Pragmatic multicentre factorial randomized controlled trial testing measures to reduce surgical site infection in low‐ and middle‐income countries: study protocol of the FALCON trial

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.

Colorectal Surgery in the time of Covid 19

At the time of writing (early August 2020) the world is still in the middle of the Covid 19 pandemic with over 18 million recorded cases and nearly 700 000 deaths. Those countries (e.g. parts of the UK and Spain) that had seen peaks in March, April & May had started to see the onset of second waves. The Australian State of Victoria had declared a state of disaster with lockdown imposed in Melbourne and the virus was widespread across the USA. Low & Middle Income Countries (LMICs) had seen rising numbers of cases and the head of the World Health Organisation, Tedros Adhanom Ghebreyesus, had declared that there is ‘no silver bullet at the moment – and there might never be’. Advances in Covid 19 research over the preceding months had focused on various drug combinations and vaccine development with each development hailed as a major victory. Despite the positive news stories with no paucity of hyperbole in the lay press, the reality remains a grossly disrupted health sector that has been crippled by the greatest public health crisis in a generation. The political fallout of the (mis)management of the pandemic continues to ripple across the world and the resultant economic recession in many nations has seen the prospect of rising health expenditure slip away as unemployment levels surge and government borrowing rockets to prop up stuttering economies.

Identifying Breast Cancer Care Quality Measures for a Cancer Facility in Rural Sub-Saharan Africa: Results of a Systematic Literature Review and Modified Delphi Process

PURPOSE
The burden of cancer is growing in low- and middle-income countries (LMICs), including sub-Saharan Africa. Ensuring the delivery of high-quality cancer care in such regions is a pressing concern. There is a need for strategies to identify meaningful and relevant quality measures that are applicable to and usable for quality measurement and improvement in resource-constrained settings.

METHODS
To identify quality measures for breast cancer care at Butaro Cancer Center of Excellence (BCCOE) in Rwanda, we used a modified Delphi process engaging two panels of experts, one with expertise in breast cancer evidence and measures used in high-income countries and one with expertise in cancer care delivery in Rwanda.

RESULTS
Our systematic review of the literature yielded no publications describing breast cancer quality measures developed in a low-income country, but it did provide 40 quality measures, which we adapted for relevance to our setting. After two surveys, one conference call, and one in-person meeting, 17 measures were identified as relevant to pathology, staging and treatment planning, surgery, chemotherapy, endocrine therapy, palliative care, and retention in care. Successes of the process included participation by a diverse set of global experts and engagement of the BCCOE community in quality measurement and improvement. Anticipated challenges include the need to continually refine these measures as resources, protocols, and measurement capacity rapidly evolve in Rwanda.

CONCLUSION
A modified Delphi process engaging both global and local expertise was a promising strategy to identify quality measures for breast cancer in Rwanda. The process and resulting measures may also be relevant for other LMIC cancer facilities. Next steps include validation of these measures in a retrospective cohort of patients with breast cancer.

Estimation of the National Surgical Needs in India by Enumerating the Surgical Procedures in an Urban Community Under Universal Health Coverage

Background
11% of the global burden of disease requires surgical care or anaesthesia management or both. Some studies have estimated this burden to be as high as 30%. The Lancet Commission for Global Surgery (LCoGS) estimated that 5000 surgeries are required to meet the surgical burden of disease for 100,000 people in LMICs. Studies from LMICs, estimating surgical burden based on enumeration of surgeries, are sparse.

Method
We performed this study in an urban population availing employees’ heath scheme in Mumbai, India. Surgical procedures performed in 2017 and 2018, under this free and equitable health scheme, were enumerated. We estimated the surgical needs for national population, based on age and sex distribution of surgeries and age standardization from our cohort.

Result
A total of 4642 surgeries were performed per year for a population of 88,273. Cataract (22.8%), Caesareans (3.8%), surgeries for fractures (3.27%) and hernia (2.86%) were the commonest surgeries. 44.2% of surgeries belonged to the essential surgeries. We estimated 3646 surgeries would be required per 100,000 Indian population per year. One-third of these surgeries would be needed for the age group 30–49 years, in the Indian population.

Conclusion
A total of 3646 surgeries were estimated annually to meet the surgical needs of Indian population as compared to the global estimate of 5000 surgeries per 100,000 people. Caesarean section, cataract, surgeries for fractures and hernia are the major contributors to the surgical needs. More enumeration-based studies are needed for better estimates from rural as well as other urban areas.

How to Implement a Small Blood Bank in Low and Middle-Income Countries Work in Progress?

