity. Several challenging scenarios for grading complications still require evidence-based guidance, and the use of the two metrics in RCTs remains unexplored. METHODS: We assessed the use of the CDC and CCI® as an outcome measure in a systematic literature search. Additionally, we asked 163 international surgeons to critically evaluate and independently grade complications in 20 complex clinical scenarios. Finally, a core group of five experts used this information to develop consistent recommendations. RESULTS: Until July 2023, 1327 RCTs selected the CDC and/or CCI® to assess morbidity. Annual use was steadily increasing with now over 200 new RCTs per year. However, only a third (n=335) of published RCTs provided the complete range of CDC grades, including all subgrades. Eighty-nine out of 163 surgeons (response rate 55%) completed the questionnaire that served as basis for the recommendations: Repetitive interventions that are required to treat one complication, complications followed by further complications, complications occurring prior to referral, and expected and unrelated complications to the original procedure should all be counted separately and included in the CCI®. Invasive blank diagnostic interventions should not be considered a complication. CONCLUSION: The increasing use of the CDC and CCI® in RCTs highlights the importance of their standardized application. The current consensus on various difficult scenarios may offer novel guidance for the consistent use of the CDC and CCI®, aiming to improve complication reporting, and better-quality control, ultimately benefiting all healthcare stakeholders, and first and foremost, all patients.
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BACKGROUND: Machine learning (ML) has been successfully implemented for classification tasks (e.g., cancer diagnosis). ML performance for more challenging predictions is largely unexplored. This study's objective was to compare machine learning vs. expert-informed predictions for surgical outcome in patients undergoing major liver surgery. METHODS: Single tertiary center data on preoperative parameters and postoperative complications for elective hepatic surgery patients were included (2008-2021). Expert-informed prediction models were established on 14 parameters identified by two expert liver surgeons to impact on postoperative outcome. ML models used all available preoperative patient variables (n = 62). Model performance was compared for predicting 3-month postoperative overall morbidity. Temporal validation and additional analysis in major liver resection patients were conducted. RESULTS: 889 patients included. Expert-informed models showed low average bias (2-5 CCI points) with high over/underprediction. ML models performed similarly: average prediction 5-10 points higher than observed CCI values with high variability (95% CI -30 to 50). No performance improvement for major liver surgery patients. CONCLUSION: No clinical relevance in the application of ML for predicting postoperative overall morbidity was found. Despite being a novel hype, ML has the potential for application in clinical practice. However, at this stage it does not replace established approaches of prediction modelling.
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Hepatectomía , Aprendizaje Automático , Complicaciones Posoperatorias , Humanos , Hepatectomía/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Complicaciones Posoperatorias/etiología , Resultado del Tratamiento , Medición de Riesgo , Valor Predictivo de las Pruebas , Estudios RetrospectivosRESUMEN
OBJECTIVES: To assess the current quality of surgical outcome reporting in the medical literature and to provide recommendations for improvement. BACKGROUND: In 1996, The Lancet labeled surgery as a "comic opera" mostly referring to the poor quality of outcome reporting in the literature impeding improvement in surgical quality and patient care. METHODS: We screened 3 first-tier and 2 second-tier surgical journals, as well as 3 leading medical journals for original articles reporting on results of surgical procedures published over a recent 18-month period. The quality of outcome reporting was assessed using a prespecified 12-item checklist. RESULTS: Six hundred twenty-seven articles reporting surgical outcomes were analyzed, including 125 randomized controlled trials. Only 1 (0.2%) article met all 12 criteria of the checklist, whereas 356 articles (57%) fulfilled less than half of the criteria. The poorest reporting was on cumulative morbidity burden, which was missing in 94% of articles (n=591) as well as patient-reported outcomes missing in 83% of publications (n=518). Comparing journal groups for the individual criterion, we found moderate to very strong statistical evidence for better quality of reporting in high versus lower impact journals for 7 of 12 criteria and strong statistical evidence for better reporting of patient-reported outcomes in medical versus surgical journals ( P <0·001). CONCLUSIONS: The quality of outcomes reporting in the medical literature remains poor, lacking improvement over the past 20 years on most key end points. The implementation of standardized outcome reporting is urgently needed to minimize biased interpretation of data thereby enabling improved patient care and the elaboration of meaningful guidelines.
