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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Multicenter Study
Surgical site infection following bowel surgery: a retrospective analysis of 1446 patients.
We sought to determine whether the administration of preoperative antibiotics, intraoperative transfusion of blood products, and intraoperative hypothermia has any impact on the incidence of postoperative surgical site infections (SSIs) in a heterogeneous patient population undergoing bowel surgery. ⋯ This study validates perioperative transfusion as an independent risk factor for SSI. The lack of effectiveness of perioperative antibiotic prophylaxis is surprising because it is discordant with the previous literature, and this finding needs further evaluation.