Compared to High-Income countries (HIC), a shortfall in the provision of blood remains a multifaceted problem in Low and Middle-Income Countries (LMIC) with a direct negative effect on clinical care. The reasons are multifactorial: not only lack of knowledge, skills, and resources, but also huge differences in environment climate, endemic transfusion transmittable infections, clinical set-up, availability of clean water, electricity. It is therefore obvious that simple translation of guidelines, standards, experiences, and the total organization from HIC to LMIC is not the best way to proceed. Adapted, but not less adequate methods for blood transfusion training, organization, and accreditation are required. The Global Advisory Panel (GAP) already formulated an adapted specific answer in terms of training and accreditation. But this is not enough. Academic centres, the GAP, countries, non-governmental organizations, and others need to test current and innovative diagnostic, production, and storage methods in a joint venture with the industry. Also, medical decisions focused on transfusion must be tested before implementation in facilities allowing pre-qualification of tests and devices. The entire transfusion chain needs to be simulated in a competence and training centre, focusing on the region where it will be applied. One of the renowned tropical institutes, currently fulfilling all these requirements could be the ideal place for such a competence centre. This review highlights this and suggests possible ways and solutions.

Ending Neglected Surgical Diseases (NSDs): Definitions, Strategies, and Goals for the Next Decade

While there has been overall progress in addressing the lack of access to surgical care worldwide, untreated surgical conditions in developing countries remain an underprioritized issue. Significant backlogs of advanced surgical disease called neglected surgical diseases (NSDs) result from massive disparities in access to quality surgical care. We aim to discuss a framework for a public health rights-based initiative designed to prevent and eliminate the backlog of NSDs in developing countries. We defined NSDs and set forth six criteria that focused on the applicability and practicality of implementing a program designed to eradicate the backlog of six target NSDs from the list of 44 Disease Control Priorities 3rd edition (DCP3) surgical interventions. The human rights-based approach (HRBA) was used to clarify NSDs role within global health. Literature reviews were conducted to ascertain the global disease burden, estimated global backlog, average cost per treatment, disability-adjusted life-years (DALYs) averted from the treatment, return on investment, and potential gain and economic impact of the NSDs identified. Six index NSDs were identified, including neglected cleft lips and palate, clubfoot, cataracts, hernias and hydroceles, injuries, and obstetric fistula. Global definitions were proposed as a starting point towards the prevention and elimination of the backlog of NSDs. Defining a subset of neglected surgical conditions that illustrates society’s role and responsibility in addressing them provides a framework through the HRBA lens for its eventual eradication.

Clinical course and short-term outcome of postsplenectomy reactive thrombocytosis in children without myeloproliferative disorders: A single institutional experience from a developing country

Objectives: To evaluate the clinical outcome and complications in the pediatric population who had splenectomy at our institution, emphasizing the incidence of postplenectomy reactive thrombocytosis (RT) and its clinical significance in children without underlying hematological malignancies.

Materials and methods: The medical records of pediatric patients undergoing splenectomy were retrospectively reviewed for the period 1999-2018. The following variables were analyzed: Demographic parameters (age, sex), indications for surgery, operative procedures, preoperative and postoperative platelet count (postplenectomy RT), the use of anticoagulant therapy, and postoperative complications. The patients were divided into two groups according to indications for splenectomy: The non-neoplastic hematology group and the non-hematology group (splenectomy for trauma or other spleen non-hematological pathology).

Results: Fifty-two pediatric (37 male and 15 female) patients who underwent splenectomy at our institution were reviewed. Thirty-four patients (65%) were in the non-hematological group (splenic rupture, cysts, and abscess) and 18 patients (35%) in the non-neoplastic hematological group (hereditary spherocytosis and immune thrombocytopenia). The two groups did not differ significantly in regards to the patients’ age, sex, and preoperative platelet count (P>0.05 for all variables). Forty-nine patients (94.2%) developed postplenectomy RT. The percentages of mild, moderate and extreme thrombocytosis were 48.9%, 30.7%, and 20.4%, respectively. The comparisons of RT patients between the non-neoplastic hematology and the non-hematology group revealed no significant differences in regards to the patients’ age, sex, preoperative and postoperative platelet counts, preoperative and postoperative leukocyte counts, and the average length of hospital stay (P>0.05 for all variables). None of the patients from the cohort was affected by any thrombotic or hemorrhagic complications.

Conclusions: We confirm that RT is a very common event following splenectomy, but in this study it was not associated with clinically evident thrombotic or hemorrhagic complications in children undergoing splenectomy for trauma, structural lesions or non-neoplastic hematological disorders.