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Procedimientos Quirúrgicos Operativos , Humanos , Procedimientos Quirúrgicos Operativos/normas , Publicaciones Periódicas como Asunto , Evaluación de Resultado en la Atención de Salud , Lista de VerificaciónRESUMEN
BACKGROUND AND AIMS: Obesity is a growing healthcare challenge worldwide and a significant risk factor for liver failure as seen with non-alcoholic steatohepatitis (NASH). Combining metabolic-bariatric surgery (MBS) with liver transplantation (LT) appears as attractive strategy to treat both, the underlying liver disease and obesity. However, there is an ongoing debate on best timing and patient selection. This survey was designed to explore the current treatment practice for patients with NASH and obesity worldwide. METHODS: A web-based survey was conducted in 2022 among bariatric and LT surgeons, and hepatologists from Europe, North and South America and Asia. RESULTS: The survey completion rate was 74% (145/196). The average respondents were 41-50 years (38%), male (82.1%) and had >20 years of clinical experience (42.1%). Centres with a high LT-caseload for NASH were mainly located in the USA and United Kingdom. Almost 30% have already performed a combination of LT with MBS and 49% plan to do it. A majority of bariatric surgeons prefer MBS before LT (77.2%), whereas most of LT surgeons (52%) would perform MBS during LT. Most respondents (n = 114; 80%) favour sleeve gastrectomy over other bariatric techniques. One third (n = 42; 29.4%) has an established protocol regarding MBS for LT candidates. CONCLUSION: The most experienced centres doing LT for NASH are in the USA and United Kingdom with growing awareness worldwide. Overall, a combination of MBS and LT has already been performed by a third of respondents. Sleeve gastrectomy is the bariatric technique of choice-preferably performed either before or during LT.
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Cirugía Bariátrica , Derivación Gástrica , Trasplante de Hígado , Enfermedad del Hígado Graso no Alcohólico , Obesidad Mórbida , Humanos , Masculino , Enfermedad del Hígado Graso no Alcohólico/epidemiología , Enfermedad del Hígado Graso no Alcohólico/cirugía , Enfermedad del Hígado Graso no Alcohólico/etiología , Trasplante de Hígado/efectos adversos , Cirugía Bariátrica/efectos adversos , Cirugía Bariátrica/métodos , Obesidad/cirugía , Internet , Resultado del Tratamiento , Derivación Gástrica/efectos adversos , Derivación Gástrica/métodosRESUMEN
Standardised and universal perioperative endpoint reporting are the cornerstone for outcomes assessment, reliable clinical trials, and health services research. The Outcome4medicine initiative recently reported consensus recommendations on how to assess the quality of surgical interventions, proposing a framework for surgical outcome assessment and quality improvement after medical interventions. In the same field, the Standardised Endpoints in Perioperative Medicine - Core Outcome Measures for Perioperative and Anaesthetic Care (StEP-COMPAC) group recently proposed standardised and valid measures of mortality and morbidity, derived from a three-stage Delphi process. Here a core group of the Outcome4medicine conference discusses how these two initiatives are aligned and emphasises the importance of standardised outcome assessment by integrating the perspectives of different stakeholders.
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Evaluación de Resultado en la Atención de Salud , Atención Perioperativa , Humanos , Mejoramiento de la Calidad , Técnica Delphi , Resultado del Tratamiento , Proyectos de InvestigaciónRESUMEN
ABSTRACT: This forum summarizes the proceedings of the joint European Surgical Association (ESA)/American Surgical Association (ASA) symposium on Quality and Outcome Assessment for Surgery that took place in Bordeaux, France, as part of the celebrations of the 30th anniversary of the ESA. Three presentations focused on a) the main messages from the Outcome4Medicine Consensus Conference, which took place in Zurich, Switzerland, in June 2022, b) the patient perspective, and c) benchmarking were hold by ESA members and discussed by ASA members in a symposium attended by members of both associations.
