Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI) : Study protocol for a multicentre, observational trial

More than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. The establishment of an accurate epidemiology of surgery-associated AKI is important for healthcare policy, quality initiatives, clinical trials, as well as for improving guidelines. The objective of the Epidemiology of Surgery-associated Acute Kidney Injury (EPIS-AKI) trial is to prospectively evaluate the epidemiology of AKI after major surgery using the latest Kidney Disease: Improving Global Outcomes (KDIGO) consensus definition of AKI. EPIS-AKI is an international prospective, observational, multicentre cohort study including 10 000 patients undergoing major surgery who are subsequently admitted to the ICU or a similar high dependency unit. The primary endpoint is the incidence of AKI within 72 hours after surgery according to the KDIGO criteria. Secondary endpoints include use of renal replacement therapy (RRT), mortality during ICU and hospital stay, length of ICU and hospital stay and major adverse kidney events (combined endpoint consisting of persistent renal dysfunction, RRT and mortality) at day 90. Further, we will evaluate preoperative and intraoperative risk factors affecting the incidence of postoperative AKI. In an add-on analysis, we will assess urinary biomarkers for early detection of AKI. EPIS-AKI has been approved by the leading Ethics Committee of the Medical Council North Rhine-Westphalia, of the Westphalian Wilhelms-University Münster and the corresponding Ethics Committee at each participating site. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and used to design further AKI-related trials. Trial registration number NCT04165369

Biomechanical advantages of dual over single iliac screws in lumbo-iliac fixation construct

The development of iliac screws has provided a markedly easier way for spino-pelvic instrumentation than the classical Galveston technique. However, high rates of iliac screw loosening and breakage are usually reported, especially in cases where bilateral single iliac screws are used. Therefore, there is a need for exploring more stable iliac fixation techniques. Thus, the objective of this study was to compare the biomechanical effects of bilateral single and dual iliac screws on the stability of L3-iliac fixation construct under total sacrectomy condition. In this study, L2-pelvic specimens were harvested from seven fresh human cadavers. After biomechanically testing the intact state simulated by L3-L5 pedicle screw fixation, destabilization was introduced by total sacrectomy. Upon destabilization, L3-iliac screw-rod reconstructions were performed by four different techniques as follows: (1) bilateral single short iliac screws (Single-Short); (2) bilateral single long iliac screws (Single-Long); (3) bilateral dual short iliac screws, placed in the upper and lower iliac columns (Dual-UL); and (4) bilateral dual short iliac screws, all placed in the lower iliac column (Dual-Lower). These four iliac screw fixation techniques were sequentially preformed in the same specimen, and the lengths of the short and long iliac screws were 70 and 130 mm, respectively. Biomechanical testing was performed on a material testing machine under 800 N compression and 7 Nm torsion loading modes to evaluate the construct stiffness. In compression, the stiffness of the L3-iliac fixation constructs of Single-Short, Single-Long, Dual-UL, and Dual-Lower techniques were 73, 76, 98, and 108% of the intact state, respectively. No significant differences were detected between Single-Short and Single-Long (P = 0.589) techniques. However, the compressive stiffness of these two techniques was significantly lower than the intact state, and the Dual-UL and Dual-Lower techniques (P < 0.05). There was no statistical difference between the intact condition and the Dual-Lower technique (P = 0.109). Interestingly, Dual-Lower exhibited notably higher compressive stiffness than Dual-UL (+10.3%, P = 0.049). In torsion, the stiffness of Single-Short, Single-Long, Dual-UL, and Dual-Lower techniques were 72, 79, 105, and 109% of the intact condition, respectively. No significant differences were detected between Single-Short and Single-Long techniques (P = 0.338), and also among Dual-UL, Dual-lower techniques, and the intact state (P > 0.05). However, Single-Short and Single-Long techniques provided markedly lower construct torsional stiffness than the other three groups (P < 0.05). For lumbo-illiac reconstruction after total sacrectomy, even the use of bilateral single, long iliac screws do not help in restoring the local stability to the intact condition. However, dual iliac screws provide much higher construct stability than single iliac screw techniques. Therefore, dual iliac screw technique should be preferred for treating the unstable situation caused by total sacrectomy

Differences between urban and rural population with respect to demand on forestry aspects, in a case study of the Turkish province of Bal kesir Diferenças entre a população urbana e rural em matéria das suas exigências de silvicultura, estudo de caso da província turca de Bal kesir

Inhabitants of urban and rural areas are important participants in the process of developing and implementing forest policy. Thus, it is essential to determine their demands and attitudes towards forestry issues. In this context, the demands and evaluation of forest functions are investigated in a case study of the Turkish province of Bal kesir. The findings of the case study show that differences in terms of demands among inhabitants of rural and urban areas are related to forest fires fighting, crimes fighting, forestry-tourism integration, forestation and regeneration activities, and the enlargement of forest areas. The main differences among their assessments of forest functions are related to fire wood production, and the provision of flood and erosion control, nature protection, and recreational opportunities. The findings are important for conflict management and for local decision making. By using the findings of similar studies, the provincial organizations should harmonize their priorities with the expectations of relevant interest groups.<br>A política de silvicultura da população urbana e rural é uma participante fundamental no processo de formação e execução das florestas. Portanto, é importante determinar as exigências e as aproximações em matéria da silvicultura. A determinação das exigências da população urbana e rural no âmbito desse processo e a interpretação destinada aos assuntos das funções da floresta foram pesquisadas tendo como base a província turca de Bal kesir. As constatações resultantes do estudo na região demonstraram que as diferenças entre as exigências da população urbana e rural em matéria da silvicultura são a luta contra os incêndios florestais, a luta contra os delitos florestais, a integração de silvicultura-turismo, as atividades de reflorestamento e rejuvenescimento da floresta e a ampliação dos campos florestais. Por outro lado, as diferenças fundamentais entre as constatações feitas em matéria das funções da floresta são a produção de lenha, a prevenção de erosão e inundação, a protecção natural, o projeto de recreação. Os resultados obtidos são importantes para a gestão de estudo e para a tomada de decisões no âmbito local. As instituições locais devem adaptar as suas prioridades e as exigências dos grupos interessados tirando proveito das constatações obtidas em estudos semelhantes