Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract
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J. Gastrointest. Surg. · Apr 2006
Randomized Controlled Trial Multicenter Study Comparative StudyEfficacy and safety of ertapenem versus piperacillin-tazobactam for the treatment of intra-abdominal infections requiring surgical intervention.
Complicated intra-abdominal infections usually mandate prompt surgical intervention supplemented by appropriate antimicrobial therapy. The aim of this study was to demonstrate that ertapenem was not inferior to piperacillin-tazobactam for the treatment of community-acquired intra-abdominal infections. A randomized open-label active-comparator clinical trial was conducted at 48 medical centers on four continents from December 2001 to February 2003. ⋯ The frequencies of drug-related adverse events, most commonly diarrhea and elevated serum alanine aminotransferase levels, were similar in both treatment groups. Six of 180 ertapenem recipients (3%) and two of 190 piperacillin/tazobactam recipients (1%) had serious drug-related adverse experiences. In this study, ertapenem and piperacillin/tazobactam were comparably safe and effective treatments for adult patients with complicated intra-abdominal infections.
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J. Gastrointest. Surg. · Apr 2006
Comparative StudyThe usefulness of drain data to identify a clinically relevant pancreatic anastomotic leak after pancreaticoduodenectomy?
Pancreatic anastomotic leak (leak) remains a persistent problem after pancreaticoduodenectomy (PD). Recent reports indicate a mean occurrence of 10% with a range of 2%-28% of patients. However, valid comparisons for these studies cannot be made because the definition of leak is variable, and many patients deemed to have a leak are not sick. ⋯ By increasing the volume criteria from greater than 30 ml per day to greater than 200 ml per day, the PPV was increased from 59% to 84% while keeping NPV at 99%. Drain data based on the volume and amylase criteria of this study may be useful for early detection of a leak that will have clinical impact. This study's criteria for leak may be a good definition to design a clinical trial.