TY - JOUR
T1 - Multi-institutional trial of non-operative management and surgery for uncomplicated appendicitis in children
T2 - Design and rationale
AU - on behalf of the Midwest Pediatric Surgery Consortium
AU - Minneci, Peter C.
AU - Hade, Erinn M.
AU - Lawrence, Amy E.
AU - Saito, Jacqueline M.
AU - Mak, Grace Z.
AU - Hirschl, Ronald B.
AU - Gadepalli, Samir
AU - Helmrath, Michael A.
AU - Leys, Charles M.
AU - Sato, Thomas T.
AU - Lal, Dave R.
AU - Landman, Matthew P.
AU - Kabre, Rashmi
AU - Fallat, Mary E.
AU - Fischer, Beth A.
AU - Cooper, Jennifer N.
AU - Deans, Katherine J.
N1 - Funding Information:
This study is funded by the Patient-Centered Outcomes Research Institute (PCORI) contract # CER-1507-31325. PCORI is an independent, nonprofit organization authorized by U.S. Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI's funding, visit www.pcori.org. This project is also supported by Award Number UL1TR001070 from the National Center for Advancing Translational Sciences. The content of this work is solely the responsibility of the authors and does not necessarily represent the official views of PCORI, the National Center for Advancing Translational Sciences or the National Institutes of Health.
Publisher Copyright:
© 2019 Elsevier Inc.
PY - 2019/8
Y1 - 2019/8
N2 - 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.
AB - 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.
KW - Antibiotics
KW - Appendectomy
KW - Appendicitis
KW - Non-operative management
KW - Patient choice trial
UR - http://www.scopus.com/inward/record.url?scp=85068174347&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2019.06.013
DO - 10.1016/j.cct.2019.06.013
M3 - Article
C2 - 31254670
AN - SCOPUS:85068174347
VL - 83
SP - 10
EP - 17
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
SN - 1551-7144
ER -