Impact of COVID-19 pandemic on surgical volume and outcomes in a terciary care center in Brazil.

BACKGROUNDS: COVID-19 pandemic led to a sharp decline in surgical volume worldwide due to the postponement of elective procedures. This study evaluated the impact of COVID-19 pandemic in surgical volumes and outcomes of abdominal surgery in high-risk patients requiring intensive care unit admission. METHODS: patients admitted for postoperative care were retrospectively evaluated. Data concerning perioperative variables and outcomes were compared in two different periods: January 2017-December 2019 and January 2020-December 2022, respectively, before (period I) and after (period II) the onset of COVID-19 pandemic. RESULTS: 1.402 patients (897 women, mean age 62+17 years) were investigated. Most of the patients underwent colorectal (n=393) and pancreato-biliary (n=240) surgery, 52% of elective procedures. Surgical volume was significantly lower in period II (n=514) when compared to period I (n= 888). No recovery was observed in the number of surgical procedures in 2022 (n=135) when compared to 2021(n=211) and 2020 (n=168). Subjects who underwent abdominal surgery in period II had higher Charlson comorbidity index (4,85+3,0 vs. 4,35+2,8, p=0,002), more emergent/urgent procedures (51% vs. 45%, p=0,03) and more clean-contaminated wounds (73,5% vs. 66,8%, p=0,02). A significant decrease in the volume of colorectal surgery was also observed (24% vs, 31%, p<0,0001) after the onset of COVID-19 pandemic, 125 (8,9%) died, no deaths due to COVID-19 infection. Mortality was higher in period II when compared to period I (11% vs. 8%, p=0,08). CONCLUSIONS: COVID-19 pandemic was associated with a decrease in surgical volume of high-risk patients without apparent recovery in recent years. No influence of COVID-19 was noted in postoperative mortality.

How to edit a surgical case video.

A video can help highlight the real-time steps, anatomy and the technical aspects of a case that may be difficult to convey with text or static images alone. Editing with a regimented workflow allows for the transmission of only essential information to the viewer while maximizing efficiency by going through the editing process. This video tutorial breaks down the fundamentals of surgical video editing with tips and pointers to simplify the workflow.

Association between anaesthesia-surgery team sex diversity and major morbidity.

BACKGROUND: Team diversity is recognized not only as an equity issue but also a catalyst for improved performance through diversity in knowledge and practices. However, team diversity data in healthcare are limited and it is not known whether it may affect outcomes in surgery. This study examined the association between anaesthesia-surgery team sex diversity and postoperative outcomes. METHODS: This was a population-based retrospective cohort study of adults undergoing major inpatient procedures between 2009 and 2019. The exposure was the hospital percentage of female anaesthetists and surgeons in the year of surgery. The outcome was 90-day major morbidity. Restricted cubic splines were used to identify a clinically meaningful dichotomization of team sex diversity, with over 35% female anaesthetists and surgeons representing higher diversity. The association with outcomes was examined using multivariable logistic regression. RESULTS: Of 709 899 index operations performed at 88 hospitals, 90-day major morbidity occurred in 14.4%. The median proportion of female anaesthetists and surgeons was 28 (interquartile range 25-31)% per hospital per year. Care in hospitals with higher sex diversity (over 35% female) was associated with reduced odds of 90-day major morbidity (OR 0.97, 95% c.i. 0.95 to 0.99; P = 0.02) after adjustment. The magnitude of this association was greater for patients treated by female anaesthetists (OR 0.92, 0.88 to 0.97; P = 0.002) and female surgeons (OR 0.83, 0.76 to 0.90; P < 0.001). CONCLUSION: Care in hospitals with greater anaesthesia-surgery team sex diversity was associated with better postoperative outcomes. Care in a hospital reaching a critical mass with over 35% female anaesthetists and surgeons, representing higher team sex-diversity, was associated with a 3% lower odds of 90-day major morbidity.

Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers.

