Background Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. Methods We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0•9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0•9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.
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.
PURPOSE The majority of women managed for breast cancer in Nigeria are relatively young, many in their forties. Mastectomy, the most common surgical treatment, raises psychosocial concerns. Understanding these concerns may help address the fears of women who refuse treatment and aid in the care of those who have had mastectomy. METHODS Using qualitative methods, we purposively sampled women 45 years of age and younger who underwent mastectomy for breast cancer at a Nigerian teaching hospital. One-on-one in-depth interviews were conducted using an unstructured interview guide. Data were transcribed verbatim and analyzed to identify themes and subthemes. RESULTS The study identified six major themes on the impact of mastectomy on psychosocial lives of women, namely decision for mastectomy, postmastectomy transition, body image changes, relationship with husband and sexual life, coping with life postmastectomy, and social support. CONCLUSION Our findings highlight the importance of addressing individual patient’s psychosocial needs and preferences when discussing breast cancer treatment with young women. The experiences of women described in this study reveal several useful themes for planning treatment protocols and postmastectomy care.
There was a poor overall clinical response rate to neoadjuvant chemotherapy in the Black population studied. Late presentation with large tumor mass may be accountable for this.
Our local institution has successfully adopted laparoscopic techniques to treat surgical diseases. Specific improvisations have helped establish and sustain this technology. We advocate similar local adaptations to increase the use of laparoscopic surgery in hospitals located in limited resource settings.
Understanding the molecular and phenotypic profile of colorectal cancer (CRC) in West Africa is vital to addressing the regions rising burden of disease. Tissue from unselected Nigerian patients was analyzed with a multigene, next-generation sequencing assay. The rate of microsatellite instability is significantly higher among Nigerian CRC patients (28.1%) than patients from The Cancer Genome Atlas (TCGA, 14.2%) and Memorial Sloan Kettering Cancer Center (MSKCC, 8.5%, P < 0.001). In microsatellite-stable cases, tumors from Nigerian patients are less likely to have APC mutations (39.1% vs. 76.0% MSKCC P < 0.001) and WNT pathway alterations (47.8% vs. 81.9% MSKCC, P < 0.001); whereas RAS pathway alteration is more prevalent (76.1% vs. 59.6%, P = 0.03). Nigerian CRC patients are also younger and more likely to present with rectal disease (50.8% vs. 33.7% MSKCC, P < 0.001). The findings suggest a unique biology of CRC in Nigeria, which emphasizes the need for regional data to guide diagnostic and treatment approaches for patients in West Africa.
Delayed presentation of breast cancer is a common theme in most low‐ and middle‐income countries. This study evaluates barriers to mammography screening in two Nigerian communities with different geographic access to screening facilities. A 35 item questionnaire was administered to women, 40 years and older, 1,169 (52.6%) in Ife Central Local Government where mammography services are offered and 1,053 (47.4%) in Iwo Local Government where there are no mammography units. Information on breast cancer screening practices and barriers to mammography screening were compared between the two communities. Most women had heard of breast cancer (Ife 94%, Iwo 97%), but few were aware of mammography (Ife 11.8%, Iwo 11.4%). Mammography uptake in Ife Central was 2.8% and 1.8% in Iwo, despite the former offering mammography services. Knowledge and practice of mammography were not statistically different between the two communities (p = 0.74, 0.1). Lack of awareness was the commonest reason cited for not having mammography in both communities. Others include lack of perceived need and cost. Awareness creation to ensure optimal utilisation of existing facilities, as well as innovative measures to address the barrier of cost, is required to improve breast cancer screening uptake in Nigeria.
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