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

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

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.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Appendectomy*
  • Appendicitis / diagnosis
  • Appendicitis / pathology
  • Appendicitis / surgery
  • Appendicitis / therapy*
  • Appendix / diagnostic imaging
  • Appendix / pathology
  • Child
  • Clinical Trials as Topic / methods
  • Humans
  • Multicenter Studies as Topic
  • Patient Preference
  • Prospective Studies
  • Quality of Life
  • Research Design
  • Severity of Illness Index
  • Treatment Outcome