INTRODUCTION: Informed consent for participation in an RCT is an important ethical and legal requirement. In placebo surgical trials, further issues are raised, and to date, this has not been explored. Patient information leaflets (PILs) are a core component of the informed consent process. This study aimed to investigate the key content of PILs for recently completed placebo-controlled trials of invasive procedures, including surgery, to highlight areas of good practice, identify gaps in information provision for trials of this type and provide recommendations for practice. METHODS: PILs were sought from trials included in a recent systematic review of placebo-controlled trials of invasive procedures, including surgery. Trial characteristics and data on surgical and placebo interventions under evaluation were extracted. Directed content analysis was applied, informed by published regulatory and good practice guidance on PIL content and existing research on placebo-controlled surgical trials. Results were analysed using descriptive statistics and presented as a narrative summary. RESULTS: Of the 62 eligible RCTs, authors of 59 trials were contactable and 14 PILs were received for analysis. At least 50% of all PILs included content on general trial design. Explanations of how the placebo differs or is similar to the surgical intervention (i.e. fidelity) were reported in 6 (43%) of the included PILs. Over half (57%) of the PILs included information on the potential therapeutic benefits of the surgical intervention. One (7%) included information on potential indirect therapeutic benefits from invasive components of the placebo. Five (36%) presented the known risks of the placebo intervention, whilst 8 (57%) presented information on the known risks of the surgical intervention. A range of terms was used across the PILs to describe the placebo component, including 'control', 'mock' and 'sham'. CONCLUSION: Developers of PILs for placebo-controlled surgical trials should carefully consider the use of language (e.g. sham, mock), be explicit about how the placebo differs (or is similar) to the surgical intervention and provide balanced presentations of potential benefits and risks of the surgical intervention separately from the placebo. Further research is required to determine optimal approaches to design and deliver this information for these trials.

Adverse drug reactions in paediatric surgery: prospective study on frequency and risk related factors.

BACKGROUND: Paediatric patients are especially prone to experiencing adverse drug reactions (ADRs), and the surgical environment gathers many conditions for such reactions to occur. Additionally, little information exists in the literature on ADRs in the paediatric surgical population. We aimed to quantify the ADR frequency in this population, and to investigate the characteristics and risk factors associated with ADR development. METHODS: A prospective observational study was conducted in a cohort of 311 paediatric patients, aged 1-16 years, admitted for surgery at a tertiary referral hospital in Spain (2019-2021). Incidence rates were used to assess ADR frequency. Odds ratios (ORs) were calculated to evaluate the influence of potential risk factors on ADR development. RESULTS: Distinct ADRs (103) were detected in 80 patients (25.7%). The most frequent being hypotension (N = 32; 35%), nausea (N = 16; 15.5%), and emergence delirium (N = 16; 15.5%). Most ADRs occurred because of drug-drug interactions. The combination of sevoflurane and fentanyl was responsible for most of these events (N = 32; 31.1%). The variable most robustly associated to ADR development, was the number of off-label drugs prescribed per patient (OR = 2.99; 95% CI 1.73 to 5.16), followed by the number of drugs prescribed per patient (OR = 1.26, 95% CI 1.13 to 1.41), and older age (OR = 1.26, 95% CI 1.07 to 1.49). The severity of ADRs was assessed according to the criteria of Venulet and the Spanish Pharmacovigilance System. According to both methods, only four ADRs (3.9%) were considered serious. CONCLUSIONS: ADRs have a high incidence rate in the paediatric surgical population. The off-label use of drugs is a key risk factor for ADRs development.

Implications of technological advancement of surgery in low and middle-income countries' a narrative review.

Countries that are striving to keep pace with emerging technologies in surgical practices and still not able to cope with exemplary international standards are in dire need of resources to build and strengthen their healthcare system. This review focusses on the impeding factors that hinder in adaptation of advanced technology and machinery in the health care industry. Considering the immense potential for current surgical technologies to transform the delivery of healthcare, their implementation in LMICs confronts considerable challenges due to lack of infrastructure, human capital and inadequate resources. To address these difficulties, various entities, including healthcare institutions, government and non-governmental organisations, and foreign partners, must work together. Building capacity through intended education and training initiatives, building infrastructure, and collaborative partnerships are critical for overcoming hurdles to effective deployment of surgical technology in low-income communities of the world.