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Benchmarking , Evaluación de Resultado en la Atención de Salud , Humanos , Francia , Suiza , Calidad de VidaRESUMEN
Objectives: Compare patient selection and postoperative outcomes after surgical treatment for gastrointestinal disorders before and during the SARS-CoV-2 pandemic. Methods: We assessed gastrointestinal surgeries conducted at a tertiary center from 2017-2021 for differences in patient populations and procedures before (up to February 2020) and during the pandemic (March 2020 to December 2021). We analyzed mortality, Intensive Care Unit (ICU) length of stay, admission to ICU and postoperative complications for complex procedures using descriptive statistics and regression models. Results: 7309 procedures were analyzed, showing a caseload reduction in March and October 2020, but no statistical evidence for fewer overall procedures overall. Population characteristics differed with lower Body Mass Indices in 2020 and 2021, more patients smoking and with diabetes treated in 2020. There was no increased mortality, ICU length of stay and in 1,144 complex procedures assessed low overall morbidity at 90 days postoperative. Conclusion: Delivering surgical care while treating patients for COVID-19 in the same hospital was safe. Healthcare officials should consider continuing surgical care during future health crises as consequences of limiting surgical treatment for gastrointestinal disorders may be fatal for patients.
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COVID-19 , Humanos , Centros de Atención Terciaria , Selección de Paciente , SARS-CoV-2 , Atención al Paciente , Tiempo de Internación , Estudios RetrospectivosRESUMEN
BACKGROUND: Coffee has been suggested to help postoperative gastrointestinal motility but the mechanism is not known. This trial assessed whether caffeine shortened time to bowel activity after laparoscopic colectomy. METHODS: This was a single-centre, randomized, double-blinded, placebo-controlled superiority trial (October 2015 to August 2020). Patients aged at least 18 years undergoing elective laparoscopic colectomy were assigned randomly to receive 100â mg or 200â mg caffeine, or a placebo (250â mg corn starch) three times a day orally. The primary endpoint was the time to first bowel movement. Secondary endpoints included colonic transit time, time to tolerance of solid food, duration of hospital stay, and perioperative morbidity. RESULTS: Sixty patients were assigned randomly to either the 200-mg caffeine group (20 patients), the 100-mg caffeine group (20) or the placebo group (20). In the intention-to-treat analysis, the mean(s.d.) time to first bowel movement was 67.9(19.2)â h in the 200-mg caffeine group, 68.2(32.2)â h in the 100-mg caffeine group, and 67.3(22.7)â h in the placebo group (P = 0.887). The per-protocol analysis and measurement of colonic transit time confirmed no measurable difference with caffeine. CONCLUSION: Caffeine was not associated with reduced time to first bowel movement. REGISTRATION NUMBER: NCT02510911 (http://www.clinicaltrials.gov).
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Cafeína , Laparoscopía , Humanos , Adolescente , Adulto , Cafeína/uso terapéutico , Resultado del Tratamiento , Colectomía/métodos , Procedimientos Quirúrgicos ElectivosRESUMEN
OBJECTIVE: To define benchmark cutoffs for redo liver transplantation (redo-LT). BACKGROUND: In the era of organ shortage, redo-LT is frequently discussed in terms of expected poor outcome and wasteful resources. However, there is a lack of benchmark data to reliably evaluate outcomes after redo-LT. METHODS: We collected data on redo-LT between January 2010 and December 2018 from 22 high-volume transplant centers. Benchmark cases were defined as recipients with model of end stage liver disease (MELD) score ≤25, absence of portal vein thrombosis, no mechanical ventilation at the time of surgery, receiving a graft from a donor after brain death. Also, high-urgent priority and early redo-LT including those for primary nonfunction (PNF) or hepatic artery thrombosis were excluded. Benchmark cutoffs were derived from the 75th percentile of the medians of all benchmark centers. RESULTS: Of 1110 redo-LT, 373 (34%) cases qualified as benchmark cases. Among these cases, the rate of postoperative complications until discharge was 76%, and increased up to 87% at 1-year, respectively. One-year overall survival rate was excellent with 90%. Benchmark cutoffs included Comprehensive Complication Index CCI ® at 1-year of ≤72, and in-hospital and 1-year mortality rates of ≤13% and ≤15%, respectively. In contrast, patients who received a redo-LT for PNF showed worse outcomes with some values dramatically outside the redo-LT benchmarks. CONCLUSION: This study shows that redo-LT achieves good outcome when looking at benchmark scenarios. However, this figure changes in high-risk redo-LT, as for example in PNF. This analysis objectifies for the first-time results and efforts for redo-LT and can serve as a basis for discussion about the use of scarce resources.
