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Contemp Clin Trials. 2019 Aug;83:10-17. doi: 10.1016/j.cct.2019.06.013. Epub 2019 Jun 26.

Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children: Design and rationale.

Author information

1
Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, OH, USA. Electronic address: peter.minneci@nationwidechildrens.org.
2
Departments of Biomedical Informatics and Obstetrics & Gynecology, The Ohio State University College of Medicine, Columbus, OH, USA.
3
Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA; Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, OH, USA.
4
Division of Pediatric Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.
5
Section of Pediatric Surgery, Department of Surgery, The University of Chicago Medicine and Biologic Sciences, Chicago, IL, USA.
6
Division of Pediatric Surgery, Department of Surgery, University of Michigan School of Medicine, Ann Arbor, MI, USA.
7
Division of Pediatric Surgery, Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
8
Division of Pediatric Surgery, Department of Surgery, University of Wisconsin School of Medicine, Madison, WI, USA.
9
Division of Pediatric Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA.
10
Division of Pediatric Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
11
Division of Pediatric Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
12
Division of Pediatric Surgery, Department of Surgery, University of Louisville School of Medicine, Louisville, KY, USA.
13
Center for Surgical Outcomes Research, The Research Institute, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA.

Abstract

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.

KEYWORDS:

Antibiotics; Appendectomy; Appendicitis; Non-operative management; Patient choice trial

PMID:
31254670
DOI:
10.1016/j.cct.2019.06.013

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