Antibiotic Use in Low and Middle-Income Countries and the Challenges of Antimicrobial Resistance in Surgery

Antimicrobial resistance (AMR) is a phenomenon resulting from the natural evolution of microbes. Nonetheless, human activities accelerate the pace at which microorganisms develop and spread resistance. AMR is a complex and multidimensional problem, threatening not only human and animal health, but also regional, national, and global security, and the economy. Inappropriate use of antibiotics, and poor infection prevention and control strategies are contributing to the emergence and dissemination of AMR. All healthcare providers play an important role in preventing the occurrence and spread of AMR. The organization of healthcare systems, availability of diagnostic testing and appropriate antibiotics, infection prevention and control practices, along with prescribing practices (such as over-the-counter availability of antibiotics) differs markedly between high-income countries and low and middle-income countries (LMICs). These differences may affect the implementation of antibiotic prescribing practices in these settings. The strategy to reduce the global burden of AMR includes, among other aspects, an in-depth modification of the use of existing and future antibiotics in all aspects of medical practice. The Global Alliance for Infections in Surgery has instituted an interdisciplinary working group including healthcare professionals from different countries with different backgrounds to assess the need for implementing education and increasing awareness about correct antibiotic prescribing practices across the surgical pathways. This article discusses aspects specific to LMICs, where pre-existing factors make surgeons’ compliance with best practices even more important.

Establishing a Sustainable Training Program for Laparoscopy in Resource-Limited Settings: Experience in Ghana

Background:
Healthcare equipment funded by international partners is often not properly utilized in many developing countries due to low levels of awareness and a lack of expertise. A long-term on-site training program for laparoscopic surgery was established at a regional hospital in Ghana upon request of the Ghana Health Service and local surgeons.

Objective:
The authors report the initial 32-month experience of implementing laparoscopic surgery focusing on the trainees’ response, technical independence, and factors associated with the successful implementation of a “new” surgical practice.

Methods:
Curricular structure and feedback results of the trainings for doctors and nurses, and characteristics of laparoscopic procedures performed at the Greater Accra Regional Hospital between January 2017 and September 2019 were retrospectively reviewed.

Findings:
Comprehensive training including two weeks of simulation workshops followed by animal labs were regularly provided for the doctors. Among the 97 trainees, 27.9% had prior exposure in laparoscopic surgery, 95% were satisfied with the program. Eleven nurses attained professional competency over 15 training sessions where none had prior exposure to laparoscopic surgery. Since the first laparoscopic cholecystectomy in February 2017, 82 laparoscopic procedures were performed. The scope of the surgery was expanded from general surgery (n = 46) to gynecology (n = 33), pediatric surgery (n = 2), and urology (n = 1). The volume of local doctors as primary operators increased from 0% (0/17, February to December 2017) to 41.9% (13/31, January to October 2018) and 79.4% (27/34, November 2018 to September 2019), with 72.5% of the cases being assisted by the expatriate surgeon. There were no open conversions, technical complications, or mortalities. Local doctors independently commenced endoscopic surgical procedures including cystoscopies, hysteroscopies, endoscopic neurosurgeries and arthroscopies.

Conclusion:
Sensitization and motivation of the surgical workforce through long-term continuous on-site training resulted in the successful implementation of laparoscopic surgery with a high level of technical independence.

Intestinal Perforations Associated With a High Mortality and Frequent Complications During an Epidemic of Multidrug-resistant Typhoid Fever in Blantyre, Malawi

Background
Typhoid fever remains a major source of morbidity and mortality in low-income settings. Its most feared complication is intestinal perforation. However, due to the paucity of diagnostic facilities in typhoid-endemic settings, including microbiology, histopathology, and radiology, the etiology of intestinal perforation is frequently assumed but rarely confirmed. This poses a challenge for accurately estimating burden of disease.

Methods
We recruited a prospective cohort of patients with confirmed intestinal perforation in 2016 and performed enhanced microbiological investigations (blood and tissue culture, plus tissue polymerase chain reaction [PCR] for Salmonella Typhi). In addition, we used a Poisson generalized linear model to estimate excess perforations attributed to the typhoid epidemic, using temporal trends in S. Typhi bloodstream infection and perforated abdominal viscus at Queen Elizabeth Central Hospital from 2008–2017.

Results
We recruited 23 patients with intraoperative findings consistent with intestinal perforation. 50% (11/22) of patients recruited were culture or PCR positive for S. Typhi. Case fatality rate from typhoid-associated intestinal perforation was substantial at 18% (2/11). Our statistical model estimates that culture-confirmed cases of typhoid fever lead to an excess of 0.046 perforations per clinical typhoid fever case (95% CI, .03–.06). We therefore estimate that typhoid fever accounts for 43% of all bowel perforation during the period of enhanced surveillance.

Conclusions
The morbidity and mortality associated with typhoid abdominal perforations are high. By placing clinical outcome data from a cohort in the context of longitudinal surgical registers and bacteremia data, we describe a valuable approach to adjusting estimates of the burden of typhoid fever.