SummaryBackgroundSurgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world.MethodsThis international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231.FindingsBetween Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p<0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05–2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p<0·001).InterpretationCountries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication.FundingDFID-MRC-Wellcome Trust Joint Global Health Trial Development Grant,...
Summary Background 80% of individuals with cancer will require a surgical procedure, yet little comparative data exist on early outcomes in low-income and middle-income countries (LMICs). We compared postoperative outcomes in breast, colorectal, and gastric cancer surgery in hospitals worldwide, focusing on the effect of disease stage and complications on postoperative mortality. Methods This was a multicentre, international prospective cohort study of consecutive adult patients undergoing surgery for primary breast, colorectal, or gastric cancer requiring a skin incision done under general or neuraxial anaesthesia. The primary outcome was death or major complication within 30 days of surgery. Multilevel logistic regression determined relationships within three-level nested models of patients within hospitals and countries. Hospital-level infrastructure effects were explored with three-way mediation analyses. This study was registered with ClinicalTrials.gov , NCT03471494 . Findings Between April 1, 2018, and Jan 31, 2019, we enrolled 15 958 patients from 428 hospitals in 82 countries (high income 9106 patients, 31 countries; upper-middle income 2721 patients, 23 countries; or lower-middle income 4131 patients, 28 countries). Patients in LMICs presented with more advanced disease compared with patients in high-income countries. 30-day mortality was higher for gastric cancer in low-income or lower-middle-income countries (adjusted odds ratio 3·72, 95% CI 1·70–8·16) and for colorectal cancer in low-income or lower-middle-income countries (4·59, 2·39–8·80) and upper-middle-income countries (2·06, 1·11–3·83). No difference in 30-day mortality was seen in breast cancer. The proportion of patients who died after a major complication was greatest in low-income or lower-middle-income countries (6·15, 3·26–11·59) and upper-middle-income countries (3·89, 2·08–7·29). Postoperative death after complications was partly explained by patient factors (60%) and partly by hospital or country (40%). The absence of consistently available postoperative care facilities was associated with seven to 10 more deaths per 100 major complications in LMICs. Cancer stage alone explained little of the early variation in mortality or postoperative complications. Interpretation Higher levels of mortality after cancer surgery in LMICs was not fully explained by later presentation of disease. The capacity to rescue patients from surgical complications is a tangible opportunity for meaningful intervention. Early death after cancer surgery might be reduced by policies focusing on strengthening perioperative care systems to detect and intervene in common complications. Funding National Institute for Health Research Global Health Research Unit.
Background Most clinical guidelines are developed by high‐income country institutions with little consideration given to either the evidence base for interventions in low‐ and middle‐income countries (LMICs), or the specific challenges LMIC health systems may face in implementing recommendations. The aim of this study was to prioritize topics for future global surgery guidelines and then to develop a guideline for the top ranked topic. Methods A Delphi exercise identified and prioritized topics for guideline development. Once the top priority topic had been identified, relevant existing guidelines were identified and their recommendations were extracted. Recommendations were shortlisted if they were supported by at least two separate guidelines. Following two voting rounds, the final recommendations were agreed by an international guideline panel. The final recommendations were stratified by the guideline panel as essential (baseline measures that should be implemented as a priority) or desirable (some hospitals may lack these resources at present, in which case they should plan for future implementation). Results Prevention of surgical‐site infection (SSI) after abdominal surgery was identified as the highest priority topic for guideline development. The international guideline panel reached consensus on nine essential clinical recommendations for prevention of SSI. These included recommendations concerning preoperative body wash, use of prophylactic antibiotics, decontamination of scrub teams' hands, use of antiseptic solutions for surgical site preparation and perioperative supplemental oxygenation. In addition, three desirable clinical recommendations and four recommendations for future research were agreed. Conclusion This process led to the development of a global surgery guideline for the prevention of SSI that is both clinically relevant and implementable in LMICs.
Background Ileus is common after elective colorectal surgery, and is associated with increased adverse events and prolonged hospital stay. The aim was to assess the role of non‐steroidal anti‐inflammatory drugs (NSAIDs) for reducing ileus after surgery. Methods A prospective multicentre cohort study was delivered by an international, student‐ and trainee‐led collaborative group. Adult patients undergoing elective colorectal resection between January and April 2018 were included. The primary outcome was time to gastrointestinal recovery, measured using a composite measure of bowel function and tolerance to oral intake. The impact of NSAIDs was explored using Cox regression analyses, including the results of a centre‐specific survey of compliance to enhanced recovery principles. Secondary safety outcomes included anastomotic leak rate and acute kidney injury. Results A total of 4164 patients were included, with a median age of 68 (i.q.r. 57–75) years (54·9 per cent men). Some 1153 (27·7 per cent) received NSAIDs on postoperative days 1–3, of whom 1061 (92·0 per cent) received non‐selective cyclo‐oxygenase inhibitors. After adjustment for baseline differences, the mean time to gastrointestinal recovery did not differ significantly between patients who received NSAIDs and those who did not (4·6 versus 4·8 days; hazard ratio 1·04, 95 per cent c.i. 0·96 to 1·12; P = 0·360). There were no significant differences in anastomotic leak rate (5·4 versus 4·6 per cent; P = 0·349) or acute kidney injury (14·3 versus 13·8 per cent; P = 0·666) between the groups. Significantly fewer patients receiving NSAIDs required strong opioid analgesia (35·3 versus 56·7 per cent; P < 0·001). Conclusion NSAIDs did not reduce the time for gastrointestinal recovery after colorectal surgery, but they were safe and associated with reduced postoperative opioid requirement.
