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

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.

• Authors: Peter C Minneci, Erinn M Hade, Amy E Lawrence, Jacqueline M Saito, Grace Z Mak, Ronald B Hirschl, Samir Gadepalli, Michael A Helmrath, Charles M Leys, Thomas T Sato, Dave R Lal, Matthew P Landman, Rashmi Kabre, Mary E Fallat, Beth A Fischer, Jennifer N Cooper, Katherine J Deans, Midwest Pediatric Surgery Consortium
• Journal: Contemporary clinical trials (Contemp Clin Trials) Vol. 83 Pg. 10-17 (08 2019) ISSN: 1559-2030 [Electronic] United States
• PMID: 31254670 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 Elsevier Inc. All rights reserved.

Topics

• Adolescent
• Appendectomy
• Appendicitis (diagnosis, pathology, surgery, therapy)
• Appendix (diagnostic imaging, 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