Adaptive clinical trials in surgery: A scoping review of methodological and reporting quality.

IMPORTANCE: Adaptive surgical trials are scarce, but adopting these methods may help elevate the quality of surgical research when large-scale RCTs are impractical. OBJECTIVE: Randomized-controlled trials (RCTs) are the gold standard for evidence-based healthcare. Despite an increase in the number of RCTs, the number of surgical trials remains unchanged. Adaptive clinical trials can streamline trial design and time to trial reporting. The advantages identified for ACTs may help to improve the quality of future surgical trials. We present a scoping review of the methodological and reporting quality of adaptive surgical trials. EVIDENCE REVIEW: We performed a search of Ovid, Web of Science, and Cochrane Collaboration for all adaptive surgical RCTs performed from database inception to October 12, 2023. We included any published trials that had at least one surgical arm. All review and abstraction were performed in duplicate. Risk of bias (RoB) was assessed using the RoB 2.0 instrument and reporting quality was evaluated using CONSORT ACE 2020. All results were analyzed using descriptive methods. FINDINGS: Of the 1338 studies identified, six trials met inclusion criteria. Trials were performed in cardiothoracic, oral, orthopedic, and urological surgery. The most common type of adaptive trial was group sequential design with pre-specified interim analyses planned for efficacy, futility, and/or sample size re-estimation. Two trials did use statistical simulations. Our risk of bias evaluation identified a high risk of bias in 50% of included trials. Reporting quality was heterogeneous regarding trial design and outcome assessment and details in relation to randomization and blinding concealment. CONCLUSION AND RELEVANCE: Surgical trialists should consider implementing adaptive components to help improve patient recruitment and reduce trial duration. Reporting of future adaptive trials must adhere to existing CONSORT ACE 2020 guidelines. Future research is needed to optimize standardization of adaptive methods across medicine and surgery.

Addition of High-Sensitivity Troponin to Perioperative Risk Assessment Improves the Predictive Ability of Death in Non-Cardiac Surgery Patients. / Adição da Troponina Ultrassensível à Avaliação de Risco Perioperatório Melhora a Capacidade Preditiva de Morte em Pacientes Submetidos à Cirurgia Não Cardíaca.

BACKGROUND: Risk stratification is an important step in perioperative evaluation. However, the main risk scores do not incorporate biomarkers in their set of variables. OBJECTIVE: Evaluate the incremental power of troponin to the usual risk stratification. METHODS: A total of 2,230 patients admitted to the intensive care unit after non-cardiac surgery were classified according to three types of risk: cardiovascular risk (CVR), Revised Cardiac Risk Index (RCRI); and inherent risk of surgery (IRS). The main outcome was all-cause mortality. Cox regression was used as well as c-statistics before and after addition of high-sensitivity troponin (at least one measurement up to three days after surgery). Finally, net reclassification index and integrated discrimination improvement were used to assess the incremental power of troponin for risk stratification. Significance level was set at 0.05. RESULTS: Mean age of patients was 63.8 years and 55.6% were women. The prevalence of myocardial injury after non-cardiac surgery (MINS) was 9.4%. High CVR-patients had a higher occurrence of MINS (40.1 x 24.8%, p<0.001), as well as high IRS-patients (21.3 x 13.9%, p=0.004) and those with a RCRI≥3 (3.0 x 0.7%, p=0.009). Patients without MINS, regardless of the assessed risk, had similar mortality rate. The addition of troponin to the risk assessment improved the predictive ability of death at 30 days and at 1 year in all risk assessments. CONCLUSION: The prevalence of MINS is higher in the high-risk population. However, its prevalence in lower-risk population is not negligible and causes a higher risk of death. The addition of high-sensitivity troponin increased the predictive ability of risk assessment in all groups.

