Preoperative anemia and complications after surgery for pelvic organ prolapse: an analysis of the national surgical quality improvement program database.

INTRODUCTION AND HYPOTHESIS: Preoperative anemia is a well-established risk factor for adverse perioperative outcomes in major surgery, but studies exploring complications after pelvic reconstructive surgery are limited. The objective of this study is to examine the impact of preoperative anemia on 30-day adverse outcomes in patients undergoing pelvic organ prolapse surgery. METHODS: A retrospective cohort of women undergoing pelvic organ prolapse surgery was captured from the National Surgery Quality Improvement Program database (2014-2019). The primary outcome was a composite of postoperative medical complications such as pulmonary embolism, acute renal failure, stroke, myocardial infarction, cardiac arrest, deep vein thrombosis, and sepsis. Secondary outcomes included surgical site infection, bleeding requiring blood transfusion, readmission within 7 days of surgery, and return to the operating room within 30 days. Multivariate logistic regression was used to adjust for important pre-specified potential confounders. RESULTS: A total of 50,848 women were included in the analysis and 9.9% (4,579) met the criteria for anemia (hematocrit <36%). Potentially serious medical complications were rare, occurring in only 348 women (0.7%), and were more common among anemic patients (1.1% vs 0.6%, p < 0.001). On multivariate analysis, preoperative anemia was associated with higher odds of both potentially serious medical complications (OR 1.38, 95% CI 1.01-1.88) and returning to the operating room (OR 1.55, 95% CI 1.23-1.94). Anemic patients had a four-fold increase in the odds of requiring a blood transfusion (OR 4.47, 95% CI 3.60-5.56). CONCLUSIONS: Preoperative anemia is associated with an increased risk of adverse postoperative outcomes in women having surgery for pelvic organ prolapse.

Ethical issues associated with the introduction of new surgical devices, or just because we can, doesn't mean we should.

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surgeons should provide their patients with an evaluation of the available evidence and inform them about possible complications and the surgeon's level of experience with the new device. Patients, who should be given an honest evaluation of the available evidence, possible complications, and the surgeon's experience, should be encouraged to evaluate the evidence and information to their own satisfaction to ensure that fully informed consent is given. Health institutions, responsible for regulating practice within their walls, should review new devices for safety, effectiveness, and economic impacts, before allowing their use. They should also limit the use of new surgical devices to surgeons trained and competent in the new technology. Professional societies should provide guidance on the early adoption of new surgical devices and technologies. We urge all those involved in the development, licensing, and use of new surgical devices to aim for higher ethical standards to protect the health and safety of patients requiring surgery. The lowest acceptable ethical standard would require device manufacturers to provide surgeons with accurate and timely information on the efficacy and safety of their products, allowing surgeons and patients to evaluate the evidence (and the significance of information not yet available) before surgery.