Journal of the American College of Surgeons
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Randomized Controlled Trial Multicenter Study Comparative Study
The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis.
This Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs gelatin sponge alone for use as a hemostat for surgical bleeding in 4 indications (ie, spinal, hepatic, vascular, soft tissue dissection). ⋯ Fibrocaps was well tolerated and significantly reduced TTH relative to gelatin sponge alone in all 4 surgical indications. These findings demonstrate the broad utility of Fibrocaps as a hemostatic agent for mild to moderate surgical bleeding.
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Multicenter Study Clinical Trial
Perfusion assessment in laparoscopic left-sided/anterior resection (PILLAR II): a multi-institutional study.
Our primary objective was to demonstrate the utility and feasibility of the intraoperative assessment of colon and rectal perfusion using fluorescence angiography (FA) during left-sided colectomy and anterior resection. Anastomotic leak (AL) after colorectal resection increases morbidity, mortality, and, in cancer cases, recurrence rates. Inadequate perfusion may contribute to AL. The PINPOINT Endoscopic Fluorescence Imaging System allows for intraoperative assessment of anastomotic perfusion. ⋯ PINPOINT is a safe and feasible tool for intraoperative assessment of tissue perfusion during colorectal resection. There were no anastomotic leaks in patients in whom the anastomosis was revised based on inadequate perfusion with FA.
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Multicenter Study Observational Study
Measuring variation in use of the WHO surgical safety checklist in the operating room: a multicenter prospective cross-sectional study.
Full implementation of safety checklists in surgery has been linked to improved outcomes and team effectiveness; however, reliable and standardized tools for assessing the quality of their use, which is likely to moderate their impact, are required. ⋯ We found large variation in WHO checklist use in a representative sample of English ORs. Measures sensitive to checklist practice quality, like CUT, will help identify areas for improvement in implementation and enable provision of comprehensive feedback to OR teams.
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Multicenter Study
Implementing a standardized safe surgery program reduces serious reportable events.
Patient safety in the perioperative period is essential for delivery of quality patient care. Mainstream quality organizations have implemented safe surgery recommended practices for ensuring patient safety. Effectively implementing safe surgery practices should result in a reduction in serious reportable event (SRE) rates. ⋯ An effectively implemented standardized safe surgery program results in a significant reduction in SREs. Robotic cases are at high risk for an SRE.
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Multicenter Study Observational Study
Impact of deceased organ donor demographics and critical care end points on liver transplantation and graft survival rates.
The criteria for organ acceptance remain inconsistent, which limits the ability to standardize critical care practices. We sought to examine predictors of liver graft use and survival to better guide the selection and management of potential organ donors. ⋯ After controlling for donor age, sex, and BMI, both hemodynamic and endocrine critical care end points were associated with increased liver graft use. Both donor BMI and lower sodium levels during the course of donor management were independently predictive of improved graft survival. These results may help guide the management and selection of potential organ donors after neurologic determination of death.