FUNDAMENTO: A estratificação ode risco é uma importante etapa na avaliação perioperatória. No entanto, os principais escores de risco não incorporam biomarcadores em seus conjuntos de variáveis. OBJETIVO: Avaliar o poder incremental da troponina à estratificação de risco tradicional. MÉTODOS: Um total de 2230 pacientes admitidos na unidade de terapia intensiva após cirurgia não cardíaca foram classificados de acordo com três tipos de risco: Risco Cardiovascular (RCV), Índice de Risco Cardíaco Revisado (IRCR), e Risco Inerente da Cirurgia (RIC). O principal desfecho foi mortalidade por todas as causas. A regressão de Cox foi usada, assim como a estatística C antes e após a adição de troponina ultrassensível (pelo menos uma medida até três dias após a cirurgia). Finalmente, o índice de reclassificação líquida e a melhoria de discriminação integrada foram usadas para avaliar o poder incremental da troponina para a estratificação de risco. O nível de significância usado foi de 0,05. RESULTADOS: A idade média dos pacientes foi 63,8 anos e 55,6% eram do sexo feminino. A prevalência de lesão miocárdica após cirurgia não cardíaca (MINS) foi 9,4%. Pacientes com um RCV elevado apresentaram uma maior ocorrência de MINS (40,1% x 24,8%, p<0,001), bem como pacientes com alto RIC (21,3 x 13,9%, p=0,004) e aqueles com IRCR≥3 (3,0 x 0,7%, p=0,009). Pacientes sem MINS, independentemente do risco avaliado, apresentaram taxa de mortalidade similar. A adição de troponina à avaliação de risco melhorou a capacidade preditiva de mortalidade em 30 dias e de mortalidade em um ano em todas as avaliações de risco. CONCLUSÃO: A prevalência de MINS é mais alta na população de alto risco. No entanto, sua prevalência na população de risco mais baixo não é desprezível e causa um maior risco de morte. A adição da troponina ultrassensível melhorou a capacidade preditiva da avaliação de risco em todos os grupos.

Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review.

OBJECTIVES: The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design. DESIGN: Secondary qualitative analysis of a systematic review. DATA SOURCES: Citation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers. ELIGIBILITY CRITERIA: Studies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers. DATA EXTRACTION AND SYNTHESIS: All relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage. RESULTS: 48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes. CONCLUSION: Identifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors' rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making.

Mortality and cardiac arrest rates of emergency surgery in developed and developing countries: a systematic review and meta-analysis.

BACKGROUND: The magnitude of the risk of death and cardiac arrest associated with emergency surgery and anesthesia is not well understood. Our aim was to assess whether the risk of perioperative and anesthesia-related death and cardiac arrest has decreased over the years, and whether the rates of decrease are consistent between developed and developing countries. METHODS: A systematic review was performed using electronic databases to identify studies in which patients underwent emergency surgery with rates of perioperative mortality, 30-day postoperative mortality, or perioperative cardiac arrest. Meta-regression and proportional meta-analysis with 95% confidence intervals (CIs) were performed to evaluate global data on the above three indicators over time and according to country Human Development Index (HDI), and to compare these results according to country HDI status (low vs. high HDI) and time period (pre-2000s vs. post-2000s). RESULTS: 35 studies met the inclusion criteria, representing more than 3.09 million anesthetic administrations to patients undergoing anesthesia for emergency surgery. Meta-regression showed a significant association between the risk of perioperative mortality and time (slope: -0.0421, 95%CI: from - 0.0685 to -0.0157; P = 0.0018). Perioperative mortality decreased over time from 227 per 10,000 (95% CI 134-380) before the 2000s to 46 (16-132) in the 2000-2020 s (p < 0-0001), but not with increasing HDI. 30-day postoperative mortality did not change significantly (346 [95% CI: 303-395] before the 2000s to 292 [95% CI: 201-423] in the 2000s-2020 period, P = 0.36) and did not decrease with increasing HDI status. Perioperative cardiac arrest rates decreased over time, from 113 per 10,000 (95% CI: 31-409) before the 2000s to 31 (14-70) in the 2000-2020 s, and also with increasing HDI (68 [95% CI: 29-160] in the low-HDI group to 21 [95% CI: 6-76] in the high-HDI group, P = 0.012). CONCLUSIONS: Despite increasing baseline patient risk, perioperative mortality has decreased significantly over the past decades, but 30-day postoperative mortality has not. A global priority should be to increase long-term survival in both developed and developing countries and to reduce overall perioperative cardiac arrest through evidence-based best practice in developing countries.

