Browsing by Author "Fischer, Beth A."

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    Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale
    (Elsevier, 2019-08-01) Minneci, Peter C.; Hade, Erinn M.; Lawrence, Amy E.; Saito, Jacqueline M.; Mak, Grace Z.; Hirschl, Ronald B.; Gadepalli, Samir; Helmrath, Michael A.; Leys, Charles M.; Sato, Thomas T.; Lal, Dave R.; Landman, Matthew P.; Kabre, Rashmi; Fallat, Mary E.; Fischer, Beth A.; Cooper, Jennifer N.; Deans, Katherine J.; Surgery, School of Medicine
    Traditionally, children presenting with appendicitis are referred for urgent appendectomy. Recent improvements in the quality and availability of diagnostic imaging allow for better pre-operative characterization of appendicitis, including severity of inflammation; size of the appendix; and presence of extra-luminal inflammation, phlegmon, or abscess. These imaging advances, in conjunction with the availability of broad spectrum oral antibiotics, allow for the identification of a subset of patients with uncomplicated appendicitis that can be successfully treated with antibiotics alone. Recent studies demonstrated that antibiotics alone are a safe and efficacious treatment alternative for patents with uncomplicated appendicitis. The objective of this study is to perform a multi-institutional trial to examine the effectiveness of non-operative management of uncomplicated pediatric appendicitis across a group of large children’s hospitals. A prospective patient choice design was chosen to compare non-operative management to surgery in order to assess effectiveness in a broad population representative of clinical practice in which non-operative management is offered as an alternative to surgery. The risks and benefits of each treatment are very different and a “successful” treatment depends on which risks and benefits are most important to each patient and his/her family. The patient-choice design allows for alignment of preferences with treatment. Patients meeting eligibility criteria are offered a choice of non-operative management or appendectomy. Primary outcomes include determining the success rate of non-operative management and comparing differences in disability days, and secondarily, complication rates, quality of life, and healthcare satisfaction, between patients choosing non-operative management and those choosing appendectomy.