Arch Surg Chicago
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Clinical research studies conducted in emergency settings under the waiver of consent provision outlined in federal regulations are uncommon, yet the importance of such research that may result in potentially lifesaving interventions is indisputable. Surgeons, as well as health care professionals in other disciplines of medicine, should be aware of the multiple challenges facing them if they contemplate conducting a research trial without the prospective informed consent of enrolled subjects. The challenges associated with conducting research studies using the exception from informed consent requirements for emergency research are numerous, beginning with ensuring an appropriate study design, understanding state and federal regulations that govern such emergency research studies, and continuing through a complicated and sometimes arduous institutional review board (IRB) process that is unique to these studies. This article will describe the challenges encountered when implementing the exception from informed consent requirements for emergency research and will provide surgeon researchers with an understanding of the ethical controversies surrounding such studies.
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The optimal treatment for hepatic metastases from neuroendocrine tumors remains controversial because of the often indolent nature of these tumors. We sought to determine the effect of 3 major treatment modalities including medical therapy, hepatic artery embolization, and surgical resection, ablation, or both in patients with liver-only neuroendocrine metastases, with the hypothesis that surgical treatment is associated with improvement in survival. ⋯ In patients with liver-only neuroendocrine metastases, surgical therapy using resection, ablation, or both is associated with improved survival.
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Open surgery for pancreatic debridement is often associated with major morbidity such as wound complications, fascial dehiscence, and intestinal fistulae. Hand-assisted laparoscopic surgery (HALS) is useful for complex abdominal procedures since the benefits of traditional laparoscopic surgery are retained. Published experience with HALS for pancreatic debridement is limited to anecdotal case reports. ⋯ This is the largest reported study of laparoscopic debridement for pancreatic necrosis. The procedure is feasible and associated with a low morbidity and mortality. Pancreatic debridement with HALS may provide a new option for the surgical treatment of selected patients with severe necrotizing pancreatitis.
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Wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events (WSPEs) are devastating, unacceptable, and often result in litigation, but their frequency and root causes are unknown. Wrong-side/wrong-site, wrong-procedure, and wrong-patient events are likely more common than realized, with little evidence that current prevention practice is adequate. ⋯ Wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events, although rare, are more common than health care providers and patients appreciate. Prevention of WSPEs requires new and innovative technologies, reporting of case occurrence, and learning from successful safety initiatives (such as in transfusion medicine and other high-risk nonmedical industries), while reducing the shame associated with these events.