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Enfermedad Hepática en Estado Terminal , Trasplante de Hígado , Obtención de Tejidos y Órganos , Benchmarking , Enfermedad Hepática en Estado Terminal/cirugía , Supervivencia de Injerto , Humanos , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Access to the liver transplant waitlist for patients with hepatocellular carcinoma (HCC) depends on tumour presentation, biology, and response to treatments. The Milan Criteria (MC) represent the benchmark for expanded criteria that incorporate additional prognostic factors. The purpose of this study was to determine the added value of skeletal muscle index (SMI) in HCC patients beyond the MC. METHOD: Patients with HCC that were transplanted beyond the MC were included in this retrospective multicentre study. SMI was quantified using the Computed Tomography (CT) within 3 months prior to transplantation. Cox regression models were used to identify predictors of overall survival (OS). The discriminative performance of SMI extended Metroticket 2.0 and AFP models was also assessed. RESULTS: Out of 889 patients transplanted outside the MC, 528 had a CT scan within 3 months prior to liver transplantation (LT), of whom 176 (33%) were classified as sarcopenic. The median time between assessment of the SMI and LT was 1.8 months (IQR: 0.77-2.67). The median follow-up period was 5.1 95% CI [4.7-5.5] years, with a total of 177 recorded deaths from any cause. In a linear regression model with SMI as the dependent variable, only male gender (8.55 95% CI [6.51-10.59], P < 0.001) and body mass index (0.74 95% CI [0.59-0.89], P < 0.001) were significant. Univariable survival analysis of patients with sarcopenia versus patients without sarcopenia showed a significant difference in OS (HR 1.44 95% CI [1.07 - 1.94], P = 0.018). Also the SMI was significant (HR 0.98 95% CI [0.96-0.99], P = 0.014). The survival difference between the lowest SMI quartile versus the highest SMI quartile was significant (log-rank: P = 0.005) with 5 year OS of 57% and 71%, respectively. Data from 423 patients, describing 139 deaths, was used for multivariate analysis. Both sarcopenia (HR 1.45 95% CI [1.02 - 2.05], P = 0.036) and SMI were (HR 0.98 95% CI [0.95-0.99], P = 0.035) significant. On the survival scale this translates to a 5 year OS difference of 11% between sarcopenia and no sarcopenia. Whereas for SMI, this translates to a survival difference of 8% between first and third quartiles for both genders. CONCLUSIONS: Overall, we can conclude that higher muscle mass contributes to a better long-term survival. However, for individual patients, low muscle mass should not be considered an absolute contra-indication for LT as its discriminatory performance was limited.