Background: Many differences exist in postgraduate surgical training programmes worldwide. The aim of this study was to provide an overview of the training requirements in general surgery across 23 different countries. Methods: A collaborator affiliated with each country collected data from the country's official training body website, where possible. The information collected included: management, teaching, academic and operative competencies, mandatory courses, years of postgraduate training (inclusive of intern years), working-hours regulations, selection process into training and formal examination. Results: Countries included were Australia,
Background The National Institute for Health Research Global Health Research Unit on Global Surgery is establishing research Hubs in low‐ and middle‐income countries (LMICs). The aim of this study was for the Hubs to prioritize future research into areas of unmet clinical need for patients in LMICs requiring surgery. Methods A modified Delphi process was overseen by the research Hub leads and engaged LMIC clinicians, patients and expert methodologists. A four‐stage iterative process was delivered to prioritize research topics. This included anonymous electronic voting, teleconference discussions and a 2‐day priority‐setting workshop. Results In stage 1, Hub leads proposed 32 topics across six domains: access to surgery, cancer, perioperative care, research methods, acute care surgery and communicable disease. In stages 2 and 3, 40 LMICs and 20 high‐income countries participated in online voting, leading to identification of three priority research topics: access to surgery; outcomes of cancer surgery; and perioperative care. During stage 4, specific research plans to address each topic were developed by Hub leads at a priority‐setting workshop. Conclusion This process identified three priority areas for future research relevant to surgery in LMICs. It was driven by front‐line LMIC clinicians, patients and other stakeholders representing a diverse range of settings. The results of the prioritization exercise provide a future framework for researchers and funders.
Objective: This case study describes a faculty initiative to create a curriculum in applied medical ethics for undergraduate medical students at the Universidad Francisco Marroquin (UFM) in Guatemala City, Guatemala. Methods: The new ethics curriculum (PRACTICE) incorporates ethics short-courses into the university’s system of nontraditional, credit-bearing electives offered to students as part of their 6-year undergraduate medical education and complements existing didactic courses in normative ethics. Structured case-based activities allow for flexibility in design and scheduling, do not compete with core requirements of the existing curriculum, and enable students to develop critical reasoning approaches to ethical situations they will encounter in medical practice. Two preliminary workshops provided teaching opportunities for the faculty, stimulated student interest in future ethics courses, and provided an evidence base to guide the development of a formal curriculum. Results: The elective currently includes six 2-hour modules, each of which is a stand-alone unit with learning goals and objectives, brief didactic lecture, assigned readings, discussion case, and assessment. To date, more than 110 students have participated in the workshops and courses. Student feedback and evaluations are being used to refine pedagogical approaches and drive future course content. Conclusions: The PRACTICE course format offers a transformative model for ethics education in Guatemala that can be used in medical education throughout the country and region.
Aim Surgical site infection (SSI) is the commonest postoperative complication worldwide, representing a major burden for patients and health systems. Rates of SSI are significantly higher in low‐ and middle‐income countries (LMICs) but there is little high‐quality evidence on interventions to prevent SSI in LMICs. Method FALCON is a pragmatic, multicentre, 2 x 2 factorial, stratified randomized controlled trial, with an internal feasibility study, which will address the need for evidence on measures to reduce rates of SSI in patients in LMICs undergoing abdominal surgery. To assess whether either (1) 2% alcoholic chlorhexidine versus 10% povidone‐iodine for skin preparation, or (2) triclosan‐coated suture versus non‐coated suture for fascial closure, can reduce surgical site infection at 30‐days post‐surgery for each of (1) clean‐contaminated and (2) contaminated/dirty surgery. Patients with predicted clean‐contaminated or contaminated/dirty wounds with abdominal skin incision ≥ 5 cm will be randomized 1:1:1:1 between (1) 2% alcoholic chlorhexidine and noncoated suture, (2) 2% alcoholic chlorhexidine and triclosan‐coated suture, (3) 10% aqueous povidone–iodine and noncoated suture and (4) 10% aqueous povidone–iodine and triclosan‐coated suture. The two strata (clean‐contaminated versus contaminated/dirty wounds) are separately powered. Overall, FALCON aims to recruit 5480 patients. The primary outcome is SSI at 30 days, based on the Centers for Disease Control definition of SSI. Conclusion FALCON will deliver high‐quality evidence that is generalizable across a range of LMIC settings. It will influence revisions to international clinical guidelines, ensuring the global dissemination of its findings.
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