Journal of the American College of Surgeons
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Randomized Controlled Trial Multicenter Study
Empiric Cryoprecipitate Transfusion in Patients with Severe Hemorrhage: Results from The US Experience in the International Cryostat-2 Trial.
Hypofibrinogenemia has been shown to predict massive transfusion and is associated with higher mortality in severely injured patients. However, the role of empiric fibrinogen replacement in bleeding trauma patients remains controversial. We sought to determine the effect of empiric cryoprecipitate as an adjunct to a balanced transfusion strategy (1:1:1). ⋯ In this study of severely injured, bleeding trauma patients, empiric cryoprecipitate did not improve survival or reduce transfusion requirements. Cryoprecipitate should continue as an "on-demand" addition to a balanced transfusion strategy, guided by laboratory values and should not be given empirically.
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Multicenter Study
Impact of Neoadjuvant Therapy for Pancreatic Cancer: Transatlantic Trend and Postoperative Outcomes Analysis.
The introduction of modern chemotherapy a decade ago has led to increased use of neoadjuvant therapy (NAT) in patients with pancreatic ductal adenocarcinoma (PDAC). A recent North American study demonstrated increased use of NAT and improved operative outcomes in patients with PDAC. The aims of this study were to compare the use of NAT and short-term outcomes in patients with PDAC undergoing pancreatoduodenectomy (PD) among registries from the US and Canada, Germany, the Netherlands, and Sweden. ⋯ NAT before PD for pancreatic cancer varied widely among 4 Western audits yet increased by 26% during 3 years. NAT was associated with improved short-term outcomes.
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Multicenter Study
Remote Assessment of Real-World Surgical Safety Checklist Performance Using the OR Black Box: A Multi-Institutional Evaluation.
Large-scale evaluation of surgical safety checklist performance has been limited by the need for direct observation. The operating room (OR) Black Box is a multichannel surgical data capture platform that may allow for the holistic evaluation of checklist performance at scale. ⋯ Remote assessment using OR Black Box data provides useful insight into surgical safety checklist performance. Many items included in the time-out and debrief were not routinely discussed. Completion of a team introduction was associated with improved time-out performance. There is potential to use OR Black Box metrics to improve intraoperative process measures.
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Multicenter Study
Novel Form of Breast Intraoperative Radiation Therapy with CT-Guided High-Dose-Rate Brachytherapy: Interim Results of a Prospective Phase II Clinical Trial.
Precision breast intraoperative radiation therapy (PB-IORT) is a novel method of IORT that uses customized CT-based treatment plans and high-dose-rate (HDR) brachytherapy. We conducted a phase-II multi-institution trial to evaluate the efficacy of PB-IORT. ⋯ This study presents the results of a planned interim analysis of a phase-II trial investigating PB-IORT and demonstrates the efficacy and safety of single-fraction, CT-based, HDR brachytherapy after breast-conserving surgery. These findings provide valuable insights into the use of PB-IORT as a treatment modality.
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Multicenter Study Observational Study
Development and Validation of a Novel Hollow Viscus Injury Prediction Score for Abdominal Seatbelt Sign: A Pacific Coast Surgical Association Multicenter Study.
High-quality CT can exclude hollow viscus injury (HVI) in patients with abdominal seatbelt sign (SBS) but performs poorly at identifying HVI. Delay in diagnosis of HVI has significant consequences necessitating timely identification. ⋯ This multicenter study developed and validated a novel HVI score incorporating readily available physiologic, examination, and CT findings to risk stratify patients with an abdominal SBS. The HVI score can be used to guide decisions regarding management of a patient with an abdominal SBS and suspected HVI.