Major surgical conditions of childhood and their lifelong implications: comprehensive review.

BACKGROUND: In recent decades, the survival of children with congenital anomalies and paediatric cancer has improved dramatically such that there has been a steady shift towards understanding their lifelong health outcomes. Paediatric surgeons will actively manage such conditions in childhood and adolescence, however, adult surgeons must later care for these 'grown-ups' in adulthood. This article aims to highlight some of those rare disorders encountered by paediatric surgeons requiring long-term follow-up, their management in childhood and their survivorship impact, in order that the adult specialist may be better equipped with skills and knowledge to manage these patients into adulthood. METHODS: A comprehensive literature review was performed to identify relevant publications. Research studies, review articles and guidelines were sought, focusing on the paediatric management and long-term outcomes of surgical conditions of childhood. The article has been written for adult surgeon readership. RESULTS: This article describes the aforementioned conditions, their management in childhood and their lifelong implications, including: oesophageal atresia, tracheo-oesophageal fistula, malrotation, short bowel syndrome, duodenal atresia, gastroschisis, exomphalos, choledochal malformations, biliary atresia, Hirschsprung disease, anorectal malformations, congenital diaphragmatic hernia, congenital lung lesions and paediatric cancer. CONCLUSION: The increasing survivorship of children affected by surgical conditions will translate into a growing population of adults with lifelong conditions and specialist healthcare needs. The importance of transition from childhood to adulthood is becoming realized. It is hoped that this timely review will enthuse the readership to offer care for such vulnerable patients, and to collaborate with paediatric surgeons in providing successful and seamless transitional care.

The safety and efficacy of balanced crystalloid vs. normal saline in non-cardiac surgeries - A systematic review and meta-analysis.

OBJECTIVE: Balanced crystalloid and normal saline are routinely used in clinical anesthesia, but their safety and efficacy in non-cardiac surgeries are still unclear. MATERIALS AND METHODS: PubMed, Embase, Web of Science, Cochrane Library, Wanfang, and CNKI, from January 1980 to March 2023, were searched. Studies comparing balanced crystalloid (BC) with normal saline (NS) during non-cardiac surgeries were included. The primary outcomes were clinical outcomes (acidosis, renal insufficiency, and mortality), and the secondary outcomes were pH value, Na+, Cl- and creatinine levels, and vasopressor requirement. RESULTS: Forty-three RCTs were included in this meta-analysis. Low evidence revealed that the development of acidosis was lower in the BC group than in the NS group (OR: 0.05, 95% CI: 0.01-0.43, I2=80.8%, p=0.00), and no between-group difference exists in renal insufficiency and mortality. At the end of surgery and on postoperative day 1 (POD 1), the pH value was higher, and the levels of Na+ and Cl- were lower in the BC group. No between-group difference exists in creatinine level and vasopressor requirement. CONCLUSIONS: Perioperative balanced crystalloids can maintain the stability of acid-base and electrolyte balance and reduce acidosis compared with saline, but they cannot reduce postoperative renal insufficiency and mortality.

[Placebo procedures in the operating room: necessary or an unnecessary risk for the patient?] / Placeboprocedures in de operatiekamer.

Sham surgeries, surgical procedures without actually carrying out the intended surgical intervention, are rarely used in research concerning a new surgical or invasive technique. The conflicting needs of minimizing operational risks and maximizing simulation present challenges in designing placebo-controlled surgical trials. It is important to thoroughly consider ethical considerations in the design of studies involving sham surgeries, including the importance of a transparent research design, objective reporting of results, challenges related to the informed consent procedure, and the inherent risks associated with surgical procedures. Furthermore, there exists a societal need to offer patients the most cost-effective intervention. Responsible sham surgeries are therefore crucial for understanding the potential and cost-effectiveness of surgical interventions compared to less invasive placebo conditions. Clinically high-quality studies involving placebo-based interventions can provide clarity regarding the balance between doing good and avoiding harm through surgical interventions.