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Carcinoma Hepatocelular , Neoplasias Hepáticas , Trasplante de Hígado , Sarcopenia , Humanos , Masculino , Femenino , Carcinoma Hepatocelular/cirugía , Carcinoma Hepatocelular/patología , Músculo Esquelético/patología , Sarcopenia/patologíaRESUMEN
BACKGROUND: Complete and correct documentation of diagnosis and procedures is essential for adequate health provider reimbursement in diagnosis-related group (DRG) systems. The objective of this study was to investigate whether daily monitoring and semiautomated proposal optimization of DRG coding (precoding) is associated with higher reimbursement per hospitalization day. MATERIALS AND METHODS: This parallel-group, unblinded, randomized clinical trial randomized patients 1:1 into intervention (precoding) and control groups. Between June 12 and December 6, 2019 all hospitalized patients (1566 cases) undergoing elective or emergency surgery at the department of surgery in a Swiss hospital were eligible for this study. By random sample selection, cases were assigned to the intervention (precoding) and control groups. The primary outcome was the total reimbursement, divided by the length of stay. RESULTS: Of the 1205 randomized cases, 1200 (precoding group: 602) remained for intention-to-treat, and 1131 (precoding group: 564) for per-protocol analysis. Precoding increased reimbursement per hospitalization day by 6.5% (160 US dollars; 95% confidence interval 31 to 289; P = 0.015). In a regression analysis patients hospitalized 7 days or longer, precoding increased reimbursement per day by 10.0% (246 US dollars; 95% confidence interval -12 to 504; P = 0.021). More secondary diagnoses (mean [SD]: 5.16 [5.60] vs 4.39 [5.34]; 0.77; 95% confidence interval 0.15 to 1.39; P = 0.015) and nonsurgical postoperative complications (mean [SD]: 0.68 [1.45] vs 0.45 [1.12]; 0.23; 95% confidence interval 0.08 to 0.38; P = 0.002) were documented by precoding. No associated was observed regarding the length of stay, total reimbursement, or case mix index. The mean (SD) precoding time effort was 37 (27) minutes per case. CONCLUSION: Physician-led precoding increases DRG-based reimbursement. Precoding is time consuming and should be focused on cases with a longer hospital stay to increase efficiency.
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Grupos Diagnósticos Relacionados , Documentación , Procedimientos Quirúrgicos Electivos , Humanos , Tiempo de Internación , Complicaciones PosoperatoriasRESUMEN
Indeterminate dendritic cell tumor (IDCT) is an extremely rare hematologic neoplastic disorder with proliferation of indeterminate dendritic cells. In the vast majority of cases, IDCTs are restricted to the skin or lymph nodes. To our knowledge, we report the first case of IDCT in the pancreas. Due to the rarity of extracutaneous IDCT, guidelines or treatment recommendations addressing their management are missing. We performed a review of literature to compare our experience to the management of other extracutaneous IDCT. Histopathological examination confirms the diagnosis of IDCT in electron microscopy and/or immunohistochemistry. Specific features are the lack of Birbeck granules and the nonreaction to Langerin antibodies. Concerning the aftercare of extracutaneous IDCT, we recommend a dermatological examination to rule out an additional cutaneous manifestation as well as annual blood examinations due to the association between IDCT and hematologic malignancies.
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UNLABELLED: Background and Objective : Contraceptive pills are generally taken orally and can cause side effects such as nausea, vomiting and hypertension. The vaginal use of these pills can reduce such complications. Our objective was to compare the efficacy and side effects of low dose contraceptive pills by oral and vaginal route in the management of dysfunctional uterine bleeding-(DUB) Methods: This comparative observational study was conducted at Beheshti and Alzahra (SA) teaching hospitals, affiliated to Isfahan University of Medical Sciences in 2010-2011. One hundred women who presented with DUB were randomly assigned into two groups of equal number, receiving the low dose oral contraceptive pills by oral or vaginal route for three month. The amount and duration of bleeding were compared at the beginning and at the end of the study and side effects by these two methods compared. RESULTS: The results of this study showed that both oral and vaginal routes effectively reduced the duration and amount of bleeding due to DUB after three courses of treatment. This effect was better in the vaginal method compared with oral administration (P = 0.03). Regarding the side effects, nausea and vomiting were significantly higher in the oral group than in the vaginal group (P = 0.03). Vulvovaginitis infection was more frequent in the vaginal group than in the oral group (P = 0.03). CONCLUSION: Low dose contraceptive pills are effective in reducing the amount, time, and duration of bleeding in patients with DUB. In addition, reduction of gastrointestinal side effects by vaginal route helps to use these pills by the patient with proper training of physicians, midwives and patients.